Managing_the_medical_equipment_lifecycle_LOW RES.pdf

PARTNERSHIPS FOR GLOBAL HEALTH
THET


MANAGING THE LIFECYCLE
OF MEDICAL EQUIPMENT




CONTENTS
About this guide


2
The Equipment Life Cycle


3
Phase 1: Planning


4
Phase 2: Budgeting & Financing


6
Phase 3: Technology Assessment & Selection


8
Phase 4: Procurement & Logistics


10
Phase 5: Installation & Commissioning 11
Phase 6: Training & Skill development


12
Phase 7: Operation & Safety


14
Phase 8: Maintenance & Repair


15
Phase 9: Decommissioning & Disposal


16
Monitoring, Evaluation & Learning


17


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THE EQUIPMENT LIFE CYCLE
This resource follows the Equipment Life Cycle as it is often
used in Healthcare Technology M


anagement (HTM
). The cycle


is divided in 4 phases and 9 topics.
The first phase ‘Planning’ consists of Planning and Assessm


ent
of the needs in the healthcare facility appropriate to its
environment, the equipment users and patients, and Budget
&


Financing in which the appropriate budgets are created and
estimated for purchase and the ‘cost of ownership’.
The second phase ‘Purchase’ contains Assessm


ent and
Selection, covering how to decide which equipment meets
the needs identified earlier. Specifications are written
and in Procurement & Logistics a tender is written, a less
complicated purchase is done or a donation is agreed upon.
The responsibilities and practicalities around logistics are
prepared and executed. In Installation & Commissioning after
the equipment has arrived in the healthcare facility and should
be unpacked, installed, and commissioned.


After these two phases of preparation the third phase is
the actual ‘Lifetime’. Starting with the training of users
and maintainers in Skill Development & Training, the daily
Operation & Safety for and by users, and M


aintenance
& Repair mostly done by the Biomedical Equipment
Professionals.
The last phase ‘End of Life’ is about Decommissioning &
Disposal of medical equipment.
As indicated in the image, Create Awareness, Monitor &
Evaluate are constant throughout the life cycle. Creating
awareness with all participants, whether they are users,
maintainers, administrators or politicians, is of great
importance to improve systems and add to better biomedical
and healthcare practices. Monitoring and evaluating
contributes to keeping track of the equipment lifecycle, and
creates opportunities to review and improve processes and
share successes and learning.


Create aw
areness


M
onitor and Evaluate


Technology Assessment
and Selection


M
aintenance


and Repair


Operation
and Safety


Training and Skill
Development


Installation and
Commissioning


Procurement
and Logistics


Budgeting and
Financing


Decommissioning
and Disposal


Planning and
Assessment


ABOUT THIS GUIDE
Health Partnerships working in low-resource settings frequently
encounter challenges relating to medical equipment that
can influence the success of their projects. These challenges
include a lack of functioning equipment, and other aspects of
what is called ‘Healthcare Technology Management (HTM)’.
HTM


concerns the management of the medical equipment life
cycle; from planning to purchase, installation, operation all the
way through decommissioning and disposal.
This resource serves as a companion to the Making it Work
toolkit, published by THET in 2013 and offers an overview of
the steps of the equipment life cycle and ways for partnerships
to integrate these considerations into their projects.


This resource identifies ‘Assumptions’; expectations which
might be valid for high-resource settings but which are not
necessarily valid for low – and middle-income countries
(LMICs). These are linked to ‘Mitigations’; potential ways to
prevent setbacks and to improve the progress of the project
and the quality of healthcare in the LMIC. Some of the
mitigations need the support of a technical expert, but many
can be done without additional resources.


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Assumptions
• Safe and stable electrical supply


and clean running water is always
available, as are medical gases


• Supporting departments function
well and deliver quality controlled
outputs e.g. sterilisation and laundry
departments


• Data is available on which to base
decisions on equipment purchases,
like user and environmental
data, appropriateness to setting,
information from this and other
hospitals


• There is consensus on and
prioritisation of what is required.
Users, maintainers, financers and
managers give their input and
requirements are written with
everyone’s agreement


• Long term plan (+budget) is in place
for equipment purchases


Mitigations
Consider all the following when planning
how you will address Planning &
Assessment.
• Do a collaborative needs-assessment


(UK and DC partner, including technical
staff, users and management)
including an inventory check, or
creation of an inventory. Consider
bringing a BM


E from your UK hospital
to support this process


• Do an infrastructure check; what is
available and what is working properly.
Is there a non-electrical alternative
for the identified needs? Work with
robust equipment, plan a back-up (e.g.
a generator)


• Do additional purchases (e.g. water
filter, air-conditioning unit) and attach
protective equipment like a stabiliser
or UPS to protect equipment from
surges


See Understanding Power
Supply Considerations on p. 44 of the
Donations Toolkit
• For bigger projects it might be worth


bringing an electrician and plumber
to site to make basic infrastructure
improvements


• Check if supporting departments
are functional and effective and take
action if necessary


• Coordinate with other agencies, the
government and other hospitals. Learn
from others by finding out e.g. which
organisations work in the same or
similar hospital. Have they purchased
equipment? How is equipment
normally planned and purchased?
Often the Ministry of Health (MoH) is
in charge of centralised procurement
and it is important to understand the
dynamics between the parties.


