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Biomed Guide

This document provides guidelines for managing biomedical equipment used by Doctors Without Borders/Médecins Sans Frontières (MSF) in the field. It outlines roles and responsibilities for equipment use and maintenance. It also provides guidance on staff recruitment and training, selecting and installing equipment, planning and record keeping, use and maintenance, repairs, and donations or disposal of equipment. The overall goal is to help MSF missions maintain reliable and high-quality biomedical equipment to ensure patient and staff safety and continuity of medical services.

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Aarsol Advance
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© © All Rights Reserved
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Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
668 views

Biomed Guide

This document provides guidelines for managing biomedical equipment used by Doctors Without Borders/Médecins Sans Frontières (MSF) in the field. It outlines roles and responsibilities for equipment use and maintenance. It also provides guidance on staff recruitment and training, selecting and installing equipment, planning and record keeping, use and maintenance, repairs, and donations or disposal of equipment. The overall goal is to help MSF missions maintain reliable and high-quality biomedical equipment to ensure patient and staff safety and continuity of medical services.

Uploaded by

Aarsol Advance
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 62

Biomedical

Equipment
Guideline

MSF Section MSF-OCG


Title Biomedical Equipment Guideline
Owner & Technical Support to the Operations
commissioner Logistics Department
Médecins Sans Frontières
Operational Center Geneva
Author Malcolm Townsend, Technical Referent Biomed & Cold chain
Purpose To provide practical advice for implementing a structured management
of biomedical equipment in the field, as defined in the OCG Biomedical
Equipment Policy.
Version 1st edition Language English
Reviewers Cécile Chapuis Date 12/2013
Dr. Annick Antierens
Christophe Fourmond
BibOp L040ZCHG04E
Biomedical Equipment Guideline MSF-OCG
Logistics Department

2
Table of Contents

1. INTRODUCTION 7
1.1 Objectives 7
1.2 Related tools and documents 8
1.3 Contact 9
2. ROLES & RESPONSIBILITIES 11
2.1 Division of responsibilities 11
2.2 Essential tasks 12
2.3 Organising positions 12
3. RECRUITING & TRAINING 17
3.1 Skills and qualifications 17
3.2 Recruitment 18
3.3 Training and opportunities 18
4. SELECTING & INSTALLING 21
4.1 Assessing existing equipment 21
4.2 Selection of equipment 22
4.3 Local suppliers and contractors 23
4.4 Structures 24
4.5 Power supply 24
4.6 Financial (budget) considerations 26
5. PLANNING & ORGANISING 29
5.1 Contingency planning 29
5.2 Maintenance scheduling 30
5.3 Setting up a workshop 31
5.4 Record keeping 33
5.5 Organising stocks and storage requirements 33
5.6 Order calculations and ordering 35
6. USING & MAINTAINING 39
6.1 Activities for medical staff 39
6.2 Activities for the biomedical service 40

3
Biomedical Equipment Guideline MSF-OCG
Logistics Department

7. REPAIRING & RETURNING 45


7.1 Signaling an equipment failure 45
7.2 Assessing the fault and options for repair 46
7.3 Return procedures for After Sales Service 49
8. DONATION & DISPOSAL 51
8.1 Receiving donations 51
8.2 Making donations 51
8.3 Disposal 52

ANNEX I Internet Ressources 55


ANNEX II Definitions of Terms 57
ANNEX III Division of Responsibilities 59

4
Table of Contents

5
Biomedical Equipment Guideline MSF-OCG
Logistics Department

6
Introduction
1.
Chapter 1
Introduction

1. INTRODUCTION

Resonsibilities
Roles &
2.
This guideline for biomedical equipment provides practical advice for

Training
Recruiting &
3.
implementing a structured management of biomedical equipment in the
field, as defined in the OCG Biomedical Equipment Policy. Rather than giving
detailed how‐-to information it aims to provide broad advice which can be
adapted to different contexts.

installing
Selecting &
4.
It is intended for all MSF staff, from all departments, who are involved with
biomedical equipment.

Organising
Planning &
5.
1.1 OBJECTIVES

The objective of this guideline is to help all MSF missions successfully care
for and maintain their biomedical equipment. It provides the fundamentals

Maintaining
Using &
6.
for HR; assigning responsibilities and recruiting and training staff. It also
aims to raise awareness of issues related to selecting and installing
equipment, workshop needs, planning and conducting regular preventive
maintenance, ensuring quality repairs, organising stocks and ordering, and
planning for the event of equipment failure.

Returning
Repairing &
7.
• Biomedical equipment directly affects the health and safety of both
patients and staff. We must ensure that appropriate standards of
safety and functioning are maintained.
Disposal
Donation &
8.
• This equipment often becomes an essential part of MSF’s operational
activities and we must ensure continuity and quality of service.
• The cost of the equipment often represents a large investment, in
some cases a significant part of a mission budget.
Resources
Internet
Annex I.

The objective for each mission/project must be to achieve good reliability,


availability, and high quality of service for all biomedical equipment.

Each project must have in place:


• Medical (national) staff who are all trained and qualified to use and
of Terms
Definitions
Annex II.

care for the equipment they use.


• Final responsibility for good care and cleaning of the all biomedical
equipment is assigned to a member of Medical (national) staff.
• A member of Logisitic (national) staff who is trained and qualified to
maintain the equipment and who is given the responsibility of managing
Responsibilities
Division of
Annex III.

and conducting technical (preventive) maintainance of the biomedical

7
Biomedical Equipment Guideline MSF-OCG
Logistics Department

equipment.
• Workshop facilities which are well located and suitably equipped.
• An up-‐to‐-date inventory and a comprehensive planning for regular
preventive maintenance and record keeping for each machine.
• Good consumption monitoring and regular ordering of spare parts
and consumables.
• A plan for back‐up equipment and spare parts stock in case of
break‐down.
• A strategy for donations (accepting and giving) and disposal

In order to ensure continuity – and in accordance with the MSF‐OCG


Biomedical Equipment Policy ‐– each mission must complete a
Country Specific Policy (CSP) on Biomedical Equipment. This is to
record the details related to biomedical equipment management in
the mission.

1.2 RELATED TOOLS AND DOCUMENTS

The following tools and documents are referred to in this guideline. They
are distributed via the current MSF ‐OCG channels for sharing support
documents and tools and are available on request from the technical
referent.

• MSF‐-OCG Biomedical Equipment Policy


• Country Specific Biomedical Equipment Policy (template)
• Biomedical Référenciel
• Sample Job Description Biomedical Technician
• Recruitment test
• Biomedical Equipment Criticality Assessment Tool
• Maintenance scheduling template
• Equipment ID sheet
• Maintenance Protocols & Checklists (for various common items of
equipment)
• Intervention request form
• Equipment Repair form
• ASS (After Sales Service) / SAV (Service Après Vente) return form
• Donation Certificate
• Guideline for audit of biomedical suppliers / Biomedical Equipment
Supplier Questionnaire

8
Introduction
1.
Chapter 1
Introduction

1.3 CONTACT

Resonsibilities
Roles &
2.
If you have any questions or suggestions related to this guideline, or
questions on biomedical equipment which are not answered in the guideline
please contact me.

Training
Recruiting &
3.
Malcolm Townsend
Technical Referent Biomed & Cold‐ chain

Technical Support to the Operations

installing
Selecting &
4.
Logistics Department
Médecins Sans Frontières
Operational Center Geneva

[email protected]

Organising
Planning &
5.
T: +41 (0)22 849 87 40

Maintaining
Using &
6.
Returning
Repairing &
7.
Disposal
Donation &
8.
Resources
Internet
Annex I.
of Terms
Definitions
Annex II.
Responsibilities
Division of
Annex III.

9
Biomedical Equipment Guideline MSF-OCG
Logistics Department

10
Introduction
1.
Chapter 2
Roles & Responsibilities

2. ROLES & RESPONSIBILITIES

Resonsibilitiess
Roles &
2.
This chapter covers the following topics:

Training
Recruiting &
3.
• Division of responsibilities Medical/Logistics.
• Essential tasks which must be assigned to the national staff teams.
• How to organise positions on your project.

installing
Selecting &
4.
All aspects of Biomedical equipment require a close collaboration between
medical and logistics staff. It is essential that everyone clearly understands
their role.

Organising
Planning &
5.
2.1 DIVISION OF RESPONSIBILITIES

Biomedical equipment within MSF is a shared responsibility between the


medical and logistics teams. The medical team has the roles of prescriber

Maintaining
Using &
6.
and user. The logistics team has the roles of supplier, installer, and maintainer.

The medical team will define the (medical) requirements of any (new)
biomedical devices which are aimed at improving or expanding medical

Returning
Repairing &
7.
activities. Usually this will be done in consultation with the MedCo and/or
HQ. After the equipment is put into service the medical staff on the project
will take responsibility for care, regular cleaning and user maintenance, and
reporting any problems to the logistic responsible. The medical team is also
responsible for consumption monitoring and ordering of consumables.
Disposal
Donation &
The logistics team will assess the technical suitability before an order is 8.
made (infrastructural needs; power, buildings etc) and prepare any changes
needed. Also this is usually done in consultation with the LogCo and/or HQ.
Ordering and follow‐-up is done through the supply team. On delivery the
Resources
Internet
Annex I.

logistics team will ensure correct installation, and afterwards the logistics
responsible will ensure regular technical maintenance is done and will
organise repair in case of breakdown. The logistics team is responsible for
ordering spare parts used during technical maintenance and repair work.
of Terms
Definitions
Annex II.

