MEDICAL DEVICE

REPROCESSING
(DECONTAMINATION
SPECIALIST)

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 Acknowledgements

Iheed would like to thank a number of organisations that provided some of the images
used in this Student Workbook.

CDC Centers for Disease Control and Prevention

Public Health Image Library (PHIL) - https://phil.cdc.gov/

M2 CDC/Janice Haney Carr; Jeff Hageman

M2-6 CDC/ Dr. Mae Melvin
M2-7 CDC/ Dr. Mae Melvin
M2-8 CDC
M2-10 CDC/Cladosporium mansonii Dr. Lucille K. Georg; Curvularia - CDC/Dr. William
Kaplan; Fusarium - CDC/ Dr. Hardin; Trichophyton tonsurans – CDC/Trichophyton
tonsurans;
M2-14 Mycobacterium tuberculosis - National Institute of Allergy and Infectious Diseases
(NIAID); Streptococcus - CDC/ Bette Jensen
M2-24 CDC/ Teresa Hammett
M2-26 CDC/ Cleopatra Adedeji, RRT, BSRT

Getinge AB
Lindholmspiren 7, SE-417 56 Gothenburg, Sweden - www.getinge.com

Getinge kindly provided the following images: M1-11, M1-21, M1-25, M1-27, M2-35, M5-
12, M5-16, M5-21, M6-6, M6-12, M6-26, M7, M7-1.

Steelco S.p.A.
Via Balegante, 27 31039, Riese Pio X (TV), Italy - www.steelcospa.com

Steelco kindly provided the following images: M1-7, M1-10, M1-14, M1-19, M1-22, M1-23,
M1-26, M1-27, M1-30, M1-31, M5-5, M5-6, M5-7, M5-9, M5-10, M5-11, M5-15, M5-20,
M6-1, M6-7, M6-8, M6-21, M6-25, M7-3, M8, M8-6, M8-7, M8-8, M8-13, M9-10, M9-11.

Steris
5960 Heisley Road, Mentor, OH 44060, USA - www.steris.com

Steris kindly provided the following images: M1-9, M1-12, M1-15, M1-25, M3-20, M3-21,
M3-22, M3-23, M3-24, M3-25, M3-26, M5, M5-8

M2-20 Holder BP, Simon P, Liao LE, Abed Y, Bouhy X, Beauchemin CAA, et al. (2011) As-
sessing the In Vitro Fitness of an Oseltamivir-Resistant Seasonal A/H1N1 Influenza Strain
Using a Mathematical Model. PLoS ONE 6(3): e14767. https://doi.org/10.1371/journal.
pone.0014767
Medical Device Reprocessing (Decontamination Specialist)

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 Contents Module 0 Introduction

2. Learning Outcomes
3. Introduction
4. Pre-Module Quiz
4. Adult Learning
9. Multicultural Workplace
11. Confidentiality
13. Introducing Khaled and Maryam
14. Exercises and Checklists

Module1 Introduction to Decontamination

16. Learning Outcomes

17. Introduction
17. Pre-Module Quiz
20. Decontamination Life Cycle
22. Decontamination Design
30. General CSSD Requirements
33. Exercises and Checklists

Module 2 Microbiology and Infection Control

35. Learning Outcomes

36. Introduction
36. Pre-Module Quiz
37. Microbiology and Decontamination
40. Microorganisms
50. Microbes and CSSD
52. CSSD Workwear and Personal Protective
Equipment (PPE)
57. Standard Precautions and Infectious Agent
Transmission
58. Chain of Infection and Routes of Transmission
63. Housekeeping and Infection Control
64. Exercises and Checklists

Contents

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 Module 3 Surgical Instrument Types

66. Learning Outcomes

67. Introduction
67. Pre-Module Quiz
67. Standard Device Manufacturing
71. Classification and Overview of Surgical Devices
83. Care of Instruments
88. Vendor Repairs
88. Powered Surgical Devices
91. Rigid, Semi-Rigid and Flexible Endoscopes
92. Endoscope Reprocessing Procedures
94. Exercises and Checklists

Module 4 Contaminated Medical Device Transportation

96. Learning Outcomes

97. Introduction
97. Pre-Module Quiz
98. Pre-cleaning
100. Transport containers
102. Spill Kit
103. Transport carts
104. Handling
106. Exercises and Checklists

Module 5 Cleaning and Disinfection

108. Learning Outcomes:

109. Pre-Module Quiz
109. Introduction
110. Choice of Decontamination Process
112. Sorting and Disassembly of Contaminated RIMD
119. Manual Cleaning
122. Disinfection
123. Process Chemicals
125. Routine Testing of Decontamination Equipment
130. Exercises and Checklists

Medical Device Reprocessing (Decontamination Specialist)

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 Module 6 Inspection, Assembly & Packaging (IAP)

132. Learning Outcomes

133. Introduction
133. Pre-Module Quiz
134. The IAP Room
137. Washer-Disinfector to Sterilizer
139. Inspection and Function Testing
141. Assembly and Checking
144. Packaging
148. Exercises and Checklists

Module 7 Sterilization

150. Learning Outcomes

151. Introduction
152. Pre-Module quiz
152. When is Sterilization Required?
153. Device Compatibility
153. Steam Sterilization
159. Dry Heat Sterilization
162. Sterilization Validation
166. Exercises and Checklists

Module 8 Sterile Storage, Handling & Transportation

168. Learning Outcomes

169. Introduction
169. Pre-Module Quiz
170. Product Release
171. Product Rejection
171. Product Recall
172. Sterile Storage Room
174. Sterile Supply Expiration
176. Quality Assurance Checks
177. Time Versus Event Related Sterility
178. Consumable Inventory Management
179. Sterile Transportation
181. Exercises and Checklists

Contents

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 Module 9 Endoscope Decontamination

183. Learning Outcomes

184. Introduction
184. Pre-Module Quiz
184. What Is an Endoscope?
186. Endoscopic Procedure and Decontamination
187. Transmission of Infection
188. Decontamination of Duodenoscopes
189. Decontamination Failure Investigation
190. Staff Education and Training
191. Staff Health
191. Record Keeping
192. Flexible Endoscope Decontamination
198. Automated Endoscope Reprocessor (AER)
199. Accessories
200. Facilities for Decontamination
203. Exercises and Checklists

Module 10 Dental Instrument Processing

205. Learning Outcomes

206. Introduction
207. Pre-Module Quiz
207. Dental Clinics and the Dental Chair Unit
214. Handpiece Decontamination and Maintenance
216. Characteristics of an LDU
219. The Dental Decontamination Cycle
219. Single-Use Devices
221. Reusable Devices (RD)
223. Dental Device Decontamination Process
228. Exercises and Checklists

Module 11 Introduction to Quality Control and

Assurance in the CSSD

232. Learning Outcomes

233. Introduction
234. Pre-Module Quiz
234. What is Quality?

Medical Device Reprocessing (Decontamination Specialist)

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 236. Quality Management Systems (QMS)
240. Staff Performance and Training
242. Key Performance Indicators (KPI)
244. CSSD Electronic Tracking Systems
246. CSSD Auditing

Appendices

248. Appendices

Contents

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 Module 0
INTRODUCTION

Key Terms
Central sterile service department (CSSD) | autonomous
competence | confidentiality | diversity

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 Learning Outcomes

By the end of this module you will be able to:

 Describe learning approaches and characteristics for

adult students

 Describe common challenges faced by returning

adult students

 Discuss challenges in a multicultural workplace and

methods to succeed

 Explain the importance of workplace confidentiality

2 Introduction

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 Introduction

Welcome to the Medical Device

Reprocessing (Decontamination
Specialist) program.

This introductory module helps you, the

returning student, prepare to come back
to an educational environment. This
module highlights basic concepts of adult
learning as well as key requirements
to be successful in a clinic or hospital
working environment.

The aim of this module is to help you

study and learn with confidence. We
will look at some of the unique issues
you may face as adults re-entering the
education system.

Becoming familiar with the material in this

module will help you achieve success
The measure of with this program. We strongly advise that
intelligence is the you take the time to study the content, as
ability to change. it will help you understand how to retain
—Albert Einstein and apply what you learn.

We wish you an interesting and

productive program.

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 The illiterate of the 21st century will not be
those who cannot read and write, but those
who cannot learn, unlearn, and relearn.
—Alvin Toffler

Pre-Module Quiz

Keep these questions in mind as you go through the

content and don’t worry if you don’t know the answers
yet—that’s what you’re here to learn.

Q:Can you list five different learning approaches you

used in your previous studies?
Q: What are the characteristics of an adult learner?
Q:W
 hat are some of the challenges you may face as a
returning student?
Q: Do you know what conscious incompetence means?
Q: In what ways could a colleague from another
country be different from you?
Q: What are good traits to ensure effective
communication in work?

Q: What does confidentiality mean to you and how

might that be different in a hospital?

Adult Learning
Students participating in this program must have a
bachelor’s degree in science, which requires strong skills
for studying and learning. Some of you completed this
degree recently, while others completed it years ago.

This gap in learning may present challenges, as you may

have forgotten previous study practices or they may not
be as strong due to lack of practice. To help reduce the
frustration of returning to the learning environment we will
look at ways to achieve successful learning and many of
the common challenges that returning students may face.

4 Introduction

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 Approaches to Learning
The table below illustrates different approaches to learning
and how they impact learners and their ability to retain and
apply knowledge. On-the-job training has the highest impact
on learning while reading has the lowest.

High On-the-job training

Case studies and teaching others

Mentoring and coaching

Impact on learner
Simulations and virtual learning
retention and
application Problem solving group activities

Interactive discussions

Lectures

Low Reading

Table M0–1 Approaches to learning

Which of these approaches to learning do you think

works best for you?

These approaches help guide us to effective techniques for

learning, but for education to truly be successful, we must
also consider the characteristics of you, the adult learner.

Characteristics of adult learners—adults are:

• Autonomous and self-directed

• Experienced and knowledgeable
• Goal oriented
• Relevancy oriented
• Practical and learn by doing
• Respectful and want to be respected

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 Autonomous
Adult learners resist learning when they feel others are
pushing information, ideas or actions.

The foundation of this program is based on reading materials

to encourage self-directed learning and we use interactive
exercises such as questionnaires and checklists for students
to complete on their own.

Experienced
Adults like the opportunity to use their existing foundation
of knowledge and apply their life experiences to their
professional development.

This program is designed to recognize the knowledge from

your bachelor’s degree and build additional learning through
your interaction with your instructors.

Goal Oriented
Adult learners are more effective when they feel a need to
learn in order to cope more satisfyingly with real life tasks
or problems.

We will ask questions that motivate reflections, inquiry and

further research to increase the motivation to learn.

Relevancy Oriented
Adult learners want to know the relevance of what they
are learning to what they want to achieve. Through the
instructors, we will check meaning, understanding and
relevance to the context of the work throughout the learning
experience.

Practical
Classroom and textbook learning create a foundation but
hands on exercises and practice provide the highest impact
of learning and retention.

We will use competency documents with clear content and

rationale explaining how it is applicable to the specialist’s
work. The strongest focus for this program will be to provide
opportunities for repetition to promote skill development,
confidence and competence.

6 Introduction

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 Respectful
Adult learners like to be respected.

We will demonstrate this by acknowledging the wealth

of knowledge and experience each student brings and
encouraging the expression of new ideas, reasoning and
feedback throughout the program.

Challenges for Returning Students

We may understand approaches to learning and the

importance of adult student characteristics but additional
challenges can also impact students returning to study after
time away.

• Responsibilities
• Social fears
• Learning curve
• Diversity

Responsibilities
Family and work responsibilities are among the greatest
challenges to returning students as many will now
have spouses and children. This program will require a
commitment from students to apply themselves and focus
on learning the content and participating in assigned tasks.
It is also structured to allow for self-study through reading,
tutorials and on-the-job training to ensure your success.

Social Fears
Age doesn’t stop the impact of social pressure and personal
fears so this program is structured with the expectation that
it may take some practice to return to learning. This program
allows for mentoring to help discuss challenges.

Diversity
As the world becomes more globalized so does the
classroom, with students from different age groups,
experiences and backgrounds. In the workplace it is also
common to work with people of different nationalities.

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 Learning Curve
Returning students often learn how things have changed
since their first classroom experience. This program will
include team work, group discussions and mentoring to help
new learners through these four stages of competence.

The Four Stages of Competence

You don’t understand or know how to

Unconscious do something. You must recognize
Incompetence your incompetence before moving on
to the next stage.

Though you do not understand or

Conscious know how to do something, you
Incompetence recognize the deficit and see the
value in learning a new skill.

You know how to do something,

Conscious but must use strong concentration
Competence to execute the new skill.

You have had so much practice

with the new skill that it has become
Unconscious second nature and can be performed
Competence easily. At this level the skill can be
performed while doing another task
and you may be able to teach it to
others.

Table M0–2 The four stages of Competence

Acquire new knowledge whilst thinking over the old, and you
may become a teacher of others.—Confucius

8 Introduction

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 Multicultural Workplace

In a multicultural team people come from many different

countries and backgrounds and may have different
perspectives and perceptions based on influences like:

• Age
• Class
• Race
• Ethnicity
• Gender
• Language
• Education
• Religion
• Disability

These items are the foundation of a person’s identity and can

lead to an increased chance of disagreements and conflicts
if they feel their view is challenged. At the least this would
only negatively affect individuals but could also negatively
impact the performance of the whole team.

To help reduce the chance of conflict in a diverse

internal environment there needs to be a clear system for
communication that allows sharing of ideas while respecting
each other’s diversity.

Multiculturalism can be defined as acknowledging,

understanding, accepting and valuing differences among
people with respect to things like age, class, race, ethnicity,
gender, language, education, religion and disabilities.

Treating people differently can constitute harassment or a

hostile work environment.

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 Basic Tools for Communication

Do Don’t

Show respect and Insult, name call or put down

positive regard for the people or their ideas
other person through
courtesy, politeness and
kindness

Actively listen to try to Never speak over or cut off

understand the other another person
perspective and allow
them to finish expressing
their viewpoint

Focus on sharing praise Share negative criticism

more frequently than
criticism and encourage
all members of the team
to do the same

Initiate discussion that Make decisions in isolation

encourages idea sharing that may impact your
to solve problems as a colleagues
team

Be aware of your body Shout and negatively gesture

language, tone of voice
and demeanor as they
can negatively impact
the perception of your
communication

Treat people the same no Treat others in a way you

matter their race, religion, would not want to be treated
gender, size, age or
country of origin so they
feel they are treated fairly
and equally

Table M0–3 Basic rules for communication

Treat others as you wish to be treated.

10 Introduction

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 We may have all come on different ships,
but we’re in the same boat now
—Martin Luther King, Jr

Confidentiality

Data regarding recruitment, compensation, and management

of employees is naturally sensitive in organizations and
workplaces. In the wrong hands, this information could be
used to commit fraud, discrimination, and other possible
violations.

Professionalism, safety, and security for all members of an

organization are dependent on confidentiality.

In a health care environment, confidentiality is given an even

higher priority as there are legal and ethical obligations to
protect a patient’s health information and ensure it is only
accessed by authorized users.

Confidentiality in the workplace is important—to maintain it

you will:

• Capture documentation accurately

• Share information only if you are authorized
• Document and store information as per local
legislation requirements
• Disclose information only to those who have the right
and need to know
• Handle confidential records securely and store them
in the correct place
• Take appropriate precautions when communicating
confidential or sensitive information to those who have
the right and need to know

In order to meet this higher obligation of confidentiality it is

important to know your local policies and who to contact if
you have questions.

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 Ethical Guidance

A good guideline for ethical behavior is to ask yourself the

following questions when considering your actions:

• Is the action legal?

• Does the action hurt anyone?
• Is the action fair to others?
• Am I being honest as I carry out the action?
• Would I publicize my actions?
• What if everyone did it?

Equal Opportunity

• All people should be treated similarly, unhampered

by artificial barriers, prejudices or preferences,
except when particular distinctions can be
explicitly justified.
• Principle of non-discrimination emphasizes that
opportunities in education, employment, advancement,
benefits and resource distribution, and other areas
should be freely available to all citizens irrespective
of their age, race, sex, religion, political association,
ethnic origin, or any other individual or group
characteristic unrelated to ability, performance, and
qualification.

We all should know that diversity makes for a rich tapestry,

and we must understand that all the threads of the tapestry
are equal in value no matter what their color.
—Maya Angelou

12 Introduction

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 Introducing Khaled and Maryam

Meet our fictional characters, Khaled, a manager, and

Maryam, a newly arriving Decontamination Specialist student.
Throughout this program, Maryam asks common questions
that new students may have, and Khaled provides answers
that are typical for most CSSDs.

Khaled

Khaled is the CSSD Manager, originally from Tabuk and has

been working in CSSD for 20 years. After high school, he
completed a two-year diploma and started working at a local
hospital as a pharmacy technician. He really enjoyed this role
as he worked closely with pharmacists, doctors and nurses
and felt he was doing important work. The pharmacy was
located next to CSSD so he frequently had lunch with their
team and found it exciting to hear their stories of assisting
surgery with complex surgical instruments sets and all the
equipment required to sterilize surgical instruments.

The manager in CSSD noticed Khaled’s interest and

recommended he complete one of the distance learning
programs from the United States. After completing the
IAHCSMM technician course Khaled was hooked, and after
5 years working in pharmacy decided to apply and switch
to CSSD.

Khaled worked diligently to learn about surgical instruments

and processes and after a year felt knowledgeable, but was
interested in learning more. He asked for additional training
from the equipment manufacturers and also took a course on
surgical instruments.

Within two years of working in CSSD, because of his

initiative, the manager promoted him to a lead technician role
so he could share his learning with others and mentor new
employees. This new role was fulfilling for Khaled as he really
loved to share his experience, so he decided to take additional
training in education, and a distance program for leadership.

After a couple of years of practice and education Khaled was

one of the favorite mentors for new employees, respected by
his CSSD team, and recognized throughout the hospital as a
CSSD expert.
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 Khaled completed a bachelor of science degree in
healthcare management, and became the CSSD manager
after his manager retired.

Maryam

Is from Riyadh, and after high school completed a bachelor’s

degree in science as she had an interest in chemistry and
research. At the end of her studies she got married and as
she began her search for work, found out she was blessed
with her first child.

Being a mother became her priority and within the next few
years she had two more children, a girl and another boy.
When her children went to school she had more spare time
and was interested in looking for work but was nervous as
she had completed her degree almost 10 years ago and had
not worked before raising her family.

That’s when she found out about the new Decontamination

Specialist program being offered for graduates returning
to work.

Maryam I’m concerned about my ability to study, it’s been over 10

years since I was in school!

Khaled We’ve designed this program with you in mind Maryam. Each
module introduces new material and builds on the previous module.
We do require a commitment from you to apply yourself and focus
on learning the content and participating in assigned tasks. There is
a mixture of reading, self-directed learning, practical exercises and
checklists to help you get used to learning again.

Exercises and Checklists

Introductory Exercise: Meet and Greet

Go to your log book and complete the exercise.

14 Introduction

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 Module 1
INTRODUCTION TO
DECONTAMINATION

Key Terms
central sterile service department (CSSD) | sterile processing department (SPD)
central supply department (CSD) | central decontamination unit (CDU)
decontamination | decontamination life cycle | sterilization
manufacturing | single use | reusable medical devices (RMD)
inspection assembly and packaging (IAP) | sterile storage | air pressure

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 Learning Outcomes

By the end of this module you will be able to:

 Describe the function of a decontamination unit and key

requirements for unit design

 Describe international standards available for

decontamination units

 Describe why policies and procedures are required for an

effective decontamination unit

16 Introduction to Decontamination

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 Introduction

Decontamination is an entry-level program for new entrants

to the field of decontamination and sterilization in a hospital,
dental or ambulatory clinic setting. In this module, Introduction
to Decontamination, we will talk about reusable medical device
reprocessing, the facilities required to carry out this function,
and how the life cycle of a reusable medical device fits in.

Pre-Module Quiz What is CSSD?

Keep these questions in mind as you go Central Sterile Service Department (CSSD)
through the content and don’t worry if you is a place in hospitals or healthcare facilities
don’t know the answers yet—that’s what that performs reprocessing of reusable
you’re here to learn. medical devices used by health workers in the
operating room for surgical and other patient
Q: C
 an you describe what procedures. This department is sometimes
manufacturing means? called the sterile processing department
(SPD), central supply department (CSD) and
Q: C
 an you list five items that you use central decontamination unit (CDU). Any of
daily that are manufactured? these or other variations will be referred to as
Q:Can you describe the CSSD in this program.
decontamination life cycle?
Manufacturing
Q: D
 econtamination facilities are
separated into key zones to maintain Manufacturing is the term most
safety, how many do you think there commonly applied to industrial production,
are? where raw materials are transformed into
finished goods on a large scale. Cars,
Q: C
 an you list five items used to
electronics, appliances, and furniture are
assist in cleaning reusable medical
examples of items we buy that are
devices?
manufactured with standards to ensure
Q: D
 o you know what the acronym PPE they are reliable and safe for use. Most
means? consumables we purchase in supermarkets
Q: W
 hat should the air pressure be are also manufactured, and need to be
in the sterile storage room of a produced in a consistent safe process to
decontamination unit? ensure no harm to consumers. With RMD,
producing quality results is especially
Q: W
 hat should the temperature be in a important as they will be used on patients
decontamination unit? with compromised health.

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 Medical Device Manufacturing

Medical devices are defined by international regulatory

bodies, such as the US Food and Drug Administration
(FDA) and the European Medical Devices Directive, as
any object or component used in the diagnosis, treatment,
prevention, or cure of medical conditions or diseases, or
affects body structure or function through means other than
chemical or metabolic reaction to humans or animals. This
includes all medical tools, excluding drugs, ranging from
tongue depressors, to surgical instruments and
radiology treatments.

Most medical procedures require the use of medical

supplies, surgical instruments and equipment. Some of
these items are single use and used once then discarded,
while many are designed for reuse. RMD must be
thoroughly cleaned, disinfected, inspected, packaged
and sterilized before they can be safely reused on
another patient.

In healthcare, CSSD is where the critical

function of reprocessing reusable medical
devices occurs.

In a hospital setting, reusable medical devices and surgical

instruments are more commonly used than disposable
ones, as it is more cost effective and creates less
environmental waste. This is especially true for surgical
procedures in operating rooms where 50 or more surgical
instruments are commonly used.

18 Introduction to Decontamination

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 Some of these groups are:

AAMI
Association for the Advancement of Medical
Instrumentation
ST79 - Comprehensive guide to steam
sterilization and sterility assurance

WHO World Health Organization Decontamination

and Reprocessing of Medical Devices for
Health-care Facilities

IAHCSMM International Association of Healthcare Central

Service Material Management Technical Manual

CBSPD Certification Board for Sterile Processing

and Distribution
The Basics of Sterile Processing

AORN Association of perioperative Registered Nurses

Recommended Practices for Cleaning and Care
of Surgical Instruments

UK DH Decontamination of Surgical Instruments

(HTM 01-01)

IE HSE Ireland Health Service Executive

Standards and recommended practices for
Central Decontamination Units
Table M1– 1 Standard practices and procedures for reusable medical device reprocessing

There is such a wide variety of equipment classified as reusable

medical devices, that regulatory agencies have no single standard,
but they do have an international standard, ISO 17664, that
specifies what all manufacturers must do to create procedures or
instructions for use (IFU) when processing their specific RMDs.
Professional groups and associations use research and
evidence-based practice to define minimum standards used
to help set guidelines for standard practices and procedures for
reusable medical device reprocessing.

These and other similar professional bodies are used to ensure

policies and procedures will produce safe, high quality and
reliable RMD.

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 Maryam: Do all hospitals have the same setup for
processing reusable medical devices?

Khaled: All hospitals follow specific guidelines for optimum

health and safety. Older hospitals may have special areas
adapted to comply with these rules, while newer facilities have
departments with rooms built specifically for decontamination.

Decontamination Life Cycle

The decontamination life cycle model shows the critical steps

required for reprocessing reusable medical devices, and the
pathway through the whole organization. This model will be
referenced throughout this program, to detail how to safely
meet standards and keep patients safe.

ACQUISITION


1. Purchase
2. Loan
CLEANING
DISINFECTION

TRANSPORT

INSPECTION
At all stages
Location
Facilities
USE Equipment PACKAGING
Management
Policies/Procedures

 DISPOSAL
1. Scrap
2. Return to lender

STORAGE
STERILIZATION

TRANSPORT
Table M1–1 Decontamination life cycle

ACQUISITION
- Purchase
- Loan

1
CLEANING & DISINFECTION

TRANSPORT

2
INSPECTION

USE DISPOSAL
- Scrap
- Return to lender

3
PACKAGING

STORAGE
STERILIZATION

TRANSPORT

Table M1–2 Cleaning and disinfection life-cycle

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 Stage Frequency

Cleaning involves removing all visible soil such as body fluids and tissues from reusable medical
Cleaning devices. This may involve wiping or pre-cleaning, ultrasonication, manual or automated cleaning.
At completion of this stage, 95% of microorganisms are removed from the device.

Disinfection follows cleaning and kills the majority of remaining microbes, usually by chemical or heat
treatment. Spores, some mycobacteria, and prions may not be inactivated by this. For flexible
Disinfection
endoscopes and other delicate reusable medical devices, this may be the final hygiene stage and
must be as rigorous as possible.

The reusable medical device is then inspected for functionality, visible soil, and damage. Remaining
Inspection soil or damaged areas on reusable medical device may harbor clusters of microorganisms that are
difficult to remove. Such reusable medical device are rejected or returned to the cleaning stage again.

Reusable medical device which have been cleaned and disinfected are wrapped in special barrier
Packaging packaging, ready for sterilization of the contents. This packaging will prevent microorganisms from
entering the pack until time of use.

Sterilization kills any remaining microorganisms in the reusable medical device pack. There is no such
Sterilization thing as a device being more or less sterile—sterile means zero live microorganisms.

Sterile reusable medical devices are transported to the storage zone or to the point of use in a careful
Transport way to prevent damage or rupture to the packaging and prevent recontamination.

Packed sterile reusable medical devices must be stored in a zone having cleanroom conditions in a
Storage way that does not damage or rupture the packaging during handling or storage.

Sterile reusable medical devices are used on patients in surgeries, theatres and wards. Once used,
Use the reusable medical device is contaminated by microorganisms on or in the patient.

Used reusable medical devices are contaminated by microorganisms and must carefully be
Transport transported back to the decontamination facility. Loss, spillage or carelessness could result in the
spread of infection. Standard Precautions are implemented.

Table M1–3 Reprocessing life cycle

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 Decontamination Design

Before the CSSD, the critical role of design, construction

and equipping of the zone areas were often neglected, but
are now recognized as significant factors in ensuring safe
practices in the reprocessing of RMD.

Some building design resources are:

HBN 13 Health Building Note: Sterile Services

Department—Department of Health UK

AAMI Building for the Future

AIA  Guidelines for Design and Construction in

Health Care Facilities

Ensuring a proper one-way flow is a key part of safe

reprocessing of reusable medical devices. Separating dirty,
clean, and sterile items avoids routes and workflows that
could re-contaminate processed reusable medical devices.
In CSSD this is achieved by using walls to separate the
work areas into three primary functional zones.

ZONE 1 ZONE 2 ZONE 3

DECONTAMINATION INSPECTION, ASSEMBLY STERILE STORAGE
& PACKAGING (IAP)

Dirty Items
Receiving
1  Clean Items
Inspection
2 
3
Sterile Items
Storage
Cleaning Assembly Dispatch
Disinfection Packaging
Sterilization

Figure M1–1 Functional Zones in the CSSD

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 Zone 1
DECONTAMINATION ZO
Figure M1–2 Decontamination zone

1. Decontamination Zone
Decontamination is the combination
of processes (including cleaning,
disinfection and sterilization) used to
render reusable medical devices safe for
1
‣ Gowning room—provides controlled
entry and exit to the wash area, space for
changing into PPE, a hand wash sink for
hand hygiene, and an eye wash station in
case of eye splash

‣ Wash room—space to carry out preparation,

handling by staff and for use on patients.
All reusable medical devices returned to cleaning and disinfection of contaminated
the decontamination zone are considered reusable medical devices
contaminated and potentially infected. You,
as a decontamination specialist, must have ‣ Environmental cleaner room— dedicated
an in-depth knowledge of microbiology, to cleaning only the decontamination room
infection control and safe cleaning practices
To ensure safety and prevent exposure
to ensure safety for yourself and for
to pathogens and other contaminants,
patients. Ideally this zone is defined by
decontamination specialists must wear personal
specific rooms or at minimum segregated
protective equipment such as:
areas to ensure safety to staff and a
• Cover gown with sleeves
unidirectional flow of reusable
• Face mask
medical devices.
• Eye protection
• Gloves
‣ Contaminated returns room—provides
•  Shoe covers or alternative shoes
outside staff with secure and controlled
or boots
access into the zone, allowing delivery of
• Head covering
contaminated containers and trolleys
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 With the wide variety of surgical
specialties and procedures,
there is an extensive range
of complex reusable medical
devices being used. In order to
clean these specialized reusable
medical devices, processes and
appropriate tools are required
such as:

• Hand wash sink– with liquid

soap and paper towels
• Instrument cleaning sink—
with two or three basins
• Brushes
Figure M1–3 Personal Protective equipment in CSSD
• Air guns
• Water guns
• Magnifiers
• Additional lighting
• Detergents
• Disinfectants
• Lubricants
• Ultrasonic washers
• Automated washer disinfectors
• Cart washer Figure M1–4 Hand wash sink and instrument cleaning sinks

• Automated endoscope
re-processer
• Environmental monitors—
temperature, humidity
 and pressure
• Spill kits Figure M1–5 Brushes Figure M1–6 Air/Water Gun Figure M1–7 Magnifying Lamp

In the decontamination zone:

• PPE is worn to ensure

specialist safety
• Reusable medical devices
received are checked for
Figure M1–8 Enzymatic Detergents Figure M1–9 Disinfectants Figure M1–10 Environmental Monitoring

missing parts, manually

pre-cleaned and prepared for
automated washing
• Reusable medical devices not
compatible with automated
washers are manually cleaned
and disinfected Figure M1–11 Automated washer disinfectors Figure M1–12 Ultrasonic washers

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 Zone 2
Inspection, Assembly and Packaging (IAP) Zone

Figure M1–13 Inspection, Assembly and Packaging (IAP) Zone

2. Inspection, Assembly and

Packaging (IAP) Zone
After cleaning and disinfection, reusable
medical devices are received in the
Inspection, Assembly and Packaging
2
Gowning room—provides controlled
entry and exit to the IAP zone, allows
for changing into personal protective
zone to prepare for sterilization. Reusable equipment, and a hand wash sink for hand
medical devices are now safe for handling hygiene to protect clean instrumentation
and extra care must be taken to ensure that from the risk of contamination
they are not re-contaminated. Strict hand
hygiene must be maintained and personal Materials transfer room—maintains an
protective equipment must be used at air-lock to bring raw materials in and out of
all times. Ideally this zone is defined by the IAP zone
specific rooms or at minimum segregated
areas to ensure safety to staff and ensure a Environmental cleaner room—dedicated
unidirectional flow. to cleaning materials and equipment for use
only in the IAP zone
Inspection, assembly and packing
(IAP) room—this room is restricted only Sterilization room—in newer CSSD
to specialists who inspect, assemble designs sterilization equipment is located
and package cleaned RMD to prepare in a room separate from IAP and Storage
for sterilization. Sterilizers are frequently to further reduce contamination risks to
located in this room. unwrapped RMD

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 The extensive range of
complex instrumentation
requires specialized processes
and appropriate tools for
inspection and packing
such as:

• Packing tables
• Chairs Figure M1–14 View Pack Pouches Figure M1–15 Tip Protectors

• Magnifiers
• Additional task lighting
• Wrappers and containers
• View pack pouches
• Heat sealers
• Surgical instrument
tip protectors
• Tray liners
• Air guns Figure M1–16 Heat Sealers Figure M1–17 Packing tables

• Pass through hatchs

• Drying cabinets
• Sterilizers—high
temperature
• Sterilizers—low temperature
• Biological incubators
• Environmental monitors
temperature, humidity and
pressure

In the Inspection, Assembly Figure M1–18 Surgical Instrument Wrappers

and Packaging zone, surgical

instruments are unloaded from
automated washers or pass
through hatches (if manually
cleaned) and:

• Visually checked to ensure

cleanliness
• Manually inspected against
a checklist to ensure items
are correct and functional
• Packaged in appropriate
materials and labelled
• Sterilized with the correct
process or passed to a
sterilization room if separate
Figure M1–19 Pass-through hatch
from IAP
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 Figure M1–20 Steam Sterilizers

Figure M1–21 Low Temp Sterilizers

Medical Device Reprocessing (Decontamination Specialist) 27

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 Figure M1–22 Low Temperature Formaldehyde sterilizers

Figure M1–23 Drying Cabinets

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 Zone 3
STERILE STORAGE ZONE

Figure M1–24 Inspection, Assembly and Packaging (IAP) Zone

3. Sterile Storage Zone

CSSD requires a safe storage zone for
sterile and clean supplies used in production.
Sterile reusable medical devices are
packaged, and stored safely in an
3
environmentally monitored (temperature,
humidity and pressure) room using:
Figure M1–25 Sterile Storage Shelving

• Washable, round-edged shelving

designed to avoid damage to packaging Additional CSSD Support
• Transport carts
Areas
• Workstations
The CSSD is segregated into three primary
zones and additional areas are required
In the Sterile Storage zone processed
to support the safety of specialists and
reusable medical devices are:
surgical instruments.

