DECONTAMINATION OF MEDICAL DEVICES

INFECTION PREVENTION AND CONTROL

APRIL 2018
 Policy title Decontamination of Medical Devices
Policy CL05D
reference
Policy category Clinical
Relevant to All staff
Date published January 2019
Implementation January 2019
date
Date last December 2018
reviewed
Next review January 2021
date
Policy lead Lead Infection Control Nurse
Contact details E-mail: [email protected] Tel: 020 3317 7383
Accountable Director of Nursing & Quality
Director
Approved by: Infection Prevention and Control Committee
Date: 30th October 2018
Ratified by: Quality Committee
29 January 2019
Document Date Version Summary of amendments
history Jan 2019 1.0 New Policy
Membership of Lead Infection Control Nurse
the policy
development/
review team
Consultation Members of Infection Prevention and Control Committee

OCUMENT
DO NOT AMEND THIS DOCUMENT

FURTHER COPIES OF THIS DOCUMENT CAN BE FOUND ON THE FOUNDATION TRUST

INTRANET.

2 Decontamination of Medical Devices_CL05D_January 2019

Contents
1. Introduction ……………………………………………………………………4

2. Responsibilities ……………………………………………………………….4
3. General principals……………………………………………………………..5
4. Methods/procedures ………………………………………………………….5
5. During outbreaks of infection ………………………………………………..6
6. Decontamination of equipment prior to service or repair …………………6

7. Environmental hygiene ……………………………………………………….7

8. Cleaning materials …………………………………………………………….7
9. National colour coding of cleaning equipment ……………………………..8
10. Environmental cleaning during an outbreak of infection ………………….8
11. Responsibilities ………………………………………………………………..9
12. Equipment retained for investigation ………………………………………10
13. Monitoring and audit …………………………………………………………11

Appendix 1: Commonly used equipment and how to decontaminate it ...............12

Appendix 2: How to use Clinell Universal Cleaning Wipes ……………………….16
Appendix 3: Infection risks and methods of decontamination …………...............17
Appendix 4: Handling and decontamination of equipment prior to service,
repair return to lending organisation or investigation of an
adverse incident …………………………………………………………18
Appendix 5: Decontamination Certificate …………………………………………...19

3 Decontamination of Medical Devices_CL05D_January 2019

Decontamination of medical devices

1. Introduction
This policy gives guidance for all staff to follow the processes of
decontamination, cleaning and disinfection. The scope of this policy
applies to all staff, including bank and agency staff who work in the
Trust.

The Medical Devices Directive (MDD) – 93/42/EEC defines a

medical device as:
‘Any instrument, apparatus, appliance, material, or other article,
whether used alone or in combination, including the software
necessary for its proper application intended by the manufacturer, to
be used on human beings for the purpose of:
 Diagnosis, prevention, monitoring, treatment or alleviation of
disease
 Diagnosis, monitoring, treatment, alleviation of, or compensation
for, an injury or disability
 Investigation, replacement or modification of the anatomy or of a
physiological process
 Control of conception and which does not achieve its principal
intended action in or on the human body by pharmacological,
immunological, or metabolic means, but which may be assisted
in its function by such means.

The purpose of this document is to ensure all staff are aware of how
to clean medical equipment, and the surrounding environment.
What products, equipment and materials to use and staff roles and
responsibilities in relation to decontamination, cleaning and
disinfection.

2. Responsibilities
It is the responsibility of whoever is required to use the medical
equipment to ensure that it is clean and fully working. It is the
responsibility of the Infection Prevention and Control Link Champion
to ensure that the checks are undertaken at the prescribed intervals
and that the equipment it cleaned. This does not mean that it is their

4 Decontamination of Medical Devices_CL05D_January 2019

 responsibility to clean it as that should be shared but their
responsibility is to monitor whether it has been undertaken.

3. General Principles
Decontamination is an umbrella term used to describe processes
that make equipment safe for re-use which includes the destruction
or removal of micro-organisms. Inadequate decontamination is
frequently associated with outbreaks of infection in hospitals, and all
health care staff must be aware of the implications of ineffective
decontamination and their responsibilities to service users,
themselves and their colleagues.