For a full description see the Biomedical Responsibilities Overview Chart


(Annex III).
Responsibilities
Division of
Annex III.

11
Biomedical Equipment Guideline MSF-OCG
Logistics Department

2.2 ESSENTIAL TASKS

Whatever the size of the project, or the quantity of biomedical equipment,


there are a number of tasks which must always be assigned. These tasks
must be assigned to national staff. The more experience the staff have with
the equipment the easier problems can be identified and solved.

• Each item of biomedical equipment must be assigned to a member of


medical staff who will ensure responsible care and regular cleaning.
• A member of logistic staff must be assigned to plan and conduct
the routine (preventative) maintenance, and to follow the inventory
of biomed equipment.

In most cases other tasks should also be assigned to the national staff
team (for example fault finding and repair, stock management and spares
ordering, etc). This will depend on the size of the project and the availability
of sufficiently skilled and qualified staff locally. Especially repair work can
require high levels of technical competence. Chapters 5. Planning and
Organising, 6. Using and Maintaining, 7. Repairing and Returning give
more details and help in performing these tasks.

2.3 ORGANISING POSITIONS

Medical staff positions are organised according to needs of the medical


activities and staff are obviously selected for their medical skills rather than
their technical knowledge of the equipment used. Some, like Radiographers
or anaesthetists for example, will have a good technical knowledge of
specific equipment. Others will probably need additional training. Check
that the tasks and responsibilities for (biomedical) equipment are included
in the medical staff job descriptions. This will also make it part of staff
evaluations and encourage the staff to pay attention to this.

Responsibility for good care, hygiene and cleaning tasks should be


assigned to each member of staff who uses an item of equipment. Overall
responsibility for the equipment, and follow‐up of routine cleanings and
user maintenance, could in most cases be given to the medical service
supervisor (i.e. one person per ward/department/facility).

Check that the following (or similar) is in each Job Description:

Medical Staff:
• Performs cleaning and minor maintenance tasks (as defined in the
protocols) for each piece of (biomedical) equipment used.

12
Introduction
1.
Chapter 2
Roles & Responsibilities

• Follows hygiene protocols.


• Takes care of any item of biomedical equipment, and uses it in

Resonsibilitiess
Roles &
2.
accordance with the documentation and instruction given.
• Alerts the Supervisor in case of any doubt regarding the correct
functioning of any device.

Training
Recruiting &
3.
Medical Supervisor:
• Signs to accept receipt of all biomedical equipment intended for use
in <name of department/location>.
• Ensure that all staff who use the equipment are qualified and trained
in it's correct use.

installing
Selecting &
4.
• Follow‐-up on and ensure cleaning and minor maintenance tasks are
performed for each piece of equipment.
• Forward any reports of damaged or malfunctioning equipment to the
logistic responsible for biomedical equipment.

Organising
Planning &
5.
Logistics staff positions will have to be organised according to the support
required. Hospital projects will certainly need a full‐time Biomedical
Technician. A smaller project, or one with very little biomedical equipment,
could already have a general technician who can also take on the biomedical

Maintaining
Using &
6.
maintenance tasks.

In missions with multiple projects it could be useful to share certain


resources; have staff at each location for basic maintenance and a more
highly qualified staff member travelling between the projects to deal with

Returning
Repairing &
7.
more complex work.

Whatever the case there are a number of tasks and responsibilities which
need to be allocated and included in job profiles; either to one person, or
divided between existing positions. These tasks are:
Disposal
Donation &
Asset Management: 8.

• Must know all the biomedical devices present on the project. Must be
able at any time to give the condition and location of this equipment.
• Understands the technical documentation, operating principle and
Resources
Internet
Annex I.

use of each piece of biomedical equipment on the project/mission.


• Organises and participates in installation and/or replacement of
biomedical equipment.
• Identifies any issues or problems in any of the locations the equipment is
used. Reports these to the supervisor and proposes solutions. (Training
of Terms
Definitions
Annex II.

of staff on a device, operating procedures ...)


• Takes the lead in organising user (medical staff) training where
required.
• Maintains the equipment files securely and ensures they are up‐-to‐-
Responsibilities
Division of
Annex III.

date; identification cards, maintenance forms, intervention requests,


repair forms, guarantee certificates, etc…
13
Biomedical Equipment Guideline MSF-OCG
Logistics Department

• Arranges for packing, shipment and contact with contractors or after


sales service of the MSF supply centre for the repair of equipment that
can not be done locally.
• Follow the different maintenance contracts, proposes renewal before
they expire.
• Ensure that as few items as possible are out of service at any given
time.

Maintenance:
• Create and regularly update the preventive maintenance schedule
according to the advice of the support documentation, the
manufacturer’s recommendations or the Biomedical Referent.
Ensure the maintenance schedule is followed.
• Report equipment failures identified by users. Make a first diagnosis
and repair proposal to the supervisor.
• Ensure good use of equipment by the medical teams, and ensure that
cleaning and simple maintenance is properly carried out.
• Record and file records of all maintenance (preventive and curative).
The date of intervention, replaced parts, problems and solutions
should be included.
• If maintenance work requires further assistance, documentation or
additional tools this shall be requested from, and provided by, the
supervisor.

Stock Management:
• Manage inventory of spare parts and avoid stock rupture by making
regular and timely proposals for orders to his superior.
• In collaboration with pharmacists, ensures adequate stock of
consumables for biomedical devices.
• Keep track of the arrival of orders and returned repairs, request
information in case of delay and / or emergency.

When deciding how much work these responsibilities involves do not


underestimate the time needed. Servicing of an item of equipment can
take from 30 minutes to a few hours. The maintenance protocols will give
an idea of the time needed for each item of equipment. Coaching and
follow‐-up of equipment use can also be time consuming, as is organising
training sessions for medical staff.

When deciding if a full‐time position is needed consider:


• Quantity and type of equipment (technical complexity, size, weight,
maintenance intervals).
• Number of locations (one hospital, multiple smaller structures).
• Distances and travel times between workshop and health structures.

14
1. 2. 3. 4. 5. 6. 7. 8. Annex I. Annex II. Annex III.
Introduction Roles & Recruiting & Selecting & Planning & Using & Repairing & Donation & Internet Definitions Division of
Resonsibilitiess Training installing Organising Maintaining Returning Disposal Resources of Terms Responsibilities

15
Roles & Responsibilities
Chapter 2
Biomedical Equipment Guideline MSF-OCG
Logistics Department

16
Introduction
1.
Chapter 3
Recruiting & Training

3. RECRUITING & TRAINING

Resonsibilitiess
Roles &
2.
This chapter covers the following topics:

Training
Recruiting &
3.
• Types of skills and qualifications needed for the position of biomed
technician.
• The recruitment process.
• Coaching and training.

installing
Selecting &
4.
Biomedical equipment directly affects staff and patient health so all staff
must have the skills to use and/or maintain the equipment well. Good
recruiting and regular review of training needs are essential.

Organising
Planning &
5.
3.1 SKILLS & QUALIFICATIONS

Most biomedical equipment is electrically powered so good knowledge of

Maintaining
Using &
6.
electricity is essential for a Biomedical Technician. In almost every location
you can find staff with basic electrical skills which are enough for day to
day electrical work. Maintaining biomedical equipment in good condition,
and certainly fault‐-finding and repair, does however require a better

Returning
Repairing &
7.
understanding of electricity, electronics and possibly also IT.

Biomedical Equipment Technician and Biomedical Engineer are recognised


studies in many countries. They combine mechanical and electrical
engineering with medical subjects. Qualifications are possible from
Disposal
Donation &
8.
certificate/diploma up to degree level. For a biomedical technician in a larger
(hospital) project a biomedical qualification could be useful. Depending on
the skill level of project staff it could be useful in a larger mission to have a
mission responsible for Biomed with a biomedical qualification.
Resources
Internet
Annex I.

There are many countries which offer biomedical related courses. A list can
be found here: http://who.ceb.unicamp.br/

The list is not complete so try an internet search also to find colleges and
other courses which could provide candidates for positions.
of Terms
Definitions
Annex II.

For project biomedical technician positions other suitable qualifications


could be in the areas of electrical or mechanical engineering, or IT. In many
countries qualified staff is available but check diplomas and try to find out
about the school, college or university where the qualification was earned.
Responsibilities
Division of
Annex III.

Especially in IT and other technical subjects there are a lot of schools out

17
Biomedical Equipment Guideline MSF-OCG
Logistics Department

there and it can be difficult to judge the true value of a qualification.

The practical skills to maintain biomedical equipment on an MSF project


can be learned. In smaller projects the most important thing is a good
technical knowledge and a willingness to learn.

A project Biomed Technician will also need planning and organisational


skills. Pedagogical skills would also be an asset in coaching and training the
medical staff on correct care, hygiene and basic maintenance tasks. Ideally
a candidate will also have experience working in a medical environment
and a basic understanding of the use of the equipment.