• Transferred from the sterilizer to this

Staff Facilities—Changing, Toilets,
room where they will either be kept until
and Showers
required or staged for end-user delivery
• Male and female toilets and areas to
• Removed from shipping boxes and
change from outdoor to working clothing
containers before being transferred here
• Lockers to accommodate storage of
for storage or staged for end-user delivery
specialist belongings
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 • Showers located close to the
decontamination area to ensure
quick access in case of a
workplace spill or contamination
incident
• Hand hygiene station
• Mirrors to check PPE

Staff Rest Room

• Facilities to prepare hot and cold
drinks for staff breaks
• Area for eating and drinking
(restricted to this area)

Materials Storage
• Separate segregated area for bulk
storing of production materials
• Sufficient stock levels of materials
to ensure smooth operations
• Not used to store sterile
processed items

Education, Training and

Meeting Rooms
• Separate from the work area
and provides space for teaching
materials and work samples
• Support for important regular Figure M1–26 Transport carts
training and education for all
grades of staff

Central Detergent Dosing Room

• Adjacent room for detergent
replacement without entering the
contaminated area, reducing the
opportunity for automated
washer contamination

General CSSD
Requirements
The unit is used exclusively for
reprocessing reusable medical
devices, must be physically separated Figure M1–27 Workstations

from other work areas and never used

as a thoroughfare to other units.
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 Unit Access Air Pressure
Due to the critical nature of this unit, access Air pressure is regulated to prevent cross
is restricted to authorized personnel and contamination of airborne pathogens
trained specialists. between each zone. A ventilation system
is used to either exhaust air out of a room,
Lighting creating negative air pressure, or vent air
The light is kept at a brightness and into the room, creating positive air pressure.
color balance for good working practices
and visual examination of reusable Work Surfaces
medical devices. Additional task lighting • Walls are smooth, non-shedding,
and magnification are available in water resistant and withstand frequent
decontamination and IAP areas. cleaning.
• Floors are a washable non-slip material
Temperature and have no exposed seams or
Room temperature is controlled between openings.
18–25°C (64–77°F) and kept at a relative • All tables, workstations and shelving
humidity of 30–60% depending on the are made of easily cleanable materials
activities carried out in the area. with non-glare surfaces. Adequate
spacing allows for staff and equipment
movement.

• Decontamination Negative (-) prevents air from exiting the room

• IAP Positive (+) prevents air from entering the room

• Sterile Storage Positive (+) prevents air from entering the room

Figure M1–32 Sterile storage zone

Positively Negatively
Pressured Room Pressured Room

Clean Dirty

 
 



 
Figure M1–28 Air pressure regulation

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 ∞ ∞
General
Changing Room
General Domestic
Contaminated (Male & Female Offices
Waste Services
Returns Lobby + WCs)
Disposal/ Room
§ Laundry
Returns One-way

*
Contaminated transfer Staff
Returns Holding Area
§ hatch entrance

Domestic Test Equip Gowning Trolley

Services and Data Wash
Room WC Reception
Room Room

*
Materials
Store

*
Training
Wash Room

Transfer
* Chemical
Transfer
Hatch

Hatches

*
*
Staff
Materials Room
Transfer
Room

* *
Washer- Washer-
disinfectors
IAP disinfectors
IAP
Gowning Goods
Packed Product Room
Transfer Facility entrance
Domestic
Services
Room

Sterilizer loading area

Despatch

Cooling
Area

Processed Products Store

*
Waste Interlocking doors

Work flow

Raw materials
∞ Controlled exterior access

Departmental personnel
§ Controlled interior access (within wash room)

Note: this diagram does not provide for specialist plant

Non-departmental personnel areas, ie ventilation plant, reverse osmosis, clean
steam and compressors

Figure M1–29 SSD layout (source: DH Estates and Facilities and HBN 13
https://www.gov.uk/government/publications/the-planning-and-design-of-sterile-services-departments)

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 Exercises and Checklists
You have been introduced to a central sterile service department and what an important
function it provides to safe patient care. The following exercises will help you compare
what you have learned to real-world examples in your current training environment.

Assignment

Compare what you have learned to real-world examples in your training

environment. Explore your current department by completing the exercise in
your log book.

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 34 Introduction to Decontamination

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 Module 2
MICROBIOLOGY AND
INFECTION CONTROL

Key Terms
CSSD | microbiology | infection | PPE | microbiome | efficacy
autoclave | instructions for use (IFU) | pathogens
standard precautions | pathogenic | commensals | biosphere
cavitation | healthcare acquired infections (HAI) | biofilm
reservoir | nosocomial infection

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 Learning Outcomes

By the end of this module you will be able to:

 Understand the basic principles of microbiology and

infection control practices

 Demonstrate the use of appropriate (PPE)

 Compare detergents, disinfectants and sterilants

 Minimize risks to self, patients, staff and visitors

 Wash your hands using proper hand hygiene technique

 Demonstrate knowledge of basic housekeeping materials

and cleaning procedures

 Follow the dress code and entry and exit rules for
each zone

 Respond to infection risks

 Handle and dispose of waste using the proper method

for each waste-stream

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 Introduction

The CSSD has an extremely important role to

play in preventing the spread of infection to and
between patients, and staff who work with or
around reusable medical devices.

Maryam: What exactly needs to be cleaned off a reusable

medical device?

Khaled: Well, the visible tissue, proteins and body fluids, need to
be removed, as well as the invisible or tiny microorganisms that are
almost always on reusable medical devices. These may have come
from a patient, people handling or transporting the reusable medical
devices, or just from exposure to the environment.

Since some of these microorganisms have the potential to

cause disease, the decontamination facility makes sure
that reusable medical devices are thoroughly cleaned,
disinfected and/or sterilized before reuse.

This module will help you understand just how critical the
role of decontamination is in reducing the risks of microbial
infection to patients and to the staff working in the CSSD.

Pre-Module Quiz

Keep these questions in mind as you go through the content,

and don’t worry if you don’t know the answers—that is what
you are here to learn.

Q: Is the workwear worn in the CSSD designed to protect

the wearer or the reusable medical device?
Q: If microbes are not visible to the naked eye, how do
you think you can ensure their removal from reusable
medical devices?
Q:What is the difference between a bacterium and a
virus?
Q: How would you kill a microbe?

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 Q: Is there a microbiology laboratory in your hospital?
Q: W
 hat type of testing and analysis is the lab set up for—
protozoa, fungi, yeasts, bacteria, viruses, or prions?
Q: D
 oes the lab perform routine clinical microbiology
doing culture and antibiotic sensitivity testing?
Q: D
 oes the lab do virus testing, or test for any other types
of microbes apart from bacteria?
Q: If not, where is the nearest lab that can do these?
Q: Can the lab test air quality?
Q: Can it test water quality?
Q: Is the lab used by the decontamination unit?
Q: What are the potential risks that one works with in a
CSSD?
Q: Why is training and education so important for staff in a
CSSD?
Q: Do you know how many work zones there are in a
typical CSSD?

Microbiology and Decontamination

Microbiology is the study of microscopic organisms, also

known as micro-organisms, microbes or germs. The largest
of these measure only two or three microns in size and the
smallest are almost 100 times smaller than that. Microbes are
invisible to the naked eye—we can see things only as small 90
microns, about the thickness of a human hair.

Figure M2–1 Tip of an unsterilized needle seen under high (200x) magnification
using an electron microscope. The tip is not much wider than a human hair.
Does it look clean?

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 This makes it difficult to know exactly where or how many
there are, and what types may be present on or in your
hands, the water, the air and your working environment,
including reusable medical devices. It also means that it is
impossible to tell visually when all microbes have been
removed during the decontamination processes.

The presence of microscopic organisms are detected

by two methods—viewing them up close with light and
electron microscopes or by culturing the microbes until
they grow into a detectable form. These processes require
specialist training and equipment and take a considerable
amount of time. The specialists who do this work are called
microbiologists.

Below is a closer view of the tip of the same needle under

much higher magnification. You can see large numbers
of bacteria, two microns long, sticking to the needle. To
decontaminate this needle, you would first clean it to
remove any dirt, soil and as many bacteria as possible.
You would then put it through a disinfection process to
kill as many of the remaining microbes as possible. A
sterilization process will kill all remaining microbes.

Figure M2–2 Clear view of the top of a needle, with bacteria 2 microns in length.

Look at how uneven the supposedly smooth surface

is when viewed under high magnification (see Figure
M2–2). Unevenness of reusable medical device surfaces
can make it difficult to clean reusable medical devices
properly. Dirt and microbes may resist removal by
lodging in any crevices or surface imperfections. This is
why disinfection or sterilization comes after the cleaning
process—in order to kill any microbes missed by the
cleaning procedures.
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 As Figures M2–1 and M2–2 show, microscopic organisms
can’t be seen with the human eye and are even difficult to
see with high magnification. Figure M2–3 shows the range
of sizes the human eye, the light microscope and the
electron microscope allow us to see.

Relative Sizes and Detection Devices

1m 1dm 1cm 1mm 100µm 10µm 1µm 100nm 10nm 1nm 1Å 0.1Å
1m 10-1m 10-2m 10-3m 10-4m 10-5m 10-6m 10-7m 10-8m 10-9m 10-10m 10-11m

Human Eye Electron Microscope

Light Microscope

Apple Ant Cell Virus Small Molecule Electron Orbital

Human Wasp Hair Bacteria DNA Atom

Figure M2–3 Relative Sizes and Detection Devices (Source: http://penpals.web.unc.edu/)

Since microbes are not visible to the human eye,

specialists in CSSD do not look for microbes on the
equipment and reusable medical devices they process.
Instead, they strictly comply with validated procedures and
processes proven to clean and decontaminate—ensuring
the safety and sterility of their reusable medical devices.
These procedures are developed and thoroughly checked
by microbiologists. Manufacturers also supply instructions
for use (IFU) for proper decontamination of their
reusable medical devices.

It is important for the CSSD specialist to know about

microbiology and microbes to understand where the risks
are, why they are doing things in a particular way and what
the consequences are if things go wrong.

There may not be procedures to cover every contamination

risk in the decontamination wash room, so it is very
important for specialists to be vigilant and to understand
the basic principles of what they are doing and how to
minimize the risks.

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 Microorganisms
What are they and which types might you encounter?

There are millions of different microbial species. It is

estimated that less than 10% of these have been identified
or studied. The best studied microbes are the ones
that cause disease—these microbes are referred to as
pathogens. Although all types may be encountered,
bacteria and viruses are the most commonly occurring
contaminating microbes.

Every year, new varieties of microorganisms are

discovered. Scientists are becoming better at finding and
recognizing them, and mutations and genetic exchange
regularly create new forms from existing microbes. Some
types, such as the influenza virus, have a high rate of
mutation. They avoid being recognized by our immune
system and create an outbreak risk.

Many microbial infections are no longer treatable using

antibiotics. Bacteria, fungi and yeasts can develop or pick
up antibiotic resistance genes from other microbes. It
becomes a serious problem when infections can no longer
be treated successfully using the previously effective
antibiotics. In some cases, they may become resistant to
many or all of the available antibiotics, making the infection
untreatable. Recent examples of this are Methicillin
Resistant Staphylococcus aureus (MRSA), multi-drug
resistant Tubercle bacillus (MDR TB) and
Carbapenem-resistant Enterobacteriaceae (CRE).

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 Environmental Conditions

What environmental conditions do microbes like?

All microorganisms grow and reproduce in an optimal

range of conditions. Their basic requirements are food
and moisture. Anything that changes these conditions
to a range that is not tolerable will inhibit or kill the
microorganisms. Human-infecting microorganisms tend
to have optimal growth conditions similar to human tissue.
Some microorganisms, including protozoa, fungi and
bacteria, develop survival strategies to cope with stressful
conditions. Cysts in protozoa; spores, somnicells
(non-culturable cells) and biofilms in bacteria; and
spores and altered metabolism in fungi are all examples
of survival strategies. Bacteria, under optimal growth
conditions, can multiply very rapidly, doubling in number
every 20-30 minutes. This is why it is so important to clean
reusable medical devices as soon as possible after use.

Figure M2–4 One bacterium can become hundreds in just two hours and many millions in 10 hours

Further Information
Go to YouTube on the internet and search for video number
zrx7Xg0gkQ4, “Bacteria Multiplying” to see a video on the subject.

Some yeasts, like Candida, can also multiply as quickly

as bacteria. Fungi grow more slowly but can reproduce in
large quantities.

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 Because viruses, prions and some protozoa are unable
to grow or reproduce outside of host cells, they do not
increase in number in the environment. They maintain their
capability to infect host cells, remain biologically inert, and
persist for various lengths of time—depending on structure
and type. In the case of both prions and viruses, they may
persist when attached to soil or dirt containing traces
of moisture.

Some viruses such as

Hepatitis B, HIV, Herpes,
chickenpox and influenza
are surrounded by a lipid
envelope. It resembles a
bubble and tends to be more
fragile and susceptible to
heat and drying. When left on
a contact surface, they may
only be infectious for minutes
or a few hours. Non-enveloped
viruses such as adenoviruses,
polio and norovirus do not Figure M2–5 Enveloped virus vs. non-enveloped virus

have the same susceptibility

and may be infectious days later.

Why are Biofilms Important?

Because most studies on microbes were carried out

in laboratories on artificial growth medium in unnatural
conditions, it was not realized until 1978 that the natural
form of growth for most microbes is as a biofilm. A biofilm
develops by microbes (usually bacteria) either sticking
to each other or to a nearby surface. Once this happens,
they secrete a matrix of slime which covers them like a
tent. This protection from disinfectants and various other
stressful situations allows them to continue multiplying,
and resist removal. Once a biofilm has formed, other types
of microbes can also take refuge in it. They have great
protection there—like living within a walled city. Within
our bodies we have useful natural biofilms growing in our
intestines, oral cavity, respiratory tract and skin. Pathogens
can also form biofilms in all of these areas and in wounds,
and on surgical implants and catheters, making them

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 more difficult to eradicate. Microbes or pieces of biofilm in
blood or soil can form more biofilms on reusable medical
devices if left on them for any length of time. Their degree
of attachment becomes stronger with time so by the time
they get to the decontamination zone in the CSSD, they
are more difficult to detach in the cleaning process.

It is best practice to avoid delays before starting

decontamination of used reusable medical devices. When
this is not possible, keep the reusable medical devices
moist and treat them with a neutral detergent and cleaning
enzymes until they can be properly decontaminated.

Biofilms also become a problem in a number of areas

of the CSSD. They can form on, and inside, ultrasonic
baths, hoses, housekeeping cleaning equipment, the
water system, wash basins, waste pipes, taps, plumbing
of washers and washer disinfectors, and moist surfaces.
Strict regular cleaning and decontamination protocols
must be in place to prevent spread of microbes to
processed reusable medical devices and staff within
the CSSD. Regular microbiological testing monitors the
efficacy of these protocols.

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 Microorganism Types and Characteristics

Protozoa
Protozoa are large complex
one-celled parasites that may
spend part of their lifecycle
in our bodies. They cause
diseases like malaria or
dysentery as they multiply
within our body.
Figure M2–6 Intestinal amoeba within a cyst in a fecal sample (protozoa 20 microns)

Cleaning: They are relatively easy to remove from

reusable medical devices during decontamination but
some have life-cycle stages which are encysted (within
a tough protective capsule). These stages are more
difficult to kill as they resist disinfectants but heat will
kill them.

Identification: The identification of protozoan pathogens

is mainly based upon direct microscopical observation
in clinical specimens or by detection of specific
serological immune reactions of the host.

Figure M2–7 Protozoa

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 Fungi

Fungi are large to medium-

sized microorganisms that grow
filamentous root-like structures
called hyphae. Some fungi
live on our skin and in our gut
naturally. They may cause
diseases called mycoses when
they invade our tissues.
Figure M2–8 Aspergillus (fungus 40-50 microns)

Cleaning: Fungi are relatively easy to clean from

reusable medical devices, however, their thick cell
walls and spores are often resistant to disinfectants but
heat will kill them.

Identification: Fungi are usually identified by growing

them in the laboratory. Although one fungal cell is
invisible to the naked eye, when allowed to multiply on
an agar plate, one cell becomes millions and they form
Figure M2–9 Fungi Colony a pile of particular shape, size and color referred to as
a colony. By noting colony appearance and examining
parts of this microscopically, it is usually possibly for
an experienced specialist to identify the type of fungus.
Newer methods based on biochemical reactions are
becoming available, as are genetic methods.

Figure M2–10 Various Fungi

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 Yeasts

Yeasts are single-celled

organisms with a nucleus and
are a type of fungus. Yeasts
are larger than bacteria, and
multiply mainly by budding.
Some yeasts live in our bodies
naturally. Yeasts like Candida
can infect the gut, urogenital
Figure M2–11 Candida (yeast 5-10 microns) tract, respiratory tract and
oral cavity.

Cleaning: They are relatively easy

to remove from reusable medical
devices when cleaning and are
susceptible to disinfectants
and heat.

Identification: The identification

of yeasts is similar to that for Figure M2–12 Different yeast species on routine agar

bacteria. It is based on culture

in the laboratory to form colonies
and then noting the characteristic
features of colony shape, size
and color. This is followed by
examining cell shapes under the
microscope, followed by testing
for production or consumption of
particular chemicals. Recently,
special chromogenic (color
forming) growth media has been
introduced which can help identify
yeast species by causing them
be a particular color. Genotyping
using molecular methods is now
also being introduced.
Figure M2–13 Different yeast species identifiable on chromogenic agar

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 Bacteria

Bacteria are small microorganisms that come in many shapes

and types. They lack a nucleus and multiply by cell division.
Some types, like Clostridium difficile, can produce tough
protective spores. Harmful bacteria may produce toxins which
can damage host tissues while some produce chemicals that
protect themselves against the immune system, allowing them
to spread. Bacteria are usually the most frequent cause of
infection in hospitals.

Figure M2–18 Loading test cards

in automated system.eps
Figure M2–17 Miniaturized biochemical
test card for automated system
Figure M2–16 Biochemical testing shows
identity profiles based on color reactions

Cleaning: Bacteria are quite small and

Figure M2–15 Bacterial colonies
on an agar plate can be difficult to remove from uneven
surfaces during cleaning. Most can be
killed by disinfectants and heat although
spores often resist disinfectants.

Identification: Many different methods

are available for identifying bacteria
because, of all the microbes, they have
been studied for the longest time. First,
they are cultured in the laboratory where
their colony appearance may indicate
the species. Microscopy of gram stained
smears can also help. They can be
further identified by using combinations
of biochemical tests and comparing with
a database or they can be identified
genetically using molecular techniques.
Many of the identification methods are
Figure M2–14 Various bacterial types

now becoming automated.

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 Viruses

Small non-living infectious

objects containing genetic
information enabling them
to hijack living cells in the
body. They take over host
cells, converting them into
factories that make hundreds
or thousands of copies of
themselves which in turn, Figure M2–19 Hepatitis B (virus 0.05 micron)

spread to neighboring cells and

the process repeats itself. Bloodborne viruses such as
Hepatitis B, C and D are a frequent risk to healthcare staff.
Cleaning: Viruses are very small and can be difficult to remove
during cleaning as they may lodge in uneven surfaces. As they
are not alive, disinfection or heat does not kill them. Instead
it dismantles or disrupts their chemical structure—most are
susceptible to this but there are some which can be resistant.

Identification: Viruses are detected and identified in a number

of ways. The most usual is to culture a sample in the laboratory
using tissue culture methods. Viruses are detected by the
damage (cytopathic effect) they cause to healthy human or
animal cells in culture. This is seen as plaques or areas of
destruction. Viruses can be identified by antibody labeling or
using molecular methods.

Figure M2–20 Detecting and counting influenza viruses by infecting cell monolayers (stained purple) in petri dishes. The clear areas are called plaques and each plaque is the
result of one virus infecting and killing cells in the monolayer. By counting the plaques one can assess the number of viruses in the original sample.

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 Prions

Very small proteinaceous

units that cause Transmissible
Spongiform Encephalopathies
(TSEs) when folded in an
abnormal way. Abnormally
folded prions can cause
disease (particularly in the
brain) by converting normally
folded prions into abnormal Figure M2–21 Normal Prion protein

ones. These then aggregate

and disrupt tissue structure
and function.
Cleaning: Prions are difficult to remove from
reusable medical devices due to their small
size and their strong adherence to surfaces.
They are very difficult to inactivate using heat
or disinfectants. Reusable medical devices
used on prion-infected patient tissues are
not used on other patients due to difficulty
Figure M2–22 Abnormal prion protein (0.01 micron) in decontaminating them. It is important
to have a traceability system for medical
devices in place to ensure these reusable
medical devices are not used again.

Identification: Prions are usually detected

by histopathology of infected tissue where
misfolded prion aggregates are revealed using
Figure M2–23 Abnormal prions clump in aggregates specific antibodies linked to dyes. Detection on
reusable medical devices is very complex and
time consuming and is not very successful.

Other prion-like agents: Not much is known

about these yet other than they are very small
molecules and are transmissible.They have
effects similar to prions and are thought to be
Figure M2–24 Creutzfeldt-Jakob disease equally difficult to inactivate.

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 Microbes and CSSD
Putting microbes in context in the CSSD environment

Microbes are the most numerous and diverse life forms known. They have
existed for over 3.5 billion years on Earth, and have adapted to and colonized the
biosphere—every environment we can think of, from several kilometers deep within
the earth’s crust to the upper reaches of our atmosphere.

Maryam: Are all microbes dangerous?

Khaled: When we think of microbes in relation to clinical environments,

where cleanliness and sterility are paramount, we treat the presence
of all microbes there as being potentially harmful. We try to eliminate
them all and we take what are known as Standard Precautions to
prevent the spread of infection.

Plants, animal and humans are all dependent on microbes

for their normal function and survival. Each individual
has their own personal microbiome or microbe collection
consisting of thousands of different species that help
protect against disease, stimulate their immune system
and carry out many other beneficial functions. These
helpful microbes are known as commensals whereas
disease causing microbes are known as pathogens.
Some of the commensal species, though helpful to the
person hosting them, may prove pathogenic or harmful if
transferred to someone else. In a hospital or healthcare
setting where patients are vulnerable to infection, we
undertake many methods of infection control to prevent the
transfer of pathogens or commensals.

Recent research has shown that on and in

the average human there are 1.3 times more
microbial cells than human cells!
A human can therefore add a large number of microbes
to their surrounding environment in a number of different
ways. Coughing, sneezing and bodily secretions can
spread microbes. Your hands spread microbes when you
touch your face, body parts or contaminated items and
then touch other items.

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 Skin

Skin covering our bodies is multilayered;

Dead cells flaking off at the skin surface

the top layer is composed of dead cells.

Stratum corneum
Stratum
lucidum
Stratum
granulosum
The top layer of skin contains a large
Stratum amount of commensals of our own,
spinosum
together with transient populations picked
Stratum basale
Keratinocytes
up from clothing, contact with others, and
Dermis move up as
they age our environment. Our body discards this
entire top layer of dead skin cells and
associated microbial biofilm over a period
of five or six weeks, to be replaced by a
fresh layer from underneath. The forearm
sheds approximately 1300 cells per cm2
The top layer of the skin is the stratum corneum
per hour.
Figure M2–25 Diagram of skin layers

Figure M2–26 High containment PPE Figure M2–27 Bacteria on skin cells

As we move around, we leave an

invisible trail of microbes everywhere
we go, and on everything we touch.
Once we understand this, we can see
Although, strict how important it is to minimize the
amount of contamination we bring into
cleaning and
clean or sterile zones in the CSSD. We
decontamination try to contain our dead skin cells and
procedures may be in microbes by using hygiene procedures
and appropriate PPE to prevent us from
place, the clean zone recontaminating the reusable medical
is rarely microbe-free! devices or their environment. Very high
levels of contamination prevention
and PPE are used in clean rooms and
sterile areas of pharmaceutical and
microelectronics factories, and when

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 Figure M2–28 PPE Figure M2–29 News article, Scientific American

assembling spacecraft. Often, two layers of

clothing are worn, one to enter semi-critical
areas and then another on top of that to You must take precautions
enter the critical areas. to protect yourself from
Despite the highest hygiene standards and
these through the use of
vigorous cleaning and decontamination particular safety and hygiene
regimes in these places, some microbes procedures and the use of
occasionally survive (See Figure M2–29
News article, Scientific American). This is particular PPE.
also the case in the CSSD clean zones.

CSSD Workwear and PPE

There are three work zones within the

CSSD—the Contamination zone, the
Inspection, Assembly and Packaging zone
and the sterile storage zone as described
in module 1. These are separate zones
which should each have their own entry
and exit points. Staff should not be able
to move between zones without passing
through gowning rooms, changing PPE and
undergoing hygiene procedures. When you
work in the Decontamination zone in the
CSSD, you are exposed to contaminated
reusable medical devices and materials
which were used with patients who may
have been carrying pathogenic microbes in
addition to their own natural commensals.
Figure M2–30 PPE

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 Decontamination Zone
PPE Requirements
Gown with Sleeves Gloves
Wear fluid resistant gowns with long- Use gloves for environmental
cuffed sleeves that can be tucked inside cleaning activities, and handling
gloves during procedures that are likely to contaminated reusable medical
generate splashes of blood or body fluids, devices and waste. Wearing gloves
or during activities that may contaminate it does not replace hand washing as
with infectious material. Change this gown gloves may have become damaged
whenever it becomes visibly soiled or wet during use, or have defects that are
and discard after use. not immediately obvious.

Plastic Bib or Apron • Wash your hands before and

In some cases, you wear a bib or apron over after using gloves.
the gown for extra protection from splashes • Wear the correct size and
during manual cleaning processes. appropriate type for the task. They
should have long enough cuffs to
Mask & Eye Protection fit over the cuffs of the gown.
Wear fluid repellent masks with visor eye • Keep your nails short so you
shields to reduce the risk of microbes being don’t puncture your gloves.
transferred to the eyes, nose and mouth. • Avoid touching your mask, eyes
These must be fitted properly and worn to or face with your gloves once you
cover eyes, mouth and nose, according to have started work.
the manufacturer’s IFU. Do not touch the • Learn how to remove gloves
mask or eye shield with your hands while without contaminating your hands
working, remove them immediately if they or snapping the gloves which may
become moist or visibly soiled, discard them spread contamination across
appropriately and replace with the room.
clean equipment. • Remove used gloves before
touching anything that can be
contaminated through contact
such as surfaces and pens.
• Discard the gloves when you are
done, or when you suspect the
gloves are torn or perforated.

Further Information
For a video, go to YouTube and look for “TwJfNfCEnKU” or
“Glove Removal” from Safety Training International.

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 Shoes or Shoe Covers
Best practice suggests dedicated shoes or clogs that are
worn only in the decontamination zone. Ideally, these should
be washable. Disposable shoe covers could also be used to
protect regular shoes from becoming wet and contaminated
during cleaning procedures however, these puncture easily
and may fall off. They must be replaced if there is any sign of
damage and the old ones discarded properly in the
waste container.

Other Workwear Requirements

Workwear requirements for CSSD other than the
decontamination zone

When you work in the IAP or sterile storage zones in CSSD, you
wear different workwear. Here the emphasis is on protecting
the reusable medical devices and their environment. Pay
attention to general hygiene and wash your hands frequently.

Uniform/Scrub
Wear a freshly laundered or new, disposable, low-lint “scrub”
uniform that minimizes bacterial shedding and is comfortable
for you. Changed scrubs daily or whenever they become visibly
soiled or wet.

Head/Hair cover
Wear a clean, single use, low lint surgical hat or hood that fully
covers and confines your hair. Discard this head covering and
replace it with a new one when re-entering the zone.

Footwear
Wear dedicated non-slip enclosed footwear that can protect
from injury or contact with accidently dropped sharp objects.
Footwear must be appropriate to the area and regularly
cleaned and disinfected.

Make-up/Jewelry
Do not wear make-up or jewelry (except a plain wedding band)
in CSSD. You may wear stud earrings that are confined within
the head cover in case they come loose.

Strict adherence to these work practices is important. For

putting on and removing PPE, there is a correct sequence
and method (Figure M2–31 Putting on and removing PPE).

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 Putting on and removing PPE

PUTTING ON PERSONAL PROTECTIVE EQUIPMENT (PPE)

Shoe Gown Mask/Respirator
1 2 3

Fully cover torso from neck to knees, Secure ties or elastic bands at middle
arms to end of wrists, & wrap around the of head and neck. Fit flexible band to
back. Fasten in back of neck and waist nose bridge. Fit snug to face and below chin.

Goggles/Face Shield Gloves

4 5

Put on scrub suit and rubber boots in Place over face and eyes and adjust Extend to cover wrist of isolation
chnanging room to fit gown

REMOVING PERSONAL PROTECTIVE EQUIPMENT (PPE)

Gloves Goggles/Face Shield Gown
1 2 3

Gown front and sleeves are Outside of goggles or face shield are Gown front and sleeves are
contaminated! Unfasten gown ties, contaminated! Remove goggles or face contaminated! Unfasten gown ties,
taking care that sleeves don’t contact shield from the back by lifting head taking care that sleeves don’t contact
your body when reaching for ties. Pull band or ear pieces. If the item is your body when reaching for ties. Pull
gown away from neck and shoulders, reusable, place in designated receptacle gown away from neck and shoulders,
touching inside of gown only for reprocessing. Otherwise, discard in a touching inside of gown only
• Turn gown inside out. Fold or roll into waste container • Turn gown inside out
a bundle and discard in a waste • Fold or roll into a bundle and discard
container.
in a waste container

Mask/Respirator Wash Hands

4 5
OR

Front of mask/respirator is contaminated — DO NOT TOUCH!. If your hands get Wash hands or use an Alcohol-based
contaminated during mask/respirator removal, immediately wash your hands or hand sanatizer immediately after
use an alcohol-based hand sanitizer. Grasp bottom ties or elastics of the removing all PPE
mask/respirator, then the ones at the top, and remove without touching the front.
Discard in a waste container

If your hands get contaminated during goggle or face shield removal, immediately wash your hands
or use an alcohol-based hand sanitizer

Figure M2–31 Putting on and removing PPE (Source: Health Protection Scotland, http://www.nipcm.hps.scot.nhs.uk/)

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 Hand Hygiene (Washing)

Hand washing may seem simple as it is something we do every day but in a hospital
setting there are specific techniques we must use for thorough cleaning, as outlined in
the following model from The World Health Organization (WHO).

WASH HANDS WHEN VISIBLY SOILED! OTHERWISE, USE HANDRUB

 Duration of the entire procedure: 20-30 seconds

0 1 2

Wet hands with water; Apply enough soap to cover Rub hands palm to palm;
all hand surfaces;

3 4 5

Right palm over left dorsum with Palm to palm with fingers interlaced; Backs of fingers to opposing palms
interlaced fingers and vice versa; with fingers interlocked;

6 7 8

Rotational rubbing of left thumb Rotational rubbing, backwards and Rinse hands with water;
clasped in right palm and vice versa; forwards with clasped fingers of right
hand in left palm and vice versa;

9 10 11

Dry hands thoroughly Use towel to turn off faucet; Your hands are now safe.
with a single use towel;
Figure M2–32 Hand washing (Source: WHO, Hand hygiene tools and resources http://www.who.int/infection-prevention/tools/hand-hygiene/en/)

It is important to care for your hands— cover any open wounds with waterproof plasters
and regularly moisturize them to avoid dry or flaking skin. Correct Hand washing
technique is important to learn.

Further Information
For a video to explain various aspects of hand-washing and
demonstrate the reasons it is necessary, go to YouTube online and
search for “mWe51EKbewk” or “A Complete Guide to Hand Washing”
hosted by the University of Leicester.
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 When it comes to working in CSSD you naturally think of
protecting yourself, but in the IAP and sterile zones you
also need to think of protecting the reusable medical
devices from contamination by you. It is important that
you are familiar with maintenance of personal hygiene
appropriate to the zone of the unit you are working in.

If you are ill with enteritis or have a severe respiratory

tract infection causing a lot of coughing, sneezing, or skin
condition, you should seek medical advice as to whether
you should be handling clean or sterile goods.

Handwashing and hand care are equally

important in the IAP and sterile zones,
to protect the reusable medical devices
from contamination by you.

Standard Precautions and

Infectious Agent Transmission
Standard Precautions are operating procedures that apply
in healthcare to minimizing the risk of infection regardless
of the perceived infectious risk. The approach is based
on the understanding that all blood and body substances
should be considered potentially infectious, therefore all
surgical instruments could be potentially contaminated
with microorganisms.

The precautions include elements such as:

• Handwashing
• Use of PPE
• Safe systems for handling blood and body
fluid contamination
• Sharps awareness and implementation of
environmental controls
• Appropriate processing of RMD
• Medical condition management
• Education and training
• Aseptic technique
• Vaccination

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 In the decontamination zone, Standard Precautions are
relevant to handling reusable medical devices, anything
associated with them or the environment they have
contacted once they have been used, up to the point after
decontamination has been completed.

The rationale for this is that some patients may

unknowingly be carriers of disease agents or they have
withheld the fact from their medical history. Others may
have had surgery before diagnostic tests were completed
or they may only be in the early stages of a slow disease
such as Creutzfeldt-Jakob (CJD). All of these unknowns
could contaminate reusable medical devices, transport
trays and boxes and be an unknown infection risk to the
unaware decontamination staff and their environment,
hence the Standard Precautions approach.

Chain of Infection and Routes

of Transmission
The spread of microbial infection requires three factors:

• A source of infecting microorganisms at a sufficient

level to cause infection
• Susceptible host or hosts
• A means for transmitting the infectious agent to the
susceptible host or hosts

The means of transmission may involve one or many steps

and is often referred to as the chain of infection.

Within the healthcare environment, much effort is invested

in trying to prevent the transmission of infection. Many
patients entering a hospital may have an infectious
disease or may be carrying infectious microbes. Over
time, a wide variety of these microbes accumulate in the
healthcare environment and are spread around it in many
different ways including: in the air, on cart wheels, shoes,
staff and other patients.