For the role of the Ministry of Health in
medical equipment management see
p.24 of the donations toolkit
• Consider both the patient journey and


all factors of service delivery when
creating specifications


• Be prepared for reactive rather than
planned purchases. Create awareness
of expected lifetimes and long term
planning.


Although reactive purchases are often
related to limited financial resources,
it is important to create awareness on
how working equipment is a source of
income. An Equipment Development
Plan can be found in Ziken’s guide 2
Chapter 7.1. This information should be
shared with hospital directors, financial
managers, procurement officers, users
and maintainers


“An early intervention at Connaught Hospital was a full inventory of
all hospital equipment. We were therefore able to work with hospital
staff to redistribute existing equipment (much of which was needed but
unused) and identify critical gaps.”
DR OLIVER JOHNSON,
King’s Health Partners, Programme director King’s Sierra Leone
Partnerships


PHASE 1: PLANNING & ASSESSMENT
The assumptions and mitigations described below apply to both planning donations and locally
purchased equipment. For detailed information on Medical Equipment Donations, see the
Donations Toolkit Chapter 1 and 2.


Reactive Vs. Planned
Purchase
Medical equipment is valuable and the
purchase/tender process takes time. In the
UK equipment is mostly replaced before
the old equipment is permanently out of
service. The Biomedical Technicians know
when equipment reaches the end of their
profitable life (when the cost of repair
and down-time become too high), the
users (doctors and nurses, but maybe also
cleaning staff) know when equipment lacks
functionality or speed. Before a tender
process is initiated an internal process
takes place in which the hospital prioritises
the needs for the coming year(s). The
users/departments make a request for a
new piece of equipment, the technicians
support the proposal with technical
background and the financial department
prioritises the request, which is then
approved by the hospital director/direction.
Normally not all requests are accepted due
to limited budgets, but when the same
request is proposed e.g. two subsequent
years, the need is clear. This is called a
planned purchase.
In developing countries purchases (or often
donations) are done centrally by the MoH.
This can be a random process in which
users and technicians not always have a say.
Purchases are often done after equipment
has been out of service for a long time. For
example: a district hospital’s X-ray is out of
service. It takes 6 months before a proper
diagnosis is made (no service engineer in
the country). It appears the tube is broken,
and replacing a tube is a huge investment.
The machine is already over 20 years old
and it is decided it should be replaced.
A request from the hospital to the M


oH
for a tender is done (in writing) and 3
months later the M


oH decided to start
a tender procedure. It is to be expected
that it takes at least 1 year to execute the
tender procedures, accept a bid, place the
order, receive and install the equipment.
The hospital in this example has to refer
its patient for x-rays for almost 2 years
before having solved the issue. Referring
patients is inconvenient and leads to a loss
in revenue.
See Phase 4: Procurement for an example
of centralised procurement in the UK.


Always Involve Local Technical Staff!
Throughout this resource this symbol will indicate the suggested involvement of a Biomedical Engineer (BME) from
your UK trust. The added value of a BME in your team is well illustrated in case study 7 of the Donations Toolkit on p.71.
However the involvement of local technical staff in the destination institution should always come first. When no local
technical staff are present, it is worth looking for a local contractor.


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Assumptions
• Hidden costs are covered and planned


for, e.g. maintenance, HR, training,
consumables, replacements


• Financial management and rules are
understandable, available and applied


• Budget is existent, usable and realistic
& implies responsibility/planning for
the future


• Spare parts and consumables are
available for reasonable prices


Mitigations
• Share the hippo model (see below).


Create awareness and encourage
budgets to be created for the
equipment lifetime (Cost of ownership
estimated by 10% of purchase cost /yr)


• Describe an equipment situation
to show that maintenance makes
economic sense


• Insist on transparent processes, for
example by proposing the use of the
long-term Equipment Development
Plan and Core Equipment Expenditure
Plan as described in chapter 7.1 and
7.3 of Ziken’s Guide 2


• Clarify responsibilities & cost
allocation, encourage flexibility on
allocations


• Prioritise needs and link to available
budgets to create a feasible plan


• Make use of local/historical knowledge
& ownership e.g. local purchasing


• Research the availability of spare
parts, consumables, and maintenance
services. Try to avoid importing parts
yourself; the local system should be
encouraged and local economies
stimulated.


• Learn from the BM
Es in your UK


hospital


More information on budgeting for
medical equipment can be found in


Ziken’s Guide 2. Guide 6 covers the
financing of Medical Equipment.