3.2 RECRUITMENT

Any recruitment process should include an assessment of both practical


and theoretical skills. Suggested steps in the selection are:

1. Pre-selection
Based on qualifications, experience and references select at most the 10
best candidates to invite for the 2nd stage.

2. Written test
You can write your own or use the example Recruitment Test. Select at most
the 5 best candidates to go though to the 3rd stage.

3. Practical test
Choose a common item of biomedical equipment on your project (one which
is not critical and which you have back‐up for! e.g. an oxygen concentrator)
and ask the candidate to do a preventive maintenance according to the
protocol and checklists provided. By observing the candidate during the
practical test you will get a good idea of their skills and ability to work
methodically.

3.3 TRAINING OPPORTUNITIES

Skills exchange
Skills exchange can be the quickest way to give staff new skills. If another
project, another MSF section or even another organisation has skilled and
experienced staff then try to arrange a work exchange. A trainee period on
another project will not only provide new practical skills but can often also
give new perspectives and insight.

18
Introduction
1.
Chapter 3
Recruiting & Training

Local training
Local training can be organised by you in the project. Short sessions to deal

Resonsibilitiess
Roles &
2.
with specific topics can be quickly organised. They are instructional but
also give the opportunity to have direct and open discussions with the staff
involved. One of the tasks of the Biomed Technician should be to organise
training sessions for medical staff on care and good use of the equipment.

Training
Recruiting &
3.
Formal training
Formal training can be arranged locally in some countries; there may
be schools or colleges offering courses in electrical engineering and
information technology for the logistic staff. Medical staff could also have

installing
Selecting &
4.
options to follow locally organised training on use of (bio)medical equipment.
This is a longer‐-term approach as these courses will either require a long
absence from the project, or a long part‐-time commitment.

MSF Training

Organising
Planning &
5.
MSF Training can also be provided. Some sections have "Flying Biomedical
Technicians" who are able to visit missions and coach (logistic and
medical) national staff. MSF‐-OCP has a one week technical training
course in Bordeaux called the “Biomedelec”, which covers electricity and

Maintaining
Using &
6.
management of biomedical equipment. MSF‐-OCA, OCB and OCG run
a one week training covering theory and practical aspects of the most
common MSF standard biomedical equipment. This is run 2 or 3 times
each year. Check the training manual for details.

Returning
Repairing &
7.
Whichever options you choose try to benefit from the "trickle‐-down"
effect. That is to say, select a key member of staff to receive training
and encourage them to pass on the information and skills to other
staff on the mission.
Disposal
Donation &
8.
Resources
Internet
Annex I.
of Terms
Definitions
Annex II.
Responsibilities
Division of
Annex III.

19
Biomedical Equipment Guideline MSF-OCG
Logistics Department

20
Introduction
1.
Chapter 4
Selecting & Installing

4. SELECTING & INSTALLING

Resonsibilitiess
Roles &
2.
This chapter covers the following topics:

Training
Recruiting &
3.
• Assessing existing equipment.
• Selecting equipment (international/local).
• Selection of local suppliers/service contractors.
• Ensuring structures are suitable.

installing
Selecting &
4.
• Energy and power supply requirements.
• Financial considerations

There is no point having equipment which no-‐one can use, is not suited
to the conditions, or for which no spares or consumables are available. A

Organising
Planning &
5.
careful analysis before ordering can help avoid this happening.

4.1 ASSESSING EXISTING EQUIPMENT

Maintaining
Using &
6.
In many cases where MSF runs a project in collaboration with another
organisation, such as a Ministry of Health, there will already be equipment
available at a health facility. Usually this equipment is owned by the partner

Returning
Repairing &
7.
organisation and this can influence MSF's ability to ensure good care and
maintenance. Assess the feasibility of using this equipment carefully by
asking these questions:
• Is the equipment in good condition?
• Is the technical documentation available?
Disposal
Donation &
8.
• Does the partner organisation have skilled staff performing regular
maintenance?
• Are there up-‐to-‐date maintenance records?
• Is there a stock of spares and consumables, and is there a reliable
(local) supplier for original parts and consumables?
Resources
Internet
Annex I.

• Is there a provider for service contracts of equipment which cannot


be repared locally?

If the answer to any of the above is no then you will need to agree on a course
of action with the partner organisation. It could be possible for MSF to
of Terms
Definitions
Annex II.

provide the necessary skilled staff or spares and consumables. Otherwise


you should select new equipment to replace the existing equipment for the
time that MSF is collaborating on the project.

If the equipment is suitable then you should include a list of the equipment,
Responsibilities
Division of
Annex III.

and a clear definition of the agreements for its support and management,

21
Biomedical Equipment Guideline MSF-OCG
Logistics Department

in the Memorandum of Understanding (MoU). If the agreement is to provide


replacement equipment the details of this should also be included in the MoU.
The equipment should be integrated into the overall maintenance planning
but keep separate inventories of MSF’s equipment and equipment owned
by others. See chapter 5. Planning & Organising for more information.

You may also be offered biomedical equipment from other sections or


organisations. Accepting these can have consequences so consider
carefully before accepting. See also chapter 8. Donation & Disposal.

4.2 SELECTION OF EQUIPMENT

Biomedical equipment will usually be requested by the medical staff, often


to improve the quality of a medical service or to expand into new activities.
Choosing the right equipment to meet this need is a collaborative effort.

Selecting new equipment requires specialised knowledge so all proposals


must be checked to see if they meet the medical usage and technical
support requirements. It's no use buying a machine which you think will do
the job only to find that it doesn't. The MedCo should discuss the choice
with the Medical responsible in the cell, who can also be advised by the
medical referent.

The choice must meet the needs of the medical activities, be appropriate
for the situation in which it will be used, and be as easy as possible to ensure
continued use. This means that the infrastructure and the skills to use and
maintain it should already be present, or must be possible to achieve with
additional investment. The LogCo can seek the advice of the Logistics
responsible in the cell and the technical referent for Biomedical Equipment.

MSF ITC catalogue items should be your first choice if they meet the
requirements, and they should be ordered through MSF-‐Logistique. This
gives a number of advantages:
• The equipment has already been medically and technically approved,
and field tested. Related articles and requirements are stated in the
catalogue
• Experienced (inter)national medical staff are probably familiar with it.
• The technical support is available through the Technical Referent.
• Better prices and technical support can be negotiated.
• Any certification or service support contracts needed will give better
guarantees.
• Greater (inter‐sectional) flexibility for training work‐ exchanges.
• Greater (inter‐sectional) flexibility for equipment back‐up or donation
in case of closures or hand‐over.

22
Introduction
1.
Chapter 4
Selecting & Installing

Local Purchase can be an option, but only where MSF catalogue items do

Resonsibilitiess
Roles &
2.
not meet the requirements, or where local factors make supply through the
international supply centre inadvisable. Local factors could include:
• Importation difficulties (impossible, or exaggeratedly expensive).
• Normal supplier will not provide service in the destination country (for

Training
Recruiting &
3.
equipment which requires annual quality control re‐certification, like
Radiology equipment, laboratory testing apparatus etc.)
• The equipment is so critical to the medical activities that fast local
support is essential.
• There is a plan to hand‐over medical activities to a Ministry of

installing
Selecting &
4.
Health or other partner who must have a continued (local) source of
consumables and spares. Availability is only one aspect of course; the
partner must have the funding and HR to continue to maintain it too!

The first choice of equipment should again be the MSF standard items.

Organising
Planning &
5.
In addition to retaining many of the advantages listed previously you
have the security that even in the event the supplier cannot deliver the
spares and consumables any more they can still be obtained through the
MSF‐-Logistique.

Maintaining
Using &
6.
Remember that manufacturers of biomedical equipment are commercial
companies so sometimes equipment is offered cheap but requires
expensive consumables, accessories, or servicing contracts. Check
also if MSF-‐Logistique consumables and parts can be used with locally

Returning
Repairing &
7.
purchased equipment. Especially laboratory equipment sometime uses
special cartridges with integrated electronics which will not work on certain
machines (e.g. different versions for different countries/continents).

Disposal
Donation &
8.
All suppliers of biomedical equipment, spare parts or consumables
must be validated at HQ level.
Resources
Internet
Annex I.

4.3 LOCAL SUPPLIERS & CONTRACTORS

If you intend to order equipment locally it is important be sure that the


supplier will offer a good level of technical support, and a reliable supply of
of Terms
Definitions
Annex II.

the consumables and spares which are needed. Equally, local contractors
for servicing and repair work must be technically competent and reliable.

Some considerations when assessing the options for local suppliers and
Responsibilities
Division of
Annex III.

contractors:
• Official dealers or servicing agents of a recognised manufacturer are
23
Biomedical Equipment Guideline MSF-OCG
Logistics Department

preferred as they are more likely to have the specific training needed
and are usually regularly quality audited by the manufacturer.
• Business links (joint‐-venture or similar) with established European
companies can give greater assurance that the company has good
financial backing and will be in business for longer.
• Check on staff qualifications and training. Official manufacturer
training on specific devices must have been followed.