This collection of microbes is referred to as a reservoir of

infection. The hospital staff constantly try to minimize
this reservoir by thoroughly cleaning and disinfecting
the environment and equipment and by treating the

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 patients with antimicrobial drugs and applying various
hygienic measures. Cleaning, disinfecting, drugs and
other measures can kill them, but microbes can also
develop resistance and become much more dangerous.
Recent examples of this are Methicillin Resistant
Staphylococcus aureus (MRSA), multi-drug resistant
Tubercle bacillus (MDR TB) and Carbapenem-resistant
Enterobacteriaceae (CRE). Prompt treatment
Decontamination
Infectious Agent Rapid Identification of Organism

Good Health and H

Susceptible Treatment of Primary Disease
Reservoir Environmental San
Host Recognise High Risk Patients Disinfection/Steriliz

Aseptic Technique Proper Attir

Portal of Portal of Wound Care Hand Hygie
Entry Exit Hand Hygiene Trash and Waste
Catheter Care Controls of Secretions

Mode of Transmission Hand Hygiene

Airflow Control
Figure M2–33 Chain of infection Disinfection/Sterilization
Proper Food Handling
Because patients in hospital are usually in poor health Isolation Precautions

and their immune system may not be functioning very well

(immunocompromised), they are particularly susceptible
to infection. If they have surgical or other wounds, they are
at even more risk. This is why we try to break the chain of
infection from the various sources or reservoirs through the
use of infection control at all levels. In the CSSD, we stop
the transmission of microbial infection by decontaminating
potentially infected reusable medical devices and ensuring
that only properly decontaminated reusable medical
devices are used on patients.
Prompt treatment
Decontamination
Rapid Identification of Organism

Good Health and Hygiene

Reservoir Treatment of Primary Disease Environmental Sanitation
Recognise High Risk Patients Disinfection/Sterilization

Aseptic Technique Proper Attire

Portal of Wound Care Hand Hygiene
Exit Hand Hygiene Trash and Waste Disposal
Catheter Care Controls of Secretions and Excretion

Hand Hygiene
Airflow Control
Disinfection/Sterilization
Proper Food Handling
Isolation Precautions
Figure M2–34 Breaking the chain of infection

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 Patients who become infected by microbes while in
hospital are said to have a healthcare-acquired infection
(HAI). This is also known as a nosocomial infection.
Staff working in the healthcare environment are also at
risk from infection, however, they are healthy, they may be
vaccinated against a number of diseases, they wear PPE
and they are trained to use Standard Precautions. This
protects them and also helps prevent them from being a
reservoir of infection or a means of transmission.

Maryam: Where do infection risks occur in the decontamination zone?

Khaled: Used reusable medical devices and materials which they have
been in contact with could be sources of infection. The staff working in
the CSSD could be the susceptible hosts, particularly, for example, if they
are not vaccinated against hepatitis B or are immunocompromised in
some way. Means of transmission could be through accidental splashes,
contact or aerosols for example.

Microbial infections are transmitted in the following ways:

Injection —  deliberate or accidental penetration of

the skin or mucous membrane, for
example, a needlestick, or an
open wound
Ingestion — swallowing into the digestive tract via a
splash or droplet
Inhalation — enter the respiratory tract via a droplet
or aerosol
 Contact — transfer from a contaminated object
to the skin, eye, mucous membrane via
a hand, glove, mask, droplet, or splash

The role of PPE, Standard Precautions and infection

control is to prevent transmission, reduce risk and break
the chain of infection.

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 Accidental Needlestick or Sharps Injury

Many reusable medical devices are designed to puncture or cut

skin or tissues (sharps). After use, these may be contaminated by
pathogenic microbes. Some of these are designed for single use
(e.g., hypodermic needles, transfusion sets, and scalpels) and will
be discarded into the infectious waste stream. This is usually done
in the operating room or surgery however some of these items may
enter the CSSD mixed in with other reusable medical devices and can
accidentally cause injury to the person handling them. If this occurs,
report it immediately and seek medical attention. The main risks are
from bloodborne viruses. Because of this, CSSD staff are usually
vaccinated against these risks when they start work in the CSSD.
Know the local policy on sharps or needlestick injury and to whom
these should be reported.

More importantly, be vigilant —

minimize risk and avoid needlestick
Aerosols
or sharps injury.

An aerosol is defined as being a suspension of tiny particles

or droplets in the air. The size of the droplet, initial velocity and
environmental conditions generally determine how long it will remain
in the air and how far it will travel. An aerosol becomes a means of
infection-transmission if the droplets or particles contain microbes.
This may spread the infectious agent from a contaminated site
or reservoir to a person or to another site which then becomes
contaminated.

An aerosol may form in the CSSD when handling liquids, operating an

ultrasonic bath, running a tap, brushing or blowing on a wet surface or
when ventilation/humidification units release contaminating microbes.
Manual brushing of contaminated reusable medical devices should be
carried out only while the device is submerged in the sink.

Figure M2–35 Keeping the lid closed when using the Figure M2–36 Coughing, sneezing or even talking creates an aerosol of microbes
ultrasonic bath prevents escape of aerosols. from your respiratory tract.

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 While large droplets do not travel very far, tiny droplets (5–10 microns,
true aerosol) can remain airborne for many minutes. (Figure M2–36).
The size of aerosol droplets or particles also affects the extent of lung
penetration if you inhale them. The smaller they are, the further they
penetrate and this usually creates a higher risk of becoming infected.

Nasopharyngeal
Particles
Naso-Pharyngeal
Particles

Inhalable Fraction
Tracheobronchial
Particles
Tracheo-Bronchial
Particles

Pulmonary

Alveolar
Particles

0.1 100
Particle size (µm)

Figure M2–37 Deposition regions of the respiratory tract for the various particle sizes (source: Roy CJ, Milton DK.
N Engl J Med. 2004; 350:1710-1712, Massachusetts Medical Society)

DROPLET PRECAUTIONS AIRBORNE PRECAUTIONS

Distance
1m 10m+


.
Droplet nuclei
. .
. . . .
.
.

100µm
Droplet size
50µm
 <5µm

Zaire ebolavirus
Respiratory viruses e.g., influenza A virus, coronavirus, rhinovirus

Figure M2–38 Droplet size and microbial transmission distance (source: Prof Ian Mackay, Simple sketch of droplet and airborne virus and
bacterial transmission, http://virologydownunder.blogspot.com)

Further Reading
For further reading, go to journals.plos.org on the internet, and search for
Airflow Dynamics of Human Jets: Sneezing and Breathing—Potential
Sources of Infectious Aerosols, published: April 1, 2013.

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 Housekeeping and Infection Control

The CSSD is a busy and critical location

where the links in the chain of infection are
broken. An important part of breaking the
links is cleaning and disinfecting the CSSD
itself and properly managing
waste streams.

Each zone within the CSSD should have

its own dedicated cleaning equipment.
Best practice recommends that each zone
clearly labels or color codes their cleaning
equipment. It is then easily identified as
in the wrong zone when borrowed or
misplaced.

• Store the cleaning equipment

(e.g., mops, buckets, and
chemicals) in a dedicated
storage room and clean and
inspect regularly
• Train staff responsible for cleaning
the zone in all aspects of cleaning
• Record cleaning activities and
monitor the quality of the
cleaning regularly

Waste material are generated in the three

zones of the CSSD. Use bins or containers
to help receive waste and segregate it into
appropriate waste streams.

Wastes from the IAP and sterile storage

zones are not an infectious risk. Waste
generated in the decontamination zone
is an infectious risk, and an important
waste stream to control. Placed this waste
in appropriate bags or bins, with sharps
waste in a dedicated sharps bin. Seal
and disinfect the exterior of the waste
containers before taking them out to the
waste collection point.

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 Exercises and Checklists

Exercise 1

Go to your log book and complete module 2, exercise

“Follow the Glow Germ”.

Exercise 2

Complete the Check Your Knowledge questions in your log book.

Exercise 3

Fill out the skills/competencies table for module 2 in your log book.

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 66 Microbiology and Infection Control

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 Module 3
REUSABLE MEDICAL
DEVICE TYPES

Key Terms
martensitic | austenitic | forging | casting
machining | sutures | serrations | distal
saline | fascia | pitting

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 Learning Outcomes

By the end of this module you will be able to:

 Differentiate between the basic instrument categories

and understand the special requirements of each
category

 Explain special handling requirements for scopes

 Explain common manufacturing methods for

surgical instruments

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 Introduction

This module provides an introduction to standard

surgical instrument types used in most surgical
specialties. We’ll also look at power tools and
commonly used reusable medical devices that
require specialized processing consideration.

Pre-Module Quiz

Keep these questions in mind as you go through the content

and don’t worry if you don’t know the answers yet—that’s
what you’re here to learn.

Q: W
 hat are the most common materials used for making
surgical devices?

Q: What does forging mean?

Q:What part of a device is the box lock?

Q: What is martensitic stainless steel?

Q: W
 hat are fiber optics made of and in what devices are
they used?

Q: W
 hat is the difference between acid-based and laser
etching?

Q: C
 an you list at least three common cleaning solutions
used at home that you should not use when cleaning
surgical devices?

Standard Device Manufacturing

Most items we use in our daily lives are manufactured in

factories using automated equipment that can produce
thousands of units per day. Surgical device development
has benefited from this technology but also requires time
consuming hands-on labor by skilled crafts persons and
special material considerations to ensure they can be used
safely on patients.

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 Raw Ingredients

Many types of materials are used in surgical device

manufacturing, such as but not limited to:

• Titanium
• Copper
• Silver
• Stainless steel
• Plastics
• Glass

With advancing technology and new manufacturing processes

a wide variety of materials may be used for device design
but stainless steel is still the most commonly used. Although
called “stainless steel” it can still spot, rust and stain but is
more resistant to these effects and if cared for properly should
perform as designed and last a long time. With the wide range
of different requirements of surgical devices depending on
their expected usage there are also different types of stainless
steel required.

Common Stainless Steel Grades

Martensitic Stainless Steel—made from 400

series stainless steel, is hard and used when
sharp cutting edges are needed, and commonly
found in scissors, osteotomes, chisels, rongeurs
and needleholders.

Austenitic Stainless Steel—made from 300

series stainless steel, offers higher corrosion
resistance but does not provide the hardness of
the 400 series so is more workable and malleable,
and is used commonly in retractors, cannulas and
suction devices.

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 Manufacturing Definitions

Casting—liquid metal is poured into a mold, then

allowed to cool and solidify.

Machining—a piece of metal is cut and carved into a

final shape and size by a controlled removal process.

Forging—metal is shaped by heating, pounding and

compressing, creating a stronger piece than if it was
cast or machined.

Tempering—heat treating metals such as steel to

achieve greater hardness and decrease the brittleness.

Passivation—a chemical reaction that creates a shield

layer of material that protects against corrosion.

Etching—applies a company name, part number and

country of origin to a device using a stencil.

Manufacturing Process

Forging is used for the manufacturing of most stainless

steel reusable medical devices in use today as it gives a
stronger piece than casting and machining alone. First
an outline is made from a bar of stainless steel, then
the device is ground and milled to remove the excess
steel to create the necessary functional details such
as serrations and ratchets. This process can require
more than 20 milling operations to achieve the required
specification.

Today, sophisticated machines assisted by computing

power are used more frequently than hand tools of
the past, but despite these advances, surgical device
making still requires hands-on intervention from skilled
craftspeople. These device makers carry out hundreds
of quality and finishing checks and need several years
of training to become competent at their craft.

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 When the assembly process is completed the reusable
medical devices are tempered to improve hardness, then
polished to achieve a smooth finish. Finally, passivation
is carried out using nitric acid (HN03) to remove all the
iron content still found on the outside layer of the device.
This final step helps to build a protective outside layer
of chromium oxide (Cr2O3), which is highly resistant
to corrosion, and continues to build up throughout the
device’s life.

The reusable medical device will be carefully examined

to ensure all the functional aspects such as ratchets, tips,
scissor blades, serrations, box locks, and spot welds are
accurate and not faulty. Then the device is ready to be
etched and packaged.

The surgical device manufacturing process requires

multiple detailed steps requiring sophisticated tools and
highly skilled and experienced craftspeople. This is a
process that can’t be rushed.

Maryam: Why does it take so long for devices to be delivered after

we order them?

Khaled: The manufacturing cycle from forging to finished device

usually takes up to six weeks.

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 Classification and Overview of
Surgical Devices
Devices are designed for a specific surgical purpose and
if the incorrect device is used there could be damage or
injury to the patient, or damage to the device. Figure M3–1 A range of sizes

For example, one might incorrectly pull a metal rod out

with a needle holder instead of a heavier device designed
for this task such as pliers and this can damage the
needle holder.

To properly inspect and test surgical devices, CSSD

specialists must know the anatomy and points of Figure M3–2 A range of sizes

inspection of the devices, and how to measure them.

This will enable them to properly and efficiently assemble
device sets.

Surgical devices not only come in a range of designs

but also in a range of sizes. It is important not only to
recognize the type of device but also to know its size.

Key Parts of Surgical Devices Common Categories of

Surgical Devices
• Tip • Shaft (shank)
• Jaw • Ratchet • Scissors
• Box lock (hinge) • Ring handle • Needleholders
Tips • Tissue & Dressing
Jaw Inspect for
serrations for
Forceps
bioburden • Knife handles
Inspect for • Hemostatic Forceps
cracks and
bioburden
Box Lock
• Retractors
• Suction devices
Length in inches • Rongeurs
or centimetres
• Specula
Shanks
• Osteotomes and
Ratchet
chisels
Rings

Hemostatic Forcep How to Measure

Figure M3–3 Key parts of hinged surgical devices, how to measure

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 Scissors
The primary function of scissors is to cut tissue, sutures,
and other materials using metal blades pivoted so that the
sharpened edges slide against each other.

Blade Features of Scissors

Surgical scissors have various blade features for specific

surgical applications, including:

Tungsten Carbide Blades (TC) Gold Handled—for a

harder and stronger cutting edge that allows the blade to
stay sharper for longer periods than standard scissors;
the TC blade is embedded into the cutting edge. These
scissors have gold handles to visibly identify them as
TC blades.

Serrated Blades—saw-like teeth or notches prevent tissue

slippage during the cutting process.
Figure M3–4 Gold handled TC bladed scissors

Supercut Blades (SC) Black Handled—while all other

scissors cut using a crushing action, supercut scissors
have one blade sharpened like a knife to slice tissue
and the other blade is a standard design that causes a
guillotine effect. Supercut scissors have a more frequent,
special sharpening process, and black handles for
easy identification.

Common Scissor Types

• Mayo—primarily for cutting fascia (connective

tissue) beneath the skin
• Metzenbaum—cutting delicate tissue and blunt
dissection
• Tenotomy/Stevens—for delicate surgery

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 Needleholders
These devices, sometimes called needle drivers, are
designed to push suture needles through tissue to close
surgical sites

Needleholder How to Measure

Inspect Jaws
for tread ware
Jaws

Inspect for Neck

cracks and
bioburden
Box Lock

Shanks

Length in inches
or centimetres

Ratchet

Rings

Figure M3–5 Anatomy and points of inspection of a needleholder, how to measure

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 Common Needleholder Jaw Types

Similar to scissors, needleholders have different jaw types

depending on their intended use.

Stainless Steel Jaws—stainless steel jaw treads are

designed with two types of patterns, smooth or serrated
and can’t be repaired or resurfaced once they have worn
out. Needle holders with this jaw will need to be replaced
often if heavily used, so they are better suited to units with
low activity and turnaround.

Tungsten Carbide Jaws (TC) Gold Handled—tungsten

carbide jaws are the most popular type for needleholders
in surgical use as they are harder, last longer and grip Figure M3–6 needleholders with stainless steel
needles more firmly. Additionally, the jaw insert itself can be and tungsten carbon jaws

replaced when necessary rather than the full device. Like

scissors, these devices have gold handles to identify the
TC inserts.

Common Needle Holder Types

• Crilewood
• Mayo-Hegar

Common Tissue and Forceps Types

Tissue forceps are tweezer style forceps designed to
manipulate tissue. They have multiple teeth at the distal
(away from the point of attachment) tip to assist in grasping
tissue with a more secure grip. The most common teeth
configuration is an interlock design with one tooth on one
side and two on the other (1x2) but they can also be found
in 2x3, 3x4 and higher configurations. Dressing forceps are
identical to tissue forceps except they have serrations rather
than teeth at the distal end. The primary function of this
device is to manipulate tissue and to pack surgical sites.

Common Tissue and Forceps Types

• Standard Bonnets • Ramsey
• Adson • De Bakey
• Mc Indoe • Russian
• Gerald • Waugh
• Bonney

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 Tips/Teeth Handle Proximal End

Inspect for
Inspect for teeth and bioburden
proper alignment Inspect for cracks

Figure M3–7 Tissue forceps

Tips serrations/Teeth Handle Proximal End

Inspect for
Inspect for alignment bioburden
Inspect for cracks

Figure M3–8 Dressing forceps

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 Knife Handles
A knife or scalpel is a tool with an extremely sharp cutting
edge or blade. Scalpels may be reusable but normally,
single-use blades, attached to re-usable handles are used,
as they give better cutting ability and reduce the chance of
injuries to hospital staff during reprocessing.

Figure M3–9 Knife handles #3 #4 #7

Maryam: In the picture, handle #3 and #7 are different lengths but

they look like they have a similar head size, is that common?

Khaled: That’s a great observation Maryam, the head is the same and
most blades are designed to work with the #3 and #4 heads.

Common Types of Blades

There is a large assortment of

Chart M3–10 blades available;
here is a common chart:

Figure M3–10 Blade types

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 A number of videos relating to the safe handling of scalpel
blades and avoiding damage to them may be viewed at
swann-morton.com/interactive.php

Hemostatic Forceps
Hemostatic forceps main function is to control the flow of
blood. The jaw features can consist of full serrations (Crile)
or partial serrations (Kelly).

Hemostatic Forcep How to Measure

Tips

Jaw Inspect jaw

serrations for
bioburden

Inspect for Box Lock

cracks and
bioburden

Shanks
Length in inches
or centimetres

Ratchet

Rings

Figure M3–11 Hemostatic forceps

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 Identification of Hemostatic Forceps

Inches Cm

Length Jaw Pattern Name

3.5-4 9-10 Full Serration Hartman Mosquito
5 12.5 Full Serration Halstead Mosquito
5.5-6.25 14-16 Full Serration Crile Hemostat
5.5 14 Partial Serration Kelly Hemostat
6.25-14 16-35 Full Serration Rochester Pean
5.75-14 14.5-35 Full Serration Rochester Ochsner or Kocher
Longitudinal Serration and Cross
6.25-8 16-20 Rochester Carmalt
Serrated Tip

Mosquito, Crile and Pean forceps

Figure M3–12 Identifying hemostatic forceps

Halstead Mosquito forcep is 5’’

Crile Hemostat five½”

Common Hemostatic Forceps

• Crile
• Kelly/Pean
• Mosquito

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 Retractors
The main function of retractors is to move tissue aside
for visualization of the surgical site. Retractors can be
hand-held, self-retaining, or table-mounted. Smaller
retractors held by the hands retract skin and tissues,
while larger retractors are used to retract muscle tissue
and organs.

Richardson
Retractor Width

Depth

Blade
Hollow
handle

Inspect blade
for burs
Shank Length in inches
or centimetres
How to Measure

Loop handle

Figure M3–13 Anatomy and points of inspection of a retractor, and proper measurement

Common Hand Held Retractors

• Senn Miller
• Richardson
• Kelly

Weitlaner Retractor
Self-Retaining Retractors

Are designed with a mechanical action that keeps them

open to a particular extent allowing retraction without
handling.
Push down and
release should
spring back up
Inspect for
Common Self-Retaining Retractors cracks and
bioburden

• Weitlaner
• Gelpi
• Beckman-Adson
Figure M3–14 Self-retaining retractors

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 Suction Devices
The primary function of suction devices is to remove blood
and fluids from the surgical site.

Some suction devices include a wire or metal stylet that is

used to remove blockages during procedures. This is not
meant to be used to clean the device in CSSD; a proper
cleaning brush must be used.

Frazier Suction Tube

Tip
Shaft

Inspect for dents

Suction Control Hole

Stylet
Diameter measure in
french scale
Length in inches
or centimetres

How to measure

Figure M3–15 Anatomy and points of inspection for a suction device, and proper measurement

Common Suction Devices

• Baron
• Poole
• Frazier

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 Rongeurs
The function of a Rongeur is to cut or bite away at bone
and tissue and can come in single or double action
closure design. For procedures requiring stronger cuts
double action is preferred as it reduces the amount
of hand strength required. These items need special
care in cleaning and lubrication due to their additional
movements.

Double action Rongeur

Inspect jaws for Inspect jfor cracks

cutting edge damage and bioburden

Inspect for cracks

Figure M3–16 Double action rongeur

Common Types of Rongeurs

Kerrison/Laminectomy—designed
specifically for spine surgery to remove the
disc or lamina. This device requires special
care and inspection in CSSD to ensure Figure M3–17 Kerrison/laminectomy rongeurs inspection for bioburden and
cutting edge damage

that microbial contamination (bioburden)

is not remaining, the cutting edge is not
damaged and that it is lubricated to ensure
good movement.

Nail Nippers—cut toe and finger nails and

occasionally, trim small bone fragments.
The cutting surface edge should be
inspected along with the hinge area
and spring.
Figure M3–18 Nail nippers

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 Specula Chisels and Osteotomes
A speculum is used to expose the anal, Both of these surgical instruments are
nasal and vaginal cavities and frequently designed to cut or carve away bone and
has thumb screws to make them tissue when struck with a mallet. Chisels
self-retaining. have one angled or beveled side while
osteotomes are angled on both sides.

Figure M3–19 Speculum Figure M3–20 Chisel and Osteotome

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 Care of Surgical Instruments

Within minutes, blood and tissue can begin to dry on

surgical devices making it more difficult to clean and
process in CSSD. Precautions should be taken to remove
gross soiling during procedures and to ensure that
blood and soil is not allowed to dry on devices after the
procedure is completed. This can be achieved by spraying
with an enzymatic foam/detergent or covering with a
moistened towel.
Solutions that Damage Devices

Surgical devices are a sizeable investment Saline may seem like a safe solution
for a hospital so it is critical that only compared to the others above, but must
compatible chemicals and solutions are never be used as a soaking or rinsing
used for their reprocessing to ensure they agent as it accelerates the rusting and
are not damaged and remain safe to use pitting of surgical devices and in most
for patients. cases will void device warranty.

Many of the solutions we use for For clinical reasons, stainless steel devices
housekeeping and kitchen-related cleaning may be exposed to saline, but it must be
purposes can damage stainless steel removed by operating room staff as early
devices so must never be used. The as possible.
product container will state on the label,
that the intended purpose is for use on
surgical devices, otherwise the product
should not be used.

Examples of some common solutions not suitable for surgical devices:

• Bleach • Laundry detergents • Peroxide

• Dish soaps • Powder cleaners • Iodine
• Hand soaps • Betadine • Saline

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 Device Sharpness Testing and
Identification
Device Sharpness Testing

It is essential to monitor the sharpness of devices.

Figures 3.21 through to 3.27 illustrate proper sharpness
testing procedures for common surgical devices.
Sharpness testing packs are available for different types
of bladed surgical instruments.

These tests consist of color-coded test fabric and

instructions for testing. The fabrics are of differing Figure M3–21 Sharpness test standards kit
thickness and density and provide appropriate test
consistency for different devices. The fabrics are
rubberlike or made of hard cardboard. Typically, the thick
rubberlike fabric is red-colored and contains latex. A
latex-free equivalent is orange-colored. A thinner fabric for
smaller device testing is usually yellow-colored. Plain white
card provides test material for rongeurs and curettes while
chisels are tested by shaving slivers off plastic rods.

Scissors 4½” and larger

Test Material: Red test material—thick

Test: Scissors must be able to cut cleanly through to

the tips of the device, two to three times. The distal
tips of scissors are the most crucial portion because
this is the most used area and where they first
become dull.
Figure M3–22 Red test material

Scissors 4” or smaller

Test Material: Yellow test material—thin

Test: Scissors must be able to cut through the tip two

to three times. The distal tips of scissors are the most
crucial portion, and must cut clean through the tips of
the device.
Figure M3–23 Yellow test material

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 Bone Cutter

Test Material: Index card

Test: Cut off a piece of the index card.

Figure M3–24 Sharpness test for bone cutters

Kerrison and Laminectomy Rongeur

Test Material: Index card

Test: Properly punch a clean hole or clean bite

through the card.
Figure M3–25 Sharpness test for laminectomy rongeur

Double Action Rongeur

Test Material: Index card

Test: The rongeur should make a clean bite through

the card. Figure M3–26 Sharpness test for double-action rongeur

Bone Curette

Test Material: Plastic dowel rod

Test: Shave off pieces of the dowel rod.

Chisels and Osteotomes

Test Material: Plastic dowel rod

Test: Shave off pieces of the dowel rod.

Figure M3–27 Sharpness test for ostetomes

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 Device Identification
The common device types are shown above, but there
are so many other types and variants of these that it is
usual for hospitals to have hundreds and even thousands
of different surgical devices. The most effective way to
identify surgical devices is to keep accurate checklists
of tray contents that identify the manufacturer and model
number and give an accurate description. This is easier
in newer facilities, or ones that dispose of and replace
old models of devices frequently. However, in many
organizations, the manufacturer and model number
information may have faded. In this instance many
facilities use marking methods to speed up and simplify
identification such as:

Acid base etching—uses a stencil, solutions, and

electricity to mark stainless steel. It is semi-permanent,
and can be buffed off. This process can be done by an
outside company but requires minimal tools so can also
be completed in-house.

Laser etching—is permanent and costlier due to set-

up charges so is often outsourced rather than done
internally.

Electric etching (physical)—this old method of electric

etching or engraving was performed as it was quick and
easy to do but this method should never be used as it
damages devices and makes them more difficult to use.

Heat-fused nylon—a color-coding process referred to

as dipping, that is typically done only in a repair facility.
Heat-fused nylon leaves a thin layer of color on the
device that can last years but must be fully removed and
replaced when chipping occurs.

Device tape—the most common and popular method

for device identification is the use of colored tape that
can be affixed to the device. This method is inexpensive
and very simple to install but requires excellent quality
inspections to ensure it is properly replaced and won’t
risk patient safety.

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 Figure M3–28 Colored tape

For application, the following steps must be followed in the

inspection and assembly area with a device that has already
been cleaned and disinfected:

1. Wash your hands to remove oils, grease, and any

possible dirt.
2. Choose a location on the shaft or stem of the device.
Never put tape on the distal tip that will be used on
the patient as a piece could fall in the patient. Never
put tape on the rings as it could interfere with action
and increase the risk of the tape coming loose.
3. Wipe alcohol on the site of the device where the tape
will be placed to remove any lubricant or moisture that
might be on the device.
4. Wrap the tape around the device one, to one and
one- half, times. Apply the tape with a firm, pulling
tension but do not stretch.
5. After the tape is applied, autoclave the device to allow
the heat to help bond the tape to the device.

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 Vendor Repairs
We’ve discussed device types and ways to identify them.
Another consideration is the regular maintenance required
to ensure safe and effective use. To reduce the chance
of sets being out of service due to device servicing and
repairs it is critical to:

• Identify most frequently used surgical sets and

critical items that will require servicing
• Plan for repairs by purchasing additional critical
items to substitute for originals when they are sent
for servicing
• Ensure all devices are inspected carefully for
cracking or damage, especially around TC inserts

Device Lubrication

Surgical devices with moving parts must be lubricated

in accordance with the manufacturer’s IFU. The use of a
neutral pH lubricant reduces friction, making it easier to
use and extends the life of the device. Lubricants must be
approved for use as a surgical device lubricant and used
in the hinged areas or any working component such as a
moving or sliding area.

Powered Surgical Devices

Complex surgical procedures require specialized tools for
drilling and sawing that require strong forces that standard
hand tools can’t provide. These devices are powered by
electric motors, compressed air (pneumatic) or batteries
and dramatically improve procedure times to the benefit
of patients.

All powered surgical devices are highly complex and

fragile with hand pieces that cannot be submerged in
fluids and often have lumens, channels and attachments
with special cleaning requirements. In the past most of
these required manual cleaning and disinfection and
could not be processed in automated washer disinfectors,
and so presented a higher risk to CSSD specialists.
Fortunately, most newer powered surgical devices are
designed to allow automated processing and therefore
greater safety to specialists and patients.

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 For all powered surgical devices, it is critical to follow
exactly the specific manufacturer’s IFU. Similar devices
may require very different processing procedures.

Electric-Powered

Devices powered by electricity require a cable that

attaches to the handpiece and to a power supply/control
unit connected to an electrical outlet. Most manufacturers
recommend leaving the cable attached to the hand piece
during cleaning to reduce the chance of fluid entering
the device.

Arthroscopic shavers are an example of frequently used

electric-powered devices.
Figure M3–29 Powered shaver system control device

Pneumatic-Powered

Pneumatic (air) powered devices work the same as

electrical devices but instead of being connected to an
electrical outlet are connected to a compressed air line of
a cylinder (tank) that uses a regulator to maintain a stable
pressure.

Different types of powered devices require different

operating pressures, and a chart of these pressures
should be available where the devices are processed.
Extreme care is required because testing devices at an
improper pressure can injure the operator and/or severely
damage the device.

Battery-Powered
Devices powered by battery are the easiest to use of the
three available power systems as there are no cables
restricting movement in the sterile field. This freedom of
movement, however, comes with a price where batteries
require charging, increased handling and space to
accommodate the chargers and have a risk of not being
charged enough to last a procedure. Older designs relied
on batteries that were sterilized, which could negatively
impact power storage, but many newer systems allow for
batteries to be loaded in the operating room to ensure a
full charge.

Figure M3–30

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 Tip: To help protect battery equipment you can create
a wash room battery - repurpose an expired battery by
labelling it, and keeping it in the decontamination wash
room so that it can be connected to the handpiece when
manually washing to protect electrical components from
moisture.

The most common problems associated with powered

surgical devices are:

• Corrosion of internal components from steam

condensation
• Corrosion of internal components from immersion in
solutions or water
• Contacts become worn and affect connections of
electric systems
• Lack of preventative maintenance

To properly care for and handle powered surgical devices:

• Never immerse in any solution or water

• Do not use detergents or lubricants unless
specified by the manufacturer
• Properly insert the cleaning brush into attachments
• Carefully wipe and rinse the outer case taking care
that water does not enter
• Keep electric/air hose, or washroom battery
attached during decontamination to protect inner
component

Common Powered Surgical Devices

• Drills • Wire drivers

• Reamers • Sternal saw
• Oscillating/sagittal saws • Dermatomes
.

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 Rigid, Semi-Rigid and Flexible
Endoscopes
Originally, surgical procedures were carried out using an
“open” method where large incisions were made to access
the body tissues and organs. With newer technologies
allowing smaller and more complex devices, many
procedures are now carried out as minimally invasive or
laparoscopic allowing for minimal tissue trauma and much
faster recovery of the patient.

For this module we will focus exclusively on rigid and semi-

rigid endoscopes as flexible module will be addressed in
module 9 in full detail.

Rigid and semi-rigid endoscopes consist of many

elements; they may have some or all of the following:

• Eyepiece with lenses—the most expensive part as it

is comprised of precisely aligned lenses, spacers
and mirrors to give an accurate viewing field
• Water/air channels
• Biopsy channel—multi-use channel
• Fiber optic light bundles—glass fibers are
distributed throughout the endoscope to allow
transmission of light
• Fiber optic image bundles—glass fibers carrying an
image from the objective lens to the eyepiece
• Camera
• Control wire bundles—in flexible endoscopes

Light Post
Eyepiece
Ocular
Assembly Spacer

Lens Objective Angle of

Block Rod Assembly View

Figure M3–31 Rigid endoscope

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 Suction Valve
Air / Water Valve
Biopsy Valve Insertion Tube
Nozzle

Water Bottle Tube

Light Source
Water-Jet LIGHT SOURCE
Connector
Universal Cord Connector

Air
Air
Pipe Pump
Biopsy/Suction Channel Water Channel Suction
Connector
Air Channel Water-Jet Channel
WATER
BOTTLE

Figure M3–32 Flexible endoscope

With the smaller diameters required, fibers are also smaller

and more fragile which makes it easier to fracture or
misalign the glass rods. If they are not handled properly,
expensive repairs and long repair lead times can result as
this work must be carried out in specialized facilities. Video
cameras are also commonly used with scopes to record
and monitor the procedure in the OR.

Scopes, cameras, and cables

are extremely fragile, and
require gentle care.

Endoscope Reprocessing Procedures

The complex structure of rigid and semi-rigid endoscopes
requires additional considerations when reprocessing
such as:

Always follow manufacturer’s IFU—ensure compatible

detergents, disinfectants and sterilization processes are
used and that correct disassembly and reassembly and
checking processes are followed.

Do not process in the ultrasonic washer—endoscopes

are made with glass lenses and fiber optic bundles; most
endoscopes are not compatible with ultrasonic washers.
Ultrasonic washers are explored in Module 5.

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 Gentle manual washing—endoscopes should be soaked in an
enzymatic solution and manually hand cleaned, brushed and
rinsed with copious amounts of water, being very careful not to
bend or drop them.

Most newer endoscopes are compatible with automated washer

disinfectors (WD) so should not require extensive manual
cleaning.

Immerse only for recommended time—do not leave

endoscopes in detergents or disinfectants longer then the
recommended duration as it may cause damage.

Use protective cases—use protective endoscope cases with

open mesh or perforated designs to reduce handling and allow for
automated washing.

Handle correctly—handle endoscopes only at the heavy

eyepiece end with support at the other, distal end.

Avoid bending, dropping or striking the metal shaft—any

tension along the shaft can alter the spacing of the rod lenses and
cause damage.

Extreme caution with thinner endoscopes—endoscopes with

shaft diameters of less than 5mm have less tensile resistance in
the shaft and are more prone to damage when pulled or stretched.

Avoid touching the lenses—the ocular and objective lenses

can be easily scratched or damaged so use soft materials
when cleaning.

Wipe lens with alcohol—if using lubricant in your automated

washer, ensure to wipe the lens with 70% isopropyl alcohol to
remove any residue or film prior to sterilization.

Always remember endoscopes

are very fragile and must be
handled with extreme care at
all times

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 Exercises and Checklists

Exercise 1

Define the terms listed for this module in your log book.

Exercise 2

Explore what surgical instruments and reusable medical devices

your unit reprocesses and complete the checklist in your log book.