PHASE 2: BUDGETING & FINANCING


In Focus
The partnership between Guy’s
& St Thomas’ NHS Foundation
Trust, Arthur Davison Children’s
Hospital and Ndola Central
Hospital in Zambia was set up in
2009, focusing on improvement
of biomedical services in those
two hospitals reaching out to
other biomedical professionals
in the Copperbelt region as well.
The lack of spare parts has been
a challenge and focus for this
project. The Zambian government
has procurement regulations
that do not allow public hospitals
to order parts from outside the
country (for example online). The
few Zambian medical equipment
suppliers present in the country
triple or quadruple prices and
are in somewhat of monopoly
position. The lack of competition
and market control allows them to
maintain this position. A potential
solution that is currently being
explored is to ask a local hardware
store to order online and have a
small commission. Often it is not
necessary to be a formal agent
to be able to order spare parts.
In the meantime cases should be
reported to the M


inistry of Health
to raise awareness and fight
for improvement of the current
situation and regulations.


The hippo model
When purchasing (medical) equipment, care providers should budget and plan for all cost hidden under water level;
Purchasing costs cover only a minor part of the total cost of ownership.
The Hippo model is an alternative way of depicting the iceberg, which can be found on p.10 of the Donations Toolkit p.10


“We use an ultrasound to identify
liver disease/cancer in patients,
which is non-invasive, quick
and acceptable to patients. This
machine often broke down, due
to lack of care/maintenance
on the local site. Also, the high
temperatures often contributed to
the machine malfunction. Without
the machine, accuracy of patient
diagnosis was limited and it slowed
the project down. The latter was
due to the need to undertake a
biopsy to diagnose disease. This
is invasive, disliked by patients
and requires a skilled surgeon,
requiring additional resources
to obtain confirmation of those
patients with liver disease. Lack of
this data would limit the data and
effectiveness of the project.”
“We procured additional (back-
up) ultrasound machines to cover
for breakdown and had medics
experienced in using/caring for
the machine spend short intensive
periods in Africa diagnosing the
patients. We also paid for regular
machine maintenance/service to
keep the machines active. Both
solutions allowed diagnosis of
patients and sufficient data for the
project outcomes.”
DR D GARSIDE
Imperial College London – Gambia
partnership, Project ManagerWWW.THET.ORG


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Assumptions
• All equipment is available to be


purchased and within reach & you can
trial it before purchase


• Users know how to use equipment and
are systematically educated


• What is advertised (equipment +service)
is available


• You can trust the market to deliver
equipment of good quality and safety


• Manufacturers or agreed agents are
locally present


• Qualified and trained technicians are
locally present


• Local spare parts stock is present
• Honesty & ethics of manufacturer are


strong


• Consumables and spare parts continue
to be available throughout the lifetime
of the equipment


• Equipment fits the purpose and is
appropriate to setting


• “Household name” or “well-known
brand” companies operate in the same
manner in an emerging economy as they
do in the UK


Mitigations:
• Pilot the equipment, visit the agents


or vendors, share information and
experiences with other parties/hospitals
(try available equipment in other
hospitals, and look for existence of
national standards (if not, use European
standards), verify the reliability of
vendors)


• Establish training needs, including basic
awareness of safety and equipment care


• Check what local vendors can deliver
on, which timescale and what kind of
service they offer. Meet the vendors,
check their facilities, and their
reputation.


• Stick to FDA and/or CE medical marked
equipment. Do not fall for cheap
options. Check if the Ministry of Health
has adopted standards and regulations
on medical equipment


• Check which vendors are present in
the country and if they are recognised
by the manufacturers. Think of service
support as well, check the presence of
licensed service engineers.


• Internationally recognised
manufacturers do not gamble with
ethics and honesty. They avoid risks
to their reputation. However, it is
advisable to ask around for references.
Check if the Ministry of Health keeps a
black list.


• Check the availability (and price!!)
of spare parts and consumables
beforehand. Consider re-usable
accessories for remote areas but bear in
mind that this only works if sterilisation
is done properly. Consider simpler
equipment to avoid the use of expensive
spare parts. Use whole-life cycle
costing, and write a tender for spare
parts or ask for price guarantees for 3
years.


• Check specifications on appropriateness
to setting and, during assessment,
include local productions or non-
profit equipment that is developed for
low-resource settings. Also consider
standardising the equipment; if all
public hospitals use the same brand
equipment, it might be advisable to
purchase the same. This helps to secure
access to service and parts.