A survey of the local or regional market can be done by the mission


supply/log team using the Biomedical Equipment Supplier Questionnaire
and Guideline (request from Technical Referent). Additional support for
evaluation of suppliers can be arranged if needed.

4.4 STRUCTURES

Dust, heat and humidity are big "biomed killers". The equipment often
contains electronic circuits, precision parts, seals and gaskets which are
sensitive to these elements. In addition some items of biomedical equipment
are themselves a hazard (e.g. radiation from radiology equipment) and so
the surroundings need to be protected.

In MSF projects you find anything from simple tents or semi‐-permanent


structures, to existing buildings which are modified for MSF's activities, or
new permantnent structures built by MSF.

Consider the following questions:


• Does the structure offer good protection from the elements? (rain,
wind, dust, heat, sunlight...)
• Does the equipment need additional ventilation? (sterilisation, etc.)
• Is heat, humidity or temperature stability an issue? (laboratory
equipment, etc.)
• Are there special considerations to avoid contamination? (e.g. positive
air pressure system)
• Do the surroundings need to be protected? (e.g. X‐-ray shielding)

Be sure to consider these aspects before any new equipment needs


to be installed. If the conditions are not suitable the equipment will not
last long. These recommendations apply not only to the equipment
but also to any areas used to store consumables and spare parts.

24
Introduction
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Chapter 4
Selecting & Installing

4.5 POWER SUPPLY

Resonsibilitiess
Roles &
2.
Poor quality power systems can endanger patients and staff, and damage
equipment. The power sources for your equipment need to be suitably
stable and the electrical installation must provide good levels of protection.

Training
Recruiting &
3.
Power sources for electrical energy are usually city power or generator(s)
and the quality and reliability can vary dramatically. Generators are usually
more reliable and provide a more stable electrical supply then city power;
however they are more expensive to run. The best solution for your situation

installing
Selecting &
4.
will depend on the options you have available.

Keep the following in mind:


• Reliability (power‐cuts, generator running hours etc.)
• Quality (voltage drops, voltage peaks etc.)

Organising
Planning &
5.
• Operating voltage (most countries have 230V/50Hz, some are the
US 110V/60Hz system)
• Power demands of the equipment (air‐conditioners and sterilisation
equipment are high power)
• Back‐up power options (generator, UPS etc)

Maintaining
Using &
6.
In most locations where MSF works the city power option should be
considered as bad quality and unreliable. It should only be used if

Returning
Repairing &
7.
there are good stabilisation and protection systems installed and a
good back‐up option is in place.

Electrical systems must be of a high standard and offer good protection


Disposal
Donation &
8.
because biomedical equipment is often either sensitive to voltage variations
or in some cases needs an uninterrupted supply. You need to ensure at least
the following protection wherever the equipment is to be used:
• Earthing - This is especially important for equipment with a metal
chassis.
Resources
Internet
Annex I.

• Circuit breakers and residual current devices - These offer protection


in case of an electrical fault in the equipment, or in case of problems
with the earth connection.
• Voltage stabilisation - A voltage stabiliser can stabilise variations
between 180 and 260V well but does not offer full protection as many
of Terms
Definitions
Annex II.

do not have over voltage protection.


• Over voltage protection (lightning protection) - This is protection
against rapid voltage spikes which can be many times the normal
voltage level and quickly destroys equipment. Some high‐-end voltage
stabilisers offer this protection too.
Responsibilities
Division of
Annex III.

• UPS (or inverter system) - These are combinations of inverters and

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batteries which are available in various sizes and provide power for
a certain period in case of power‐-cut. The most common systems
are switch‐-through, meaning that when there is power the electricity
is switched directly through to the device(s) connected to it. This
offers no stabilisation or over-voltage protection. There are also UPS
systems available which always route the power through the inverter
and batteries. These have integrated over voltage protection and
stabilisation.

More information on power supply and electrical systems is available


in the Energy Guidelines or from the technical referent for energy.

Battery powered equipment often uses standard AA (HR6) size batteries but
sometimes other standard sizes are used. Using rechargeable batteries can
reduce waste. Chargers can be installed in the health structure, for example
a nurses' station in a hospital, so the medical staff can charge when needed.
Be sure the staff knows how to do this correctly. Rechargeable batteries
can however reduce the usage time or reliability so verify they work with
the equipment before putting this in place.

Other items of equipment may have other types of battery. Check your
inventory and stocks to be sure that you have spare batteries of each type
used. If you have equipment which uses rechargeable batteries it is usually
good to have a spare in stock.

4.6 FINANCIAL (BUDGET) CONSIDERATIONS

When ordering equipment it is easy to concentrate only on the initial


purchase costs. It is equally important to ensure that resources will continue
to be available to cover not only the initial investment but also the ongoing
costs. Depending on the nature and complexity of the equipment the total
costs can include:

Initial investments
• Purchase price.
• Building costs for construction or modification, installation technicians
etc.
• Improvements to energy systems (generators, protection devices,
installation costs).
• Staff training in use or maintenance.

26
Introduction
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Chapter 4
Selecting & Installing

Ongoing running costs


• Consumables (filters etc) and spares.

Resonsibilitiess
Roles &
2.
• Maintenance and service contracts.
• Running costs for improvements in electrical supply (additional fuel
for generator).
• HR costs for additional (specialised) staff to use the equipment.

Training
Recruiting &
3.
• HR costs for (additional) maintenance staff.

Remember these points at PoA time and during budget revisions!


If we want to ensure that the equipment will continue to be well cared

installing
Selecting &
4.
for and available we need to be sure these costs are included in the
project budgets.

On average the annual running costs will be between 15% and 25%
of the purchase price.

Organising
Planning &
5.
Maintaining
Using &
6.
Returning
Repairing &
7.
Disposal
Donation &
8.
Resources
Internet
Annex I.
of Terms
Definitions
Annex II.
Responsibilities
Division of
Annex III.

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28
Introduction
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Chapter 5
Planning & Organising

5. PLANNING & ORGANISING

Resonsibilitiess
Roles &
2.
This chapter covers the following topics:

Training
Recruiting &
3.
• ‐Contingency planning. ‐
• Maintenance scheduling. ‐
• Setting‐-up a workshop. ‐
• Keeping records of inventory and maintenance work. ‐

installing
Selecting &
4.
• Organising stocks and storage requirements. ‐
• Selecting items and defining quantities for orders.

With careful structuring and planning you can avoid many common
problems. Preparing contingency plans in case of failures will reduce the

Organising
Planning &
5.
consequences of a failure, good maintenance will reduce the chance of
failure.

Maintaining
Using &
6.
5.1 CONTINGENCY PLANNING

At some point the equipment may give problems, even if you think you've
done every thing you can to ensure that equipment is well cared for and

Returning
Repairing &
7.
maintained regularly. Be prepared for this so that when it happens the
consequences for the related medical activities will be limited. This means
having equipment or spare parts in back‐up stock, or having a local service
support contract.
Disposal
Donation &
8.
The easiest way to decide the needs for back‐up equipment is to follow
the general advice in the “Biomed Référenciel”. This lists spare parts and
consumables for all MSF standard biomedical equipment, and a suggestion
for contingency stock.
Resources
Internet
Annex I.

A more time consuming, but potentially better adapted to each project/


mission, method is the criticality assessment. It is a method whereby
you evaluate each type of equipment against a number of criteria which
influence either the chance of a failure, or the consequences. By a simple
calculation it will highlight which items are the most critical, and so help
of Terms
Definitions
Annex II.

you define a back‐up strategy.

The assessment should be done by the MedCo and LogCo, together with
the project staff. A Criticality Assessment Tool has been created to help
with this and instructions are included in the tool.
Responsibilities
Division of
Annex III.

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The back‐up strategy you adopt will depend on the type of equipment. The
back‐up choice could be:
• Identical item of equipment kept in back‐up stock.
• Alternative item of equipment. This may impact the medical protocols
or require (temporary) changes to the activities.
• Critical spare parts kept in stock (depending on competence level of
national staff responsible).
• A service support contract with an external contractor. The contractor
must be validated and the contract must give a good level of cover,
and guarantee sufficiently quick response times for call‐out.

The location of the back‐up solution needs to take into account the space
required and storage requirements (i.e. temperature or humidity), and the
time to get the back‐up equipment to where it is needed. Options include:
• Project back‐up stock
• Centralised mission back‐up stock
• Inter‐sectional possibilities (in‐-country)
• Local supplier (must be validated and guarantee availability)
• MSF Supply Centre

Make sure you have a contingency plan for each project, and for the
mission as a whole.

5.2 MAINTENANCE SCHEDULING

Prevention is better than cure. The benefits of conducting regular preventive


maintenance on the equipment are increased life ‐expectancy, better ability
to assess condition, and better safety. Be sure you have a comprehensive
schedule of the maintenance for all biomedical equipment.

Lack of regular maintenance is the biggest cause of breakdown for


biomedical equipment.

The schedule should be made and kept up to date by the biomedical


technician on each project. There should be a schedule for each project,
and each health structure. A maintenance scheduling template has been
made which you can use for this.

The MSF maintenance protocols provide information on the tasks for the

30
Introduction
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Chapter 5
Planning & Organising

most common items of biomedical equipment, with spare parts needs and
rough time estimations. This will help in making the maintenance schedule.