Decontamination can be a singular or a combination of processes

that render the equipment safe to be used again on the same or
another person.

There are three levels of decontamination, general cleaning,

disinfection and sterilisation.

Equipment used in health care may be designated as single use,

single patient use or reusable multi-patient use. Any equipment not
designated as a single use item must be made safe following use to
prevent micro-organisms being transferred from equipment to
patients and potentially resulting in infection.

This label denotes a single use item that must not be re-used

2
4. Methods/Procedures
4.1 Choice of decontamination method for multi-patient use devices
All equipment will require cleaning. Some equipment will also
require disinfecting or sterilizing. Decontamination will work less
efficiently on equipment that is difficult to clean, and/or in a poor

5 Decontamination of Medical Devices_CL05D_January 2019

 condition. The level of decontamination required is based on the
risk (matrix is provided at Appendix 3 to inform the risk assessment)

Compatibility of equipment with the chosen method of

decontamination will be determined from information from the
manufacturer. Manufacturers of medical devices are required to
provide decontamination guidance for reusable products.

The choice of method also depends on the purpose of the

equipment and other risk factors.

Cleaning and/or disinfection of medical equipment must:

 Take place after and between uses on individual service users.
 Once cleaned/disinfected, pieces of equipment e.g. drip stands,
commodes should be labelled with an appropriate tag to identify
that it has been cleaned. The label should be dated and signed.
 Audits should be carried out regularly on cleanliness of
equipment in each area. An audit form can be obtained from the
Infection Control Team.
 Equipment requiring service or repair must be thoroughly
cleaned and decontaminated prior to inspection and a label
attached identifying method of decontamination.

See Appendix 1 for a list of common equipment used in the Trust

and what should be used to decontaminate it. Appendix 2
demonstrates how the Clinell wipes should be used.

4.2 During an outbreak of infection

In the event of an outbreak of infection the Infection Prevention and

Control Team may recommend additional measures when cleaning
medical equipment. This advice should be followed and if there is
uncertainty then the Infection Prevention and Control Team should
be contacted.

4.3 Decontamination of equipment prior to service or repair

including the need for it to leave site)

6 Decontamination of Medical Devices_CL05D_January 2019

Equipment that leaves an area for any reason, such as service or repair
must be correctly labelled, with the green label. When being sent for repair,
the equipment type, ID number and label number should be entered in the
loan register located in the Estates Information folder. The
‘Decontamination Label’ must be signed by the user who knows the
conditions in which the equipment has been used. (See appendix 4 and 5)

5. Environmental Hygiene

The environment must be visibly clean, free from dust and dirt
and acceptable to service users, their visitors and staff. In order for
the environment to be kept clean areas must be kept tidy and free of
clutter. Cleaning frequencies should be in line with ‘The national
specifications for cleanliness in the NHS: a framework for setting
and measuring performance outcomes’ (April 2007 NHS Patient
Safety Agency). A cleaning schedule should be available on the
ward with daily and weekly cleaning tasks; this should be available
for review although not on show.

Within the cleaning contracts there will be method statements for

how each area is cleaned, the frequency and which products should
be used.

Methods for cleaning are usually termed “dry” or “wet”

 Dry - Vacuum or dust attracting mops (sticky or static)
 Wet - General detergent solutions on surfaces and floors.

Cleaning materials

 Vacuum, cleaners should contain bacteria retaining filter or bag

and the exhaust directed away from the floor.
 Brushes must not be used in clinical/ward areas as they disperse
bacteria into the air in large numbers.
 Cleaning materials such as cloths and mops if kept moist act as
an ideal growth medium for bacteria, which will multiply rapidly. It
is important, therefore that disposable materials that are for
single use such as cloths, are disposed of after the task.