• Learn from the BMEs in your UK hospital


See p.25 of the Donations Toolkit
for ‘Asking the right questions’ to


understand whether the equipment is
appropriate to setting


PHASE 3: TECHNOLOGY ASSESSMENT
& SELECTION


When purchasing equipment there are roughly 4 options:
1. New equipment from big manufacturer
– Plus + good quality
– Plus + access to service, spare parts and consumables
– Minus- expensive in purchase
– Minus- difficult and expensive to maintain/repair
– Minus- more functionality than necessary
2. Second-hand or manufacturer refurbished equipment
from big manufacturer
– Plus +less complicated in use
– Plus +attractive price/quality
– Plus +Refurbished equipment might come with a


guarantee for availability of spare parts and consumables
– Minus -not as desirable as new equipment (wanting the


‘gold standard)


3. Equipment produced for low-resource settings (often
start-ups or NGOs)
– Plus +appropriate to setting (functionally and technically)
– Plus +not expensivec
– Minus-unsure if the company will last (availability of spare


parts)
– Minus- not as desirable as new equipment (wanting the


‘gold standard)
The Donations Toolkit mentions several of these initiatives
on p. 41 “Supplying Appropriate Technologies Designed for
Low-Resource Settings” and p. 81 for contact details
4. New equipment of inferior quality mostly produced in
Asia
– Plus +not expensive
– Plus +fast delivery
– Minus -no quality guarantees (CE/FDA)
– Minus -access to service/spare parts
– Minus -short life time
– Minus -higher level of break downs


“We standardised our BP, pulse,
temp and sats monitors on the
wards, and bought the most
simple to use and maintain.”
DR BIPLAB NANDI
Queen Elizabeth Central hospital
Blantyre, Malawi & Great Ormond
Street Hospital London, developing
country lead


In Focus
Rwanda has introduced law saying
that no second hand equipment
can be brought into the country.
For donations and refurbished
equipment this can mean that
equipment is not cleared and
sent back to its origin at a cost
to the sender. Although second-
hand high-end equipment might
be more appropriate to the
setting (safe and reliable) than
new Chinese equipment, often
these rules are strict and without
exceptions.


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Assumptions
• Tender procedures are well known and


respected
• Logistics are costed, including customs


and transport (effective/reliable/
timely and safe) from port to hospital


• Supplier is honest & efficient
• Specifications are relevant &


appropriate
• Company honours warranty
• User knows warranty is there, and can


use the information
• In case of accidents there is insurance


in place


Mitigations
• Follow local rules e.g. customs and use


local experience. Often the ministry
of health centrally procures medical
equipment and knowledge of tender
procedures and logistics are available
there


The process of Clearing Customs is well
described in Chapter 6 of the Donation
Toolkit and can be found on p. 61
• Include transport in specifications.


Delivery in port/airport or in the
hospital? Best to include transport
until the exact place of installation.


• Check if the space in the hospital is
available and appropriate. Go and
look.


• If supplier does not do clearance and
local transport, prepare a transport
plan and ensure reliable carriers, who
take ownership for each leg of the
journey. Include worst-case scenarios.


More information can be found in
Donations Toolkit Chapter 5, p. 51-59
• Access standard specifications (W


HO,
Nepal)


• Get references on reliable partners –
use consumer power


• Make use of a pre-purchase demo or
loan


• Make sure user knows exact warranty


conditions and has access to service
provider


• User involvement in every stage of the
procurement process


• Verify if all stages of the transport are
insured and under which conditions.


• Learn from the BM
Es in your UK


hospital
See p.52/53 of the toolkit


For more information on logistics
see the Donations Toolkit Chapter


5 and 6, and Ziken’s Guide 3
accurately describes all elements of


Procurement and Commissioning


PHASE 4: PROCUREMENT
& LOGISTICS


In Focus
In the Comoro Islands, technicians
were receiving a container with
an X-ray in the port of Anjouan.
When they opened the container,
the forklift was struggling to get
the crate out of the container
and the technicians assumed
the wood had warped, and
consequently it was jammed in
the container. After transporting
the equipment to the hospital the
technicians started installing the
equipment and found out it was
broken. Although the crate was
not visibly damaged, apparently
an impact from outside had bent
the container wall, crushing the
equipment inside. No proof was
present that the damage was
caused during transportation
and insurance didn’t want to
take responsibility. Therefore,
ALWAYS check all packaging
before opening, and take photos
in case of abnormalities. And only
remove crates when they have
arrived at the final destination.
Crates also protect during local
transport. Report to supplier,
insurance and transporter within
24hours in writing, adding photos.


Testing Equipment
Mulago National Referral Hospital
in Uganda has not had access to
test equipment for many years.
Once the devices are fixed, the
technicians have to rely on the
users to tell whether they are
functioning normally. Recently,
new test equipment have
been donated and the hospital
technicians are slowly getting
adapted to their use. Oxygen
concentration test device is
missing yet the hospital produces
its own oxygen. Volunteers are
routinely asked to bring some of
these tester around to test for the
concentration.