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 Module 4
REUSABLE MEDICAL
DEVICE TRANSPORTATION

Key Terms
Association of peri operative registered nurses (AORN) | cart washer
saline | operating room (OR) | needlestick | sharps
impermeable bags | incident report | adverse occurrence report

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 Learning Outcomes

By the end of this module you will be able to:

 Use, handle and care for transport equipment

 Select appropriate PPE for transportation and handling tasks

 Use Standard Precautions when transporting reusable

medical devices

 Identify locations for issue and collections of reusable

medical devices and the importance of restricted access to
these rooms

 Explain decontamination procedures for transport equipment

 Take appropriate action when any faults occur in transport

equipment

 Explain unit and organizational policies and procedures

relevant to the transportation of hazardous materials

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 Maryam: What is so important about transporting the contaminated
surgical instruments?

Khaled: Surgical instruments may have been exposed to dangerous

microbes like Hepatitis B & C or HIV so transporting them around a
facility could expose staff and patients to these hazardous items. Also in
larger healthcare facilities the distances travelled are far longer and
sometimes between buildings so we need to make sure items are
contained to prevent the risk of exposure.

Introduction

In this module, Reusable Medical DeviceTransportation,

we’ll cover safe methods and precautions required when
transporting contaminated surgical instruments and reusable
medical devices. Safe transportation is necessary to protect
RMD against accidental damage, and to protect staff, patients
and visitors, as RMD may be hazardous and pose a significant
risk. We’ll also cover other integral components associated
with safe transportation of RMD including PPE, waste disposal,
documentation, equipment and transport methods.
Pre-Module Quiz

Keep these questions in mind as you go through the content and don’t
worry if you don’t know the answers yet—that’s what you’re here
to learn.

Q: Who is at risk when transporting reusable medical devices?

Q: What PPE do you think is required for transporting reusable medical

devices?
Q: What might be some important features of a transport container?

Q: W
 hat do you think you would do if you spilled contaminated items
on the ground when moving them?

Q: W
 here should contaminated surgical instruments be stored until
they are collected?

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 Requirements

When we are transporting contaminated items back to

CSSD from the point of use the following requirements
need to be reviewed and defined:

• Pre-cleaning
• Transport containers
• Spill kit
• Transport carts
• Handling

The main risk to someone transporting used, reusable

medical devices, is from the potential risk of pathogen
transmission if PPE is not used or is used incorrectly. As
discussed in module 2, we are unable to see dangerous
pathogens so we must assume all items used on a patient
are potentially infectious.

Pre-cleaning
The Association of periOperative Registered Nurses
(AORN), which is the leading advocate for practice
in operating rooms (OR), advises staff to begin the
decontamination process immediately after use on a patient,
which can be achieved both during the procedure and
before transportation.

During the Procedure

A simple but effective way of reducing risk is for the OR

nurse or end user to wipe the surgical instruments down
with a moist, lint-free swab or cloth during the procedure and
after use. The swab can be moistened using sterile water.
Never use saline, which is a mixture of sodium chloride and
water as it can damage stainless steel due to its
corrosive effect.

Before Transportation

Enzymatic foam sprays (Figure M4–2) or pre-moistened

plastic bags are recommended to allow the breakdown
of contamination with enzymatic action or to minimize the
drying of contamination onto items.
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 Figure M4–1 Wipe the surgical instruments down with a moist, lint-free swab Figure M4–2 Foam sprays

Safety step—remove all disposable items prior to sending

reusable medical devices to CSSD, including needles, any
sharp disposable items like blades and wires, and sponges
or gauze that may hamper visibility and increase the risk
for injury.

Both practices improve safety by reducing contamination levels with wiping, ensuring the
decontamination process starts immediately with the enzymatic spray and reducing the
chance of drying by bagging as blood is extremely difficult to remove if left to dry on the
RMD for any period of time.

A nurse in the OR will already be wearing full surgical PPE during the procedure such as:

• Hair cover • Gloves

• Gown with sleeves • Scrub shoes or shoe covers
• Facemask with visor

For other areas or users, they must, at minimum, be wearing gloves and also a mask with
visor if spraying items with enzymatic spray to protect from a possible eye splash.

Maryam: Why are the surgical instruments kept moist?

Khaled: For the same reason we rinse our dishes at home. Have
you ever tried to clean off food that has dried or cooked onto your
dishes or cutlery? By keeping the surgical instruments moist, you
make them easier to clean and disinfect.

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 Transport Containers
We now have safer surgical instruments as the user wiped
them, sprayed them with an enzymatic and/or placed them in
a moist bag. The transport container is the next critical step
to protect the surgical instruments and to ensure the safety of
those handling the reusable medical devices, the environment
and others. When storing items until they are ready for transport
from the point of use to the CSSD, containers must be located
in a soiled utility room that has access control and negative (–)
air pressure to ensure that air is contained and does not pose a
risk to other staff or patients outside of the room.

Bins with lids and closed sterilization container systems are

among the preferred types of containers to be used to transport
contaminated items. All transport containers should be:

• Leak-proof to prevent fluids from spilling out

• Rigid, to contain RMD and prevent them from
becoming a hazard when handled
• Capable of being closed securely, and preferably
lockable to prevent tampering
• Clearly identified with biohazard labels to identify the
risk to others
• Clearly labeled, where applicable, with the identity of
the user and the contents
• Sufficiently robust to prevent RMD being damaged
in transit
• Easily cleaned, disinfected and dried if reusable, or
discarded (as appropriate)

Individual or loose items are placed in impermeable bags

within the container. Sterilization containers, which will be
discussed in Module 6, should only be used for transportation
of reusable medical devices if they will be processed in an
automated washer disinfector (AWD) after each use.

As we discussed in module 3, a wide range of reusable

medical devices require special handling to reduce the risk
of damage to them, and the hazard to our safety, especially
when contaminated. Sharp items like scissors and skin hooks
pose a greater risk as they can puncture or pierce gloves and
skin (Figure M4–3 and Figure M4–4).

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 An additional risk of needlestick and sharps injuries can
occur where commonly used single-use needles and sharp
items, like blades, staples and glass, are accidently left
in the container. All sharps and disposable items should
be removed prior to placing reusable medical devices in
transport containers for collection. If these items have been
accidentally left in the transport container, then you must
report it immediately as it poses a risk to staff safety.

Figure M4–3 Sharp medical scissors Figure M4–4 Skin hooks

Maryam: What if transport containers are not available?

Khaled: As we talked about, transport containers provide a critical

role in safety so they should always be used. If they aren’t available,
the person transporting the surgical instruments must take care that
sharps do not visibly protrude from baskets or puncture transport
bags until a correct container can be purchased.

Figure M4–5 Transport containers

Transport containers protect the surgical instruments

from damage during transit and the handler from possible
contamination.
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 Spill Kit
Our users have taken great care to pre-clean and spray the
used surgical instruments, remove all needles and sharps,
and place them in closable sealed containers—ready to be
transported to CSSD.
Figure M4–6 Biohazard spill kit

This is where an additional hazard may occur, especially if

containers are not used, as there is always a risk of surgical
instruments or containers being knocked or dropped when
being transported from one location to another. Contaminated
items soiled with blood or bodily fluids can fall on the floor. If
this happens in a public area the infection risk to patients and
families from dangerous pathogens is increased.

Standard Precautions must be used to contain the hazard and

a spill kit (contents determined locally), should be available for
trained staff to use to clean up the spill. (Figure M4–6).

Only trained staff should handle the cleaning of spills, using

the following as a guide:

• Get help and put warning signs in place

• Collect the spill kit
• Follow protocol precisely
• Check the material safety data sheet if indicated
• Put on PPE
• Assemble cleaning equipment
• Clean the spill
• Dispose of waste appropriately
• Replenish supplies
• Complete an incident or adverse occurrence report

Adverse Event Procedure

Adverse events may include: potential or actual sharp injury,

significant/dangerous spills, personal injury or accident, or
negligence on another’s part.

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 When an adverse event occurs:

• Follow local protocol

• Seek assistance if unsure
• Report to senior person, team leader/manager promptly
• Document the adverse event through your organization’s
report form

Transport Carts (trolleys)

We discussed the importance of transport containers and how to
deal with spills but in order to transport items safely back to CSSD
without ever dropping or spilling we need to focus on the correct
transport cart. Key factors to consider are:

Closed Cart

Ideally closed or at minimum covered, to protect when transporting

reusable medical devices through public areas and reduce the
chance of items falling out of the cart.

Correct Size and Weight

The cart should be an appropriate size with adequate shelves to

hold the items being collected without stacking or overfilling, with the
potential for damage to reusable medical devices, and increasing the
risk of falls and spills.

The size must also be appropriate so users have safe visibility when
moving them through corridors and be of an appropriate weight that
allows them to be moved in a controlled manner. Larger and heavier
carts may need two people to move safely.

Washable

The cart should ideally be compatible with a cart washer if

available, or be designed to facilitate effective manual cleaning and
disinfection between uses.

Servicing

The carts should be constructed from robust materials to withstand

the rigors of daily use. Doors, shelves and wheels must be
maintained to ensure safety and ease of use to the users
transporting items in the facility.
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 Handling
We discussed the key requirements for safety when
transporting contaminated surgical instruments and are now
at the final step of handling.

Collection Preparation

Proper handling starts with being prepared. Make sure you do

the following:

• Select the most appropriately sized cart for the

collection process and ensure it is functioning correctly
• Bring spare gloves if collecting from areas that may
not have them available
• Bring any required documentation necessary to log
items being collected

Soiled Collection

All items have been prepared, placed in transport containers

and either left in a soiled utility room, or in a transportation
cart for collection. When loading or unloading transport carts
Standard Precautions must be followed as the containers
may have been contaminated when handled by the user.

When collecting individual containers (multiple areas) to

place in a transport cart:

• When you arrive at the soiled utility room, perform

hand hygiene and put on clean gloves
• Before transferring items, move the transport cart as
close as possible to the container(s) and open the doors
of the cart. This will reduce the distance to carry items
and minimize the risk of dropping them
• Place heavier items on the middle or lower shelves
and never on high shelves to reduce the risk of
dropping
• When all containers have been placed inside the
transport cart remove your gloves and perform
hand hygiene before closing the doors to reduce
contaminating the outside of the cart
• Document your collection after your hands are clean.
• If you discover sharps or items that should have been
discarded, make sure to report to your supervisor
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 When collecting a closed cart from a soiled utility room:

• Perform hand hygiene and put on clean gloves if you

are opening the transport cart to verify contents
• Perform hand hygiene after handling to ensure the
outside of the cart is not contaminated and also before
any documentation is completed

When travelling through the facility make sure you:

• Take care to follow correct hand hygiene and glove

techniques to reduce the chance of contaminating
other areas of the facility
• Do not leave contaminated transport carts unattended
particularly if they cannot be locked as other staff or
patients could open them and put themselves at risk
• When collections are complete, bring your cart back to
CSSD for decontamination
• Ensure appropriate hand hygiene and PPE are used
before transferring items
• Empty carts should be processed through a cart
washer if available or manually cleaned and
disinfected if not, as per local policy

If these practices are followed correctly, the risk of

transmission should be very low for the CSSD staff collecting
RMD and others in the organization. Many facilities have
variations of these processes and if so, they should be
discussed with and validated by the infection control
department to ensure safety

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 Exercises and Checklists

Exercise 1 - Documentation

Check your organizations policies and procedures.

Check your log book for instructions and complete the documentation.

Exercise 2 - Procedure

Visit the OR and follow a used surgical tray after use back to the CSSD.

Check your log book for instructions and complete the documentation.

Exercise 3 - Scenario

You have arrived at the soiled utility room to collect contaminated
surgical instruments.

Check your log book for instructions and complete the documentation.

Checklist

Complete the checklist.

Check your log book for instructions and documentation.

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 Module 5
CLEANING AND DISINFECTION

Key Terms
thermo-labile | critical | semi-critical | non-critical
shadowing | stylet | lumened | thermometric
ultrasonic | kitemark

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 Learning Outcomes

At the end of this module you will be able to:

 Effectively complete daily test procedures of

reprocessing equipment

 Identify the different cleaning processes required

for different types of reusable medical devices
and equipment

 Demonstrate correct device preparation, basket loading

and configurations for washer disinfectors and ultrasonic
washers

 Identify reusable medical devices that require special

processes or attention

 Demonstrate clear knowledge of the limitations of manual

cleaning processes

 Outline specific cleaning processes for non-submersible

items

 Understand the importance of maintaining a clean and

tidy work environment

 Explain local standard operating procedures related

to cleaning and disinfection of contaminated reusable
medical devices

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 Introduction

This module covers methods of receiving, cleaning

and disinfecting contaminated reusable medical
devices. We discuss equipment used for automated
processes such as washer disinfectors, ultrasonic
washers, and cart washers as well as manual
cleaning and disinfection processes. We’ll also cover
procedures for testing equipment, water quality, and
chemistries.

Pre-Module Quiz

Keep these questions in mind as you go through the content

and don’t worry if you don’t know the answers yet – that’s
what you’re here to learn.

Q: C
 an you name the three Spaulding classifications?

Q: W
 hat are two of the most common types of disinfection
processes used by CSSDs?

Q:W
 hat are three types of soil removal tests most
commonly found in CSSDs?

Q: W
 hat are the five recommended actions when sorting
and disassembling reusable medical devices prior to
automated cleaning?

Q: W
 hat are three common user errors when loading a
washer-disinfector?

Q: What does an ultrasonic cleaner do?

Q: W
 hat is the meaning of the term IFU?

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 Choice of Decontamination Process
Surgical Instrument Processing Steps
Must follow established department protocol

In/Near 1. Pre-Preparation (wiping & keeping moist)

OR

2. Manual Cleaning
SPD
Dirty side
3. Ultrasonic Cleaning 4. Automated Washer
(if necessary)

5. Instrument Care
SPD
Clean side

6. Sterilization

Figure M5–1 Surgical device processing steps

To prevent infection, all RMDs that come into contact

with the patient or surgical field should be systematically
decontaminated after each surgical procedure, giving
attention to all potential sources of contamination. All
decontamination processes must be validated and
the reusable medical devices reprocessed to a level
appropriate for their intended use. The appropriate level
depends on the body sites where the device will be used
and the risk associated with a particular procedure.
The minimum levels of processing, based on three risk
categories of use, are shown in a classification system
called the Spaulding classifications (Figure M5–2). For
example, non-critical would be a stethoscope, semi-critical
would be a Parkes retractor and critical would be a
Travers retractor.

Device Minimum Inactivation

Patient Contact Examples Classification Level

Cleaning and/or Low/

Skin surface
Non-Critical Intermediate Level
non-invasive
Disinfection

Mucous membranes
Semi-Critical High Level Disinfection
or non-intact skin

Sterile areas of the

body, including blood Critical Sterilisation
contact

Figure M5–2
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 The minimum levels of reprocessing for different types
of sites are:

Critical site – devices must be sterile at the time of

use. This means devices are either single use, steam
sterilized (for devices that are capable of withstanding
heat), or have undergone low temperature sterilization
(for “thermo-labile” devices that are not capable of
withstanding heat).

Semi-critical site – devices are either single use or

sterilized after each use. If this is not possible, high-
level disinfection is the minimum acceptable level of
reprocessing.

Non-critical site – cleaning alone is generally sufficient

for all noncritical items after every individual use,
although either intermediate or low-level disinfection
may be appropriate in specific circumstances.

Later in the module, when we learn about procurement

or acquisition of new devices, we will discuss choosing
decontamination processes based on compatibility
with the reusable medical device.

Reprocessing methods must provide minimum

decontamination and safety standards, while keeping
up with the demands of clinical services.

Maryam: So how do I know I am choosing the right method of

decontamination for the devices I’m dealing with?

Khaled: Always remember—the appropriate level of

decontamination will depend on the body sites where the device
will be used and the risk associated with the procedure. So for a
device that enters the body, like surgical scissors, it is considered
a critical risk and must be sterilized. An endoscope, that comes
in contact with intact skin or mucous membranes, is considered
a semi-critical risk, and a high level of disinfection is needed. A
blood pressure cuff that comes in contact with healthy skin, is
considered non-critical, and a good cleaning is needed.

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 Sorting and Disassembly
of Contaminated RMD
As mentioned in module 4, to be effective, reusable medical
device decontamination must be carried out in a timely manner.
Sorting, disassembly and cleaning facilitates timely cleaning
and in a way that minimizes risk to you, the decontamination
specialist.

Once the containers are received and unloaded from the

transport carts you learned about in module 4, the reusable
medical devices are sorted—usually according to whether they
need a manual or an automated cleaning process. Policies and/
or procedures should be developed for the handling, sorting
and disassembly of all devices used within the facility, and for
handling specialized items if required.

The manufacturer’s instructions for cleaning are followed in order

to ensure the device is not damaged and is cleaned adequately.

Disassembly of RMD

Complete the following activities to facilitate • Arrange medical devices in an

effective cleaning: orderly fashion in mesh trays so
that all surfaces are exposed to
• Open all reusable medical device the cleaning action when using an
box locks, hinges etc. automated cleaner (Figure M5–3c).
• Place the medical devices in a • Place each jointed medical device
mesh basket in a way that ensures in the open position in the mesh
effective cleaning of the device. Do basket. If extra mesh baskets are
not place reusable medical devices required for cleaning a device set, a
on top of one another. Overloaded marker is placed in the extra baskets
baskets will result in ineffective to identify the set name and number.
cleaning • Place heavy retractors and other
heavy medical devices on the
bottom or in a separate tray.
• Secure small and light items with
a hold down screen or by other
means, to ensure they are not free
to move around during the cleaning
Figure M5–3a Overloaded baskets result in ineffective cleaning
process. Place scissors, light-weight
medical devices, and microsurgical
devices next (Figure M5–4).
• Receivers and gallipots (bowl-
shaped items) must not be placed
New-M5-3b Poor Arrangement WD New-M5-3c Better Arrangement WD

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 over any other reusable medical • Open ratcheted devices for cleaning
devices, as they may cause to ensure the box joints and jaws are
shadowing and interfere with the being cleaned thoroughly and all
cleaning process. debris removed.
• Separate all sharp devices from • Dismantle any devices with valves,
general devices. This is to ensure ports or multiple parts as far as
ease of identification for personnel possible for cleaning, following
assembling the devices after manufacturer’s instructions (Figure
cleaning, in order to prevent sharps M5–6).
injury. • Open, flush and brush taps that do
• For medical devices with one or not come apart, before mechanically
more lumens (tubes), connect each cleaning.
lumen to the appropriate flushing • Stylets are used to unblock devices
system provided for that purpose during use. Remove them, and
(Figure M5–5). flush and brush the devices prior to
• Ensure the tips of devices align mechanical cleaning (Figure M5–7).
and meet at the tip, and are not Stylets need to be checked for
hooked or snagged—items that are correct fit and function.
misaligned, damaged or worn need
to be sent for repair.

Figure M5–4 Hold-down screen for small or light items Figure M5–5 RMD with Lumens attached to flushing system

Figure M5–6 Flush tubes for Lumens Figure M5–7 Cleaning lumens

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 Automated Cleaning (including pre-cleaning)

As we have learned, cleaning is an essential prerequisite

for all effective disinfection and sterilization processes, as
organic residue may prevent the disinfectant or sterilants
from contacting the surfaces of the item being processed
and may also bind and inactivate chemical disinfectants.
In other words—if the item can’t be cleaned, it can’t be
disinfected or sterilized.

Twenty years ago, decontamination experts focused

on the sterilizer, while today it is globally accepted that
cleaning is the initial and most crucial step in breaking
the chain of disease transmission. The use of mechanical
cleaners such as washer-disinfectors (Figure M5–8) and
ultrasonic cleaners (Figure M5–16 to 12) is preferred to the
manual cleaning of items.

The advantage of using automated cleaning equipment

is that it provides an efficient, validated, reproducible
process which is more easily controlled than manual
methods. A simple example of this is the temperature of
the water at <40C for pre-cleaning. Controlling tap water
temperature is less accurate than controlling the washer-
disinfector temperature—even if you have a thermometer.
Also, recent research advises changing the sink water
for every tray—so in the busy CSSD’s of today—that
would be an exhaustive process. Another consideration
is the human factor. Some people work better or worse,
depending on the day. The machine, if maintained and
tested regularly, always reproduces the same result.

Automated processes are generally more convenient and

also provide protection for the user in reducing exposure
to contaminated devices and chemicals. Ideally, manual
cleaning should be used only where no pre-treatment has
been carried out by the user, and gross soiling remains on
the device. All soiling must be removed before automated
cleaning takes place.

Figure M5–8 Washer disinfector

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 Washer-Disinfectors

All washer-disinfectors used for decontamination of reusable

medical devices conform to the medicines and healthcare
products regulatory authority (MHRA) requirements,
are compliant with EU legislation and have CE Marking
(Conformité Européene), and are approved by the US Food
and Drug Administration (FDA) or an equivalent competent
authority. The water for the final rinse stage is purified water
(prepared by reverse osmosis or deionization) giving the
lowest levels of process residuals. Questions to consider
when determining if the device is compatible with the washer-
disinfector include:

• What does the manufacturer’s IFU indicate?

• Is it water submersible?
• What is the maximum operating temperature?
• Will mechanical damage occur from the impact
of the water jets or other items in the load?
• Is the device compatible with the process
chemicals?

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 When ready to load the reusable
medical devices there are a few key
points to note:

• Ensure the washer-disinfector and

all services are operational. The
washer-disinfector should not start if
any anomalies are present including
blocked or occluded spray arms
Figure M5–9 (Figure M5–11).

• Wearing PPE, load the rack

or machine ensuring that the
arrangement of devices does not
get in the way of the cleaning
process, and the rotary spray arms
can rotate.

• Use the load carrier and racks for

items they were designed to hold
(Figure M5–9 and Figure M5–10).

• Keep a record of each device

and device set processed in each
Figure M5–10 Load carrier with racks washer-disinfector, and each cycle
in order to trace them through the
decontamination process.

• Load the load carrier into the

washer-disinfector (Figure M5–11).

• Secure the door (if fitted), and select

and start the appropriate cycle.

• When the cycle is done, make sure

that all stages and parameters have
been achieved.

• When the automated cleaning

process is complete, inspect the
processed devices.

Figure M5–11

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 Phases of a Typical Cycle

Cold flushing/pre-rinsing – chamber is filled with cold water

(<40C), to prevent coagulation of blood and protein, soil fixation
- devices are rinsed to remove gross soil before the chamber
drains.

Warm washing – chamber fills again with warm fresh water plus
detergent and is heated to about 60C - this wash removes any
remaining soil with the physical and chemical action of detergent
and again drains when completed.

Rinsing – chamber fills again, but this time with filtered or reverse
osmosis (RO) water to rinse and remove any chemical residues
from the previous cleaning phase - in many washers this phase is
repeated a second time.

Disinfection – the chamber is filled for a final time again with

filtered or RO water but this time the temperature is raised to 80-
93C and held for a predetermined time (usually 90C for 5 minutes)
to ensure effective disinfection.

Drying – this phase purges the load and chamber with filtered
heated air to remove residual moisture.

Record information for each washer-disinfector cycle.

Documentation is required for every washer-disinfector cycle and

at a minimum should contain the following:

• Operator’s name
• Date and time of start of cycle
• Washer-disinfector identification number
• Type of washer-disinfector
• Type of cycle used
• Cycle number
• Load contents, for example: general device set, stitch set,
mayo scissors
• Critical parameters for the specific washer-disinfector cycle
• Results of washer-disinfector process
• Signature of a qualified person (decontamination)
confirming whether or not the process cycle was within
recommended parameters
• Any notes or observation for the process cycle

Document aborted cycles in a log book, recording the reasons and

actions taken. Where single-ended washer-disinfectors are used,
make sure you keep the unprocessed devices segregated from the
processed ones.
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 Ultrasonic Cleaners

The ultrasonic cleaner is used to

remove fine soil from surgical devices
after they have been manually cleaned
and before they are sterilized. The
equipment works by converting
high-frequency sound waves into
mechanical vibrations that free soil
from the surface of devices. The high-
frequency energy causes microscopic
bubbles to form on the surface of the
devices and as the bubbles implode,
minute vacuum areas are created,
drawing out the tiniest particles Figure M5–12 Ultrasonic cleaner

of debris from the crevices of the

devices. This process is called cavitation. Plastics and
other similar materials cannot be successfully processed by
this method. Cemented glass syringes and lenses will be
damaged if repeatedly subjected to this process. Consult the
manufacturer’s IFU to see if ultrasonic cleaning is suitable for
the device.

General Guidelines

• Follow the manufacturer’s IFUs and standard

operating procedures (SOP)
• Older machines – de-gas time is between 5 and 15
minutes (de-gas is the removal of air from the water to
allow the ultrasonic waves to pass more freely)
• Cycle time depends on the machine, cycle program
and how much soil is on the medical device
• Water temperature is usually <35C
• Thermal disinfection option – temperatures between
80C – 93C with holding time >20 seconds to 10
minutes
• Document, scan and record all cycles and
processes—preferably using automated track and
trace systems

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 Manual Cleaning
The use of automated cleaning methods
may be contra-indicated for washing
certain delicate or complex devices, for
example when:

• Medical devices cannot be

immersed in water e.g, certain
power tools (Figure M5–13)
• Medical devices have an operating
temperature lower than is achieved Figure M5–13

in automated washing
• Mechanical damage may result from
the impact of the water jets or other
items in the load

Carefully wash and rinse these devices

according to the manufacturer’s instructions.
Non-immersion manual cleaning methods
are appropriate for certain devices like
electrical tools that may be compromised by
soaking in wet solutions.

Immersion Method Essential

Requirements

• Sink—(not a hand hygiene sink), or

a receptacle which will hold enough
water and detergent to fully immerse
the item to be cleaned
• Detergent—and a validated method
of dispensing a measured quantity,
following manufacturers’ instructions
for dilution and temperature of warm
detergent solution
• Temperature control—in the wash
and rinse sinks (usually <40C),
thermostatic mixer taps are preferred
• Brushes—a selection of non-
damaging brushes in a range of
diameters and lengths for cleaning
both the external surfaces and the
internal surfaces of devices (Figure
M5–14). Single-use is desirable. If
not using single-use, there must be
a protocol in place to decontaminate Figure M5–14

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 the brushes at least daily. The manufacturer should provide
information regarding the appropriate brush size. Always
use brushes under water to avoid splashing and aerosols.
•After cleaning, dry the manually washed devices that are
not to be further processed through the washer-disinfector.
• Place devices in a drying cabinet (Figure M5–17). Where
a drying cabinet is not available use a clean, disposable
lint-free, absorbent wipe to dry the devices.

To ensure effective manual cleaning, follow written procedures

(including wearing PPE (module 2) at all times while handling
contaminated devices). Fill the sink with water to a predetermined
level, at the specified temperature and with the appropriate
amount of detergent (as per manufacturers’ instructions). Use
the sink solely for the cleaning of devices and not for any other
purpose. It is recommended to use three sinks—washing, potable
or tap water rinse, and purified water rinse (Figure M5–15).

Use detergents specifically

designed to clean RMD.
Household soap must never
be used! A mild detergent is
preferred for manual cleaning
(pH range 8.0–11.5). Follow the
manufacturer’s instructions and
local policies and procedures
for detergent dilution and water
temperature. Consider the use
of an enzymatic detergent to
facilitate the cleaning of devices
with channels or complex parts.

• Immerse the item,

carefully, in the solution in
order to displace trapped
air—it is important to ensure
Figure M5–15 Three cleaning sinks washing, potable or tap water rinse, and purified water rinse

that the cleaning solution

reaches all surfaces including those of lumened (tubed)
devices.
• Remove all visible soiling, including lumens and valves.
Remove stubborn staining by using inside non-abrasive
scouring pad or soaking in an approved stain-removing
solution.
• Flush all lumened devices with a jet-gun (discharge under
water to avoid splashing and aerosols) (Figure M5–16).
• Rinse the item finally in warm-to-hot water (unless
contra-indicated).

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 • Dry mechanically in a drying cabinet or hand dry
with a clean, lint-free cloth. Note: items should not
be left to dry in ambient air (Figure M5-17).
• Inspect devices and equipment to establish that
they are clean before further processing or storage.

Ideally, use single-use brushes or identify cleaning

brushes as for cleaning only, and wash, thermally
disinfect, and store them dry.
Figure M5–16

Keep a record of each device and device set that has

been manually cleaned. The records should contain,
at a minimum:

• Name of device or device set

• Name of processor
• Date
• Type of cleaning
• Type of detergent and detergent dilution used

Figure M5–17

Maryam: “If the machine isn’t available can I just hand-clean the
devices?”

Khaled: “When you are cleaning reusable medical devices

manually you need to think about your training and competence
level (are you confident?), the water temperature and detergent
concentration the device can handle, what kind of soil is on
the devices, how to get the soil off, and whether the item can
be submerged or not. Maryam, where possible it is best to use
automated methods!”

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 Disinfection
There are two types of disinfection, thermal and chemical.

Thermal disinfection can be achieved in a thermal

washer-disinfector by choosing the appropriate cycle. It is
the simplest, most efficient and cost-effective disinfection
method. Thermal disinfection equipment should allow you
to monitor or record the length of time it was at a specific
temperature, to make sure the microbes were killed.

The effectiveness of chemical disinfection depends on a

number of factors, including the initial number of microbes
present, temperature, pH, and concentration. It can be
achieved with a compatible RMD-grade disinfectant of
the required level, used alone or with a chemical washer-
disinfector. Rarely used in a CSSD setting, it can be seen
regularly in areas that reprocess ultrasound probes and is the
main disinfectant of choice in endoscopy units.

In order to know if chemical disinfection processes were

adequate, the processes are validated microbiologically,
defining the concentration, contact time and minimum/
maximum temperatures for adequate disinfection.

Disinfection eliminates many or all pathogenic

micro-organisms on inanimate objects, with the exception
of bacterial spores. It makes infectious agents inactive, using
either thermal (moist or dry heat) or chemicals. The level of
disinfection achieved depends on the temperature, exposure
time and/or type of chemical disinfectant used. High-level
disinfection (example used for thermo-labile endoscopes
which you will learn about later) is the minimum treatment
recommended for reprocessing medical devices that cannot
be sterilized. These medical devices are used in semi-
critical sites or when there are specific concerns regarding
contamination of surfaces. Low-level disinfection
is the minimum treatment recommended for reprocessing
non-invasive medical devices for use in non-critical sites.

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 Drying
Drying minimizes rusting, and staining and reduces
the risk of recontamination during inspection and
assembly of RMD. Residual moisture interferes with
the sterilization process. Place RMDs in a drying
cabinet (Figure M5–18) and apply the following key
considerations:

• Use a clean disposable lint-free, absorbent

wipe when a drying cabinet is
not available
• Take care not to exceed the temperature
tolerances advised by the manufacturer
• Dry the RMD in a sloping position to facilitate
drainage
• Do not use alcohol or other flammable liquids
as drying agents, other than in automated
equipment designed for this purpose, for
Figure M5–18

example, some endoscope washer–disinfectors

Process Chemicals
We now know that thorough cleaning of used surgical devices prior
to sterilization is critical. The main agent that affects cleaning is the
process chemical used in the wash area of the CSSD. Chemicals such as
detergents and disinfectants may have hazardous properties associated
with them (may be irritant, corrosive, flammable), for example bleach
and ammonia if mixed will release lethal chlorine gas. Process chemicals
are potentially hazardous as they may cause irritation to the skin, eyes,
respiratory tract and mucous membranes. Things to think about when
dealing with process chemicals are choice of process chemicals, the
controls required, safety data sheets and labeling.

Choice of Process Chemicals

Choose process chemicals that are compatible with:

• The medical device

• The decontamination equipment to be used and the intended use
of the device

Choose the least hazardous chemical that will fulfil the process
requirement.

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 According to the Association for the Advancement of Medical
Instrumentation (AAMI) the characteristics of process
chemicals are at minimum:

• Non-abrasive
• Low-foaming
• Free-rinsing
• Biodegradable
• Non-toxic
• Able to dissolve/disperse soil easily
• Economical

Dosage of process chemicals or detergent should be

determined by Manufacturer IFU and validated during
commissioning.

Type of DETERGENT

Cleaning
Quality of WATER and Type of INSTRUMENT
disinfection

Type of WASHER
Figure M5–19

Control of Process Chemicals

• Use defined, written procedures and methods for

handling and storage of process chemicals.
• Clearly identify chemicals that should not be stored
together.

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 • Store chemicals below shoulder height.
• Make sure Safety Data Sheets (SDS) and labels are
available to all staff in designated areas at all times, so that
appropriate action can be taken in case of exposure to a
hazardous substance.
• Read and follow the precautions and instructions given on
the SDS and on the label prior to handling and use.
• Train all personnel who handle chemicals e.g. detergents,
rinse aids, disinfectants, etc.

Water Quality

The quality of water used at all stages in the cleaning process

is critical to the successful outcome of the process, as the
water is the last thing to make contact with the RMD prior to the
user procedure. Unfavorable water compositions can have an
adverse effect on the reprocessing process and on the devices
themselves. At each stage in the cleaning process the water
quality should be compatible with the:

• Washer-disinfector (WD) construction materials

• Medical devices to be processed
• Process chemical to be used
• Process requirements of that particular stage

Other factors to take into consideration are:

• pH and hardness—dissolved salts (lime scale)

• Temperature
• Ionic contaminants—heavy metals, phosphates and
silicates leading to corrosion
• Microbial population
• Bacterial endotoxins

Routine Testing of
Decontamination Equipment

Washer-Disinfector

After validation and when the washer-disinfector has been passed

for use, it is subject to a schedule of periodic tests at daily, weekly
quarterly and yearly intervals. The daily, weekly and quarterly tests
supply evidence that the washer-disinfector is still operating within
the limits established during commissioning.