7 Decontamination of Medical Devices_CL05D_January 2019

 National colour coding of cleaning equipment

RED BLUE
Bathrooms, washrooms, General areas including,
showers, toilets, basins and wards departments, offices
washroom floors and basins in public areas
GREEN
Catering departments, ward YELLOW
kitchen areas, patient food Isolation areas
service areas

Colour coding of hospital cleaning materials and equipment ensure

that these items are not used in multiple areas, therefore reducing the
risk of cross infection. These colours are nationally recognised to
increase understanding across the whole of the NHS.

All cleaning materials and equipment, for example, cloths, mops,

buckets, aprons and gloves must be colour coded according to the
cleaning code.
Buckets should be cleaned and left dry and inverted at the end of the
task.

5.1 Environmental cleaning during an outbreak of infection

Increased levels of cleaning should be enforced in during outbreaks

of infection to at least twice daily or on advice from infection
prevention and control. Facilities/service provider should be informed
as soon as an infection or outbreak is suspected.

The Infection Prevention and Control Team will identify what special
cleaning measures, if any, need to be introduced in an effort to
reduce the spread of infection. This advice will include actions for
both the domestic staff and the clinical staff and products to be used,
which wherever possible should include disposable single use cloths
and mops.

8 Decontamination of Medical Devices_CL05D_January 2019

6. Responsibilities

6.1 All staff (who provide care in the healthcare setting) have a
responsibility to:

 Apply the principles of standard infection control precautions

 Follow cleaning schedules which are clearly defined, monitored,
documented and available on the ward, area or via Facilities
Department.
 Meet the requirements of the Health and Safety at work act
(1974) and the Control of substances Hazardous to Health
(COSHH) regulations (HSE, 2004) to ensure that the equipment
in their area is correctly decontaminated between uses and
patients. Manufacturer’s guidance must always be followed for
cleaning and disinfecting equipment.
 Report to line manager any deficits in relation to knowledge of
management of care equipment, the environment or any incident
that may have resulted in cross contamination.

6.2 Managers have the responsibility to ensure that:

 Manufacturer’s guidance is available for equipment prior to any

purchase.
 All staff under their supervision apply the principles of standard
infection control precautions.
 All staff have had instruction and education on the principles of
managing care equipment and controlling the environment which
will include standard infection control precautions.
 Adequate resources are in place to allow for recommended
infection prevention and control measures such as, medical
device cleaning, staff training and appropriate storage of medical
equipment.
 A risk assessment where necessary, is used to optimise patient
and staff safety, such as the use of chlorine based solutions,
consulting relevant infection control and prevention policies as
required.
 Cleaning schedules and standards are defined, monitored,
documented and can be made available.

9 Decontamination of Medical Devices_CL05D_January 2019

6.2 Infection Prevention and Control Team have responsibility to:

 The Lead Nurse within Infection Prevention and Control will act
as the Trust lead for decontamination of medical equipment.
 Provide education for staff and management on this policy. Act
as a resource for guidance and support when advice on
controlling the environment and managing of care equipment is
required.
 Provide advice on individual risk assessments for controlling the
environment and management of equipment decisions.

6.3 Estates and Facilities staff and the Trust contracted repair
company must:

 Draw attention to any instances where equipment presented for

repair is seen to be dirty / contaminated or where, in the case of
repair a decontamination label is not attached.
 Take adequate precautions if any contamination is found
internally after equipment covers have been removed. These
precautions will be as stated in the Estates Department’s Policy
for staff working on dirty or contaminated equipment together
with additional advice, as required depending on the hazard, and
from Infection Prevention and Control team (IPCT).

7. Equipment retained for investigation

In some instances where an item of medical equipment has failed

and an investigation is being undertaken it may be necessary to
secure the piece of equipment. In this instance it would not be
appropriate to decontaminate the equipment as this could affect the
investigation.

In this situation the equipment should be stored securely so that it is

not used and the Infection Prevention and Control Team notified for
advice. It must be labelled as not decontaminated and not for use.