Centralised
Procurement in
the UK
In the UK Hospitals procure
their own equipment, but
often use joint supply agencies
(‘consortium’) to process. That
route uses some bulk discount,
and there is an ‘NHS catalogue’ of
approved products and prices. So
it is a sort of prequalified system,
but hospitals are free to act on
their own.


Assumptions
• Facilities exist and are appropriate,


e.g. space to store the equipment,
doors big enough for equipment entry,
floors strong enough, water and power
supplies are available


• Room preparation needs assessment
has been done; everyone knows what
needs to be done


• Room preparations are done
• Someone will receive it at site,


supervise and sign off the installation
• The equipment is delivered and


installed by the supplier
• Test equipment and skilled technicians


are present to perform functional and
safety tests


• Financial penalties for delays are well
communicated and understood by all
parties


Mitigations:
• Perform a Needs Assessment, create


plan for room preparation
More information Pre-installation work
can be found in Ziken’s Guide 3 p.200
and estimation of pre-installation cost in
Ziken’s guide 2 p111
• Cross-department communications


and agreement on who is responsible
for which part of the installation and
commissioning


• Follow up on room preparation plan,
check well in advance


• Plan for user approval on delivery
(no damage, is it well installed, is it
functioning properly? – standard forms
available)


• Let the vendor’s service engineer open
the boxes, let it be supervised by the
hospital’s technician


• Makes sure this is included in the
tender document or purchase
agreement


• Ideally the supplier performs
installation and tests under
supervision of the hospital technician


(directly training the technician). Often
test equipment is not available and
if available the technician does not
always know how to use it. Providing
the technician with test equipment
and following the Acceptance log
sheet helps the partnership to be
guided through all the possible checks,
but bringing a UK Biomedical Engineer
with test equipment for a release test
visit (and training) might be the most
feasible solution


Chapter 4 of the Donations Toolkit for
more information on verifying the quality
and safety of equipment, p48 onwards.
• Financial penalties and insurance


clarified on delays, damage and
malfunctioning equipment


• Warranty commences and payment
made only after successful installation


• End users are aware of warranty
conditions. Confirm in writing that the
supplier will honour the warranty if
purchased in-country


• For smaller items that do not need
installation the reception process
should be well planned as well.
The content of the boxes should be
checked against the packing list and
the content should be checked on
completeness and functionality. In
case of discrepancies the supplier
should be contacted directly.


For more information on receiving
equipment: Donations Toolkit Chapter 6
and Ziken’s Guide 3


Acceptance log-sheets guide
technicians through the procedure


of receiving, testing and installing
equipment. Such a sheet is an


extensive document of about 10
pages and includes all steps to be


undertaken, such as technical tests,
execution of training of personnel,


presence of manuals, consumables
and spare-parts. An example of an


acceptance log-sheet can be found in
Ziken’s Guide 3 p332.


PHASE 5: INSTALLATION
& COMMISSIONING


In Focus
It happens that hospitals are not
aware of the arrival of medical
equipment. Often these are
donations, agreed upon by a
certain doctor or administrator
or the central government
deciding equipment should go
to this place. M


any hospitals
in developing countries have a
lack of space. When a piece of
equipment arrives without notice,
it can happen that this equipment
sits outside until space is created.
This can take a while, with a lack
of ownership and awareness, a
rainy season and a dry season
and the equipment is rusted and
rotten without having been used
at all.


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Assumptions
• People are used to working with


technology
• People have had full medical training


and participate in/have access to
continuous professional education


• Training is seen as good for skills and
prospects both at management level
and working on the floor


• Training is included in a tender and
executed by the supplier


• Training takes place between
installation and taking the equipment
into service


• Training is repeated if needed


Mitigations
Refer to Donations Toolkit Chapter 7 –
putting the equipment into service, p.67
training of users and maintainers
Consider all the following when planning
how you will address training and skills
needs.
• Include training in tender


specifications (describe needs), and
specify who should be trained for how
many days with what outcomes


• Cover essential safety and care before
putting equipment into service for
both maintainers and users


• Begin by doing an


assessment of current knowledge,
both for users as technicians. Consider
bringing a UK BME to identify the needs
• Create training that fits the local


needs. The materials and examples
used in the training should resemble
reality


• Ensure training includes assessment of
individual competencies


• Build motivation for the future, explain
how training can increase status and
respect


• Identify champions, train the trainer,
to guarantee continuation of training
for new staff and repetition for current
staff


• Repeat user training every 6 months,
for changing staff. It is possible to
include follow-up training in a tender,
e.g. 50 hours of training in the
following 2 years.


• Explain to management the value of
training


• Give the BMET the responsibility for
user training; let him/her join the
vendor’s training. Collaborate with
Head of Departments for planning and
content.