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 Periodic tests consist of the following:
Other Washer-Disinfectors
a. Daily
• Spray arm rotation Tunnel Washers
• Spray nozzles Tunnel-washers are the CSSD
• Removes and clean strainers and version of a mini car-wash! The main
filters advantage of these units is that most
of them allow totally hands-free re-
processing of the used medical devices.
b. Weekly Surgical instruments that have been
• Automatic control test disassembled and prepped for cleaning
• Safety checks in the OR are placed in perforated or
• Water hardness mesh-bottom trays and come directly
• Water conductivity from the OR or other department and
• Cleaning efficacy test (residual soil placed into the tunnel washer without
detection—see below). any further handling or arranging. Inside,
the surgical instruments are subjected to
cycles of pre-rinse, washing, ultrasonic,
c. Quarterly
rinse, and drying (Figure M5-20).
• Automatic control test
• Calibration verification of RMD
• Thermometric test for thermal
disinfection
• Cleaning efficacy test by
assessment of soil removal

d. Annually
• Automatic control test
• Calibration verification of RMD
• Water system
• Drainage
• Doors
• Door interlocks
• Fault interlocks
• Water vapor discharge
• Aerosol discharge
• Chemical additive dosing
• Load carriers
• Air quality
• Cleaning efficacy
• Over-temperature cut-out
• Thermometric tests for thermal
disinfection
• Load dryness test
• Process residues

Figure M5–20

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 Cart Washers
Clean carts and other transportation
vehicles and containers routinely to
remove dust and spillage. Most cart-
washers have wash, rinse, steam and
drying cycles. Place carts in the washer
in a tilted position to enable water to
drain out and prevent restriction of any
moving parts within the washer. Items
removed from this type of washer are
very hot and must be allowed to cool
before they are handled. Thoroughly dry
carts before they have contact with clean
or sterile supplies. Figure M5–21 Cart washer

Ultrasonic Cleaners

After validation and when the b. Weekly

ultrasonic cleaner has been passed • Automatic control test (if using
for use, it is subject to a schedule of an automated ultrasonic cleaner)
periodic checks and tests at daily, • Safety checks
weekly, quarterly and yearly intervals • Cleaning efficacy test (residual
depending on what standards you soil detection)
are following, for example EN ISO
15883 (International Organization for
c. Quarterly
Standardization) or HTM 2030 (Health
• Automatic control test
Technical Memorandum). The tests
• Verification of calibration of RMD
supply evidence that the ultrasonic
• Ultrasonic activity test
cleaner is still operating within the limits
• Cleaning efficacy test
established during commissioning.
Annual tests (revalidation procedures)
prove that the data collected during
commissioning and performance d. Annually
qualification are still valid. Revalidation • Weekly safety checks
may also be required under certain • Automatic control test
circumstances. Checks and tests at a • Verification of calibration of RMD
minimum include: • Water system
• Drainage, doors and door
interlocks
a. Daily • Fault interlock
• Remove and clean strainers and • Aerosol discharge
filters • Chemical additive dosing
• Visual inspection of device
post-cycle
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 • Load carriers
• Air quality
• Cleaning efficacy
• Chamber wall and load carrier temperature test
• Over-temperature cut-out test
• Thermometric test for thermal disinfection
• Load dryness test
• Test for ultrasonic activity
• Sound pressure test

Cleaning Efficacy Tests

Soil removal and detection tests ensure that the cycle is able
to adequately clean a heavily soiled load. The cycle must
remove the soil from a strip coated with an artificial soil in
order to pass the test.

It is important to use the correct test soil or process challenge

device (PCD) for your machine as recommended by the
manufacturer. Using the wrong cleaning efficacy test or PCD
may provide misleading results. Some examples of these
commercially available tests are:

• TOSI—protein detection test

• Hemo-check—protein detection test
• Brownes soil test—visual test
• Ninhydrin test—protein detection test
• Foil test—ultrasonic cleaner

Disposal

An important consideration during the device life cycle is the

disposal of RMD. Disposal means either returning the RMD
to a third party or scrapping it. Do not underestimate the
importance of documentation at this disposal stage. Consult
the manufacturer’s IFU to see if details are included on any
unusual risks related to the disposal of the RMD.
Decontaminate all RMD before disposal and include a
certificate stating the decontamination method. Transport and
destroy devices that are being scrapped by known, reliable
contractors who certify their destruction.

Acquisition

Before ordering any medical or surgical device, obtain

the written instructions for reprocessing. This information

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 includes detailed information on disassembly, cleaning (including
equipment and detergents to be used), testing, packaging and
methodologies.

RMD must be accompanied by the manufacturer’s IFU. Consult

these IFU for specific guidance on cleaning, handling, inspection
and decontamination and to determine whether the RMD will
tolerate immersion. Always verify that your facility has the
recommended equipment to clean and sterilize the reusable
medical devices and the recommended chemicals for cleaning
and disinfection. If not, either do not purchase the device, or get
approval to purchase the needed equipment to process
the device.

Maryam: The IFU for this ronguer recommends ultrasonic cleaning.

We don’t have an ultrasonic cleaner here, but we’ve been cleaning
other scissors without one. Can we clean them here?

Khaled: You would be modifying the device manufacturer’s

instructions for cleaning if you did not use an ultrasonic cleaner!
The manufacturer tested and validated the cleaning process using
ultrasonics so non-compliance could result in an unclean reusable
medical device being used in surgery. Also, other cleaning
methods may deteriorate the scissors.

All RMD and accessories must comply with applicable EU

legislative standards and be CE Marked by the manufacturer.
The manufacturer’s instructions provide direction for care,
cleaning and handling of RMD and powered equipment. If the
instructions for cleaning and sterilization are correctly followed, the
device should be reusable, without causing injury to the patient or
staff that are using the RMD (ISO, 17664).

Maryam: So, the surgeon wants these particular scissors, do we

order them first, then figure out how to clean them?

Khaled: Always make sure you can clean them according to the
manufacturer’s instructions before you order them. All RMDs should
fit around your ability to effectively and safely reprocess the items…
not the other way around. Although I am sure you will find, in good
time, someone will argue against your reasoning!!

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 Exercises and Checklists

Exercise 1
Demonstrate and discuss examples of simple hinged devices,
cannulated medical devices, multipart devices, and difficult to clean
RMD. Write your findings in your log book.

Exercise 2
In your CSSD what factors do you think affect the efficacy of
disinfection? Write your findings in your log book.

Exercise 3

Discuss the daily/weekly validation methods in your C.S.S.D. Which

do you think is the most effective? Write your findings in your log book.

Exercise 4

Go to your log book and complete the Decontamination Wash Room

Competency Checklist

Exercise 5

Go to your log book and complete the relevant unit Equipment

Competency Checklists for a washer disinfector, ultrasonic washer,
and cart washer

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 Module 6
INSPECTION, ASSEMBLY
AND PACKAGING (IAP)

Key Terms

strike-through | aseptically | function-testing | microbiological monitoring

settle plates | contact plates | active air | diathermy | peel pouch
envelope fold | sequential wrapping

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 Learning Outcomes
By the end of this module you will be able to:

Demonstrate correct hand hygiene before entering

 

the area

 Describe and demonstrate ability to:

• Check devices against a tray checklist

• Lay devices in the correct sequence and take/follow



appropriate actions when devices are missing or damaged

• Package materials

• Wrap with proper technique

• Label packs and trays

• Seal and test packages

Explain why disinfected only (not sterilized) items are

 

packaged differently

Demonstrate the operation of the tracking and

 

traceability system.

 Understand the dress requirements of the IAP

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 Introduction

This module covers key aspects of inspecting clean

reusable medical devices, function testing and
reassembling as per the manufacturer’s IFU function.
We discuss packaging types, wrapping and sealing
techniques, labelling and package sealing equipment,
environmental maintenance and dress code.

Pre-Module Quiz

Keep these questions in mind as you go through the content

and don’t worry if you don’t know the answers yet – that’s
what you’re here to learn.

Q: C
 an you list two main types of wrapping material used
in packaging?

Q: T
 here are many microbiological tests carried out at
IAP, can you name two?

Q: What attire is recommended for the IAP?

Q: W
 hat five checks would you carry out at the Inspection
phase in the IAP?

Maryam: We don’t have much space in our CSSD, can we do all the
work in one area?

Khaled: Absolutely not. At a minimum, the area where you receive,

wash and disinfect the used devices is segregated from the area
where you inspect and package them for sterilization (IAP Room).

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 The IAP Room

Figure M6–1

The IAP room is usually the central point of CSSDs (Figure

M6–1) and where the crucial job of inspection, function-
testing and appropriate maintenance of cleaned reusable
medical devices takes place. This job is carried out by
trained decontamination specialists, in accordance with
the manufacturer’s IFU. All reusable medical devices and
accessories are inspected to ensure that they are clean,
intact and that there are no chips, worn spots, flaking or
other damage. The functionality of all RMD are tested or
checked before being packaged for further processing
or storage. The area where inspection takes place is
designated and controlled to optimize the effect of the
sterilization process and minimize the risk of contamination
of the RMD sets.

Environmental Requirements for IAP

Ventilation for the inspection, assembly and packing room

meets clean room standards according to ISO 14644-1:
1999 Class 8 or other internationally accepted equivalent
standard. This room must be maintained under positive
pressure to ensure no contaminants can enter.

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 As outlined in module 1, all rooms in the department are
ventilated and controlled to provide a comfortable working
environment of 18–25C and a relative humidity within the
range 30–60%.

Environmental cleaning must follow policies and procedures

that have been approved by the hospital infection control
committee. A dedicated cleaning room is located within the
IAP room to clean this area—no outside areas should be
cleaned from this location.

Microbiological monitoring is carried out in this room

according to hospital infection control policies. This
monitoring is used as an early warning system to alert staff
when environmental quality is drifting out of control. One
method of monitoring involves placing contact or settle plates
in pre-planned locations in the room and then sending them
to the lab for culturing and analysis.

The results of the analysis are then compared to

baseline counts of microorganisms (accepted levels of
contamination) predetermined by either the microbiologist
or a contracted specialist. Testing results should be the
same or better than this baseline.

To determine how well the IAP room is being cleaned and

give you a good idea of contamination during traffic flows
and peak periods, part of the sampling program should
be carried out when the facility is unoccupied to achieve
a baseline contamination level prior to sampling when
occupied.

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 Dress Code Requirement
Staff movement, between dirty and clean areas is not
possible without passing through a clothing change and
hand-wash area.

Protective clothing is worn by personnel entering the IAP

room to reduce the risk of possible contamination of the
clean reusable medical devices and the environment.
Managers ensure that protective clothing is available and
all personnel are responsible for correct use and disposal.
Specialists working in the IAP wear a freshly laundered
scrub suit (Figure M6–6). Scrub suits are low-linting attire
that minimize bacterial shedding and provide comfort and
Figure M6–5 Clothing change and hand wash area a professional appearance. Freshly laundered attire is
changed daily or whenever it becomes visibly soiled or wet.
Appropriate clothing is used by anyone entering this area,
including staff involved in the maintenance of reprocessing
equipment, and visitors.

Figure M6–6 Scrub suit

Head/Hair Cover
A clean, single-use, low lint surgical hat or hood that
confines all hair is always worn in IAP. The hat or hood
must be designed so that microbial dispersal is minimized
with all head and facial hair confined as well as covered.
After use, headgear and beard masks should be
discarded in the appropriate waste stream. Stud earrings
may be worn as long as they are totally confined within the
head cover. Make-up and jewelry, apart from a wedding
band, are not worn in the IAP.

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 Washer-Disinfector (WD) to Sterilizer
Following on from module 5 we are now ready to unload the washer-
disinfector containing clean, disinfected surgical instruments and
accessories. Depending on your specific equipment this may be an
automated process using conveyor belt-type unloading mechanisms
(Figure M6–7).

Figure M6–7 Conveyor belt unloading mechanism

If not automated, the washer carriage can be manually removed from

the chamber taking care to wear heat-resistant gloves if necessary—
remember the temperature in the chamber can reach over 90c. Be
careful with utensils like gallipots or kidney dishes that may have
turned upside down during the washing process and contain hot
water. When unloading, quality checks are carried out before any
further processing. Quality checks consist of:

Correct cycle—for example, if a container cycle was inadvertently

used for instruments then the load should be rejected and sent back
for reprocessing.

Spray arms not blocked — If arms were blocked by RMD during

cycle the load must be rejected as correct cleaning and disinfection
may not have occurred.

Soil or stain — any soil or staining seen on visual inspection is

rejected and items must be sent back for reprocessing.

Excessive wetness — excessive wetness could be caused by

blocked arms, incorrect loading or problems with the WD settings so
should be investigated.

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 Damage due to configuration — for example if items
were impacted by spray arms or the the RMD was not
compatible for WD processing.

Devices correctly disassembled — If items were

not disassembled, adequate cleaning would not
have occurred so the full set should be returned for
reprocessing.

Completed documentation — load contents and

any non-conformances and rejected loads must be
documented and reported to the line manager. For
example, you may notice a device that was not properly
disassembled in the wash area, so the entire tray must be
considered contaminated and sent back to the wash area
via the transfer hatch or chamber. A more serious issue
may be where the specialist notices the spray arm rotation
has been hindered and therefore the whole load has been
compromised and must be returned for re-processing.
These non-conformances must be documented and
reported to the line manager immediately.

Local Policy Checks After Unloading

What happens to the load next depends entirely on local
policies, procedures and guidelines. These are some
standard processes that should also take place:

• Check that the chart record for the cycle conforms

to the information established during validation and
that all recorded variables are within the parameters
permitted.
• Check that the operating cycle selected is in
accordance with the specification for the load e.g.
surgical instruments or anesthetic equipment would
need different cycle types.
• Make a visual inspection of the load in order to
ensure that there is no obvious damage, staining or
residue.
• If staining and/or residue are present, this may be
due to the configuration of the load, overloaded cart
or malfunction in the washing cycle.
• Make a visual inspection of the load for dryness.
• Unless there is clear indication why a small
percentage of RMD in a load were not cleaned
and/or dried effectively, the entire load should be
returned for re-processing.

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 Maryam: What should I do if a few items didn’t clean or dry effectively
but I can’t determine why?

Khaled: You should automatically reject the full cycle and return for
reprocessing as we don’t want to risk the safety of patients or our
fellow decontamination specialists when they handle them.

Manually Cleaned Device Acceptance

Quality checks must also be carried out when accepting items
that were not processed in a WD. These quality checks consist of:

Soil or staining—any visible soil or staining is rejected and

items must be sent back for reprocessing.

Excessive wetness—items that have been manually cleaned

and disinfected must be dry before moving to the IAP room.

Damage—if the item was handled incorrectly or immersed

in fluid when it should not have been it must be reported
immediately to the line manager.

Correctly disassembled devices—if items were not

disassembled, adequate cleaning would not have occurred
so the item is returned for reprocessing.

Documentation completed—manually cleaned items

and any non-conformances and rejected items must be
documented and reported to the line manager.

Inspection and Function Testing

All surgical devices unloaded from the washer-disinfector
must be inspected for cleanliness, stains, corrosion, cracks,
breakage, and stiffness of movable parts before being
placed in device sets. Where possible, devices should
be checked under magnification because small pieces of
Figure M6–8 Inspecting and function testing
bioburden or debris can otherwise be difficult to see.

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 • Inspect each RMD from a set separately.
• Critically inspect all areas of the devices e.g., box
joints, serrations and crevices, for cleanliness.
• Check hinges (such as artery forceps and clamps)
for ease of movement.
• Check jaws and teeth (such as found on Kocker-
Mosquito forceps, Figure M6–9) for alignment.
• Check ratchets (Figure M6–10) for easy closure and
firm hold.
• Report any damaged, incomplete or malfunctioning
devices immediately to the supervisor.

Figure M6–9 Figure M6–10 Ratchet mechanism

• Check cannulated devices to ensure channel is

patent (clear).
• Function check telescopes and light cables as per
the manufacturer’s instructions.
• Check each device set for completeness.
• Check cutting edges (such as scissors, rongeurs,
chisels, curettes) for sharpness, see device
sharpness testing, module 3.
• Devices that have an outer insulation coating, for
example diathermy
forceps (Figure
M6–11), require
close inspection
to ensure that the
insulation remains
intact.
Figure M6–11 Insulation coating on diathermy forceps

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 • Check insulated devices using a diathermy
pin point tester. Damaged surfaces allow dirt
and bacteria to collect, and can also lead to a
potential burn risk for the patient and/or the user.
• Check each device for free movement of all parts
and non-sticking joints. A water-based lubricant
may be used if required (read IFU for dilutions
and application).
• Check that the edges of clamping RMD meet with
no overlap and that teeth mesh together properly.
• Check all screws on jointed RMD for tightness
as they may become loose during the
cleaning process.

Maryam: If we are really busy surely it is acceptable just to make sure

the correct number of devices are in the tray?

Khaled: A device count on its own is not acceptable Maryam. Making

sure the devices are clean and working properly is crucial to the safety
of the patient. For example, if an artery forcep is broken it may lead to
unnecessary bleeding of an artery, possibly with fatal consequences.

Assembly and Checking

Once the devices have been inspected and
function-tested they are now ready to be assembled
into their respective trays. Many CSSDs today are
switching to one of the many types of computerized
track and trace systems on the market. These systems
are now accepted as one of the most essential
requirements in the modern CSSD. The system allows
for the accurate tracking of the devices and device
trays through the whole decontamination process. In the
IAP room the track and trace system usually consists of
handheld barcode readers (Figure M6–12) connected Figure M6–12 Handheld barcode reader
to PC’s that log and store the information for each tray.

Once the barcode label is scanned by the specialist

preparing the tray it automatically produces a packing
list (Figure M6–13) and also generates a unique
barcode label (Figure M6–14) which contains the serial
number specific to that tray and process. Once a new Figure M6–13 Packing list

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 Figure M6–14 Packing label Figure M6–15 Manual label gun

processing cycle begins, a new unique unit number is

produced each and every time. For those CSSDs that do
not have such a computerized system in place, a manual
system may be used. This usually consists of a pre-printed
tray checklist and a manual label gun (Figure M6–15).

There are some general rules when it comes to assembling

devices into trays. Most often items are arranged from left
to right in accordance to when they will be required in a
procedure, for example, the scalpel handle used to make
the initial incision is the first device on the left and the
needle holders used to close the wound are on the far right.
They can also be arranged by size so they don’t get tangled
or from Surgeon and OR Nurses preferences, but the most
important aspect is to have an accurate checklist that all
specialists follow to ensure consistency. Forceps should be
placed on instrument pins to hold them together and reduce
tangling. (Figure M6–16A) This can also be done using a
forceps but isn’t recommended. (Figure M6–16B)

Follow the manufacturer’s IFU for devices that should be

sterilized in a particular way or disassembled. This ensures
that all surfaces are presented to the sterilants. Aim to
Figure M6–16A Forceps on instrument stinger
leave all forceps with ratchets open but if stringers are not
available close devices with ratchets on the first ratchet
only, to ensure that steam can penetrate all surfaces.
Spread devices evenly by weight over the tray surface to
help prevent condensate flowing together. Evenly place
plastic items in the tray; avoid collecting them in one
area as this may also lead to moisture collection post-
sterilization. Validated tip protectors (Figure M6–17) should
be placed on delicate or sharp items. Tray liners (Figure
Figure M6–16B Artery forceps attached with forceps

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 Figure M6–17 Validated tip protectors

M6–18) or silicone mats (Figure M6–19)

may also be used to protect delicate Figure M6–18 Tray liners

devices but placing them in a manner that

protects them, especially away from heavy
devices, is also very important.

Any missing or extra devices found while

assembling the tray should be reported
to the supervisor for further action and a
non-conformance documented. This is an
extremely important matter as an incorrect
count may lead to long delays in the OR
if an item is found to be missing before or
after the case. Figure M6–19a Silicone mats

Figure M6–19b Silicone mats

Maryam: If the OR is missing a device, can’t they just open another

one from a peel pouch?

Khaled: Yes, they can but this causes delays while searching for a
spare and also may lead to an incorrect device count. Always make
sure the device count matches what is specified on the tray list before
packaging for sterilization.

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 Packaging
Let’s recap the steps completed—so far we have:

• Checked that the Washer-disinfector cycle has

been successful and the load is released
• Removed the tray of devices from the washer carriage
• Placed the tray on a clean workbench surface
• Inspected each individual device for cleanliness
and functionality
• Assembled the devices that were disassembled for
washing
• Laid the tray out in a manner that ensures good
presentation of the devices and that they are
protected against damage in accordance with the
tray list.

So now we are ready to wrap or package the tray and

prepare it for sterilization. The two main considerations here
are the type of wrap or packaging chosen and the packaging
techniques applied. The packaging material and packaging
techniques are designed to hold and protect the devices in
order to facilitate sterilization and to maintain sterility. As a
barrier material used in the perioperative practice setting,
packaging material must provide an effective barrier to
microbial penetration, protect the packaged items from
contamination during handling, and allow aseptic delivery
of the contents to the sterile field. Re-usable linen is old
practice and completely discouraged due to strike-through
risk and also leads to linting which can be a serious risk for
cross-contamination. Today there are many different types of
packaging materials that are used but the most common are:

Rigid containers Peel Pouches of plastic Sterilization Wraps

and/or paper

Figure M6–20 Rigid containers Figure M6–21 Peel pouches Figure M6–22 Sterilization wraps

While most hospitals use all of these packaging options,

the most commonly used method is sterilization wraps.
The choice and type of wrapping material will depend
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 on the type of sterilization process used and the size of
wrapping material needed to attain adequate coverage of
the item. As a minimum, materials used must comply with
EN ISO 11607-1 and EN ISO 11607-2, 2006 and EN 868
parts 2-10, inclusive. Regardless of the type of packaging
chosen the main requirements are that the packaging will:

• Provide an adequate barrier to microorganisms and

particulates
• Be suitable for the items being sterilized
• Maintain the sterility of the contents until the
package is opened
• Allow the sterilants to penetrate, and come into
direct contact with the item and surfaces
• Permit removal of the sterilant
• Permit aseptic delivery of the contents to the sterile
field with minimal wrap memory (when opened they
stay open, without closing back along crease lines).
• Allow for complete and secure enclosure of the item(s)
• Protect the contents of the package from physical
damage as far as possible due to stacking or
compression
• Allow a method of sealing that results in a complete
seal and provide adequate seal integrity
• Be resistant to tears, abrasions and punctures
• Ensure the seal is tamper-proof and able to seal
only once
• Permit adequate air removal

Sequential Wrapping
Sequential wrapping refers to when two layers of wrap
material are wrapped individually using a fold technique.
A single layer is folded completely and then sequentially Figure M6–23 Sequential Square Fold Wrapping

followed with a second sheet of wrap material and repeating

the wrap sequence to form a package within a package.

Simultaneous Wrapping
Simultaneous wrapping refers to when both layers of wrap
material are wrapped together simultaneously. Two single-layer
wrappers or one bonded double-layer wrapper can be used. Figure M6–24 Simultaneous Envelope fold technique

Both methods are acceptable but sequential wrapping is

the most commonly used in CSSD.

Square Fold Technique

The items to be wrapped are placed on the table parallel
to the wrapper. This method is generally preferred with
heavier items. Figure M6–25 Figure M6–25 Square fold technique

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 Envelope Fold Technique
The items to be wrapped are placed on the table in a
diamond shape to the wrapper. This method is frequenlty
used for smaller items. Figure M6–26

Containers
Figure M6–26 Envelope fold technique
Rigid reusable containers are making a comeback
recently. Very popular in the 70’s and 80’s they can be
seen in many CSSDs today. The technology has improved
significantly and containers are far more user friendly and
can be very cost effective if used properly.

As a barrier, rigid containers are almost indestructible,

providing sterility and customer reassurance if handled and
maintained as per the manufacturer’s instructions. Some
things to consider when using containers are that they are:

• Easily disassembled for cleaning, drying and

storage
• Suitable for the method of sterilization being used
• Compatible with the cleaning method and cleaning
agent being used
• Suitable for the storage configuration
• Lockable, tamperproof and non-resealable
(Figure M6–27)
• Packed in a manner which allows for penetration of
the sterilizing agent
• Able to remove contents without the risk of
contamination of the contents

Rigid containers have filter and/or valve systems that

are secure and must be in proper working order before
sterilization. Examine the filter plate for integrity both
before use and after the sterilization process. If the filter is
damaged or dislodged or has holes, tears, or punctures,
consider the contents contaminated. Clean containers
between each use; preferably in an automated process,
and check the seal between the base and the lid for
possible damage. Containers should be serviced regularly Figure M6–27 Lockable, tamperproof and
by the manufacturer as per the IFUs. non-resealable

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 Pouches and Reels
There are a variety of packaging materials available for
individual surgical instruments, depending on the item
to be packaged. Peel-apart pouches with a see-through
front and paper backing are often used for single devices
or small loads. They come in reels of various sizes where
both ends need to be sealed or as single form of various
sizes for self-seal.

(Figure M6–28)

Sealing peel-apart pouches is essential to ensure that the

product remains sterile after autoclaving. In self-sealing
pouches, adhesive is manufactured into the open end of
the bag or plain top and either a heat sealing machine or
autoclave tape is then required to create a seal.

The see-through peel packaging is a time-saving concept.

It is fast and easy to pack an item into a pouch and to
close it with a heat sealer (Figure M6–28) or self-seal.
Recommended sealing temperatures and pressures and
other technical advice should be followed carefully. The
identification of packed device(s) is easy because of the
transparent plastic film.

Maryam: Why package devices before sterilization?

Khaled: The package allows the item to be sterilized and then protect
it so that it will remain sterile. If we sterilized and then packaged
we would risk contaminating the items again. This is why it is so
important to check the integrity of the packaging for strike-through
and pinholes etc.

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 Exercises and Checklists

Exercise 1

Investigate what wrapping/packaging systems you use in your

CSSD. Can you suggest any other type of packaging material or
techniques that may improves the system in your department?
Complete the exercise in your log book.

Exercise 2

Complete the Equipment Competency Checklists for the heat sealer

and drying cabinet, in your log book.

Exercise 3

Complete the IAP Competency Checklist in your log book.

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 Module 7
STERILIZATION

Key Terms
gas plasma | ethylene oxide | gravity displacement
indicators | thermocouple test | bowie-dick test
porous load | flash sterilization | steam sterilization
validation

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 Learning Outcomes

By the end of this module you will be able to:

 Describe design function and operational requirements

for each sterilizer type

 Carry out routine user testing

 Illustrate/interpret the sterilization process stage values

required to verify parameters have been met

 Effectively log the results of cycles and tests

 Explain batch labelling and the importance of tracking

and traceability

 Demonstrate operational competence with sterilizers

 Handle loads with correct handling techniques

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 Introduction

Sterilization is the complete Ideally, sterilization methods:

destruction of microorganisms • Have rapid throughput

including bacterial spores. • Are easily validated
• Are capable of processing
This level of decontamination wrapped items to enable storage
is required for all reusable after processing without the risk
of environmental contamination of
invasive medical devices processed items.
(RMD).
Sterilization is most commonly achieved by
using either thermal energy (heat) or low
temperature chemical processes with the
following methods:

• Steam (moist heat) at high

pressure—cycle time approximately
40–60 minutes
• Dry Heat, similar to an oven, using
normal pressure—cycle time up to
2 hours
• Gas plasma at ambient
temperature—cycle time 45–75
minutes
• Ethylene Oxide (EO) at sub-
atmospheric or high pressure1
• Low temperature steam and
formaldehyde vapor—cycle time
<3 hours

Always use moist heat sterilization using

steam under pressure in preference to
other methods since it is more reliable and
can be more effectively monitored and
validated. However, this method is not
suitable for items that are damaged by heat
or moisture, including flexible endoscopes.
Remember to establish the sterilization
requirements before the reusable medical
device is purchased so that the correct
sterilization method is available.
*Ref: ANSI/AAMI ST41:2008/(R)2012 Section 8.8.4
1
cycle time 8–12 hours

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 Pre-Module Quiz

Keep these questions in mind as you go through the content

and don’t worry if you don’t know the answers yet—that’s what
you’re here to learn.

Q: What methods of sterilization are you aware of?

Q: How are they monitored?

Q:What are these methods used for?

When is Sterilization Required?

This is based on the Spaulding classification of risk

assessment. Sterilization is required for RMD, medical devices
that come into contact with a break in the skin or mucous
membrane or enter a sterile body cavity.

Risk Category Recommended Decontamination Medical Device Examples

Level

High (critical) Sterilization Surgical instruments, implants/

prostheses, rigid endoscopes
Items that are in contact with and needles
a break in the skin or mucous
membrane or entering a sterile
body cavity

Intermediate (semi-critical) Disinfection (high level) Respiratory equipment, non-

invasive flexible endoscopes,
Items in contact with mucous bedpans, urine bottles
membranes or body fluids

Low (non-critical) Cleaning (visibly clean) Blood pressure cuffs,

stethoscopes
Items in contact with intact skin

Choosing the correct sterilization process is important to avoid

damage to the item or compromising sterility. Sterilization and
providing sterile devices for patient procedures is dependent
on the whole cycle of decontamination, including cleaning,
packaging, sterilization, and storage/transport. Handling the
device in theatre may also have an impact on maintaining
sterility until actual patient use.

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 Device Compatibility
The ability of the sterilization system to effectively
sterilize the medical device depends on the device’s
component materials and design, as well as the level
of bioburden (microbes) prior to sterilization.

If items are not cleaned and disinfected correctly,

effective sterilization may not be achieved.

Functionality is the ability of a medical device to

withstand the sterilization process and to remain
within operating specifications. The device
manufacturer will test its functionality after processing
through repeated sterilization cycles and provides
fully validated IFU on how to process the medical
devices they supply (ISO EN 17664).

Steam Sterilization
The process of steam sterilization requires direct
contact between the material being sterilized and
pure dry2 saturated steam at the required temperature
for the required time in the absence of air. The
recommended combinations of time and temperature
are shown below.

132
Sterilization temperature (°C) 115 121 126 134
(USA)

Max allowable temperature (°C) 118 124 129 137 135

Minimum holding time (minutes) 30 15 10 3 4

The higher temperature of 134°C for 3 minutes is

the preferred time/temperature for devices that will
withstand this temperature and associated pressure.
A steam sterilization cycle involves air being
displaced and removed by steam entering the
chamber. This can be done with gravity using a
2
Dry steam is steam that is at the temperature of saturation, but does not contain water particles in
suspension. It has a very high dryness fraction, with almost no moisture.

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 gravity displacement sterilizer, or with a vacuum using a
porous load or vacuum assisted sterilizer. Air removal is
essential for effective sterilization, as it will affect steam
access to all areas of the device or pack.

Figure M7–1 Steam Sterilizer

Gravity Displacement Steam Sterilizers

This type of sterilizer has no assisted air removal and is

dependent on gravity, so steam penetration is slow and
cannot be assured. Cycle times are much longer for this
type of sterilizer and load selection is critical. They are not
suitable for wrapped items or items with channels (lumens)
as they trap air and prevent correct temperatures from
being attained. Gravity displacement steam sterilizers
may be used for solid metal items such as non-complex
surgical instruments.

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 Porous Load (Vacuum Assisted) Steam Sterilizers

Porous load sterilizers incorporate a vacuum-assisted air

removal stage prior to steam admission and they require a
consistent supply of suitable quality steam.
A typical cycle consists of:

• Evacuation of air from the chamber and load,

assisted by flushing or pulsing with steam
• Sterilization of the load for not less than 3 mins at
134oC
• Steam removal and load drying by mechanical
evacuation
• Admission of filtered air to restore atmospheric
pressure
Automatic pressure

Pressure: Kpa
100
control valve

Pulse vacuum Sterilizing times Drying time

times

Sterilizing
temperature
Pulse power Pulse upper
limit

Time: T

End

Pulse
sucking Heating Sterilizing Exhausting Drying

Figure M7–2 A typical porous load sterilizer cycle

Steam Quality

Proper steam quality will prolong the life of RMDs by

reducing water impurities that have adverse effects on
device materials. Lime, rust, chlorine and salt can all be
left as deposits on devices if treated (reverse osmosis)
water is not used. These compounds can lead to stress
corrosion, pitting and discoloration of the devices and the
sterilizer. Pitting, corrosion and precipitates provide areas
where organisms can accumulate and be protected from
the killing effects of the steam process; increasing the
infection transmission risk due to inadequate sterilization.

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 IUSS System

Immediate use steam sterilization (IUSS) or flash

sterilization is a common term that describes the practice
of fast sterilization of surgical instruments at the point
of use, often associated with dropped instruments.

Flash sterilization is for non-porous and/or non-hollow

surgical instruments in an unwrapped condition. These
gravity-type steam instrument sterilizers are usually
located in the operating room, in order to process
instruments for extremely urgent use, for example a
dropped instrument when no alternative is available. These
sterilizers operate at 134oC for 3–10 minutes, resulting in
wet and very hot medical devices in the operating
room environment.

Indications for Use of IUSS

An IUSS sterilizer must be used only after all of the

following conditions have been met:

• Proper cleaning, inspection, and arrangement of

surgical instruments before sterilization
• Physical layout of the area which ensures direct
delivery of sterilized items to the point of use
• Procedures are developed, followed and audited
to ensure aseptic handling and staff safety during
transfer of the sterilized items from the sterilizer to
the point of use
• Items are needed for use immediately following
IUSS, as soon as the device cools so as not to burn
the patient
• Sterilizers are routinely tested prior to use and
appropriate records maintained

There is now a strong movement towards the routine

preparation of sterile instruments in a dedicated area like
the CSSD for the following reasons:

• Immediate advantages of case-by-case

organization of sterile instruments by
operating theatre staff
• The typical operating theatre is not designed or
equipped to wash and clean instruments as
reliably and consistently as a properly located and

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 designed CSSD, and there are concerns regarding the adequacy of cleaning
and drying of surgical instruments in the operating theatre prior to using
IUSS processing
• Sterility of sets of instruments can be uncertain following the use of sterilizers
designed and intended only for single dropped instruments; they should not be
used for routine sterilization of instrument sets
• The sterilizer may not be located in an area immediately adjacent to the operating
theatre; so the delivery of IUSS-sterilized devices to their point of use compromises
their sterility

IUSS Recommendations

• Restrict use to emergencies, such as unexpected surgery, or dropped devices

• In most emergency situations, the risk/benefit ratio is low enough to justify the use
of IUSS-sterilized devices
• IUSS sterilizers must never be used for implants, suction tubing or cannulae or
any other product not specifically validated for the IUSS process. In
non-emergency situations, the risk/benefit ratio is higher, particularly when
implantable devices are involved

Loading

Load steam sterilizers in the following manner to ensure steam contact and penetration:

• Avoid overloading
• Place non-perforated trays and containers on their edge
• Keep packages away from chamber walls
• Place concave devices on an angle to avoid condensate pooling
• Load textile packs perpendicular to the sterilizer cart shelf
• Place pouches on their edge
• Place multiple packages paper to plastic
• Do not stack rigid containers unless validated by the manufacturer

Unloading

When the cycle is complete, unload the sterilizer in the following manner:

• Place heavier items, trays and containers on lower shelves and lighter items
e.g. peel packs on higher shelves
• Review the sterilizer printout for the following:
• Correct sterilization parameters
• Cycle time and date
• Verify that the cycle number matches the lot control label for the load
• Verify and initial that the correct cycle parameters have been met
• Examine the load items for:
• Any visible signs of moisture

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 • Any signs of compromised packaging integrity
• Retain printed records of each cycle parameter
(i.e., temperature, time) in accordance with the
local policy

Load Cool-Down

After removing the sterilized load:

• Visually verify the results of the external chemical

indicators
• Allow the load to cool to room temperature before
touching or moving sterile packs. The amount of
time for cooling depends on the devices that have
been sterilized for example, a heavy item such as
an orthopedic mallet may require a longer
cooling time
• Ensure that cool-down occurs in a traffic-free area
without strong warm or cool air currents

Troubleshooting—Wet Pack Problems

Packages are considered wet when moisture in the form

of dampness, droplets or puddles are found on or within
a package. There are two types of wet packs; those with
external wetness and those with internal wetness. When
wet packs are found, either on removal from the sterilizer
or upon opening in the operating theatre, sterility is
considered to be compromised and the package contents
may be contaminated. Wet packs should be rejected and
re-processed according to the local policy.