10 Decontamination of Medical Devices_CL05D_January 2019

8. Monitoring and audit

The Trust ensures either directly or through its contracts that all staff
responsible for cleaning and decontamination of medical equipment
have been trained and been given the appropriate knowledge and
skills to undertake their role.

All clinical staff will undertake mandatory two yearly Infection

Prevention and Control Training.

The Medical Devices checklist will be completed every week by the

clinical staff detailing that the equipment is not only clean but
functioning. (Some equipment will need to be checked more
frequently and this should be documented on a separate form).

The Infection Prevention and Control Link Champions are

responsible for ensuring that the environmental audit tool is
completed and entered onto the Meridian audit system.

The Infection Control Team will carry out yearly audits to monitor
compliance with the policy in line with their annual plan, be part of
the annual PLACE audits and undertake spot audits when visiting
wards/teams.

The Facilities Contract Monitoring Team will share their audits which
are based on the Cleaning Standards with the Infection Prevention
and Control Team.

The policy will be reviewed in light of any changes or

recommendations to products and equipment use and cleaning.

Various staff visit clinical teams and the re-use of single use
devices should be flagged up where identified and reported on the
Trust internal reporting system (Datix).

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Appendix 1: Commonly used equipment and how to decontaminate it

Individual items Recommended method of Routine Cleaning

Airway SINGLE USE ONLY
dispose after use

Ambubag and Mask SINGLE USE ONLY

dispose after use

Auriscope Ear piece Single use

Auriscope Clinell Universal wipes

Bedpans and urinals Disposable recommended or if non disposable automated washer/disinfector at

80 degrees for at least a minute
Additional Notes
If cleaning required in home setting use detergent solution and dry. If service
user has enteric symptoms use hypochlorite solution ( see spillage policy)
Use PPE and empty contents into toilet
Beds Clean between patients with hot water and detergent solution or Clinell Universal
wipes

If soiling evident t then immediately clean and then wipe over with hypochlorite
solution ( see spillage policy)

Blood pressure monitoring Wipe after each use with a Clinell Universal wipe
equipment
Additional Notes
Should have weekly clean as part of Medical Devices checklist

Commodes and toilet seat Wipe after each use with a Clinell Universal wipe. Use separate wipes for
raisers/surrounds armrests and seats

Additional Notes
If soiling evident or in an outbreak situation, clean and then wipe over with
hypochlorite solution ( see spillage policy)

12 Decontamination of Medical Devices_CL05D_January 2019

 Duvets Should have wipe able covers
Clinell Universal wipe
Detergent solution and dry

Dressing trolley/trays Clinell Universal wipe

Detergent solution and dry

ECG Equipment Use disposable electrodes

-Electrodes Clinell Universal Wipe for leads and machine or
-Leads Manufacturers Guidance
-Machine

Examination Couch Clinell Universal Wipe

Additional Notes
Cover with disposable paper ( change between service users and dispose as
clinical waste)

(Hypochlorite solution if soiled with body fluids(see spillage policy)

Furniture Damp dust with a general purpose detergent or wipe with a Clinell Universal
wipe

Gym Equipment Hot water and detergent solution or Clinell Universal wipes at the end of each
session and between people

Additional Notes
If soiling evident or in an outbreak situation, clean and then wipe over with
hypochlorite solution ( see spillage policy)

Hair brushes/combs Individual service user use only. Wash weekly in detergent solution

13 Decontamination of Medical Devices_CL05D_January 2019

 Hoist Hot water and detergent solution or Clinell Universal wipes
Hoists slings must be for individual patient use only and should be laundered
when soiled or when the patient is discharged.

Inhalation compliance For individual patient use only – and must be labelled as such
devices e.g. Volumatic If dirty, wash with warm water and detergent. Rinse and dry thoroughly.

Mattress (and pillows) Hot water and detergent solution or Clinell Universal wipes

Additional Notes
Must be wipeable. Must be cleaned weekly, on discharge or when visibly soiled.
If soiling evident clean and then wipe over with hypochlorite solution ( see
spillage policy)
Medicine pots and oral Single use only.
medicine syringes

Ophthalmoscopes Clinell Universal wipe

Shaving equipment Each service user should have their own shaving equipment including electric
razors. Clean electric razors as per manufacturers’ instructions.