• Award trained people with a certificate
Ziken’s Guide 3 covers initial equipment
training and Guide 4 covers user training


PHASE 6: TRAINING & SKILLS
DEVELOPMENT


User Training
Biomedical Equipment
professionals are often not well
respected in the hospital, due to
the invisibility of their work. By
making the BMET responsible for
executing regular user training
(s) he/she has the opportunity to
make him/herself visible and to
spend some time on explaining his
role in the healthcare system. This
only works with support from the
head of departments, the head of
nursing and administrators.


Local Champions
In every department, team or
professional group you can find
champions. Potential champions
are those who pay serious
attention to the subject, who ask
the most questions and who want
to talk to the teacher at the end
of the class. When you are looking
for sustainability of your training,
you should look for people who
can perform your training in
the future. Identify a potential
champion and help him/her to get
a champion status by providing
extra time with him/her, asking
him/her to share or take over your
class, or even taking him/her to
lunch: rewarding their effort and
creating a status that will support
them to perform training in the
future.


“We try to teach the importance of
maintaining equipment when we
are there, and produce guidance
on maintenance on simple
documents. We always take one
team member now who has better
understanding of the equipment
that we have introduced, such
as the oxygen concentrators,
and spends time with potential
maintenance champions at the
hospital.”
FRANKIE DORMON
M


edical Lead in Poole Africa


“We saw student nurses and
midwives trained in a lovely new
college, with excellent equipment
then going out to clinical areas
and experiencing little equipment
and what there is being of poor
quality or not working. This
is demotivating for staff and
unhelpful for patients. There are
sparse supplies of oxygen for
example and so nurses in the
special care baby unit have to
decide which babies get it and
which don’t.”
SANDRA PAICE
Juba link Isle of Wight, Nursing and
midwifery advisor


Coincidentally, the first cohort of the Rwandan BMET training in Kigali had the opportunity to spend a day with a representative of Zeiss,
training the technicians on the working principles and basic maintenance of microscopes. The students insisted on receiving a Certificate,
which was created, printed, and signed on the spot. The value of training is not only in increasing your knowledge, but also in having proof
of the trainings you’ve participated in.


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Assumptions
• Training is followed, assimilated,


practiced, and knowledge shared
• Governance & training of trainers is in


place
• There is a safety culture and personal


protection is available
• The hospital is clean and hygiene is


highly respected
• Patient Safety comes first, protocols


exist, are used and respected
• People will say when they need


training
• Errors are reported and followed up
• Equipment present is working
• Single use consumables are disposed


after use.
• The sterilisation service delivers clean


and sterile devices.


Mitigations
For more information on using and
maintaining equipment see the
Donations Toolkit Chapter 7, p70
• Plan for refresher training, Train the


trainer, BM
ET to remind heads of


departments to organise trainings.
Encourage briefings and debriefings
for exchange of knowledge


• Do safety checks eg: every 3 months,
train on awareness and safety
practices. Check personal protection is
available (e.g. gloves, face masks but
also radiation protection items like
aprons)


• Organise training on sterility and
hygiene. Check what products are
used to clean. Do not only focus on the
cleaning staff. Hygiene is a basic skill
for everyone working in a healthcare
setting.


• Introduce good practice protocols and
train the staff how to use them


• Encourage staff to identify their needs
with head of departments and other
leaders


• Create awareness around errors and
how we can learn from them. Avoid
guilt and blame culture. Introduce
anonymous reporting to be able to
track errors and create an investigation
structure


• Check if equipment is operational.
Bring or report malfunctioning
equipment to the BM


ET department.
Remove faulty equipment from the
workspace.


• Consider reusable consumables and
not single use. Verify the quality of the
sterilisation equipment


• Teach technicians or sterilisation staff
how to clean, disinfect and sterilise
devices, and to verify whether
autoclaves are working (measure
pressure and Temperature cycles)


Ziken’s Guide 4 describes all elements
of daily operation and safety of medical
equipment


For more information on logistics
see the Donations Toolkit Chapter


5 and 6, and Ziken’s Guide 3
accurately describes all elements of


Procurement and Commissioning


Protocols
M


edical guidelines or protocols are not
always common in developing countries.
Introducing best practices guidelines
in trainings and distributing them/
sticking them to wall helps staff to work
consistently. The WHO has developed
some useful tools as well, like the
surgical safety checklist.


PHASE 7: OPERATION & SAFETY
In Focus
Mariette Jungblut, an expert
of sterile medical devices from
the Netherlands, was teaching
about sterility and hygiene in a
South-African nursing college
when she came across cleaners
that disinfect the entire hospital
with chlorine. Chlorine is very
aggressive and not suitable to
clean medical equipment or
e.g. mattresses with. Hospital
mattresses are supposed to be
watertight, to prevent body fluids
to enter the foam, but by using
chlorine, the cover becomes
porous and the mattress far
from hygienic. Her advice: stick
to cleaning with soap and warm
water. Use chlorine only on floors,
walls or sanitary if it is soiled with
body fluid. Never use chlorine to
disinfect medical instruments,
because corrosion will destroy
your instruments. Good hygiene
is cleaning with soap and warm
water.