Steam Sterilization: Advantages and Disadvantages

Advantages Disadvantages

Highly effective Moist process

Inexpensive Unsuitable for heat sensitive items

Rapid process

Items may be packaged

No toxic residues

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 Dry Heat Sterilization
The dry heat method may be used for glassware and metal
items, heat stable powders and non-aqueous liquids like
paraffin. A typical cycle consists of heating the chamber to
the required sterilization temperature, holding the load at
this temperature for a defined time period and then cooling
the load.

This process does not use steam so the typical times

required for sterilization are much longer. The typical time
and temperatures used are:

Temperature (o C) Time (minutes)

160 120

170 60

180 30

Advantages Disadvantages

Suitable for non-aqueous fluids and glassware High temperatures

Unsuitable for heat sensitive items

Long sterilization and cooling times

Items cannot be wrapped

Low Temperature Sterilization Considerations

• Temperature involved—is the method compatible

with the devices being processed?
• Cycle time—will this fit with the workload/turnaround
time of the CSSD? Will more devices be required?
• Availability of equipment
• Validation requirements
• Compatibility with devices being processed

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 Figure M7–3 Low Temperature Steriliser

Ethylene Oxide (EO)

These sterilizers operate at 37oC or 55oC so are suitable

for heat sensitive items. They are used commercially and
in some hospitals, but are banned in hospital settings
in many countries due to the costly health and safety
requirements for operating and housing these machines.
The EO process works well for heat sensitive equipment
such as invasive flexible endoscopes, and cardiac and
ophthalmic devices, but requires very long cycle durations
to allow of adequate aeration. A typical cycle consists of:

• Load pre-conditioning—vacuum and humidification

• Sterilizing gas exposure
• Gas exhaust and air purge

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 Atmospheric pressure
100
Absolute pressure (kPa)

Air purge

55°C (100min)
50

Humidification

0
0 20 40 60 80 140 160 180 200

Time (min)

Figure M7–4 A typical ethylene oxide cycle

Advantages Disadvantages

Suitable for heat sensitive reusable medical devices Equipment is expensive

Extremely penetrative—suitable for lumened Lengthy cycle with aeration and validation
devices
Ethylene oxide gas is toxic, explosive and
Items may be wrapped flammable

Dry process Separate accommodation is recommended

Non-damaging Lengthy aeration required to remove toxic residues

Gas Plasma

This method is also suitable for heat sensitive items

such as flexible endoscopes or complex laparoscopic
instruments as the operating temperature is 45oC. The
cycle time can vary from 45–75 minutes but no aeration is
required. A typical cycle consists of a vacuum to remove
air, injection and diffusion of the hydrogen peroxide and
generation of the plasma for a defined sterilization time,
followed by aeration and venting.

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 Advantages Disadvantages

Suitable for heat sensitive devices Non-cellulose wrapping materials required

Short cycle May not be suitable for long narrow lumens

Sterilization Validation
Validation establishes documented evidence providing
a high degree of assurance that a specific process will
consistently produce an end result meeting specifications
and quality attributes by:

• Measuring the critical parameters of the process

such as temperatures, time and pressure, load
configuration (contents) and documentation of the
results
• Assuring all components of the process such as
proper cleaning, functionality, packing, wrapping
are met
• Proper protocol management

Steam Sterilizer Testing

Routine testing of sterilizers should be performed daily,

weekly, quarterly and yearly as per ISO 17665.

Daily
Bowie-Dick test for steam penetration (also known as air
removal test).

Unprocessed Pass Fail

Figure M7–5 Bowie-Dick test for steam penetration

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 BROWNE TEST

DATE DEPT

MACHINE

RESULT PASS/FAIL

OPERATOR DATE

SUPERVISOR CYCLE

Figure M7–6 Bowie-Dick test for steam penetration

Weekly
• Safety checks
• Vacuum leak test
• Air detector function test (if equipped)
• Automatic control test
• Bowie-Dick test

Quarterly
• All the above plus
• Thermometric test,
• Surgical instrument calibration verification

Yearly
• All the above plus
• Steam quality tests
- Non-condensable gas
- Steam superheat
- Steam dryness
- Endotoxins
• Testing of dry heat sterilizers
• Thermocouple test
• Biological indicators
• Chemical indicators

Ethylene Oxide Sterilizer Testing

• Physical parameters i.e. temperature, pressure and

humidity
• Biological indicators
• Chemical indicators

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 Gas Plasma Sterilizer Testing

• Physical parameters i.e. temperature, pressure

and humidity
• Biological indicators
• Chemical indicators

Chemical Indicators for Sterilization

ISO 11140 classifies chemical indicators into six types, according to their
intended use. They are further subdivided by their indicated sterilization
process. The classifications describe the characteristics and intended use
of each type of indicator and has no hierarchical significance.

Chemical indicator types

Types Purpose

These indicators are intended for use with packs or

containers to indicate that they have been directly
Type 1
exposed to the sterilization process and to distin-
Process indicators
guish between processed and unprocessed units.
They do not indicate that the reusable medical
devices are sterile.

Type 2 These indicators are intended for use in specific

Indicators for use in specific tests test procedures, such as the Bowie-Dick test for air
removal.

These indicators are designed to react to one of

Type 3 the critical sterilization variables, e.g., time and
Single variable indicators temperature, and are intended to indicate exposure
to a predetermined sterilization process variable,
e.g., 134°C

These indicators are designed to react to two or

Type 4 more of the critical sterilization variables, e.g., time
Multivariable indicators and temperature, and are intended to indicate
exposure to predetermined sterilization process
variables, e.g., 134°C, 3 minutes

These indicators are designed to react to all critical

variables of the sterilization process, e.g., time,
Type 5
temperature and presence of moisture, and are
Integrating indicators
intended to be equivalent to or exceed the perfor-
mance requirements given in the ISO 11138 series
for biological indicators

These indicators are designed to react to all critical

Type 6 variables of the sterilization process, e.g., time,
Emulating indicators temperature and presence of moisture, and are
intended to match the critical variables of specified
sterilization cycles

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 Examples of indicators

Type 1 indicator.

Used to show that the pack has been subjected to

a sterilization process but not that sterilization has
actually been achieved.

Type 2 indicator

Specifically used to show air removal from a steam

sterilizer.

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 Exercises and Checklists

Exercise 1

What type of sterilizers do you have in your department?

What temperature do they utilize?

Complete the questions in your log book.

Exercise 2

Look at the indicators used for sterilization in your unit.

Complete the questions in our log book.

Exercise 3

Carry out a Bowie-Dick test on one of your steam sterilizers and

comment on the result in your log book.

Exercise 4

Complete of Sterilizer Competency Checklist in your log book

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 Module 8
STERILE STORAGE, HANDLING
& TRANSPORTATION

Key Terms
time related expiration | event related expiration
heating ventilation and air conditioning (HVAC) | compression
case cart system | pick list | process challenge device (PCD)
events

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 Learning Outcomes

By the end of this module you will be able to:

 Clearly understand product release practices for

processed goods

 Describe environmental requirements for storage areas

 Understand the need to segregate items produced

in-house from commercially produced items

 Understand health and safety requirements for manual

handling and movement

 Describe the tracking and traceability requirements for

medical devices

 Demonstrate understanding of potential damage to sterile

items when being transported

 Outline procedures for product recalls

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 Introduction

This module will give you an

understanding of Time related and
Event related sterility practices and
the elements that can impact these
practices. We focus specifically on
the importance of appropriate storage
locations and conditions, maintenance of
stock levels and technician handling.

Maryam: Why would handling matter if the items are already

packed and sterilized?

Khaled: We use excellent processes to ensure a safe product

but the packaging has limitations—if we aren’t careful about how
we handle it afterwards, we could risk contaminating devices
before they are used on a patient. This can be an even bigger risk
in larger healthcare facilities as they may have a large number of
storage areas and greater distances to travel.

Pre-Module Quiz

Keep these questions in mind as you go through the

content and don’t worry if you don’t know the answers
yet—that’s what you’re here to learn.

Q: W
 hat does time related expiration mean?

Q: What does event related expiration mean?

Q:With your understanding of CSSD design, what do

you think are the key environmental aspects that would
need to be monitored for sterile storage?

Q:Where do risks occur when transporting sterile sets?

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 Q: What would you do if you dropped a sterile set on the
ground or found one on the floor?

Q: What PPE precautions need to be taken when

transporting sterile items?
Q:With your understanding of the sterilization process
and its monitoring, what conditions must be met to
release sterile products for use?

Q: What are some important features of a transport cart?

Product Release

Before we explore the storage, handling and transportation

of processed items we must ensure we have met the
requirements for safe product release.

As we explored in module 7, there are key aspects that must

be assured after the sterilization process before we can
release for storage or patient use, such as:

Biological Monitoring
Monitoring must be carried out according to your local policy,
but generally you monitor with the first full load of the day and
with all implant loads. Biological indicators require anywhere
from 1–48 hours of incubation before release so it is important
to know your IFU (Figure M8–1).

Did the biological monitor pass and was this documented?

Figure M8–1 Chemical and biological monitoring

Chemical Monitoring
Have chemical indicators been placed inside all packages
and external indicators used on packages that can’t be
viewed, like containers and wraps? (Figure M8–1) Was an
additional process challenge device (PCD) run with the cycle
for assurance? Did the PCD chemical indicator pass and
was this documented? Do the users in your facility check the
indicator before using on a patient?

Cooling
Was an adequate amount of time given for the items to cool
after sterilization before moving to storage? For most items
a marked set of 30 minutes is allowed for cooling but longer
times are required for larger and heavier sets.

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 Physical Inspections
Was a physical inspection made of all packs to
ensure the following:

• Items were correctly placed on sterilization

racks and shelves with small and lighter items
on top and heavier on bottom?
• Correct packaging and sterilization methods
were used, for low temperature steam?
Figure M8–2 Residual Moisture on Set

• Identification labels are correctly attached?

• No residual moisture on outside of package?
(Figure M8-2)
• Tapes and identification labels are attached?

Product Rejection

During the product release checks above, all must be

fully met or the item(s) will not be released for use. For
all release check failures, the item must go through
the full reprocessing starting from decontamination—
no short cuts can be made.

Product Recall

There is always a possibility that items have been

released but later recognized as items that should
have been rejected. Some reasons for this include:

• Biological or chemical indicator wasn’t used or

didn’t pass
• Documentation wasn’t correctly completed
• Manufacturer recalled a defective item

When any of these things occur, it is critical to use

your process documentation to identify all items that
are affected by the error and carry out an immediate
recall. Your facility should have a procedure for
recall that includes at minimum, notifying all users
impacted and documenting all actions in an adverse
occurrence report.

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 Sterile Storage Room

As we explored in module 1, CSSD requires multiple

storage locations, one for storing sterile products and
another for storing clean (unsterile) supplies that are
used in production. For this module we will focus on
the sterile storage room where the items we released
from the sterilizer room will be kept until required or
staged for later delivery.

Key Requirements

Temperature and humidity controls—control the room temperature between 18–25 C

(64–77 F) and a relative humidity of 30–60%. Humidity below 30% can reduce the barrier
effectiveness of packaging materials while excess humidity and temperatures can allow
moisture to condense on packages.

Positive air pressure—to prevent cross contamination, this room must be maintained
under positive pressure to keep contaminants out (Figure M8–3).

Hand hygiene sink—hand hygiene must be performed before handling sterile products
to ensure no dirt or oils will be left on the packaging.

Lighting—although additional lighting and magnification will not be required there must
still be adequate lighting to ensure items can be easily identified for use.

Restricted access—only authorized personnel have access to this room to ensure items
are handled appropriately and not contaminated.

Shelves, transport carts and workstations—must be washable, designed to avoid

damage to packaging, and allow for items to be stored without excess stacking.

Positively Negatively
Pressured Room Pressured Room

Clean Dirty

 
 



 
Figure M8–3 Air pressure regulation

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 Figure M8–4 Sterile Storage shelving

Figure M8–5 Transport Carts Figure M8–6 Workstation

Figure M8–7 Sterile Storage shelving

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 Sterile Supply Expiration

Time Related Expiration

When referring to medical devices, time related sterility1
is defined as “a package remains sterile until a specific
expiration date is reached”.

Time Date
This method is particularly important for perishable items like
food that can spoil or grow dangerous levels of bacteria and
relies on the ‘first in - first out’ principle where items with the
shortest expiration date are always used first.

Maryam: Using only time related expiration, it is expected that

as long as it hasn’t expired, it’s safe to use, much like the laban I
have atmicroorganisms,
Hand hygiene—ensures home. Is it the same for sterile
soil and medical devices?
oils are

Khaled: Much like the laban you have at home, incorrect storage
and handling can damage the integrity of packaging and damage
sterility so we must also consider other factors rather than
expiration dates alone.

Event Related Expiration

Event related sterility2 is defined as “items are

considered sterile unless the integrity of the packaging is
compromised or damaged, regardless of the sterilization
date.”

Events are the interactions that can cause a negative

impact on sterile products and occur from both storage
and handling.

We identified the requirements for a safe sterile storage

room above. Some additional considerations include:

1,2
AAMI – Central Service Technical Manual, 7th Edition

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 reduced on hands to minimize contamination. Hand wash facilities should be
available but segregated to prevent splashing on sterile sets.

Correct handling—do not drag or push items against surfaces causing

friction or abrasion. This damages the packaging and compromises sterility.

Correct Shelving—shelving should be of correct size and design to hold

items safely and ideally the top and bottoms shelves should be solid or
covered to reduce or prevent dust accumulation.

Walls—packs must be at least 5cm from walls and windows to reduce

condensation risks.

Floors—packs should be kept at least 25-30cm above the floor to prevent

contamination from floor cleaning products, spills and inadvertent touching.

Ceilings—there should be at least 45cm between the highest package and

the ceiling or fire sprinkler heads.

The importance of avoiding contact with sterile packages

can’t be overemphasized. This includes bumping into,
leaning on, backing into, touching when counting and
excessively rearranging the packages.

Removing items from a shelf—lift the front of the package underneath with
one hand, place the other hand midway under the package and lift the whole
item free from the shelf.

Minimal handling—this is a critical element as each time a package is

handled it is considered an event.

Food or drinks—never consume, store or

transport food or drinks through a sterile supply room.

Corrugated boxes—harbor moisture, mold,

mildews, insects and potentially contaminating
micro-organisms. Do not use cardboard boxes
(Figure M8–8).

Figure M8–8 Corrugated cardboard

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 Figure M8–9 Forced packages on shelves Figure M8–10 Over-stacked Figure M8–11 Good

Don’t force or stack on shelves—items when forced,

stacked, bent or compressed can force contaminated air
inside or cause ruptures to closures and seams that me by
difficult to detect (Figure M8–9 to 11).

Dropped items—jarring and compression from landing,

forces dust and airborne microorganisms into the package.
Dirt from the floor can also be carried onto the shelf and
contaminate the next pack placed in that position. Dropped
items must be considered contaminated and removed even
if no damage is apparent.

Sunlight—items should not be exposed to direct sunlight

and ideally not located near windows.

Moisture—packages must not be stored near or under

sinks, pipes, sewage lines, drains or other items that could Figure M8–12 Ball point pen
expose sets to moisture.

Ball pens—only validated markers should be used for

writing on packages as ink from pens may seep into
packages and also physically damage the surface
(Figure M8–12).

Rubber bands—force or compress packages so should

never be used for sterile items (Figure M8–13). Figure M8–13 Rubber bands

Quality Assurance Checks

We explored the events that can negatively impact sterile

items but since we can’t watch items 24/7 we must carry out
quality assurance monitoring of our environment and safety
checks each time we interact with the sets.
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 Environmental Monitoring
Monitoring the environment ensures the conditions have been maintained
consistently and no events have occurred that could reduce package integrity.

• Are you measuring temperature, humidity and room pressure regularly

and documenting the results?
• Is there a regular schedule of environmental cleaning and is this
documented?
• Are heating ventilation and air conditioning (HVAC) units serviced
regularly and documented?

Safety Checks when Handling

Like the environment, we can never assume our colleagues have always
handled items correctly so we should always look for signs of events that may
impact sterility:

• Tears or abrasions?
• Tracks, or fuzzy or worn areas from dragging?
• Dents or punctures?
• Dirt?
• Moisture or evidence of moisture-like spotting?
• Sterilization label with date?
• Chemical indicator inside set or view pack?

Time Versus Event Related Sterility

In most parts of the world, both time and event related sterility are used
together to ensure safe items for patient use. In some countries there is a shift
to using only event related expiration with the idea that as long as handing
is minimal and environmental conditions are stable, then items should never
expire. If you are considering using only event related sterility can you answer
yes to the following questions?

1. Is your storage appropriate?

2. Are you handling sets correctly?
3. Are quality assurance checks carried out each time items are handled?

Case Cart System

In many hospitals, a Case Cart system is used for the preparation of surgical
procedures. This system uses a Pick List that lists all the specific CSSD sets,
consumables and equipment needed for an individual surgical procedure. In
most facilities that use this system, it is CSSD that “pick” the case cart so this
requires additional storage considerations for consumables.

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 Consumable Inventory Management

For reusable items processed in CSSD we have a fixed

number of items and rely on a ’first in - first out’ out
method to ensure items are used on a rotational basis.
Consumables are used and disposed of and require
replenishment systems to ensure they are available
when needed. A lack of consumables can pose a risk
to patients. Consumables are also an additional cost to
a facility so it is important to maintain correct levels so
there isn’t an overstock or risk of waste if items expire
before use. For this module we will focus on the top three
management systems: periodic automated replenishment
(PAR), exchange cart and requisition.

Periodic Automated Replenishment (PAR) or 2 bin—

uses a defined minimum and maximum level of supplies,
frequently with 2 bins so that an order is placed when one
bin is empty.

Example

Bin 1—10 Pieces Bin 2—10 Pieces Bin 1—10 Pieces Bin 2—0 Pieces

Minimum 10 Pieces Bin empty

Maximum 20 Pieces Re-order

Figure M8–14 Figure M8–15

This system is preferred as it is simple to use, and does

not require manual counting of stock levels for re-ordering.
Once a bin is empty, the amount needed to refill the bin is
ordered.

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 Exchange cart—a cart with determined levels is
exchanged at a regular interval with a new fully stocked
cart. This system is commonly used for laundry or areas
with high usage as it allows a cart to be filled in a central
location and simply exchanged with the depleted cart.

Sterile Transportation

In module 4 we discussed how transport carts play

a key role in protecting us and the environment from
contaminated items during transportation. For sterile items,
transport carts play an equally important role but instead
they protect the sterile items from us and the environment
as we move them through the hospital. The same Figure M8–16 Exchange cart (closed)

principles for carts apply:

Closed Cart
Ideally closed or at minimum covered, to protect sterile
items from contamination risk when travelling through
public areas. Closed carts also reduce the chance of items
falling out of the cart.

Correct Size and Weight

The cart should be an appropriate size with adequate
shelves to hold the items being collected without stacking,
stuffing, or overfilling as this counts as an event that
can negatively impact sterility. The size must also be
appropriate so users have safe visibility when moving them
through corridors and be of an appropriate weight that
allows them to be moved in a controlled manner. Larger
and heavier carts may need two people to move safely.

Washable
This cart is used for sterile items but will be travelling
outside sterile areas so needs to be cleaned effectively
before returning to use in CSSD. The cart should ideally be
compatible with a cart washer if available, or be designed
to facilitate effective manual cleaning and disinfection
between uses.

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 Servicing
The carts should be constructed from robust materials to withstand
the rigors of daily use. Doors, shelves and wheels must be
maintained to ensure safety and ease of use to the users transporting
items in the facility.

Handling
We discussed the key requirements for minimal handling to meet
event related sterility but for transportation we must also consider:

• Select the most appropriately sized cart for the

collection process and ensure it is functioning
correctly.
• Bring any required documentation necessary to log
items being delivered.
• Perform hand hygiene before loading or unloading
carts.
• Before transferring items, move the transport cart
as close as possible to the destination to reduce
the distance you carry items and minimize the risk of
dropping them.
• Place heavier items on the middle or lower shelves
and never on high shelves to reduce the risk of
dropping.

When travelling through the facility make sure you:

• Take care to follow correct hand hygiene to reduce

the chance of contaminating items in the cart.
• Do not leave sterile transport carts unattended
particularly if they cannot be locked as other staff or
patients could open them and compromise sterility of
the items.
• When deliveries are complete, bring your cart back to CSSD
for decontamination.
• Empty carts should be processed through a cart washer if
available or manually cleaned and disinfected if not, as per
local policy.

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 Exercises and Checklists

Exercise 1

Explore your sterile storage room.

Check your log book for instructions and documentation.

Exercise 2

Complete the competency checklist.

Check your log book for instructions and documentation.

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 184 Sterile Storage, Handling & Transportation

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 Module 9
ENDOSCOPE
DECONTAMINATION

Key Terms
endoscope | flexible endoscope | endoscopic retrograde | invasive
non-invasive | channels | upper GI | raiser bridge channel
pre-clean | manual clean | disinfection | validation | storage
HEPA | Automated endoscope re-processer (AER)

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 Learning Outcomes

By the end of this module you will be able to:

 Describe the design requirements of the endoscope

decontamination unit

 Describe the design of flexible endoscopes and key

considerations for their processing

 Explain recent international outbreaks and what changes

occurred to processing procedures as a result

 Explain different standards and how to ensure safe

practice

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 Introduction

Endoscope Decontamination focuses exclusively on the

requirements for design of the area, equipment used
and procedures required for successful flexible
endoscope reprocessing and discusses the added
challenges faced internationally with these items.

Pre-Module Quiz
Keep these questions in mind as you go through the content, and don’t worry
if you don’t know the answers—that is what you are here to learn.

Q: What level of decontamination do you think a flexible endoscope requires?

Q: How many channels does a flexible endoscope have?

Q: Since most flexible endoscopes require only high level disinfection, does
that mean they have less risk than items requiring sterilization?
Q: What are the most common disinfectants used in processing flexible endoscopes?
Q: What are the critical parameters that should be monitored for disinfection?
Q: What is a leak test and why would we do one?
Q: Should flexible endoscopes be processed in CSSD only?

What Is an Endoscope?
The term is derived from endo (from within) and scope (examine). An endoscope is a
medical device specifically used for examining cavities within the body. They are available
in two forms—rigid and flexible, and can be used for both invasive and non-invasive
procedures. An endoscope may also have one or more channels so the doctor can insert
tools to collect tissue or provide treatment.

Figure M9–1 Example of a rigid endoscope Figure M9–2 Example of an endoscope with the manufacturer’s stamp to certify
that it can be autoclaved

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 Rigid Endoscopes
Rigid endoscopes are relatively easy to clean, disinfect
and sterilize as they have a simpler design than flexible
endoscopes. Most suppliers now have autoclavable
endoscopes, which eliminates the need for chemical
disinfectants. All reprocessing of autoclavable
endoscopes and their accessories take place in a
CSSD. They are cleaned and disinfected in a thermal
automated washer disinfector (with the appropriate
channel irrigation connections) and then sterilized.

Flexible Endoscopes
This module focuses specifically on flexible endoscopes
and the particular challenges involved in their
decontamination. Unlike rigid endoscopes, they are more
complex and difficult to process as they have many other
factors that impact cleaning and disinfection such as:

• They can be damaged by heat

• They are sensitive to damage from pressure and bending
• They can have multiple long narrow channels
-- Difficult to access for cleaning
-- Uncertain channel penetration of
detergents and disinfectants
• They are usually only chemically disinfected
(some invasive endoscopes are processed
using low temperature sterilization)
• They are made of materials that may not be
compatible with some disinfectants
• Disinfectants used may be toxic or
damaging to the device

Typical channel configuration of a flexible endoscope

Suction Valve
Air / Water Valve
Biopsy Valve Insertion Tube
Nozzle

Water Bottle Tube

Light Source
Water-Jet LIGHT SOURCE
Connector
Universal Cord Connector

Air
Air
Pipe Pump
Biopsy/Suction Channel Water Channel Suction
Connector
Air Channel Water-Jet Channel
WATER
BOTTLE

Figure M9–3 Example of a typical channel configuration of a flexible endoscope Figure M9–4 Example of a flexible endoscope

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 Because of these Invasive endoscope — passed into normally sterile
factors they are most body cavities or introduced into the body through
often decontaminated a break in the skin or mucous membrane.
in a dedicated flexible
endoscope processing Non-invasive endoscope — comes in contact with intact
unit located within the mucous membrane, but does not enter sterile cavities.
endoscopy department
rather than in CSSD.
Flexible endoscopes and Type Level of decontamination
their accessories are
very expensive so most Invasive Sterilization by steam or a low temperature method
facilities rely on fewer e.g. gas plasma
scopes and reprocess
them multiple times each Non-invasive High-level disinfection, e.g. immersion in
glutaraldehyde, peracetic acid, chlorine dioxide
day. This short time
between decontamination Table M9–1 Levels of decontamination

and use creates Endoscope Body cavity Simple/Channeled Invasive/

added pressure for non-invasive
safe processing.
Nasendoscope Nasal cavity and simple non-invasive
flexible/rigid vocal cords
Endoscopic Procedure
and Decontamination
Arthroscope Joints (knee, multi-channeled invasive
An increasing number rigid shoulder etc.)
of diagnostic and
Gastroscope Upper GI tract multi-channeled non-invasive
therapeutic procedures flexible (buccal cavity,
are carried out using pharynx,
an endoscope.Tables esophagus,
stomach, and
M9–1& M9–2 illustrate duodenum)
the procedure type
and the recommended Colonoscope Lower GI tract multi-channeled non-invasive
method of disinfection flexible (small intestine
and large
and or sterilization, as intestine)
outlined in module 2. The
level of decontamination Bronchoscope Lungs one or two non-invasive
required is based on flexible/rigid channels

whether the endoscope is

Cystoscope Bladder one or two invasive
invasive or non-invasive. rigid channels

Duodenoscope Upper GI multi-channeled non-invasive

flexible (duodenum; bile,
gallbladder and
pancreatic ducts)

Table M9–2 Endoscope usage and structure

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 Transmission of Infection
There is very little evidence for transmission
of infection associated with inadequate
decontamination of rigid endoscopes.
The transmission of infection has been
implicated with flexible endoscopes, and in
the last few years, infections associated with
duodenoscopes have been widely reported1,2.

The source of infection or

contamination may be due to:

• The previous patient and

inadequate decontamination of
the endoscope before reuse
• Contaminated lubricants, dyes,
irrigation fluid or rinse water
• Inadequate decontamination of
the reprocessing equipment

Inadequate Decontamination

Inadequate cleaning—the failure to

remove deposits of blood, feces, tissue,
mucous, microorganisms, or slime
from all channels, leads to inadequate
decontamination. This may result in infection,
misdiagnosis, or instrument malfunction.

Endoscope reprocessor use leading

to inadequate decontamination:

• Inadequate cleaning and maintenance

may result in the formation of
biofilm within the machine
• Use of static water within pipes or tank
• Use of poor microbiological quality of water
• Use of hard water

1 Kovaleva J, et al. Transmission of infection by flexible gastrointestinal endoscopy and

bronchoscopy. Clin Microbiol Rev 2013;26: 231-254.
2 Kenters Nikki et al. Infectious diseases linked to cross-contamination of flexible endoscopes…
Endosc Int Open 2015; 03: E259–E265

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 Raiser bridge (or elevator wire channel) present on duodenoscopes

Cleaning tube Syringe

Inlet Cleaning tube

Inlet Elevator Wire
Channel
Elevator

Figure M9–5 Raiser bridge (elevator wire channel) on duodenoscopes

Forceps elevator Decontamination of Duodenoscopes

Recent media reports have shown the potential for
infection associated with duodenoscopes. Publication
described a bacterial infection outbreak and
identified an issue with the design and reprocessing
of a new duodenoscope. Outbreaks similar to
this have been reported in the US as well.
Forceps elevator
recess Duodenoscopes are challenging because they have a
Figure 9- 6 Forceps elevator
raiser bridge channel (a channel that a wire passes through
to operate a lever at the other end) which on some models
of endoscopes requires cleaning, disinfection and rinsing
as part of the decontamination procedure (Figure M9–5).
Staff must be aware of the accessibility of this channel.
The British Society of Gastroenterology
(BSG), highlighted the following points to staff
carrying out the decontamination of flexible
endoscopes, in particular duodenoscopes:

• Adhere to manufacturers’ instructions at all times.

• Perform the pre-clean procedure at the patient’s
bedside, as described in the instructions from
the UK suppliers and BSG guidance.

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 • Remove the cover on the raiser bridge mechanism
at the distal tip, prior to brushing all areas of the
distal tip and cleaning with detergent.
-- Replace the cover on completion of
the decontamination process.
-- Use the brush on all surface areas of the distal
tip to ensure that all debris is removed.
• Flush the elevator wire with detergent during the manual
cleaning, ensuring the correct size syringe is used.
-- When automated flushing systems are used
for this stage of the process, ensure that
the elevator wire channel is included.
• Ensure that the endoscope washer disinfector has
the capability of flushing the elevator wire channel
with detergent, disinfectant and rinse water.
• If stored in a drying cabinet, flush the elevator wire channel
with HEPA filtered air along with all the other channels.
-- If this channel is not flushed with air, use the
endoscope within three hours or the endoscope
must be reprocessed before patient use.
-- Not all cabinets have the facility to flush with air. An
EN standard, EN 16442, has now been published
for endoscope storage drying cabinets.
• Routine microbiological surveillance of processed
endoscopes is not recommended.
-- Surveillance may be carried out on advice
from the infection prevention and control team
if an outbreak is known or suspected.
• Staff must receive comprehensive training, and retain
records, on all aspects of the decontamination of
endoscopes, in particular, duodenoscopes.

Guidance has also been issued by the professional

organizations in the United States and Australia.

Decontamination Failure Investigation

Records are kept for equipment of the decontamination
procedures for each and every use, and a list of the
patients it was used on. If there is a failure in the
decontamination process, the patients can be recalled.
The following procedure must be followed if a
failure of disinfection or sterilization is known
or suspected (Rutala W A, 2007)3.

3 Rutala WA and Weber DJ. How to assess risk of disease transmission to patients when there is a failure to follow recom-
mended disinfection and sterilization guidelines. Infect Control Hosp Epidemiol 2007; 28 (2): 146–55.

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 1. Confirm and document the disinfection
or sterilization reprocessing failure
2. Impound any improperly disinfected/sterilized items
3. Do not use the disinfection/sterilization unit
(e.g., sterilizer, automated endoscope reprocessor)
until proper functioning can be assured
4. Inform key stakeholders
5. Conduct a complete and thorough evaluation of
the cause of the disinfection/ sterilization failure
6. Prepare a list of potentially exposed patients
7. Assess whether disinfection/sterilization
failure increases patient risk for infection
8. Inform expanded list of stakeholders
of the reprocessing issue
9. Develop a hypothesis for the disinfection/
sterilization failure and initiate corrective action
10. Develop a method to assess
potential adverse patient events
11. Consider notification of local
and national authorities
12. Consider patient notification
13. Develop long-term follow-up plan
14. Perform “after-action” report and take
appropriate action to prevent reoccurrence

Staff Education and Training

It is essential that all staff involved in the decontamination
process are fully trained and regularly updated as
appropriate to ensure that they are aware of the
complexities of the endoscopes they are processing.

New employees must be tested for competency before

processing endoscopes and all staff retested on an annual
basis. When there is a change in endoscopes, disinfectants
or reprocessors, additional retraining must be carried out.
All training must be documented and kept for reference.

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 Examples of competency assessments for
flexible endoscope reprocessing can be found on
multiple company and society websites like:

• Olympus
• Pentax
• British Society of Gastroenterology

Staff Health
All personnel working in an endoscopy unit must
be educated about the biological, chemical, and
environmental hazards. Staff are required to:

• Be immunized against hepatitis B

• Wear PPE
-- Wear gloves and a disposable
waterproof gown with sleeves
-- Use gloves for short contact time (15–20 min);
nitrile gloves can be worn for longer contact times
-- Change gloves and wash hands between tasks
-- Use eye protection to protect from splashes
-- Have an approved vapor respirator (fitted with
charcoal filters) available in case of spillage
or other emergencies—store away from
disinfectants as the charcoal will absorb fumes

Record Keeping
Documentation for all endoscopes must be maintained
with all the decontamination equipment to ensure that
the correct decontamination process is being used.

To ensure that all endoscopes can be tracked

throughout the decontamination process and
traced to the patients upon whom they were used,
the documentation log includes the following:

• Procedure name
• Patient medical record number
• Endoscopist who has performed the procedure
• Serial number or identifier of the endoscope used
• Proof of the decontamination procedure
and the equipment and method used

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 Rigid Endoscope Decontamination

The decontamination life cycle for rigid endoscopes

are as described in modules 1 and 2.