Resonsibilitiess
Roles &
2.
this information is included in the “Biomed Référenciel”. (chapter 5. Using
& Maintaining) gives more details of the maintenance task.

Where there are no MSF maintenance protocols the maintenance

Training
Recruiting &
3.
recommendations of the manufacturer should be followed. Take into
account that the manufacturers’ recommendations are often based on
use in western home or hospital settings so are rarely perfectly suited
to MSF usage conditions. The technical referent can give guidance on
additional maintenance tasks, or changes to recommended time between

installing
Selecting &
4.
maintenance works, for the conditions on your project.

When filling in the planning schedule, be realistic about the time it takes
to do the maintenance work well, and the number of items of equipment
which can be serviced each day. Each device can take between 30 minutes

Organising
Planning &
5.
and a number of hours to service correctly. Remember also that preventive
maintenance is just one of the tasks of the biomedical technician. They
must also have time for repair work, staff coaching and all the other tasks
listed in the job description (see chapter 3. Roles & Responsibilities).

Maintaining
Using &
6.
5.3 SETTING UP A WORKSHOP

Returning
Repairing &
7.
Equipment cannot be effectively maintained in the health structure(s). This
would get in the way of the medical activities and the technician is unlikely
to be able to work effectively. A workshop is therefore needed. Due to the
sensitive nature of biomedical equipment the workshop facilities should be
free of dust, as cool and dry as possible, and must be easy to keep clean.
Disposal
Donation &
8.
Similar conditions to those in the health structure where it is used would
be ideal.

The workshop should preferably be located close to the health structure,


ideally in the same building. This is for a number of reasons:
Resources
Internet
Annex I.

• The biomedical technician can respond more quickly to any problems


reported.
• The equipment does not have to be transported far, or be exposed
to rain or dust. Biomedical equipment is sensitive to heat, dust, and
moisture, it can also sometimes be large or heavy.
of Terms
Definitions
Annex II.

• The biomedical technician is better able to monitor the care and


cleaning follow‐-up and coach the medical staff where needed.
• The biomed technician will be able to spend more time in the health
structure and be able to see and hear the equipment working well.
Responsibilities
Division of
Annex III.

This makes it easier to recognise potential problems or trace faults.


• The proximity will strengthen communication between the medical
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services and the biomedical service, helping it become better


integrated as part of the team.

The size of the workshop depends on the quantity and type of equipment on
the project. The maintenance schedule will give you an idea of the quantity
of equipment you will need to service, and how often. Allow additional space
for administration files (see chapter 5.4 Record keeping) and stocks (see
chapter 5.5 Organising Stocks and Storage Requirements).

The workshop must have a stabilised and protected source of


electricity, and preferably a water supply.

Tools and test equipment commonly needed are listed below. You may need
additional tools for specific items so check the technical documentation
to see if this is the case. Remember that often if special tools are required
then it is likely that more specialist skills are needed too.

Basic tools and equipment:


• Set of metric spanners (open‐-ended and ring) sizes 5mm ‐to 17mm
• Socket set (1/4" set) with sockets sizes 5mm ‐to 17mm
• Set of bits with wrench, full set of Torx and Hex head (Allen) bits
• Set of electricians screwdrivers (insulated), flat blade, Phillips and
Posidriv
• Set of various electricians pliers and cutters (insulated)
• Stanley knife
• Soldering iron (with stand)
• Solder pump or desoldering braid (to remove old solder)
• Set of soft paint brushes for dislodging dust
• Source of compressed air for blowing dust (aerosol cans for low use,
compressor for more frequent use)

Basic test equipment:


• Oxygen flow and concentration meter. (EHOECONC3AO, Oxygen
Analyser)
• Digital multi‐meter (PELEMULT03‐, MULTIMETER, with amp clamp
meter, AC & DC)
• Stopwatch (for testing syringe pump)
• 5 liter plastic bucket and silicon tubing (for testing suction pumps)

Other tools or test equipment may be needed for certain items of equipment.
Check the manuals of the equipment for details of these, or ask the biomed
referent at HQ.

Tools are available from the supply centres but if you can find good quality,
32
Introduction
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Chapter 5
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name brands (not low quality copies) then you should purchase locally. For
some equipment there is a toolkit available in the MSF ITC catalogue. Test

Resonsibilitiess
Roles &
2.
equipment must always be ordered through the supply centre.

5.4 RECORD KEEPING

Training
Recruiting &
3.
Keeping records of your equipment, and all maintenance work can give a
complete history of each device, in the same way that a vehicle logbook
records the service history of a Land Cruiser. This can be very useful in

installing
Selecting &
4.
helping trace faults and assessing the general condition of a machine to
decide if it needs replacing.

The Marmota inventory is the primary tool for record‐-keeping. Ensure

Organising
Planning &
5.
that all biomedical equipment is entered in included. Unless you have a
very small quantity of biomedical items, and the biomedical technician is
overall responsible for the entire inventory it is better to keep the biomedical
inventory separate from the main inventory. The biomedical technician
should be responsible for keeping the inventory updated.

Maintaining
Using &
6.
The archive 'hardware' you use is less important than the way you arrange
the information. If you have little biomedical equipment then a few files
(binders) will do, if you have a lot then use a filing cabinet. What is important
is that the information is logically organised and can be accessed quickly

Returning
Repairing &
7.
by the biomedical technician. The best place to store these records is
therefore the biomedical workshop.

File your records according to equipment family, and subdivide (tab‐sheet


or separate folder) for each machine. This way you can quickly find the Disposal
Donation &
8.
complete record for each machine.

For each machine you should have a collection of the following forms:
• Equipment ID sheet.
• Maintenance checklist for each preventive maintenance done.
Resources
Internet
Annex I.

• Repair sheets recording any repair work done.


• Cleaning follow‐-up sheets
• Any other relevant documents for that specific machine (photo's,
receipt copies, etc).
of Terms
Definitions
Annex II.

5.5 ORGANISING STOCKS AND STORAGE REQUIREMENTS


Responsibilities
Division of
Annex III.

The stocks you will have to consider for biomedical equipment fall into

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three main categories and their storage is best arranged to have the best
accessibility for those who need it. The categories are:

Consumables are the various parts which need changing between each
patient, or periodically. The medical staff is in charge of some of these tasks.
Examples of medical consumables are humidifiers and foam pre‐filters for
oxygen concentrators, sensors for the pulse oxymeters, mouth‐pieces for
anaesthesia ventilators etc. Other consumables are used by the (logistic
staff) biomedical technician during routine maintenance work. This includes
chassis filters for oxygen concentrators, anti‐bacterial filter for the mucositis
suction pump, etc.

Spare parts are replacement parts which are needed by the biomedical
technician to repair equipment, either after discovering a problem during
routine maintenance, or as a result of equipment failure. This includes
everything from valves, gaskets and seals, to electronic and power supply
components.

Back‐up equipment is all items of equipment which are kept in stock to


replace damaged or failed in the health structure.

Storage requirements for all items are basically the same. As they are
often made from (or contain parts which are made from) a variety of
plastics and rubber, contain precision mechanical parts, or they have
electronic components the conditions in any storage area must prevent
the components degrading before they can be used. Degradation is caused
by heat, humidity and dust.

The manufacturer’s documentation will give specific requirements for


each device but as a general rule the suggested storage conditions for
the majority of items are:
• Temperature <30ºC
• Humidity <85% non‐-condensing
• Dust‐-free

Be aware that if you move equipment from an air‐conditioned storage


area to a hot or humid working environment you should leave it for
10 minutes or so to avoid condensation forming on electronics. This
could damage the equipment.

Stock location, responsibility for monitoring and ordering, and availability for
those who need it are all closely linked. See also division of responsibilities
overview chart (ANNEX III) and chapter 1. Roles & Responsibilities. The
best division of your stocks will depend partially on the size of the project
34
Introduction
1.
Chapter 5
Planning & Organising

and the arrangement of your other stocks but most cases the following
separation should be used:

Resonsibilitiess
Roles &
2.
Health Facility:
Small supply of medical consumables, enough to cover the period between
orders/requests to the central project pharmacy.

Training
Recruiting &
3.
Central Project Pharmacy:
The main stock of consumables (medical and logistic) and spares. Also the
bulk of the back‐up equipment.

installing
Selecting &
4.
Biomedical workshop:
A small supply of logistic consumables and spares, enough to cover routine
maintenance needs according to the maintenance schedule. A selection
of back‐up equipment to cover critical equipment in case of failure, and
to have replacement equipment to exchange while maintenance work is

Organising
Planning &
5.
being carried out.

Monitoring of the main stock will then be done by the staff member
responsible for the central project pharmacy. They must work closely with

Maintaining
Using &
6.
the biomedical technician to keep track of the consumption of all spares
and consumables, and avoid stock rupture.

In some missions/projects the central pharmacy management falls

Returning
Repairing &
7.
under logistics responsibility, in others under medical responsibility.

Disposal
Donation &
8.
5.6 ORDER CALCULATIONS AND ORDERING

Aside from equipment orders you will have to make regular orders for
consumable and spare parts. There are a number of sources of information
to help you define which parts you need for each item of equipment, and
Resources
Internet
Annex I.

how many. These sources also include reference numbers which you must
use when ordering to be sure that you receive the part you ordered.