Assumptions
• The environment in which the


equipment is used is stable and known
(24h/24h).


• M
aintenance culture exists and is


respected by the technicians, users
and other staff


• Technical staff present, trained and
know how to maintain and repair the
equipment


• Technical staff respected
• Preventive maintenance (PM)


schedules exist and PM
is performed


regularly
• Technicians have access to an


equipped workshop
• Technicians have access to spare parts,


on stock in the hospital or ordered in
and spare parts are delivered within
24 hours if necessary


• Technicians have access to digital or
paper service and user manuals


• Technicians have access to and know
how to use test equipment to calibrate
and test medical equipment


• Users know how to use and take care
of the equipment


Mitigations
For more information see the Donations
Toolkit chapter 7; using and maintaining
the equipment p. 70
• Prepare for environmental challenges,


e.g. humidity, dust and heat
• In case of a lack of technical staff, see


if there is a way to create contractual
obligations to support maintenance


• Identify the technical staff, get an
idea of their skills and knowledge and
encourage/organise training


• Help technicians to
structure their ways of working and
spread these principles in the hospital


(e.g. users understand what to do with
broken equipment). Help to create
visibility and encourage technicians to
keep track of their work and successes,
to be able to report to the hospital
director. Consider inviting a UK BME to
your team to cover this work


• See if the technicians make
use of Planned Preventive Maintenance
Schedules and if not, create them
for your most crucial equipment.
Instructions can be found in the Service
manuals


• Check what space and
tools the technicians have to perform
maintenance and repair. In case of
insufficient infrastructure, it is worth the
effort to create an inventory, identify the
needs and write to the director/M


oH.
See the Donations Toolkit p.45 for more
information on sourcing biomedical
engineering tools and test equipment
• Check that supply chains for service


support exist. Access to spare parts
is one of the biggest challenges for
biomedical technicians in low-resource
settings. Estimate in advance spare
parts and consumables needs, and
discuss budget needs and supply chain


• Often Medical Equipment in
developing countries is donated
and manuals are not present.
Manufacturers are protective of their
manuals and these are normally not
easy to find online. See box below for
available resources


• Consider bringing a UK BM
E


with test equipment to check crucial
equipment for safety and quality
• Often equipment failure is caused by


user errors. Train the users to properly
operate the equipment but also to
take care of the equipment. Most of
the weekly preventive maintenance
can be performed by the users (e.g.
nurses can clean filters)


• Label all tools and test equipment
and inform management about them.
Nominate a person to be in charge of
them and have others to sign them out
and upon return so that equipment
are not easily lost


See Ziken’s Guide 5 for more information
on M


aintenance M
anagement of


M
edical Equipment.


PHASE 8: MAINTENANCE & REPAIRService manuals are often missing
in developing countries’ hospitals,
and it’s difficult to find manuals
online. However there are several
resources where we can find
manuals:
The manufacturer, the UK
trust biomedical workshop,
Frank’s Hospital Workshop
the INFRATECH mailing list and
manuals collected by the French
NGO Hum


atem.
Also see the Donations Toolkit
p. 44 “Getting the right service
manuals”


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Assumptions
• Disposal channels are available for


when equipment reaches the end of
its life


• When disposing equipment the
environment is considered


• There are clear regulations on waste
disposal


• Companies that buy old equipment
exist


• Decommissioning regulations exist,
e.g. erasing of patient data and
decontamination and the technicians
know how to do this


• When purchasing new equipment the
supplier may take responsibility for the
equipment that is being disposed


Mitigations
• Create awareness and share best


practices on disposal from the UK
• Awareness-raising, explain the


environmental impact
• Encourage hospitals to create disposal


routes and raise awareness on
Ministry level


• Teach technicians how to
decommission, e.g. decontaminate and
erase patient data
• Include disassembly and disposal


of equipment in the tender
specifications, consider if that is
acceptable for the owner (the
hospital/MoH might see a value
– auction to scrap buyers. Try to
convince that cleaning up is a more
suitable solution than keeping a
junkyard)


Assumptions
• Data is accessible and of adequate


quality to demonstrate progress,
understand successes and challenges


• Staff understand the importance of
data collection, management, and
analysis


• Staff are willing to undertake
monitoring and evaluation tasks


• Staff reflect on findings from the data
to review practices and implement
change where it’s needed


• There is resource to transform data
into information that can be used to
engage with stakeholders


• There is an appetite to engage with
stakeholders with findings from
institution data


• The institution fosters a culture of
learning


Mitigations:
• Include exploration and discussion of


data accessibility in the planning phase
of the project. Where data is missing,
establish a means to gather the data
or agree proxy measures.