1. Fully dismantle the endoscope and

accessories and clean all accessible surfaces
with freshly-prepared detergent.
2. Brush all accessible channels with a soft brush.
3. Rinse and dry the instruments.
4. Inspect and package for sterilization in
accordance with local procedures.
5. Automated systems are available to facilitate
the cleaning of rigid endoscopes.

Flexible Endoscope Decontamination

Stages in the flexible endoscope decontamination lifecycle

Stage Why

1. Bedside Removes readily detachable organic matter—

procedure this helps reduce the possibility of drying and
(pre-clean) causing channel blockages, especially if there
is a delay before manual cleaning takes place

2. Leak test Ensures the integrity of the endoscope

any damage to the outer surface could
allow body fluids or chemicals into the
internal workings of the endoscope

3. Manual clean Removes organic matter by brushing accessible

channels and flushing all channels—this stage
also allows the detection of channel blockages

4. Rinsing Removes detergent residues that may affect

the—performance of the disinfectant

5. Drying/air Expels excess fluid that may

dilute the disinfectant

6. Disinfection Eradicates potentially pathogenic micro-

organisms, i.e. bacteria, including
mycobacteria and viruses

7. Rinsing Removes disinfectant residues that

could be harmful to patients

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 8. Drying/air Expels excess fluid before use
on the patient or—storage

9. Storage Using a method that will reduce the risk of

environmental contamination and allow the
endoscopes to dry e.g. active drying cabinet.

Table M9–3 Stages in the flexible endoscope decontamination lifecycle

Figure M9–7 Stages in flexible endoscope decontamination lifecycle

1. Bedside Procedure (pre-clean)

This procedure is usually carried out by an endoscopy

nurse. It is important to ensure that the manufacturer’s
instructions are followed at all times.

1. Immediately after use on the patient, wipe the

insertion tube of the endoscope with freshly-prepared
detergent solution and a single-use cloth.
2. Suck the detergent through the suction biopsy channel.
3. Fit an adaptor to the air/water channel port and flush
the air/water channel with water from the water bottle.
4. Immediately after completing the pre-clean,
transport the endoscope to the decontamination
room for processing by a specialist.

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 2. Leak Test

This critical step must be carried out prior to manual

cleaning, following the manufacturer’s instructions.
If a leak is detected, the decontamination procedure
must not proceed. The endoscope must be sent
for repair. A leak will allow body fluids (which could
transmit infection to a subsequent patient) or
chemicals (that may damage the endoscope) to
enter the internal workings of the endoscope.
Irrigation devices are used for all stages of
the decontamination procedure where manual
flushing of the channels is required.

3. Manual Cleaning

The requirements for manual cleaning are:

• A dedicated, single-purpose sink, large enough

to fit the endoscope without excessive coiling
• Detergent
-- Neutral pH or enzymatic
-- Endorsed by the endoscope
manufacturer as being compatible
-- Specific for medical devices not
general housekeeping
-- Prepared at the correct concentration
and temperature
-- Brush the accessible channels, i.e., suction/
biopsy, before flushing with detergent
• Pass the brush along the entire length of the
channel, dislodging adherent material, and
repeat until the brush is visibly clean
• Submerge the brush under fluid to reduce
the risk of aerosols before withdrawing the
brush, all material must be removed
• After brushing, flush all channels with
freshly-prepared detergent solution using the
irrigation device supplied with the endoscope
• Discard the detergent solution after use
• Clean external surfaces, particularly around
the control box, with a soft sponge or cloth
• Pay particular attention to the raiser bridge channel on a
duodenoscope and the correct adaptor for this channel

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 4. Rinsing

• Use freshly drawn potable tap water

to remove detergent residues.

Channel Irrigation

Cylinder plug Biopsy Valve Cap

Water-Jet
Connector Plug

Air Pipe (Port)

Suction Port (Inlet) Suction Channel (Port)

Figure M9–8 Example of an irrigation device

5. Drying

After rinsing, drying expels excess fluid that may

dilute the disinfectant. Flushing air down the channels
will remove excess fluid, but will not completely dry
the channels. The use of 70% alcohol to flush all
channels reduces this risk and is recommended prior
to storage if not using an active air drying cabinet.

6. Disinfection

It is best practice to use an automated endoscope

reprocessor (AER) also known as endoscope washer
disinfector (EWD) for this stage of the process as it will
protect you and others from exposure to potentially
hazardous chemicals and provide a standardized process.

If you don’t have an AER, use a compatible disinfectant

at the right concentration for the recommended
contact time and keep it in contact with all surfaces/
channels. The most widely used disinfectants are

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 glutaraldehyde (2%) and peracetic acid. Some disinfectants
are single-use, the more widely-used disinfectants are
multi-use, and test strips and kits are available to test
for the minimum effective concentration (MEC).

The disinfectant should be changed when the MEC

is reached which may be a much shorter time than
the use life stated on the disinfectant container.
1. Measure and record these critical
parameters for effective disinfection.
- Concentration
- Temperature
- Contact time
2. Place the endoscope in a vessel with sufficient
capacity to allow it to be completely submerged.
3. Have a lid in place at all times to reduce
the risk of disinfectant vapor release.
4. Ensure that the disinfectant is in contact with
all accessible surfaces and channels.

7. Rinsing

The second rinse stage is essential to remove disinfectant

residues, which could be harmful to the patient. One of
the major causes of post-endoscopic infection or
pseudo-infection is due to recontamination during the final
rinse. Infections with Pseudomonas species and atypical
mycobacteria have been reported. The higher risk procedures
are cystoscopy, bronchoscopy and endoscopic retrograde
cholangiopancreatography (ERCP). The use of filtered (0.22
µm) water treated by reverse osmosis, or sterile water is
recommended for these endoscopes. To avoid the build-up of
disinfectant residues, discard this rinse water after each use.

Figure M9–9 Example of endoscope brushing

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 8. Drying

A “3-hour” rule is observed in many countries. Endoscopes

have to be used within three hours of processing as
this is the window in which microorganisms present
in the final rinse water may multiply to numbers that
may initiate infection. Flushing air down the channels
will remove excess fluid, but will not completely dry
the channels. The use of 70% alcohol to flush all
channels reduces this risk and is recommended prior
to storage if not using an active air drying cabinet.
This practice is not recommended in the United
Kingdom and most countries in Europe due to
the fixative properties of alcohol and the potential
for transmission of prion-related disease.
There is a trend towards the use of drying cabinets
with HEPA filtered air drying. However, these may
not be widely available, so manually flushing with
air after the rinse stage is essential. Alcohol may
be used to assist with the drying process.

9. Endoscope storage

Flexible endoscopes are stored, preferably hung, to

allow drainage of channels in a dust-free environment.
Lockable storage cabinets are available. Some are
described as drying cabinets as they feed HEPA filtered
air down the channels to allow for prolonged storage,
some validated up to 30 days. These cabinets must
comply with the requirements of EN 16442 (2015)4

Figure M9–10 Sample

pictures of cabinets

4 EN 16442 (2015) Controlled environment storage cabinet for processed thermolabile endoscopes.

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 The use of an endoscope washer disinfector
does not remove the need for the leak test or
the bedside and manual clean.

Automated Endoscope Reprocessor

(AER)
(Also known as Endoscope Washer Disinfector (EWD)

Automated Endoscope Reprocessors

(AER) are now more widely available and
provide a standardized and reproducible
decontamination process, while protecting staff
from exposure to chemical disinfectants.

Important Points About Using an AER

• A daily machine disinfection cycle must

be run as water may remain in the washer
and lead to the formation of a biofilm,
particularly with Pseudomonas spp., a
potential source of contamination.
• Some require a fume extraction Figure M9–11 Sample washer disinfector

to remove disinfectant vapor.

• All endoscope channels must be connected
to ensure irrigation by the AER.
• A water treatment system may be required
to avoid the risk of recontamination of
endoscopes from rinsing after disinfection.
• Weekly testing for the bacteriological quality of the
final rinse water should be carried out. ISO 158834
recommends that the final rinse water contain <10
cfu/100ml and that there are no Pseudomonas
aeruginosa or atypical mycobacteria detected.
• Use either a single use disinfectant or if using a
multi-use disinfectant a test strip/kit must be used to
ensure the disinfectant is at an effective concentration.
• In the event of finding contaminated final rinse
water, there should be a corrective action plan
developed by the infection prevention and control
team with the decontamination and clinical staff.

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 Automated Endoscope Reprocessor Regulations

The AER must comply with ISO EN 15883 parts 15 and 46

or a national regulation. These standards describe the tests
that are carried out to validate and verify its efficacy.

It is important that efficacy tests are carried out at

the time of installation to establish the performance
of the machine and to provide a baseline for
comparison when periodic tests are performed.

Accessories
Many accessories used in endoscopy—
biopsy forceps, diathermy, etc.—are invasive
items, and considered high risk.

• Sterilization is the preferred option for decontamination.

• Single-use sterilants are preferred
for invasive accessories.
• Most items are heat tolerant and ideally should
be sent to the SSD for steam sterilization.
• Immersion in a high-level disinfectant is acceptable
if steam sterilization is not possible due to
lack of instruments or available facilities.
• Cleaning of these items is difficult but essential, prior
to steam sterilization or exposure to chemicals.

5 EN ISO 15883-1: 2006 Washer-disinfectors — Part 1: General requirements, definitions and tests.
6 EN ISO 15883-4: 2008 Washer-disinfectors — Part 4: Requirements and test for washer disinfectors employing
chemical disinfection for thermolabile endoscopes

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 Facilities for Decontamination

Figure M9–12 Facilities for decontamination

Decontamination of rigid endoscopes is preferably

undertaken within the CSSD as the process controls
and the validation required are already in place.
Use of the CSSD is not so practical for endoscopes
with a rapid turnaround, for example gastrointestinal
endoscopes, and these are often processed at the
point of use. It is important that staff responsible for
reprocessing these endoscopes are aware of the need
to follow the recommendations for decontamination.

• Decontaminate flexible endoscopes in a dedicated

room away from the patient/clinical room.
• Ensure adequate ventilation to remove
potentially harmful disinfectant vapor
• The room must be equipped with a sink with sufficient
capacity to accommodate the largest endoscopes and
a dedicated hand wash basin equipped with soap and
disposable paper towels (and alcohol based hand rub).
• There must be a flow within the room from
dirty to clean to avoid the possibility of
recontamination of decontaminated endoscopes
from those just used on a patient.

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 • New units are being designed following the principles
of HBN 13 (see module 1) with a two room design and
pass through endoscope washer disinfectors. This
design is preferred to avoid the risk of recontamination
and the use of an unprocessed endoscope.
• A system must be in place to indicate which
endoscopes are ready for patient use.
-- This could be a printout from the
AER or a manual check sheet.
• More up-to-date units have a two-room system
with pass-through washer-disinfectors to provide
a separation between clean and dirty.
• Storage of endoscopes must be in an area that will
not allow recontamination of processed endoscopes.
• There must be sufficient storage for the
consumables used during the decontamination
procedure, e.g. PPE, chemicals, cleaning brushes
and sufficient capacity for waste disposal.

Reasonable space for access

Double sink units with work areas either side Water

treatment
EWD equipment/
filtration

Optional
table

PPE
storage
Endoscope
Clean route for single door
storage cabinets

Optional clean
endoscope
release via double-
Storage ended storage
cabinet

Dirty returns Alternative staff Key Waste bins

Depending on site
and staff location and scale, one and dispatch exit
Telephone
or two entrances can be (portable) and
utilisedand staff IT station

Figure M9–13 An example of a single room layout (HTM 01 01 Part B (2016) available from www.gov.uk)

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 Pass-through hatch or
PPE optional drying and/or storage
Cleaners’ EWD(s) cabinet or both
cupboard
Controlled staff entrance and
clean endoscope exit
Double sink units with
Dirty returns work areas either side

Table Table Double-ended ventilated

WHB endoscope
storage units

Storage unit

PPE Flow

Endoscope storage
Bin units
EWD(s)
PPE

Figure M9–14 An example of a two room layout (HTM 01 01 Part B (2016) available from www.gov.uk) Assignments

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 Exercises and Checklists

Exercise 1

Visit your endoscope decontamination department and observe the

decontamination process. Record your observations in your log book.

Exercise 2

You are given the freedom to design a new endoscope

decontamination department.

Do a sketch of the department and create the flow from dirty to clean.

Record your observations in your log book.

Exercise 3

List the types of endoscopes (gastroscopes, colonoscopes etc.)
reprocessed in your unit and establish what channels they have.

Record your observations in your log book.

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 Module 10
DENTAL INSTRUMENT
PROCESSING

Key Terms
central sterile service department (CSSD) | dental chair unit (DCU)
local decontamination unit (LDU) | sterile processing department (SPD)
dental unit waterline (DUW) | set down space | cuspidor
amalgam | single use devices | cassette | irrigation
kit | handpiece

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 Learning Outcomes

By the end of this module you will be able to:

 Describe how the design of the unit differs from hospital

decontamination units

 Discuss packaging types and strategies to reduce risk of

package damage

 Describe the design and function of the dental chair unit

(DCU)

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 Introduction

The decontamination of dental instruments is

a vital element of any dental practice, large or
small. Reusable items are made safe for staff to
handle and use on patients through a complex
process that involves a number of stages, with
potential for error throughout. Decontamination
of reusable dental devices may be done in a
central CSSD if the dental surgery is a dedicated
dental hospital, or within a medical hospital.
Many dental surgeries are not within or
associated with a hospital and do not have a
typical CSSD. Their decontamination units will
often be smaller, and staffed by fewer specialists
in what is known as a local decontamination unit
(LDU). Even though they provide all of the same
standard decontamination services as a CSSD,
LDUs servicing very small dental clinics do not
have much space, the layout may vary, and
the specialists often have to be more versatile.
Although the specialist training is the same, the
practices in a dental decontamination LDU may
differ from those in a CSSD as some of the work
takes place in the surgery. Some immediate
after use device pre-cleaning may be needed if
they are contaminated with rapid-set adhesives,
impression polymers or dental cements.

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 Pre-Module Quiz

Keep these questions in mind as you go through the content

and don’t worry if you don’t know the answers yet—that’s what
you’re here to learn.

Q: W
 hat is the smallest dental clinic you have visited?
How many dental chair units?
Q: W
 here do you think the decontamination was carried
out?
Q: Can you remember the layout of the clinic?
Q: W
 here do you think the biggest infection risks are in the
dental clinic?
Q: H
 ow do you think one decontaminates a dental chair
unit and its accessories between patients?
Q: W
 here does the water used to irrigate the patient’s
mouth come from?

Q: W
 hat is a dental ‘kit’?

Figure M10–1 Single dental chair unit clinic Figure M10–2 Multiple dental units in larger clinic

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 Dental Clinics and the Dental Chair Unit

Dental clinics come in many different sizes and

configurations. Small clinics may have their
decontamination unit closely integrated and large
clinics or hospitals may have more remote units.

Regardless of size, all clinics are designed around the

focal point of patient treatment—the dental chair unit
(DCU). Small clinics may have as few as one or two
DCUs, more often there are ten to twenty, while dental
hospitals may have up to four or five hundred DCUs.

A DCU may come in many designs but all have

similar features:

• Reclining seat for the patient

• Equipment console for the dentist or hygienist
• Equipment console for the dental assistant
• Work tray and a lighting unit.

Figure M10–3 Dental chair features & place beneath image

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 All of these are movable, and
apart from the seat, usually
attached to a central pillar on
flexible arms. The DCU may
also have advanced suction
systems, or a cuspidor (spitoon)
for the patient to rinse and spit
into, and a patient mirror or a
viewing monitor. The DCU is
controlled by foot pedals and
is usually closely surrounded
by work surfaces and storage
space within easy reach.

Two people (dentist or hygienist

and an assistant) work within
this space around the DCU,
seated on stools. Depending
on the size of the clinic,
other assistants may bring
instruments or supplies to
or from the decontamination
area or sterile supply storage
area. As the DCU is classed
as a medical device and has Figure M10–4 DCU with all attachments including chair mounted on a single pedestal

many attachments that enter

or contact the patient’s oral
cavity, in small clinics the
decontamination specialist may
be responsible for overseeing
its decontamination.

Maryam: What are the main differences between decontamination in a

dental clinic LDU and decontamination in a hospital CSSD

Khaled: The principles are exactly the same for both, however, you
will probably be processing some different types of devices, often
smaller devices, using smaller processing equipment. You also may
need to help clean and organize devices in the surgery including the
dental chair unit (DCU) depending on how many staff are employed.
This requires a good understanding of infection control, how the
dental chair unit operates and how the water, air and vacuum systems
operate and how disinfection of these is carried out. As the amount
of space in a LDU is often limited, you need to be particularly well
organized with regard to work flow.

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 DCU Decontamination

A dental chair unit is quite complex and

may contain:

• Compressed air
• Water supply
• Vacuum for suction and drainage
• Plus many electrical items

There are many contact surfaces on

the control panels, attachments and
movable arms which will be handled
by the operator’s blood and saliva
contaminated gloved hands during
patient treatment. These contact surfaces
are covered using thin clear plastic film
before patient treatment and disposed
of in the appropriate waste stream. The
surfaces may also be wiped down with
appropriate disinfectant wipes after the
film has been removed. Fresh film is used
to cover the surfaces before the next
patient, remembering that changing PPE
and disinfecting surfaces will help reduce
Figure M10–5 DCU syringes, scalers and lamp handles with disposable infection control
covers in place

infection risk from aerosols and splashes

that happen during treatment.

A range of handpieces including air/water

syringes, descalers, suction tips and drills
are removed from their respective hoses
for decontamination between patients.
Before doing this, each handpiece is
flushed through with water and/or air
for 5-10 seconds. Drill handpieces are
fitted with a ‘chuck’ which grips the tiny
interchangeable drill bits or ‘burs’. These
burs should be removed from the chuck
and stored in their respective racks before
returning both handpieces and bur sets for
decontamination.

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 Aerosols generated around the dental
chair unit can constitute a major health
hazard to patients and particularly
staff. Combinations of high speed
drills, ultrasonic scalers, compressed
air and irrigation water and improperly
disinfected suction systems can spread
blood , microbes, biofilm, mercury fumes
and saliva in a radius of over 1.75 meters
around a DCU.

DCU Waterlines

Each DCU is supplied with water, either from

a water distribution circuit or from a refillable
water bottle. Water may be used by a cup
filler, the air/water syringe, and by a number
of different handpieces. Multi-lumen hoses on
the DCU supply the handpieces with water,
electricity or compressed air depending on
their purpose, including ultrasonic scalers, Figure M10–6 Ultrasonic scaler handpiece with probe

air/water syringes, or high and low speed

drills. Some of these are designed to be
autoclavable while others contain electric
motors or fragile electronics. They are all
supplied by Dental Unit Waterlines (DUW)
to irrigate and lubricate the work area within
the mouth and to cool down high speed burs
which rotate at around 200,000 rotations per
minute (RPM).

There may be 10–20 meters of DUW in

each DCU, vital to the proper function of
the handpieces and their attachments. The
lumens of the DUW are quite small at only
2–3mm and along with the tiny valves that
control flow, are easily blocked. Poor quality
water, a lack of regular and effective cleaning,
and microbes from the patient’s mouth Figure M10–7 High speed handpiece with bur

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 travelling back up the handpiece, lead to the growth of
microbial biofilm within the DUW.

Between patients, the handpieces are removed and

sent for cleaning and decontamination and the DUW
are flushed for a few seconds. New decontaminated
handpieces and attachments are fitted before use on
the next patient.

Prevention of biofilm buildup or blockage in the DUW

requires flushing disinfectants through them at regular
intervals, for example, at the end of each day. This can
be done manually, or automatically on some modern
DCUs.

The American Dental More about the workings of dental drill handpieces can
Association suggests be found at pocketdentistry.com; search for Chapter
19: Cutting Instruments.
that dental irrigation
water entering the
patient’s mouth should
contain less than
200 bacteria per ml.
Surveys showed that
most DCU waterlines
are poorly disinfected
and introduce 40-
50,000 bacteria per ml Figure M10–8 Handpiece for saliva ejection

into the patient’s mouth. The dental assistant has handpieces for saliva
ejection on the DCU. These remove irrigation water,
debris, amalgam, blood and saliva from the mouth.
The handpieces are fitted with removable tips which
may be disposable or reusable. All tips are removed
between patients, the hoses are flushed, and new
decontaminated fittings are attached. Just as for the
previously described hoses, these are decontaminated
by flushing disinfectants through them periodically.
Both manual and automatic methods are used on
different brands of DCU.

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 Imaging Devices

In addition to the DCU, there may be an X-ray or imaging

device in the clinic. This may be mounted on the DCU
itself and may use film-holders, clamps and other devices
requiring decontamination between uses, although it is
now more usual to have disposable, single-use items for
these purposes.

Amalgam Handling

When old tooth amalgam is removed or new amalgam is

being inserted, any debris is usually removed using the
high suction handpiece and will be caught by an amalgam
trap in the suction unit.

Best Management Practices for Amalgam Waste

DO DON’T

Do use precapsulated alloys and stock a variety Don’t use bulk mercury
of capsule sizes

Don’t put used disposable amalgam capsules in

Do recycle used disposable amalgam capsules biohazard containers, infectious waste containers
(red bags) or regular garbage

Do salvage, store and recycle non-contact Don’t put non-contact amalgam waste in biohazard
amalgam (scrap amalgam) containers, infectious waste containers (red bags) or
regular garbage

Do salvage (contact) amalgam pieces from Don’t put contact amalgam waste in biohazard
restorations after removal and recycle the containers, infectious waste containers (red bags) or
amalgam waste regular garbage

Do use chair-side traps, vacuum pump filters Don’t rinse devices containing amalgam over drains
and amalgam separators to retain amalgam and or sinks
recycle their contents

Do recycle teeth that contain amalgam Don’t dispose of extracted teeth that contain amalgam
restorations. (Note: Ask your recycler whether restorations in biohazard cntainers, infectious waste
or not extracted teeth with amalgam restoration containers (red bags), sharps containers or regular
require disinfection) garbage

Table 10–1 Best management practices for amalgam waste © 2004, 2007 American Dental Association. All rights reserved.
(source: http://www.ada.org/~/media/ADA/Member%20Center/FIles/topics_amalgamwaste_brochure.ashx)

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 Handpiece Decontamination and Maintenance

Handpieces are complex devices and have many

miniaturized components within them. Clean and disinfect
or sterilize handpieces according to the manufacturer’s
IFU and carefully identify which processes and chemicals
are compatible with them.

Some are designed to be steam sterilized in an

autoclave, some cleaned in a washer disinfector while
others are only externally wipe-able and have a flushable
channel.

Lubrication is very important to extend the working life

of handpieces with moving parts. Lubricate handpieces
before washing and repeat after washing if it does
not pass inspection tests. Equipment is available for
automated lubrication of handpieces.

Common Handpiece Maintenance Mistakes

Not enough lubricant—apply a sufficient amount of

lubricant. The lubricant should come out of the head of
the handpiece to ensure all bearings have been covered.

Lubricating the wrong hole—one line is lubricated, the

drive air tube that leads directly to the turbine and vital
moving parts. The rest of the holes act as exhaust, water,
or chip air (to disperse water spray).

Failure to run handpieces after lubricating—causes

the oil to gum up inside the turbine and other moving
parts, decreasing performance over time. Running the
handpiece helps distribute the oil throughout the moving
parts.

Chemical wipe before sterilizing—this is redundant,

and the high temperatures of an autoclave cycle may
multiply harmful chemical reactions.

Ultrasonic cleaner use—never immerse handpieces in

any fluids, including an ultrasonic cleaner.

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 Burs in the chuck during autoclaving—when burs are
installed, the springs in an auto-chuck are under tension.
Autoclaving’s extreme heat will weaken the springs under
tension reducing the lifespan of the chuck. When burs are
left in a manual chuck, it causes a buildup of debris inside
the chuck creating problems during operation.

Early autoclave removal—the autoclave must complete

the drying cycle and the handpiece must cool down to
prevent condensation build-up, which causes internal rust
that destroys the device.

Not cleaning the fiber optics—fiber optics are there to

enhance operator visibility. Improper cleaning reduces
the amount of light that can be transmitted, reducing the
brightness of the operating field.

Dirty air and water Lines—having contaminated air or

water lines may contaminate all handpieces on those
lines. To check, purge the lines onto clean white paper
towel. Dirt or discoloration indicates your line may be
contaminated.

Small dental clinics are often located

in areas with restricted space for
decontamination activities. In the past,
some of these shared the same room
for both clinical and decontamination
activities—an unsatisfactory
arrangement.

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 Characteristics of an LDU
Although the space for an LDU may be quite small, there are a number of general
requirements to meet:
• Physically separate location from the clinical area and exclusively for
decontamination activities and ideally with separate zones dirty and clean
rooms like a CSSD
• Separate changing area
• Personal protective equipment (PPE)
• Dirty to clean workflow
• Smooth and easily cleanable surfaces
• Good lighting
• Ventilation, preferably flowing from clean towards dirty zones (no small portable
fans as rapid uncontrolled air circulation can spread contamination)
• Enough space for easy access to necessary equipment
• Dedicated set-down areas (particularly important when space is limited)
• Storage area for processed items, located in the clean zone or in the clinic

To ensure safe practice the flow should move from dirty to clean:

1. Hand wash sink

2. Instrument wash sink

3. Ultrasonic bath (particularly

Administration
useful for cleaning small
PPE
Storage Area

instruments when used Cooling and

between the wash and rinse

dispatch
Clinical

sinks) Waste Benchtop

Bin under Sterilizer
bench Dirty
Item
4. Rinse sink Set-down Benchtop
Sterilizer
Wash Sink
5. Washer disinfector
Benchtop
Ultrasonic Sterilizer
6. Inspection area cleaner
Post-Wash
Set-Down

7. Handpiece lubrication device Heat Sealer

(If required)
Pre-Rinse
8. Packing area including heat Set-Down

sealable pouches Rinse

Heat Seal Packaging
Dispenser (If required)
Sink
Dental Handpiece
9. Sterilizer or autoclave Lubricator (If required)

Post-Rinse Under Bench, Benchtop

Magnifying Inspection Lamp
10. Administration area
Set-Down Washer Disinfectors

Water Treatment

Figure M10–9 An example of an LDU consisting of a single room laid out with an anticlockwise work flow
© Health Facilities Scotland, a Division of NHS National Services Scotland
(source:http://www.wales.nhs.uk/sites3/Documents/254/SHPN13Part%2021.pdf)

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 Figure M10–9 shows an example of a single room LDU
which has only one doorway. In this situation the workflow
takes place in an anti-clockwise direction. The room is
divided along an imaginary line into a dirty side and a
clean side. This layout requires staff diligence to avoid
cross-contamination.

Figure M10–10 is another example of a single room LDU.

In this one, the work flow is linear and there are two doors
which allow the work to flow from the wash area towards
the clean area. In this design, there is less possibility of
cross-contamination but staff must still be rigorous about
their movements within the zones.

Ventilation
Ventilation extraction or
input output

Wash-hand
CLEAN DIRTY Wash-hand
basin
ZONE ZONE basin
(optional)
OUT
OUT IN
(optional,
dependent
upon space Inspect
and layout) Inspection and,
where
and storage applicable, Deliver
pack
Sterilizer
Rinsing Ultrasonic
sink Washing
cleaner
sink
Key (optional)

Instrument flow
Airflow

Notes
1. The use of an ultrasonic cleaner is optional. Where such a cleaner is not provided,
handling difficulties will be reduced by siting the washing sink near to the rinsing sink or
by combining both sinks through the installation of a double-bowl sink assembly.

2. Practices may increase the number of sterilizers if capacity and service continuity
dictates.

Figure M10–10 Example of a single room LDU

© Crown copyright 2009, 2013 (source: http://www.idsc-uk.co.uk/docs-2013/HTM_01-05_2013.pdf)

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 The preferable design for a LDU is shown in Figure M10–
12. It is similar to the previous linear flow design, however,
it has a physical division between the clean and dirty
zones, with a pass-through washer-disinfector. No devices
enter the clean zone without coming through the washer-
disinfector process, contaminated air does not enter the
clean zone and staff change their footwear and clothing
before moving between zones.

Double-ended
Double-ended
Ventilation
Ventilation washer-disinfector
extraction or or washer-disinfector
extraction Ventilation
Ventilation
output
output inputinput

Wash-hand
Wash-hand Wash-hand
Wash-hand
basin
basin basin
basin
Inspect
Inspect
CLEAN
CLEAN
and, and, DIRTY
DIRTY
wherewhere
OUTOUT applicable,
applicable, IN IN
pack pack

Ventilation
Ventilation Ventilation
Ventilation
inputinput Inspection extraction or or
extraction
Inspection
and and
storage output
output
storage Deliver
Deliver
Sterilizer
Sterilizer
Rinsing
Rinsing
sinksink
Ultrasonic
Ultrasonic
Washing
Washing
KeyKey cleaner
cleaner sink
(optional) sink
(optional)
Instrument flowflow
Instrument
Airflow
Airflow

Notes
Notes
1. An1. alternative is toishave
An alternative a single-ended
to have washer-disinfector
a single-ended in the
washer-disinfector in dirty area.
the dirty TheThe
area.
provision of a transfer hatch between the two rooms would be beneficial
provision of a transfer hatch between the two rooms would be beneficial in reducing in reducing the the
risksrisks
of manual
of manualhandling.
handling.
(While double-ended
(While double-ended washer-disinfectors offeroffer
washer-disinfectors advantages in reducing
advantages the risks
in reducing of manual
the risks of manual
handling, the use
handling, of a of
the use single-ended washer-disinfector
a single-ended will fulfil
washer-disinfector the objectives
will fulfil of this
the objectives of this
guidance provided
guidance providedit is itvalidated.)
is validated.)

2. The use use

2. The of anofultrasonic cleaner
an ultrasonic is optional.
cleaner Where
is optional. suchsuch
Where a cleaner is not
a cleaner is provided,
not provided,
handling
handling difficulties will be reduced by siting the washing sink near to rinsing
difficulties will be reduced by siting the washing sink near to the sinksink
the rinsing or or
by combining both sinks through the installation of a double-bowl sink assembly.
by combining both sinks through the installation of a double-bowl sink assembly.

3. Practices maymay
3. Practices increase the number
increase of washer-disinfectors
the number and and
of washer-disinfectors sterilizers if capacity
sterilizers and and
if capacity
service continuity dictates.
service continuity dictates.
Figure M10–11 Example of a two room LDU
© Crown copyright 2009, 2013 (source: http://www.idsc-uk.co.uk/docs-2013/HTM_01-05_2013.pdf)

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 The Dental Decontamination Cycle

The decontamination cycle begins in the clinic with

segregation of items after use. Dispose of single-use

2
items and other waste materials in appropriate waste
containers. Place hypodermic needles and other
disposable sharp items in dedicated sharps boxes.

Figure M10–12 Figure M10–13 The symbol for single use items

Do not re-use or reprocess any items carrying the single-

use symbol. This symbol on an item constitutes part of
the manufacturer’s IFU.

Single-Use Devices

A single-use device (also called a disposable device),

is designed to be used on one patient only and then
discarded, and never reprocessed (e.g., cleaned,
disinfected, or sterilized) for use on another patient.
Single-use devices in dentistry are usually not heat-
tolerant and cannot be reliably cleaned. Burs, endodontic
files and broaches have physical constructions that are
difficult to clean, and the cutting surfaces can deteriorate,
leading to possible breakage during patient treatment.
Burs and endodontic instruments exhibit signs of wear
during normal use, making it practical to consider them
as single-use devices.

There is also the possibility that endodontic devices are

in contact with nerve tissue, and in rare cases could
become contaminated with prions from infected patients.
Prions are currently impossible to reliably decontaminate.

Examples of items that are difficult to decontaminate and

should be substituted with single use items include:

Three-in-one syringe tips—3-in-1 disposable air /

water syringe tips to be used as an alternative to metal
autoclavable tips

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 Matrix bands—often heavily contaminated with blood, tissue and
cements and cannot be cleaned easily.

Endodontic files—these small items are difficult to decontaminate

and keep track of

Metal impression trays—are difficult to decontaminate. Plastic

impression trays are single-use although dental labs often
return them to clinics. Time and effort to reprocess these is not
worthwhile.

Steel burs - These are used to drill out damaged or infected

areas of tooth and may have complex patterns in which material
can lodge. These can be difficult to decontaminate and are
relatively cheap so they can often be treated as disposable.
These should not be confused with fine tungsten carbide or
diamond-coated burs which are easier to decontaminate using
ultrasonication and can be extremely expensive.

Figure M10–14 Reusable matrix bands Figure M10–15 Endodontic files

Figure M10–16 Metal impression trays Figure M10–17 Plastic impression trays

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 Reusable Devices (RD)

Devices ready for decontamination and processing for

reuse must be transported safely to the CSSD or the
LDU as soon as possible in securely enclosed transport
boxes Figure M10–18. Keep the RDs moist as described
in Module 4, using compatible enzymatic or detergent
solutions. Avoid high level disinfectants or alcohol which
may bind protein to surfaces, and saline or bleach
(hypochlorite) solutions which can corrode. When working
with substances that can harden on devices e.g., cements,
wipe the devices immediately with a non-lint swab.

The transport boxes should be rigid, have lids and be

easy to clean. These transport boxes must be easily
identifiable as containing either ‘dirty’ or ‘clean’ items to
avoid any potential confusion and must be subject to a
decontamination process themselves. Color-coded boxes
are often the simplest way to ensure this. Using markers or
labelling on only the lids can lead to confusion as lids may
become separated from their respective boxes.