The Biomedical Référenciel gives a list of spare parts and consumables


for each item of MSF standard equipment, including ordering codes and
of Terms
Definitions
Annex II.

advice on how many you should have in stock for emergencies.

MSF Catalogues (ITC) give lists of related articles for each item of
(biomedical) equipment. This includes spares and consumables.
Responsibilities
Division of
Annex III.

Manufacturer's documentation often provides lists of parts with a


35
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Logistics Department

manufacturer's part number for non standard equipment, or spare parts


which have not yet been assigned an MSF order code.

The Maintenance protocols give detailed information on the individual


maintenance tasks and the parts which need to be changed.

Define consumables (medical and logistic) to order for each item of


equipment using the documentation listed above.

For the most common equipment ordered through MSF Supply Centres
the "Maintenance needs" and "Parts ordering" tabs in the Referential gives
clear guidance.

Define spare parts to order based on you own assessment of the risks (from
the contingency plan) and the recommendations in the Referential. Order
what you think you will need but never order spares which you do not have
the capacity to install correctly.

It is vital that all repairs are done well. Having spares which the biomedical
technician is not trained to install can lead to unsuccessful repair attempts.
At best this will simply waste the money, at worst this could endanger the
life of the patients or staff.

In case you have any doubt about which parts to order contact the
biomedical referent.

Define order quantities using the expected consumption based on the


maintenance requirements and verifying this with historical consumption
figures. If no consumption figures are available the supply team can
probably help you with historical order quantities from the order database.

For example:
You have 10 oxygen concentrators. Each is serviced every 3 months
and requires a new air filter at this time. Every year the anti‐bacterial
filter must be changed: ‐> The order for 1 year will be 10x4X1=40 air
filters, and 10x1x1=10 antibacterial filters.

The medical team is responsible for ordering medical consumables and


spare parts for user maintenance.

The logistics team is responsible for ordering spare parts for technical
maintenance and critical spare parts for repair work.

36
Introduction
1.
Chapter 5
Planning & Organising

Ordering will be done through the current supply software. Logistix software
is currently used for logistic orders and EasyMed for medical orders but in

Resonsibilitiess
Roles &
2.
some cases other software is used to collate orders. Coordinate this with
your supply team.

To be sure you receive the items you need be sure to include the MSF code

Training
Recruiting &
3.
and description for each order line, and to check with the manufacturer
documentation if this is the correct part. If there is no MSF code for the item
you wish to order then be sure to at least include the manufacturer's name,
model of the equipment and the manufacturer’s part number.

installing
Selecting &
4.
Be sure that each order line includes a full description and a code.
Non-coded items must include at least a manufacturer's reference
code.

Organising
Planning &
5.
Maintaining
Using &
6.
Returning
Repairing &
7.
Disposal
Donation &
8.
Resources
Internet
Annex I.
of Terms
Definitions
Annex II.
Responsibilities
Division of
Annex III.

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38
Introduction
1.
Chapter 6
Using & Maintaining

6. USING & MAINTAINING

Resonsibilitiess
Roles &
2.
This chapter covers the following topics:

Training
Recruiting &
3.
• ‐Activities for medical staff.
• Activities of the Biomedical Service (logistics).

Good care and regular preventive maintenance are vital in order to extend

installing
Selecting &
4.
the life of your equipment. Regular maintenance can also help identify a
potential problem before it leads to equipment failure.

Organising
Planning &
5.
6.1 ACTIVITIES FOR MEDICAL STAFF

As previously described in the Roles & Responsibilities chapter the medical


staff are responsible for care of the equipment, cleaning and hygiene, and
small preventive maintenance tasks.

Maintaining
Using &
6.
The tasks and frequencies for each item of equipment are listed in the
"Biomedical Référenciel". Cleaning follow‐-up sheets and a user maintenance
protocol are available as separate documents for many MSF standard items

Returning
Repairing &
7.
of equipment.

Medical staff must be instructed on how to perform these tasks well for the
items of equipment they use. If many staff are unfamiliar with these tasks
it is a good idea to organise training sessions. The biomedical technician
Disposal
Donation &
8.
should be the one to lead these trainings.

Remember: The biomedical technician can only give instruction on good


care and cleaning of the equipment. It is the responsibility of the medical
team to ensure that all medical staff knows how to use the equipment
Resources
Internet
Annex I.

correctly for the treatment or diagnosis of the patient(s)!

Follow‐-up sheets must be used for each item of equipment. The sheet
header should be filled‐-in, stating the type of equipment and the serial
number or MSF code, and giving details of the activities to be performed
of Terms
Definitions
Annex II.

(i.e. cleaning and any checks which need to be done to verify the equipment
is working well). For larger devices you should attach the follow-up sheet to
the equipment itself, for smaller devices put up a board in each room with
all the follow-‐up sheets.
Responsibilities
Division of
Annex III.

Medical staff supervisors must ensure that the tasks are done and the

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follow-‐up sheets filled-in. The biomedical technician should check this


periodically also and discuss with the medical supervisor if support or
further training is needed.

A copy of the user maintenance protocol should ideally be hung in each


room of the health structure, or at least be available for quick reference.

Remember: Use of chlorine solutions to disinfect biomedical


equipment should be avoided if possible as they are corrosive
and toxic. They will damage the equipment and shorten its life
considerably. Especially sensors (for example those used with the
ultrasound equipment) are very sensitive to this and are damaged
very quickly. The toxicity presents a potential risk to patients if used
to disinfect respiratory accessories. If chlorine solutions are used the
equipment should be rinsed well afterwards, remembering to avoid
water entering the equipment!

6.2 ACTIVITIES OF THE BIOMEDICAL SERVICE

As previously described in the Roles & Responsibilities chapter the logistics


staff is responsible for conducting routine preventive maintenance work.

After contingency plans have been made, and a schedule of routine


maintenance has been drawn‐-up (see chapter 6. Using and Maintaining)
the schedule must be followed.

The tasks and frequencies for each item of equipment are listed in the
"Biomedical Référenciel". The maintenance protocols provided by MSF
for common items of equipment give clear instructions for the work.
Maintenance checklists for the most common items of equipment are also
provided and these must be used to record each maintenance.

Preventive maintenance work must be done according to the schedule. The


biomedical technician should collect the equipment which is scheduled for
maintenance from the health structure. If possible the equipment should
be replaced with a similar item from the back‐up stock for the time it takes
to complete the work.

For the most common items of equipment the maintenance work should
be done with the help of the maintenance protocols, and a maintenance
checklist should be completed for each maintenance job.

40
Introduction
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Chapter 6
Using & Maintaining

For items of equipment for which there is no protocol, maintenance should


be done according to the manufacturers recommendations as described in

Resonsibilitiess
Roles &
2.
the user manuals or technical guides. For these items there is also currently
no maintenance checklist so you should create one using the information
in the user manual.

Training
Recruiting &
3.
Essential points for maintenance are:
• A physical check of the condition of the equipment.
Look for damage to the casing, screens or displays, power cords,
cables, tubes etc.

installing
Selecting &
4.
• Functional check of the equipment.
Check if the equipment switches on correctly, that any controls
(buttons, dials, switches etc) are functioning according to the
description in the user manual, and that any audible (beeps) or visual

Organising
Planning &
5.
(lights) alarms can be triggered. If the equipment's documentation
describes any specific values which need to be verified for any of the
functions then check these.

• Clean the equipment thoroughly.

Maintaining
Using &
6.
In many cases it is possible to remove accessories or covers to
carefully remove any dust or debris that may have collected. It is
preferable to do this with compressed air as this reduces the risk of
damage by direct contact with sensitive parts. Precision mechanical

Returning
Repairing &
7.
parts can be damaged by knocking and electronic components are
sensitive to electrostatic discharges which can be produced when
fingers come into close proximity with components.

In some areas dust may be difficult to remove with compressed


Disposal
Donation &
8.
air and may need to be loosened with a soft brush first. Take care
with electronic components as the brushing action can cause static
electricity which could damage them.

• Condition rechargeable batteries if fitted.


Resources
Internet
Annex I.

Over a period of time these batteries will loose their capacity to hold
a charge and so the autonomy of the equipment will be reduced.
In some cases the equipment will have a maintenance function to
recondition the battery so it retains its capacity for longer. It usually
consists of an automatic discharge and recharge cycle. This must
of Terms
Definitions
Annex II.

be done as part of the periodic (preventive) maintenance. If the


equipment does not have this facility then you should do it manually by
turning the equipment on and letting the battery run down completely,
then recharging it again to 100%.
Responsibilities
Division of
Annex III.

41
Biomedical Equipment Guideline MSF-OCG
Logistics Department

Do not do anything which you are not absolutely certain of, nor
remove any component which you are not confident that you can
re‐fit. Equipment could easily be damaged by removal of covers or
parts by inexperienced persons.

If in doubt... DON'T DO IT!

The header of the checklist must be completed with all the equipment
information requested and each step of the work should be confirmed after
successful completion. If during the maintenance work any problems are
encountered with the equipment which can be repaired immediately the
additional parts used should be recorded on the maintenance checklist.