• Gain consensus for data collection
tools, especially if introducing a new
tool and wherever possible, use
existing data collection systems/tools


• Decide on what data is actually
needed, and limit collection to that


• Include training on data collection,
management and analysis in the
project plan. Seek out individuals
willing to champion the importance of
data


• Plan for regular project meetings
that include data review and action
components


• Discuss who your stakeholders are,
what they want to know about the
project, and how best to provide them
with this information e.g. in a project
meeting, a report, a poster, etc


For more information on evaluation and
learning, see Section 7 of the Donation
Toolkit.
THET has tools and guidelines for
health partnerships to assist them with
monitoring and evaluation. See http://
www.thet.org/health-partnership-
scheme/resources for details.


PHASE 9: DECOMMISSIONING & DISPOSAL
MONITORING, EVALUATION & LEARNING


Make sure that monitoring and evaluation is on-going process by establishing the systems that you
will use to gather, manage and analyse data at the start of any project you undertake; do not leave
data collection to the end of the project.
Be clear from the outset what information you need and why so that you can plan your data collection systems accordingly with a
clear rationale for your monitoring activities and to keep your efforts focused.
Robust, well-thought out M&E processes will mean that the partnership can better understand what is working, what isn’t and
ways to address challenges that arise. The information that your M&E system yields will be: a tool for programme and partnership
development, data to back up advocacy activities, and to raise the awareness of your work with key stakeholders.


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REPORTING FOR BMEs
About the Author


In general, low- and middle-income countries struggle to procure, manage and maintain medical
equipment. This is due to many factors, not least the lack of training and education opportunities
for technicians and a lack of spare parts (and consumables). Part of the solution to these two
challenges is to collect data. When technicians can prove there is a work overload and a structural
lack of spare parts there is a chance that directors and Ministries of Health will become more
aware, and will create budgets/priority for solutions; solutions like training people and facilitating
access to spare parts.
The way to collect data is well described
in the 6 HTM guides we follow in this
resource. Some elements are creating,
updating and archiving an equipment
inventory and equipment history files,
which contain manuals, acceptance log
sheets, planned preventive maintenance
plans and work orders (to know the
number of breakdowns and fixes or
equally if it is not possible to fix due to
lack of spare parts, and to be able to
track the equipment through its lifetime.
An example of a work order can be found
in Ziken’s Guide 4 p208.
In general technicians do not like
paperwork and prefer to work with
tools and equipment. However, the
relevance of these types of documents
to technicians is that it gives them the
opportunity to create a monthly report,


which they can present to the hospital
director to give visibility to their work,
successes and struggles. In Rwanda,
working on the administration side of the
BMET job has proven very successful and
many cases of improvement of status
and success have been reported.


Additional resources:
Guide 1: How to Organize a System of
Healthcare Technology M


anagement
Guide 2: How to Plan and Budget for
Healthcare Technology
Guide 3: How to Procure and
Commission your Healthcare Technology


Guide 4: How to Operate your
Healthcare Technology Effectively and
Safely
Guide 5: How to Organize the
M


aintenance of your Healthcare
Technology
Guide 6: How to Manage the Finances
of your Healthcare Technology
M


anagement Team


http://resources.healthpartners-int.
co.uk/resource/how-to-manage-series-
for-healthcare-technology/
WHO resources http://www.who.int/
medical_devices/management_use/en/


Fram
ew


ork/structure
Organizing a network of


HTM
Teams (Guide 1)


Ensuring eĸciency
Financial M


anagement of HTM
Teams (Guide 6)


Chain of activities
in the equipm


ent
life cycle


Maintenance
management (Guide 5)


Daily operation and


safety (Guide 4)


Planning and


budgeting (Guide 2)
Procurement and


commissioning (Guide 3)


Anna Worm is a biomedical engineer focused on training and
equipment management in low- resource settings.
With an MSc in BioMedical Engineering from Delft University
of Technology (the Netherlands) Anna set up a BSc in BME
in Ghana at Valley View University (2007-2008), then joined
Philips Healthcare Interventional X-ray headquarters in the
Netherlands (2008-2011) before returning to Africa to become
Country Manager for Engineering World Health in Rwanda
(2011-2013), where she successfully ran a BMET diploma
programme. Since the end of 2013 Anna has worked as an
independent Biomedical Engineering Consultant for THET. Anna
Lives in Benin, West-Africa.


THET is also grateful to the following reviewers; Andrew
Gammie, Fishtail Consulting Ltd, Robert Ssetikoleko - part-time
lecturer at Makerere University, Kampala, Uganda, Billy Teninty,
Marc Myszkowski and Peter Cook - Clinical Engineer at Guy’s &
St Thomas’ Trust in London


This publication was funded through the Health Partnership
Scheme, which is funded by the UK.
Department for International Development (DFID) for the
benefit of the UK and partner country health sectors and is
managed by THET.
Any reproduction of any part of the Toolkit must acknowledge
THET’s copyright. Copyright@THET 2015


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