Figure M10–18 Transport boxes (dirty and clean)

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 Work Flow of Dental Instrument Reprocessing

TRANSPORTATION

POINT OF USE
PREPARATION
- Pre-Cleaning CENTRAL STERILIZATION
- Dispose of waste SUPPLY DEPARTMENT

DENTAL
CHAIR UNIT RECEIVING AND SORTING OF INTRUMENTS

NON HEAT-SENSITIVE NON HEAT-SENSITIVE

1. CRITICAL 1. CRITICAL
2. SEMI CRITICAL 2. SEMI CRITICAL

MECHANICAL HEAT-SENSITIVE
CLEANING OF 1. NON CRITICAL
INSTRUMENTS 2. SEMI CRITICAL

PAKAGING OF HIGH LEVEL

INSTRUMENTS DISINFECTION

STERILIZATION PACKAGING OF
1. STEAM INSTRUMENTS
2. PLAZMA

STORE IN DRY – PROTECTED AREA

Figure M10–19 Work flow diagram

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 Dental Device Decontamination
Process
The process of dental device decontamination is about the
application of both knowledge and skills in the LDU and includes
cleaning, inspection, sterilization and packing for storage.

Decontamination Process Principles

• Consider all instruments set out for each patient as being

contaminated after the treatment regardless of whether they
have been used.
• Process all items according to manufacturer’s instructions,
however the instruction provided may not be clear or explicit.
In that case, request information from the manufacturer or
supplier.
• Return items to the start of the cycle if there is visible soil
detected at inspection. The flow in the decontamination
process is always from the dirty zone to the clean zone.
• Use an automated cleaning process for consistent results.
Washer disinfectors are essential for proper disinfection of
dental instruments, and an initial ultrasonic cleaning helps
remove adherent particles of cement, bone and amalgam
from devices.
• Sterilize all re-usable items before use, even if they are not
sterile at the point of use.
• Read and make sure you have easy access to all policies and
procedures in place for all aspects of decontamination.

Dental Device Classification for Sterilisation or Disinfection

CDC guidelines for infection control in dental health care settings

provide guidance on the classification and sterilization or disinfection
of dental instruments. Dental instruments are classified as:
• Critical—invasive devices used to penetrate soft tissue or
bone—sterilized after each use
• Semi-critical—devices that do not penetrate soft tissues or
bone but contact oral tissues—sterilized after use (high-level
disinfection for heat-sensitive devices)
• Non-critical—instruments that come into contact with intact
skin only—low-level or intermediate level disinfection

Heat sensitivity and fragility determines the method of processing.

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 Cleaning
There may not
Three methods of cleaning reusable dental devices are be procedures
currently available:
to cover every
• manual contamination
• ultrasonic
risk in the
• washer-disinfector
decontamination
These processes were covered in detail in Module 5, for
wash room, so it
reusable medical devices in general. Some dental devices
differ in size and detail and require different processing. The is very important
number of sharp, pointed devices used such as probes,
for specialists to
picks, scalers and scrapers is greater in dentistry and many
of these devices are double-ended. The risks of sharps be vigilant and to
injuries from handling these or manually cleaning them is also
understand the
greater. Many of the items are also quite small (e.g. burs,
scaler tips) and it is good practice to use special organizer basic principles
trays for these which can be used in ultrasonic cleaning
of what they are
, washer disinfectors and autoclaves avoiding having to
handle these small items individually. doing and how to
minimize the risks.

Figure M10–20 Single and double ended picks Figure M10-21 Organiser cassette for small items

Further Reading

Details of full manual cleaning processes for dental devices can be found
in The SCDCEP guidance document—Cleaning Dental Instruments,
accessible at www.sdcep.org.uk under published-guidance,
decontamination.

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 Avoiding Instrument Damage Washer Disinfector Use

When manually cleaning you must avoid Washer disinfectors offer the best option for
damage to a protective layer on dental the control and reproducibility of cleaning.
devices. The corrosion resistance of most This means that the cleaning process can
dental devices is based on their high- be validated. Washer disinfectors carry out
quality alloy composition and structure. The the processes of cleaning and disinfection
alloy forms a protective layer on the surface consecutively, reducing handling.
of the device, giving it the ability to resist
corrosion. A typical washer disinfector cycle for
devices includes the following five stages:
• Don’t use wire brushes, as they can
compromise the protective layer and 1. Flush—removes gross contamination.
increase the chance of breakage. A water temperature of <45°C is used to
• Stop using any devices that have prevent protein coagulation and fixing
rust spots. Never use wire brushes of soil
to remove rust spots. 2. Wash—removes any remaining soil.
• Don’t use wire pot scourers to clean Detergents used in this process must
devices as these damage the be specified by the manufacturer
surface of devices. as suitable
• Some chemicals can damage for use in a washer disinfector.
devices, avoid contact. 3. Rinse—removes the detergent used
during the cleaning process.
4. Thermal disinfection—the temperature
Rinsing and Drying of the load is raised and held at the
pre-set disinfection temperature for
After manual or ultrasonic cleaning, the required disinfection holding time: for
rinse devices thoroughly in clean water example, 80˚C for 10 minutes, or 90˚C
to remove residual soil and detergents for one minute.
and then dry them thoroughly. Don’t air 5. Drying—heated air removes residual
dry them, as inadequate drying may moisture.
enable moisture to be trapped, promoting
corrosion or microbial growth. The use of clip trays or cassettes instead of
trays or baskets in a washer disinfector to
Immerse cleaned instruments in clean hold particular sets of devices saves time,
water in a separate sink dedicated for protects devices and avoids extra handling
rinsing instruments, and use disposable, (Figure M10-21). It avoids overloading and
low-lint towels to dry the devices ensures better access for the cleaning
immediately after rinsing. process.

Figure M10–22 Clip tray

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 Inspection and Packaging

After thoroughly cleaning, drying and inspecting dental

supplies, assemble them into sets or trays for wrapping.
Some small individual items may be placed into heat sealable
pouches. Always place critical and semi critical instruments
that will not be used immediately into sterilization packaging
(sterile wrap (SMS wrap), heat sealable pouch, etc.) It is
not appropriate to re-use pouches or wraps that have been
designated single-use. Strengths and limitations of common
packaging options for dental practices are shown in Table
10–2.

Common packaging materials used in Dental Practice:

Peel Pouches Reusable Wrap Paper-based Wrap SMS Wrap

• Excellent barrier
• Can visualize item • Strong & tear resistant
Strengths inside • Strong • Fairly inexpensive • Drapable
• Fairly inexpensive • Drapable • Water repellent
• Low flammability
• Cost effective

Limits • Only for single or •P

 roduces lint • Tends to have memory • Can tear with heavy
small items •M
 any have poor and not drape well sets
• Can tear when microbial barrier • Wicks moisture, making • Cannot be used in
opening protection it hard to detect items Dry Heat Sterilization
contaminated by water because it will melt
• Can burst (blowout) •B
 arrier degrades
in sterilizer over time — unable • May lint — depending
• Correct loading is to determine when upon how well the fibers
critical barrier becomes are bound
unacceptable
• Some have poor barrier
protection
• Weak — tears easily
• Flammable

Table 10-2: Common packaging materials used in dental practice (source: https://cdn.vivarep.com/contrib/va/pdf/dt_halyard_kcd_pdf_01.20171595625215.pdf)

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 Wrapping Dental Instruments

Before use, hold packaging materials at room temperature

(20°C to 23°C [68°F to 73°F]) and at a relative humidity
ranging from 20% to 60% for a minimum of 2 hours.
Examine all packaging materials, woven or nonwoven,
regularly for defects and extraneous matter. Policies
and procedures should be developed for packaging
techniques and should be consistent with the
manufacturer’s recommendations.

Double-wrapping is recommended for terminal sterilization

in acute care settings, and double-wrapping may be
prudent for some dental items—depending upon strength
and barrier requirements. If only a single wrapper is used,
it is especially important that it provide excellent barrier
protection. Look for packaging that provides the highest
level of barrier protection possible.

Storage

Similar principles apply for storage of dental devices as for

reusable medical devices described in Module 8.

Exercises and Checklists

Exercise 1

Fill out the Skills/Competencies Table for Module 10 in

your log book.

Exercise 2

Go to your log book and complete the Dental Decontamination

Competency Checklist.

230 Dental Instrument Processing

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 Module 11
INTRODUCTION TO
QUALITY CONTROL AND
ASSURANCE IN THE CSSD

Key Terms
quality management system (QMS) | quality assurance (QA)
quality control (QC) | tracking system | defects
standards | performance monitoring
key performance indicator (KPI) | notified body | audits

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 Learning Outcomes

By the end of this module you will be able to:

 Define quality in the context of the CSSD

 Understand and explain the difference between quality

assurance and quality control

 Describe the fundamentals of a quality management

system including the role policies and procedures play in
quality outcomes

 Explain how audit can help with continuous improvement

in the CSSD

 Understand the role of key performance indicators (KPIs)

in CSSDs

 Describe the actions to take when a product recall is

required

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 Maryam: Isn’t it good enough that we do our best at all times? Why
such tight control?

Khaled: Doing your best is very important but tight documented

controls will help you and your CSSD colleagues to work in a
standardized manner and minimize problems that can arise due to
different practices being followed.

Introduction

The aim of this module is to describe the role quality

plays in ensuring all reusable medical devices
processed in the CSSD are “fit for purpose” and that
all work activities consistently support this outcome
to ensure patient safety. Using a quality management
system (QMS), having written policies and procedures,
a system of auditing practices and a means to
record defects, all contribute to high quality devices
being produced. As we have covered in previous
modules, decontaminating reusable medical devices
is a complex, multistage process. Having a well-
trained workforce that approaches each stage of
the processing in the same manner supports device
standards in production. We will discuss each of these
aspects of quality in more detail in this module.

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 Pre-Module Quiz

Keep these questions in mind as you go through the content

and don’t worry if you don’t know the answers yet—that’s what
you’re here to learn.

Q: What role does quality play in the CSSD?

Q: H
 ow can quality be measured?
Q: Can you remember the layout of the clinic?
Q: H
 ow does a tracking system contribute to and improve
quality?
Q: H
 ow can key performance indicators support
measuring quality?
Q: W
 hat does the term “continuous improvement” involve?
Q: H
 ow can quality be improved by the use of auditing
practices?

What is Quality?

What do we mean by quality in relation to the work of the

CSSD?

There are many aspects of this service associated with quality

including:

• The production of reusable medical devices that are fit

for purpose
• How we process and provide these devices using
industry best practices and the latest technologies
• Customer service, and how we deal with device users
Quality is the consistent delivery of products and
services according to established standards.

Quality integrates the concerns for healthcare customers with

those of the CSSD. CSSDs always work towards producing
100% defect-free devices for the sake of the people on whom
they will be used. Always keep in mind “would I like this used
on me?” when working, it’s a good reminder to strive for
excellence in everything you do in the CSSD.

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 CSSD manages an optimal flow of devices, under
the highest standards of quality and infection control,
from the moment they have been used until they
are cleaned, disinfected and/or sterilized in new
packaging and returned for use again. In order to
succeed, we need to ensure we can measure and
monitor quality at all stages of the decontamination
life cycle.

To demonstrate the quality of our work, we need to

define which standards will be applied to all work
undertaken.

Figure M11–1 Health Building Note 13 (HBN13), Department of Health, UK, 2004

ACQUISITION


1. Purchase
2. Loan
CLEANING
DISINFECTION

TRANSPORT

INSPECTION
At all stages
Location
Facilities
USE Equipment PACKAGING
Management
Policies/Procedures

 DISPOSAL
1. Scrap
2. Return to lender

STORAGE
STERILIZATION

TRANSPORT

Standards

Standards can be defined as “a level of quality or

attainment, something that can be used as a measure” or
similarly “a level of quality or achievement, especially a
level that is thought to be acceptable”.

In the CSSD, standards can be defined by a statement

specifying how activities will be carried out and by quoting
the official standards for both equipment and processes;
for example, there are standards for washer disinfectors
and for medical device packaging materials.
The International Standards Organization (ISO)

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 standards cover a variety of decontamination activities
and equipment, and have been created by committees
that include worldwide representatives. There are also
European standards prefixed by EN that cover similar
decontamination related topics, for example, EN868
Packaging.

There are over 250 official standards that relate to the

work of the CSSD. There are also guidance documents
developed by professional organizations, often country
specific, but adopted worldwide in the absence of locally
produced standards. For example, the British Society of
Gastroenterology (BSG) is well known for guidance and
standards describing flexible endoscopy processing.

Quality Management Systems (QMS)

In order to ensure that required standards are met and

that appropriate controls are in place, a formal QMS is
established and implemented in the CSSD. A QMS is a
formalized system that documents processes, procedures
and responsibilities for achieving quality policies and
objectives. A QMS helps coordinate and direct an
organization’s activities to meet customer and regulatory
requirements and improve its effectiveness and efficiency
on a continuous basis.

BS EN ISO 13485:2014 is a recognized standard

for medical device management regarding QMSs
appropriate for manufacturers of medical devices. The
term manufacturers in this instance is related to CSSD
processing medical devices and not manufacturing
devices in the literal sense!

ISO 13485 is similar in structure to BE EN ISO 9001, a

general QMS widely used across various non-medical
industries, ISO 13485 places greater emphasis on a
number of issues specific to processing reusable medical
devices including product cleanliness and environmental
control. Some CSSDs use both quality systems, as
when they are combined they cover all aspects of
device reprocessing and a commitment to continuous
improvement, (ISO 9001).

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 Formal accreditation for these quality management systems
can be achieved by identifying and applying standards
to processing and seeking external audit to confirm
compliance, after which a certificate is issued. CSSDs not
needing or wishing to achieve formal accreditation, can still
use the principles contained in quality systems ISO 9001
and/or ISO 13485 to implement control on their activities.

Both standards require a quality manual to be written which

includes a quality policy.

• A quality policy provides a short declaration of how

an organization will ensure the quality of its product
or service by detailing what processes are in place
 to ensure that an organization delivers what it says
it can.
• The Quality Manual contains procedures to outline
activities in each area of the CSSD supplemented
by work instructions that provide step-by-step
instructions to specialists who will carry out the
work.
• Some elements of these activities require a set of
standardized forms to capture required information.
Together, all of standards form a quality
management system. The hierarchical
documentation system can be seen in Figure M11–2.

Figure M11–2 BS EN ISO 13485:2014

Documentation hierarchy

Manual

Standards Procedures
Regulations
Permits
Work Instructions

Quality Records
Forms / Logs / Files

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 Further Reading
• BS EN ISO 13485:2016, Medical devices – Quality management systems –
Requirements for regulatory purposes (iso.org/standard/59752.html)

• BE EN ISO 9001, Quality Management

(iso.org/iso-9001-quality- management.html)

Quality Improvement (QI)

QI is a formal system of performance analysis and systematic

improvement. It involves measuring current performance, and
identifying ways to make things better. QI specifically attempts to
avoid attributing blame, and instead creates systems to prevent
errors from happening. It can be challenging to find where the
defect in the system is, and figure out new ways to do things. It’s a
great opportunity to think outside the box and improve how things
work.

Before addressing quality improvement approaches, we need to

understand the difference between quality assurance and quality
control, both equally important in different ways to the work of the
CSSD specialist.

Quality assurance (QA) focuses on preventing defects. Quality

assurance ensures that the approaches, techniques, methods
and processes used to manage and create procedures were
followed correctly and are operative. It is a proactive process and
preventative in nature. It recognizes flaws in the process. Quality
assurance precedes quality control, although one cannot exist
without the other.

Quality control (QC) focuses on identifying defects. It ensures

that the approaches, techniques, methods and processes
are followed correctly. It monitors and verifies that defined
quality standards have been met. It is a reactive, detection-
based process. Quality control must be completed after quality
assurance has been completed.
However, quality assurance and quality control are often used
interchangeably as they are inextricably linked, referring to the
actions performed to ensure the quality of a product, service or
process.

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 Figure M11–3 Quality improvement

Defining Qulaity

Report Set Standards

Develop Indicators

Improving Assess Measuring

Qulaity Qulaity

Performance Monitoring and Management in CSSD

Once we have a written QMS and we have defined

the standards to which we are going to process our
medical devices, we must monitor the process to
ensure the standards are being followed. We must
consider quantitative (data and statistics) and qualitative
(descriptive) information to determine the quality of the
service offered.

Monitoring quality can pose many challenges and involves

evaluating current performance—including end-user
perspectives—against a standard or expected level of
performance. One way of keeping track of the quality
of service is by using a defect reporting system, where
quantitative data is collected relating to defects received
by customers. Undertaking an annual customer survey is
a good way to seek views of the service from individuals
whose perception may not be reflected by statistics on
defects. For example, if a customer is constantly not
getting a response to phone calls they will think they are
being ignored and not have a good impression of the unit.
CSSDs need to know what the customer likes and dislikes.
It is clear that everyone in the CSSD must act as a team
and see their actions as reflecting the quality of the total It takes years to
service offered. CSSD customers cover a wide variety
of healthcare providers including hospital departments
gain the confidence
like the OR, out-patient departments, clinics or wards, of customers and
primary care users including general practitioners—almost
anyone who receives instruments, trays or medical device but only minutes to
accessories from the CSSD. lose it!
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 Maryam: Why do we monitor quality?

Khaled: We monitor quality to ensure standards are maintained

and to identify opportunities to improve where we have noticed that
performance is not at the standard we want it to be.

Product Recall

Most reported defects associated with CSSD can be managed

by identifying the cause of the defect, determining an appropriate
corrective action and closing the investigation.

In circumstances relating to RMD not being fit for purpose, it may

be necessary to recall a single product or a batch of devices,
for example, if a sterilizer load was not sterilized to the required
standard.
There must be a written procedure for product recall describing
how it will be undertaken and who is responsible for completing the
action. In some circumstances where risk to patients is identified, it
is necessary to inform users/hospital management or a responsible
person at the customer end.

Staff Performance and Training

For all specialists working in CSSD a consistently high standard of

work is required and each member of staff must be made aware of
the relevance and importance of their work in contributing to patient
safety. Training is key and all staff must receive instruction, not only
on the technical requirements of carrying out their jobs, but also in
other areas, for example, in customer service when answering the
phone, giving their name and asking how they can help. Staff must
be empowered to take any necessary action to deal with phone calls
themselves and not pass them to someone else. All decontamination
specialists need the knowledge, skills and tools to perform assigned
work according to expected standards.

Staff orientation is the first point at which basic training is provided.

The quality of all future work is based on how well staff are trained in
every aspect of reusable medical device processing. This training
is reinforced by reference to the QMS documentation, policies
and procedures and the step-by-step instruction provided by work
instructions. Following the procedures is a requirement of the audit

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 process for QMS compliance and accreditation maintenance, so staff
training using these as the basis of the theory is extremely important.
Decontamination specialists cannot be held accountable for
the quality of their work unless they have received adequate,
documented training, and refresher training is provided on a regular
basis or when procedures change. All staff working in the CSSD
must recognize their role in supporting the unit’s quality goals.
Staff annual appraisal systems provide an opportunity for two-way
conversations about work. The supervisor or manager has the
opportunity to discuss performance with the specialist, including
feedback on general work involvement and personal defects. It
gives the specialist an opportunity to share their opinions about
work and potentially identify additional training requirements and
more importantly share ideas on how practices may be improved.
Specialists want to provide an excellent service to customers and
they often know how to improve operations; their suggestions
regularly streamline procedures and can save time helping the unit
to be more efficient.

Documentation

Documentation is critical to the operation of the CSSD. We have talk-

ed about having a QMS containing clear policies, procedures and
work instructions. We also need to document information relating to
the reusable medical devices processed and be able to prove that
each and every one has been processed to an acceptable standard.

“Keep in mind, if it is not written down, it

did not happen!”

In other words, make sure records are kept of all activities, and cover
all stages of the decontamination life cycle. It is also important to link
the records to the decontamination specialist who has carried out
each activity. It sounds complicated but it is relatively easy using a
good electronic system which can ensure all information is captured.
(See section on Tracking Systems). The effectiveness of the QMS is
assessed to a large extent using the records as evidence.

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 Key Performance Indicators (KPI)

Key performance indicators are critical elements of

performance that provide an indicator of how well or
badly an organization is performing. Examples of quality
indicators are:

• Numbers of defects by customer as a % of total

volume
• Instrument trays contain correct contents, as per
the tray list
• Customers are X% satisfied with the service
as measured by the annual customer survey
questionnaire
• Sterilizer records are maintained in accordance with
QMS specified standards
• Turnaround times are met X% of the time for all
customers

For example, a customer KPI might be how many defects

are found on trays delivered in a given period of time, for
example, in a month. These may be broken down into
sub-divisions of defects including torn wrap, missing
instruments or incorrect contents. The KPI identifies an
acceptable level of defects over a given period of time,
usually as a percentage of the total volume, and then
monitors it through a customer complaints system. The
complaints are reviewed on a regular basis with the
customer. High volume customers, for example the OR,
would require more regular meetings than those receiving
only a small number of devices, e.g., doctors’ practices.
Any customers reporting a high number of defects must
receive immediate attention to determine the root cause.
Do not wait for routine meetings to be scheduled. Other
examples of customer KPIs may include late deliveries
where a specified turnaround time is agreed or a time
period for putting new devices into use. Remember all
KPIs need to be agreed, reasonable and achievable to
both parties, i.e., the CSSD and the customers.

Well-studied and carefully set ranges for targets are

necessary for a successful strategic plan (Figure M11–4).
Once KPIs and targets have been set, it is important to
routinely monitor performance against them.

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 Universal target ranges

Performance

Green Yellow Red

> = 100% 70% - 99% < = 69%

Meets or exceeds Failing below Fails significantly

target expected target short of target

Figure M11–4 typical target ranges

Continuous Improvement Cycle

It is important to routinely monitor standards within the CSSD.

Monitoring helps show where there is room for improvement, by
comparing actual performance against identified standard targets and/
or expectations. This is to ensure maintenance of standards, improve
adherence to standards, reach a better/higher quality level, and to
resume a standard where performance has fallen below the specified
standard. Figure M11–5 shows how this can be approached.

Figure M11–5 Continuous improvement cycle

Pl
ct
an
A

Purpose:
To achieve higher
levels of performance
k
ec

o
Ch

s
bje ctive
ults ent of o
Res enance hie vem
t
main ent, ac
provem
an ce im
orm
Perf

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 CSSD Electronic Tracking Systems

There are many IT tracking systems on the market, all with very
different features and benefits. Each CSSD must evaluate its own
requirements and purchase the system most closely matching their
local needs. The IT system is an electronic documentation system
also used to demonstrate compliance with the procedures in the
QMS as long as they can be retrieved to show to an auditor. It is
important to test the system internally to become familiar with how
records can be accessed.

As a minimum, the system records all items in circulation including

surgical instruments and trays, and contain information on tray
contents supporting the printing of tray lists for assembly. All devices
must be uniquely marked in some way to allow scanning. This may
be achieved using a number of different options including bar codes,
matrix marks, laser etching and radio frequency identification (RFID).
Below are some of these examples.

Most tracking systems will scan bar coded devices at each stage
of the decontamination process, thereby logging the activity. Many
systems will prevent items from moving to the next stage of the
process before successful completion of the previous one; this
is quality control. No device can easily miss a critical step in the
process. Decontamination specialists can be provided with bar-
coded personal identification badges, that are scanned at various
points within the department, marking an association between them,
the devices they handle and the equipment used in the department.

Figure M11–6 Barcodes Figure M11–7 Radio Frequency Identification

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 Customer

Delivery Collection

Logistics

Logistics

Full Track
and Trace
Stock & Throughout
Dispatch
procuct cycle Inbound

Product
Release Decontamination
and Cleaning

Sterilization IAP

QA, Quarantine,
Repairs and Maintenance

Figure M11–8 QA, quarantine, repairs and maintenance

Most modern systems integrate with the OR and allow

devices to be tracked back to the patients on which they
were used (Figure M11–8).

Some electronic systems have a defect reporting element,

allowing customers to report online, linking the report back
to the bar code of the actual device in question. This allows
the CSSD to respond immediately to customer complaints
and take the necessary action to deal with any problem.
For example, if the OR reports blunt scissors, they can be
identified when the tray returns to the unit and replaced
immediately, rather than a week later when the tray may
have been processed and returned to the OR without
Figure M11–9 Scanning
replacement happening. Most CSSD specialists will have
heard of calls from the OR asking why blunt scissors they
reported a week ago have not been replaced? A good IT
system will help to avoid such calls, but only when CSSD
staff are vigilant in following up customer reports. All such
calls affect the user’s perception of the department’s
service quality.

IT systems can also assist with inventory control, as they

can record how many of each type of trays or sets are in

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 use, and how often they are used—showing when too
many or too few are in circulation. Where devices require
servicing, for example a power tool, the system can be
programmed to provide a reminder to remove the device
from use and return it to the manufacturer.
These systems are able to support identification of the
decontamination specialists working in the CSSD and
allow them to link their activities to the devices passing
through their hands. This relates, for example, to handling
trays and individual surgical instruments in the washing
room, linking them to the decontamination equipment in
which they are processed, linking them to individual cycles
on each machine, and linking them to the sorting of clean
instruments in the IAP.

CSSD Auditing

Regular auditing is a requirement of any QMS. An audit

system covers all relevant processes and procedures
in order to determine the effectiveness of the QMS’s
application. All audits must be documented and the
records kept for inspection.

Different types of audit are routinely carried out both

internally and externally.

Internal Audits

• Procedure audits
• Traceback audits
• Observed practice audits
• Annual System audit—compares the QMS with the
relevant standards

Internal audits identify non-conformities, are counted

in departmental defect reporting and are discussed at
management review meetings.

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 External Audits

External audits comprise those carried out by the notified body

(certification body for accredited CSSDs) and those carried out
by customers. In Europe, the current audit system allows for
unannounced audits to be carried out by both the notified body and
the Medicines Healthcare Products Regulatory Agency (MHRA).
This means that all CSSDs must be audit ready at all times or face
losing their accreditation if applicable, or at a minimum receive non-
conformities for not following procedures.

Any failures (non-conformances) or results that fall outside of the

specified standard may indicate the need for further staff training
or a work review. Where non-conformities are found, an action
plan detailing the corrective action to restore the quality of work to
the expected standard, is generated. A further audit takes place
after completion of the action plan to ensure standards have been
restored.

Only appropriately experienced and trained staff carry out audits.

Records are kept of all audits, including date, time and outcome,
and are discussed at regular management review meetings. The
frequency of audits is defined in the procedures and a schedule is
developed to ensure compliance to the documented timescales, and
any action plans generated are retained.

Internal audits will be reviewed by external audits where CSSDs are

accredited to ISO 13485 and/or ISO 9001 quality system standard
by a notified body. A notified body is a completely independent
certification organization registered to carry out audits on
organizations wishing formal accreditation to a QMS. They thoroughly
review the application of the QMS (contents of policies, procedures
and records) by the CSSD under review. These external audits are
usually carried out annually.

Further Reading
For further reading, go to the Institute of Decontamination Science Training
Manual at www.idsc-uk.co.uk. And the International Association of Hospital
Sterile Service Materials Management (IAHSSMM) at iahcsmm.org.

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 248 Introduction Quality Control and Assurance in the CSSD

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 Appendices

GlossaryofTerms.indd 249 02/05/2017 20:39

 Medical Terminology

Word Elements Combined to Form Medical Terms

Word Elements
Prefix Root Suffix
hemi-( gastro ectomy hemigastrectomy
half) (stomach) (surgical removal) (removal of half of
the stomach)
hemi-( colo ectomy hemicolectomy
half) (colon) (surgical removal) (removal of half of
the colon)
hemi- cardio hemicardia
(half) (heart) (only two of the four
chambers of the
heart are formed)

Common Roots
Roots are base word elements that refer to the main body of a medical word

Common Medical Roots

Root Meaning Example Meaning
adeno gland adenoma glandular tumor
aero air anaerobe an organism that
lives only in absence
of air
angio blood vessel angiogram radiography of blood
or lymph vessels
arthro joint arthritis inflammation of a
joint
broncho bronchus bronchitis inflammation of the
bronchus
cardia heart electrocardiogram electrographic
record of the
heartbeat
cerebro brain cerebrospinal referring to the brain
and spinal cord
chole bile cholecyst gall bladder
chondro/io cartilage chondroma cartilaginous tumor
costo rib intercosto between the ribs
cysto bladder cyst any fluid-filled sac

250 Appendices

GlossaryofTerms.indd 250 02/05/2017 20:39

 Common Medical Roots contd.
Roots are base word elements that refer to the main body of a medical word

Common Medical Roots

Root Meaning Example Meaning
derma skin dermopathy skin disease
gastro stomach gastrointestinal pertaining to the
stomach and
intestines
gingiv gums gingivitis inflammation of the
gums
glosso, glotto tongue glossodynia burning mouth
syndrome
gyne woman gynecology the study of diseases
affecting the female
hema or hemat blood hemophilia inability of the blood
to clot
hepat liver hepatitis inflammation of the
liver
nephro/ reno of or pertaining to nephritis inflammation of the
the kidney kidney
pneumo/pulmo of or pertaining to pneumonia lung infection
the lungs
spleno spleen splenomegaly enlargement of the
spleen
utero of or pertaining to uterine fibroids muscular tumors
the uterus or womb that grow inside the
womb
Common Surgical Roots
arthro joint arthroscopy visual examination of
a joint
colo colon colectomy removal of part of
the colon
cranio skull craniotomy surgical opening
into the skull
herni rupture herniorrhaphy surgical repair of a
rupture
hyster uterus hysteropexy abdominal fixation of
the uterus
laryngo larynx laryngoscopy visual examination of
the larynx
lipo fat liposuction aspiration of fatty
tissue
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 Common Surgical Roots contd.
Root Meaning Example Meaning
litho stone lithotripsy crushing of a stone
masto/mammo of or pertaining to mastectomy surgical removal of
the breast the breast
myringo eardrum Myringotomy surgical incision on
the ear drum
oopher ovary oophorectomy surgical removal of
the ovary
rhino of or pertaining to rhinoplasty surgical
the nose reconstruction of the
nose
salpingo of or pertaining to salpingostomy surgical unblocking
the fallopian tubes of a blocked
fallopian tube
tracheo trachea tracheostomy surgical procedure
to create an opening
through the neck
into the trachea

Common Prefixes
Prefixes are word elements that are placed before the root to alter or modify its meaning

Common Medical Prefixes

Prefix Meaning Example Meaning
a, an without asepsis without infection;
sterile
ab away from abduction movement of a
limb away from the
midline of the body
ad toward (in the addiction toward dependence
direction of) on a drug
ambi both ambidextrous ability to use right
and left hands
equally well
anti against antiseptic preventing sepsis
(infection)
brady slow Bradycardia heart rate that is
slower than normal
carcino cancer carcinogenic cancer-causing
cyano denotes a blue color cyanosis bluish discoloration
of the skin and
mucous membranes
252 Appendices

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 Common Prefixes contd.
Prefixes are word elements that are placed before the root to alter or modify its meaning

Common Medical Prefixes

Prefix Meaning Example Meaning
dis apart, away hip dislocation displacement of
femur from pelvic
joint
dys painful dysentery painful inflammation
of the intestine
homo Same homogenous similar in structure
hyper above, excessive hyperacidity excessive acid in
the stomach
hypo below, deficient hypoglycemia low sugar content in
the blood
mal bad, poor malnutrition poor nutrition
micro denoting something Microscope optical instrument
as small, or relating used to visualize
to smallness very small objects
neo new neonatal newborn
pre before preoperative before surgery
sub under, beneath subcutaneous beneath the skin
supra above suprapubic above the pubis
Common Surgical Prefixes
Prefix Meaning Example Meaning
bi two/ both sides bilateral total hip two (both) total hip
reconstruction (THR) reconstructions
circum denoting something circumcision removal of the
as around another foreskin from the
human penis
cryo cold cryoablation uses extreme cold to
destroy or damage
tissue
hemi half hemigastrecromy surgical removal of
half of stomach
para beside, near parathyroidectomy surgical removal of
tissue near thyroid
peri around, about periosteal elevator instrument used
to remove tissue
around the bone
post after post partum after delivery of a
baby

Medical Device Reprocessing—Student Workbook 253

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 Common Suffixes
Suffixes are word elements that come after the root word, and may be one or two syllables

Common Medical Suffixes

Suffix Meaning Example Meaning
algia pain neuralgia nerve pain
cide kill germicide destruction of germs
ectasis expansion, dilation bronchiectasis chronic enlargement
of parts of the
airways of the lung
emia blood hyperglycemia high blood sugar
genic origin osteogenic originating in the
bones
itis inflammation tonsillitis inflammation of the
tonsils
lysis destruction, break lipolysis break down of lipids
down
megaly large or enlargement cardiomegaly enlargement of heart
necrosis death of tissue arterionecrosis tissue death of artery
ology study of bacteriology the study of bacteria
oma tumor carcinoma malignant tumor
pnea breathing dyspnea difficulty of breathing
rrhage flow hemorrhage uncontrolled flow of
blood
trophy nourishment, Hypertrophy increase in volume
development of an organ or tissue
Common Surgical Suffixes
Suffix Meaning Example Meaning
centesis Puncture a cavity to Pericardiocentesis aspiration of fluid
remove fluid from the pericardial
space
cise cut excise to cut out
ectomy surgical removal cystectomy removal of a cyst
oscopy visual examination of Iaparoscopy visual examination
an organ or joint of organs in the
abdomen
ostomy creation of a new colostomy creation of new
opening to colon on
the body
otomy incision into an organ gastrotomy incision of the
stomach

254 Appendices

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 pexy surgical fixation orchiopexy surgically fixation
of an undescended
testicle to the correct
location
plasty surgical restoration, rhinoplasty surgical repair of the
plastic repair nose
rrhaphy to suture myorrhaphy to suture muscle
wound
tome a cutting instrument dermatome an instrument used
for cutting skin

Suffixes that Mean “Pertaining To”

Suffix Example Meaning

ac cardi-ac pertaining to the
heart
al ren-al pertaining to the
kidney
ic hem-ic pertaining to blood
cal esophag-eal pertaining to the
esophagus
ary pulmon-ary pertaining to lungs
ous cancer-ous pertaining to cancer

Letters in Word Elements May Be Dropped or Added

Word Elements and Meaning Word Letter(s) Changed

Prefix Root Suffix
procto (rectum) itis (inflammation) proctitis O is dropped
endo (within) artery (artey) ectomy (removal) endarterectomy O and Y are
dropped
chir (hand) plasty (surgical chiroplasty O is added
revision)

Medical Device Reprocessing—Student Workbook 255

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 Notes

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 Notes

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 Notes

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 accredited medical education online

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