If the spare parts for repair are not available then the biomedical technician
should order them and store the equipment in a separate area of the
biomedical workshop, with the maintenance form attached to ensure that
it is clearly labelled as "work in progress".

The technician should inform the medical staff of the problem, advise
an expected time for the work to be completed, and if possible provide a
replacement item of equipment to cover the intervening period.

After completion of a maintenance job the biomedical technician signs the


form and files it in the records file (see chapter 5.4 Record keeping). The
equipment can then be returned to its place in the health facility and the
next item taken for servicing.

Medical staff supervisors will be checking that the tasks are done and
the follow‐-up sheets kept up‐-to-‐date. The biomedical technician must
check this periodically also and discuss with the medical supervisor if any
equipment is being badly cared for.

It could be that cleaning is not being done often enough, or that equipment
is left lying on the floor with cables and tubes trailing everywhere, causing
a tripping hazard and possibility of cable breaks. This is a major cause
of problems with biomedical equipment. The problem could be lack of
understanding by the medical staff, or it could be that there is simply no
good place to store the equipment when it is not in use.

Whatever the case the biomedical technician should discuss the issue with
the medical supervisor (and staff) and together they should find a solution.

42
1. 2. 3. 4. 5. 6. 7. 8. Annex I. Annex II. Annex III.
Introduction Roles & Recruiting & Selecting & Planning & Using & Repairing & Donation & Internet Definitions Division of
Resonsibilitiess Training installing Organising Maintaining Returning Disposal Resources of Terms Responsibilities

43
Using & Maintaining
Chapter 6
Biomedical Equipment Guideline MSF-OCG
Logistics Department

44
Introduction
1.
Chapter 7
Using & Maintaining

7. REPAIRING & RETURNING

Resonsibilitiess
Roles &
2.
This chapter covers the following topics:

Training
Recruiting &
3.
• Signalling an equipment failure.
• Assessing the fault and options for repair.
• Arranging After Sales Service returns.

installing
Selecting &
4.
To ensure the reliability of biomedical equipment it is important that
only skilled staff conduct repairs. Sometimes repair can be done locally,
otherwise equipment should be returned to the manufacturer.

Organising
Planning &
5.
7.1 SIGNALING AN EQUIPMENT FAILURE

Medical ward staff (nurses) will usually be the ones who discover a device
failure as they are the ones using it and responsible for care and cleaning.

Maintaining
Using &
6.
Before reporting it they must confirm that the device has actually failed by
cleaning the device and changing batteries (if applicable) or cables.

If the problem is not solved then the nurse will inform the Supervisor and

Returning
Repairing &
7.
together they must fill ‐in the intervention request form provided. Two
copies should be made, one to be kept in the ward and the other should
be given to the biomedical technician. The description of the fault must
be as complete as possible to help the biomedical technician identify the
probable cause.
Disposal
Donation &
8.
Equipment which is not functioning correctly must be removed from
active use until it has been successfully repaired and the correct
functioning has been confirmed. This avoids the risk of accidental
Resources
Internet
Annex I.

use by other staff who are not aware of the fault.

The medical supervisor and the biomedical technician should discuss


whether a temporary replacement is needed. This will depend on the impact
of Terms
Definitions
Annex II.

the failure has on the medical services. If there are sufficient devices,
alternative equipment available, or alternative medical procedures which
can be used then there is probably no need for temporary replacement. If
there is a back‐up device available (and needed) the biomedical technician
should install that for the duration of the repair.
Responsibilities
Division of
Annex III.

45
Biomedical Equipment Guideline MSF-OCG
Logistics Department

The biomedical technician will then conduct a full assessment to decide


the course of action for repair.

7.2 ASSESSING THE FAULT AND OPTION FOR REPAIR

The biomedical technician must first take a repair form and fill ‐in the
information on the location and equipment type. This document ensures
that there will be a record of the repair work.

The biomedical technician will do an assessment using the fault finding help
in the manufacturer's documentation and give try to identify the fault. For
some items there are also trouble‐shooting guides or maintenance manuals
written by MSF.

Fault finding steps:


If you remove any parts be sure to make notes and take pictures of the
disassembly method. Keep fasteners (screws bolts etc) in bags (medication
bags from the dispensary are great for this!) and label them so they do not
get lost. It can be useful to have a box to keep all the removed parts in so
they stay together.

Make notes (and maybe pictures too) of your observations as you go


through these points. These notes will be a useful reference later if
you are not able to complete the repair immediately.

• Ask questions of the medical staff member who reported the fault.
Probably the fault description in the intervention request form is not
complete, or still raises questions. It could be useful to know if the
machine made any unusual noises before it failed, or if there were any
other indications or alarms shown in lights or on displays.

• Check the easiest things first.
Without taking anything apart you can first check power cords, tubes
and attachment points, cables etc. for damage. Try exchanging the
cables and sensors with cables and sensors from other devices of
the same type which you know work.

Check the casing for cracks or signs of damage, from knocks or falls.
This could indicate that there could also be internal physical damage;
parts which have become disconnected or fragile components which
have cracked.

46
Introduction
1.
Chapter 7
Using & Maintaining

• Before disassembling try starting the device.


If nothing happens at all possibly the power supply is damaged.

Resonsibilitiess
Roles &
2.
This could be simply a blown fuse or it could be other components.
Any damaged components are likely to look burned and show black
traces. If the equipment starts then check for any alarms, or fault
messages if it has a screen or display. These can be checked with

Training
Recruiting &
3.
the manufacturer's documentation.

If the equipment starts but there are no alarms then listen for any
unusual noises or vibrations. Try using the different functions, a fault
may triggered by one of these. It is useful to know what equipment

installing
Selecting &
4.
normally sounds like so familiarise yourself with all the different items
of equipment when they are working normally.

• Open the device.


Do not do this if it invalidates the warranty or if the equipment has

Organising
Planning &
5.
a service contract. Read the manufacturer's documentation before
removing covers. Pay attention to warnings and the disassembly
method. Do not force parts while disassembling, they can easily be
damaged.

Maintaining
Using &
6.
Check for blocked vents, or dust or debris choking cooling fans, filters
etc and clean if needed. Check for damage to any internal tubes,
pipes or valves.

Returning
Repairing &
7.
With the cover removed you can again start the machine and try the
different functions. Any unusual noises will be easier to localise and
you can also check for leaks or other indications of a fault. Be sure
to observe good safety practice and avoid contact with live electrical
parts.
Disposal
Donation &
8.

Remember: To ensure the reliability of biomedical equipment it is


important that repairs are only attempted if the technician has the
skills and training to do the repair well. Badly repaired equipment can
Resources
Internet
Annex I.

be more dangerous than broken equipment!

If the fault can be identified then a decision needs to be taken on how the
repair can be done. The options could include:
of Terms
Definitions
Annex II.

• Repair on the project by the biomed technician.


• Repair externally by another contractor, either in the project location,
or the coordination.
• Return to the supply centre for repair by the manufacturer.
Responsibilities
Division of
Annex III.

The document "Biomedical Référenciel" gives general advice on this.


47
Biomedical Equipment Guideline MSF-OCG
Logistics Department

If a repair can be done on the project then the biomedical technician will
conduct the repair. Possibly the problem can be solved by replacement
of consumables (cables etc) or spares which are in stock. If not then the
biomedical technician will order the required spares. Your biomedical
referent can help identify the needed parts.

If a repair can be done by an external contractor then it is essential that this


contractor be validated for the work. A contractor must have sufficiently
skilled and trained staff and use quality spares (original manufacturer parts).
See chapter 4.3 Local Suppliers & Contractors for more info on contractor
validation.

If there is no 100% guarantee of repair on the mission (i.e. there are any
doubts about the skills of staff or contractors to conduct a repair) then the
equipment should be returned to the supply centre for repair. This must be
done according to the procedure for After Sales Service returns.

Whichever option is chosen for repair it is essential that an estimation is


made of the expected repair time and this is communicated to medical
supervisor. If there is a needed for replacement equipment but there is no
device available the biomedical technician and medical supervisor should
discuss and propose an alternative solution which should then be agreed
with the LogCo and MedCo. This could include:
• Borrowing equipment temporarily from other sections or organisations.
• Placing an emergency order (and revising the contingency plan!).
• Temporarily changing medical procedures (in consultation with
MedCo/HQ).

The repair form must be completed by the biomedical technician to reflect


the action taken:

For project repair the form must detail the fault found, action taken and
any spares used to effect the repair. If spares are ordered the equipment is
placed in the biomedical workshop with the form attached until the spares
arrive and the repair can be completed.

For repair by external contractor the form must be completed to reflect


the order placed with the contractor and be kept on file until the equipment
returns. When the equipment returns to the project the biomedical
technician should check the functioning and confirm the repair has been
done correctly.

For After Sales Service return the ASS (SAV in French) form must be
completed to reflect that the equipment has been returned and filed
together with the ASS (SAV) form. When the equipment returns to the
project the biomedical technician should check the functioning and confirm
48
Introduction
1.
Chapter 7
Using & Maintaining

the repair has been done correctly.

