Biomed Guide
Biomed Guide
Equipment
Guideline
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
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Biomedical Equipment Guideline MSF-OCG
Logistics Department
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.
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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
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.
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
installing
Selecting &
4.
Logistics Department
Médecins Sans Frontières
Operational Center Geneva
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.
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10
Introduction
1.
Chapter 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
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.
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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.
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
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.
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.
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.
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
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16
Introduction
1.
Chapter 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
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.
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.
Especially in IT and other technical subjects there are a lot of schools out
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3.2 RECRUITMENT
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.
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.
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20
Introduction
1.
Chapter 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.
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.
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.
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,
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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.
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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.
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
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Biomedical Equipment Guideline MSF-OCG
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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.
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.
24
Introduction
1.
Chapter 4
Selecting & Installing
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.
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.
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Biomedical Equipment Guideline MSF-OCG
Logistics Department
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.
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.
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
1.
Chapter 4
Selecting & Installing
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.
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
1.
Chapter 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.
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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Biomedical Equipment Guideline MSF-OCG
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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.
The MSF maintenance protocols provide information on the tasks for the
30
Introduction
1.
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.
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 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).
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.
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
1.
Chapter 5
Planning & Organising
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.
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.
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.
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.
The stocks you will have to consider for biomedical equipment fall into
33
Biomedical Equipment Guideline MSF-OCG
Logistics Department
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.
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.
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.
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.
MSF Catalogues (ITC) give lists of related articles for each item of
(biomedical) equipment. This includes spares and consumables.
Responsibilities
Division of
Annex III.
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.
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 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.
37
Biomedical Equipment Guideline MSF-OCG
Logistics Department
38
Introduction
1.
Chapter 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
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.
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
39
Biomedical Equipment Guideline MSF-OCG
Logistics Department
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.
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
1.
Chapter 6
Using & Maintaining
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.
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.
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.
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.
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.
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
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.
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 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.
• 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
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.
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.
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.
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 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.
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 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
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
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
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.
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.
51
Biomedical Equipment Guideline MSF-OCG
Logistics Department
• 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.
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
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.
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
Maintaining
Using &
6.
countries, training courses, and much more.
www.who.int/medical_devices
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