Sputum Pots Disposable single use-please discard into the orange clinical waste bins

Stethoscopes Wipe with a Clinell Universal wipe after each use

14 Decontamination of Medical Devices_CL05D_January 2019

 Tablet Computers (e.g. Wipe with a Clinell Universal wipe after each use
iPads)

Additional Notes
Must have washable cover and screen protector.

Thermometers Tempa-dot thermometer-single use only

All others-use single use plastic cover and dispose of after use-wipe with a
Clinell Universal wipe

Tourniquet Use single use

Wipe with a Clinell wipe between uses

Walking Aids Wipe with a Clinell Universal wipe between uses by different patients and when
dirty

Weighing Scales Wipe with a Clinell Universal wipe between uses by different patients

Height Stick Wipe with a Clinell Universal wipe between uses by different patients

Additional Notes
Should have weekly clean as part of Medical Devices checklist

Wheelchairs Wipe with detergent and hot water solution or Clinell Universal wipes
If soiling evident t then immediately clean and then wipe over with hypochlorite
solution ( see spillage policy)

Additional Notes
Should be cleaned weekly as part of the medical devices checklist, between
uses by different patients and when dirty.

15 Decontamination of Medical Devices_CL05D_January 2019

Appendix 2: How to use Clinell Universal Cleaning Wipes

Ensure that all surfaces are cleaned, that includes those underneath and
above the working areas.

16 Decontamination of Medical Devices_CL05D_January 2019

 Appendix 3 Infection Risks and Methods of Decontamination

Risk Category Level of decontamination Method of decontamination

required
Examples

High
 In close contact with a  Cleaning and  Sterilisation,
break in the skin or sterilisation e.g. autoclave
mucous membrane. surgical instruments
 Sterile single-use
 Introduced into a item
sterile body cavity or
circulatory system.

Medium
 In contact with mucous  Cleaning and  Sterilisation, high
membranes. disinfection or level disinfection
sterilisation e.g.
 Prior to use on any  Autoclave
vaginal specula,
immune compromised commodes and  Sterile single use
individual. bedpan holders
 Contaminated with  Washer/disinfector
body fluids particularly  Chemical disinfection
virulent or readily
transmissible
organisms

Low Risk
 In contact with intact  Cleaning is usually  Manual cleaning
skin adequate using detergent and
water
 Items not in direct  Disinfection if
contact with patient infection risk is  Automated
present e.g. cleaning/disinfection
washbowls and
mattresses  Disinfectant

Minimal Risks
 Items not in close  Cleaning  Damp dusting
contact with the
 Manual or automated  Wet mopping
patient or their
cleaning e.g. floors,
immediate  Vacuum cleaners
surroundings walls, ceilings and
furniture.

For further information regarding how to decontaminate an item contact the

Infection Prevention and Control Team

17 Decontamination of Medical Devices_CL05D_January 2019

Appendix 4: Handling and decontamination of equipment prior to
service, repair return to lending organisation or investigation of an
adverse incident

(Note: it is illegal to send contaminated equipment through the post)

Decontaminate item:
Label with
Can the equipment be decontamination
decontaminated without removing certificate, note the
evidence important to the repair or Yes fault or defect, and store
investigation in preparation for
service, repair or
investigation
No

Inform repair
organisation or Repair organisation or
investigating body investigating body agrees
dispatch

ON
Yes

Arrange visit by Label with decontamination

service/repair company certificate, note the fault or defect,
or investigating body. pack and dispatch for repair or
Label with investigation
decontamination
certificate, note fault or
defect and quarantine in
preparation of repair or
investigation

18 Decontamination of Medical Devices_CL05D_January 2019

Appendix 5 – Decontamination Certificate

19 Decontamination of Medical Devices_CL05D_January 2019

20 Decontamination of Medical Devices_CL05D_January 2019