Resonsibilitiess
Roles &
2.
Whichever repair procedure has been followed it is vital that when
the equipment returns after being repaired it is tested before being
put back into service. This must be done together with a member of

Training
Recruiting &
3.
the medical staff who is familiar with the equipment. The final part of
the repair form has provision for both medical staff and biomedical
technician to sign‐-off on the repair.

installing
Selecting &
4.
If after discussion between the supply centre and the LogCo, MedCo and
biomedical referent it is decided that the equipment cannot be repaired
then it must be disposed of correctly. See chapter 8.3 Disposal.

Organising
Planning &
5.
7.3 RETURN PROCEDURES FOR AFTER SALES SERVICE

If a return to the supply centre is the chosen repair method the the LogCo

Maintaining
Using &
6.
must contact the supply centre to obtain a confirmation and a return
number. When the confirmation has been received the SAV return form
must be completed and the equipment sent with one copy of the form. A
second copy must be kept in the equipment file on the project. Transport
of SAV returns should be coordinated by the supply team.

Returning
Repairing &
7.
An electronic version of the form should be sent to the supply centre in
advance of the equipment arriving and a copy to the desk Log and biomed
referent at HQ. The SAV return form must be signed by both the LogCo and
the MedCo. Be sure to include as much information as possible about the
Disposal
Donation &
8.
fault, or the problems identified, on the return form.

The SAV form contains the instructions for return and contact informations.
Resources
Internet
Annex I.
of Terms
Definitions
Annex II.
Responsibilities
Division of
Annex III.

49
Biomedical Equipment Guideline MSF-OCG
Logistics Department

50
Introduction
1.
Chapter 8
Using & Maintaining

8. DONATION & DISPOSAL

Resonsibilitiess
Roles &
2.
This chapter covers the following topics:

Training
Recruiting &
3.
• ‐Receiving donations
• Making donations
• ‐Disposal of equipment

installing
Selecting &
4.
Accepting or making donations can cause many difficulties in the long
run. There can be good reasons, but consider the consequences first. If
donation is not possible dispose of unwanted equipment correctly.

Organising
Planning &
5.
8.1 RECEIVING DONATIONS

You may be offered equipment by other MSF sections or other organisations.


This often happens when projects close and it can be tempting to accept

Maintaining
Using &
6.
these donations. If you decide to accept the donation it will become a part
of the inventory, either for use or for back‐up, and it must be maintained
to ensure continued service. If for any reason the equipment is difficult to
maintain then accepting it will ultimately only lead to frustration for everyone.

Returning
Repairing &
7.
Always ask the following questions. If the answer to all of them is yes then
confirm with the biomedical referent and the cell before accepting the
donation.
• Is there a medical need for the equipment, and is it in line with
Disposal
Donation &
8.
operational strategy?
• Is it possible to find spares and consumables?
• Is there support documentation available?

If the equipment is not appropriate but there is a medical need for similar
Resources
Internet
Annex I.

equipment, then you should consider choosing new equipment. See


chapter 4.2 Selection of Equipment.
of Terms
Definitions
Annex II.

8.2 MAKING DONATIONS

In many health facilities in contexts where MSF works you will find
biomedical equipment lying unused, simply because there are no parts,
the skills are not there to maintain and repair them, or there is simply no
Responsibilities
Division of
Annex III.

money to keep them running. When considering donating equipment to

51
Biomedical Equipment Guideline MSF-OCG
Logistics Department

other organisations it is important to first consider if the recipient is able to


use and maintain the equipment. When closing a project or handing over a
medical activity to others consider the following points:

• Does the recipient's staff have the skills and experience to use the
equipment correctly? If not then consider giving training before
making the donation.
• Is there sufficiently skilled staff to carry out maintenance and repair
work? If not then consider training or finding a local service contractor.
You should consider giving a service contract for a given period
together with the donation.
• Are spares and consumables available, does the recipient have the
(financial) means to procure them?
• If not then you should consider giving spares and consumables for a
given period together with the donation.

Equipment which MSF intends to continue to use and support should


obviously not be donated as there is then no control over the use and
maintenance.

If you have equipment which is in good condition but you have no further
need for it then you should consider transferring it to other projects, other
missions in your region, or returning it to the supply centre for use on other
missions for your section.

8.3 DISPOSAL

If you have an item of biomedical equipment which is broken, and can no


longer be repaired, then you will need to dispose of it in order to be sure
that it cannot accidentally be used.

Be sure you have investigated all the repair options first. If you have more
equipment of the same type there may be some parts you could disassemble
and keep for other repairs. Be sure the parts are in good condition.

Biomedical equipment often contains electronic parts and the exportation of


this type of waste to developing countries is a major source of environmental
pollution. Some biomedical equipment can also contain parts which are
a direct hazard to the environment. This is the case for some items of
laboratory testing apparatus and x‐ray equipment for example.

Consult the manufacturers' documentation for disposal information or


contact the biomedical referent to see if there are other options for correct
disposal.
52
1. 2. 3. 4. 5. 6. 7. 8. Annex I. Annex II. Annex III.
Introduction Roles & Recruiting & Selecting & Planning & Using & Repairing & Donation & Internet Definitions Division of
Resonsibilitiess Training installing Organising Maintaining Returning Disposal Resources of Terms Responsibilities

53
Using & Maintaining
Chapter 8
Annex I MSF-OCG
Internet Resources Logistics Department

54
Introduction
1.
ANNEX I

Resonsibilitiess
Roles &
2.
Internet Resources

Training
Recruiting &
3.
This guideline covers the basics for management of biomedical devices in
MSF projects/missions. The following sites provide more detailed information,

installing
Selecting &
4.
manuals etc.

Technologies Biomedicales
French language site with documentation and discussion forum.

Organising
Planning &
5.
www.technologies‐biomedicales.com

WHO Medical Devices


WHO site in English, French and Spanish with information and documentation
to download. In addition there are links to regulatory information for different

Maintaining
Using &
6.
countries, training courses, and much more.

www.who.int/medical_devices

Frank's Hospital Workshop

Returning
Repairing &
7.
English language site with a large collection of manuals and other biomedical
equipment related documentation. It also has useful technical/electronics
tutorials.
Disposal
Donation &
8.
www.frankshospitalworkshop.com

MedWrench
English language site with manuals, discussion forum and information related
to medical equipment.
Resources
Internet
Annex I.

www.medwrench.com

Manuals Online
English language site with collection of user manuals.
of Terms
Definitions
Annex II.

www.manualsonline.com
Responsibilities
Division of
Annex III.

55
Annex II MSF-OCG
Definition of Terms Logistics Department

56
Introduction
1.
ANNEX II

Resonsibilitiess
Roles &
2.
Definitions of Terms

Training
Recruiting &
3.
Biomedical equipment
All equipment with a medical or laboratory related application (diagnosis or

installing
Selecting &
4.
treatment) which requires an energy source (AC, battery, or mechanical), and/or
requires preventative maintenance or periodic (re)certification.

Consumables
Items requiring periodic replacement. Some of these are medical (anti-bacterial

Organising
Planning &
5.
filters, humidifiers, nasale canulars, masks etc), and some are technical (e.g. air
filters, batteries etc).

Spare parts
Components which need to be replaced only in the event of a breakdown.

Maintaining
Using &
6.
Preventive maintenance
Work which is carried out regularly to ensure continued functioning. This
includes cleaning and exchange of consumables (user maintenance; medical

Returning
Repairing &
7.
responsibility) and additional periodic checks (technical maintenance; logistics
responsibility).

Corrective maintenance
Work which is carried out in order to repair an item of equipment which has
Disposal
Donation &
8.
malfunctioned. This is a logistic responsibility.

Supplier
An external company or organisation which provides products. This can be
equipment, consumables or spares.
Resources
Internet
Annex I.

Contractor
An external company or organisation which provides support services. This
includes installation, servicing, repair, or (quality control) re‐certification.
of Terms
Definitions
Annex II.

Policy
A policy is a number of written statements that describes principles, requirements
and limitations. The statements are characterised by indicating "what" must be
done rather than "how" to do it. Such statements have the force of establishing
rights, requirements and responsibilities.
Responsibilities
Division of
Annex III.

57
Annex II MSF-OCG
Definition of Terms Logistics Department

Procedure
A procedure is a set of mandatory steps providing specific how-to information,
aiming at an objective.

Protocol
A protocol is a plan for a course of action, often with step-by-step instructions
and illustrations for ease of comprehension.

Guideline
Guidelines detail recommended or customary methods of working to accomplish
an objective. A guideline is not enforced but is generally followed.

58
1. 2. 3. 4. 5. 6. 7. 8. Annex I. Annex II. Annex III.
Introduction Roles & Recruiting & Selecting & Planning & Using & Repairing & Donation & Internet Definitions Division of
Resonsibilitiess Training installing Organising Maintaining Returning Disposal Resources of Terms Responsibilities
Responsibilities

59
Division of
ANNEX III
Annex III MSF-OCG
Division of responsibilities Logistics Department
for biomedical equipment

60
1. 2. 3. 4. 5. 6. 7. 8. Annex I. Annex II. Annex III.
Introduction Roles & Recruiting & Selecting & Planning & Using & Repairing & Donation & Internet Definitions Division of
Resonsibilitiess Training installing Organising Maintaining Returning Disposal Resources of Terms Responsibilities

61

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