15

Medical Equipment Management

Table of Contents Page

Section 1 Introduction 15-1
Section 2 Operational Standards for Medical Equipment Management 15-2
Section 3 Implementation Guidance 15-3
3.1 Medical Equipment Management Unit 15-3
3.2 Medical Equipment Committee 15-3
3.3 Medical Equipment Maintenance Workshop 15-4
3.4 Medical Equipment Inventory 15-4
3.3.1 Equipment Risk Classification
3.3.2 Spare Parts Inventory
3.5 Equipment History File 15-9
3.6 Model Medical Equipment List 15-9
3.7 Medical Development/ Operational Plan 15-10
3.8 Procurement of Medical Equipment 15-11
3.9 Equipment Donation 15-11
3.10 Preparing for Equipment Delivery and Commissioning 15-12
3.11 Acceptance Testing and Installation 15-13
3.12 Standard Operating Procedures 15-14
3.13 Calibration Inspection, Testing and Maintenance 15-15
3.14 Disposal of Medical Equipment 15-19
3.15 Training in Equipment Use and Maintenance 15-19
3.16 Budgeting for Medical Equipment Management 15-21
3.17 Medical Equipment Incident Reporting 15-23
Section 4 Implementation Checklist and Indicators 15-23
4.1 Assessment tool for Operational Standards 15-23
4.2 Implementation Checklist 15-24
4.3 Indicators 15-24
Source Documents 15-26
Appendices
Appendix A Sample Inventory Data Collection Form
Appendix B Typical Equipment Lifespan
Appendix C Sample Medical Equipment Risk Assessment Form
Appendix D Sample Bin Record Card for Spare Parts
Appendix E Sample Stock Record Card for Spare Parts
Appendix F Common Site Preparation Steps for Installation of Medical Equipment
Appendix G Guidance for Unpacking and Inspecting Equipment Orders
Appendix H Sample Acceptance Test Log Sheet
Appendix I Sample Planned Preventive Maintenance Log Sheet
Appendix J Good Practice Checklist for Corrective Maintenance
Appendix K Sample Corrective Maintenance Report
Appendix L Sample Work Order Form
Appendix M Sample User Training Verification Form
Appendix N Principles behind Replacement Cost Calculation
Tables
Table 1 Sample Template for Equipment Development Plan
Table 2 Steps to Develop an Equipment Training Plan
Table 3 Medical Equipment Management Checklist
Table 4 Medical Equipment Management Indicators
Figures
Figure 1 The Medical Equipment Management Cycle
Figure 2 The Hidden Costs of Medical Equipment Management
Boxes
Box A Definition of Medical Equipment
Abbreviations
CEO Chief Executive Officer
EDP Equipment Development Plan
FAMU Fixed Asset Management Unit
FMOH Federal Ministry of Health
MEC Medical Equipment Committee
PPM Planned Preventive Maintenance
RHB Regional Health Bureau
SOP Standard Operating Procedure
TOR Terms of Reference

Section 1 Introduction
There is a recognition that health technology management, including medical equipment, is among areas included
in the Healthcare Sector Transformation plan (HSTP) for the next 5 years (2015/16-2019/20(2008-2012 EFY)).
Specific areas that require improvement in the coming years include the development of local innovative
healthcare technologies through technology transfer and increased local production capabilities. In Ethiopia, lack
of proper management of medical equipment has limited the capacity of health institutions to deliver adequate
health care. It is estimated that only 72% of medical equipment found in Addis Ababa public hospitals that are
functional and 50% in some regional hospitals.
The rising number of these non-functional equipment is due to Poor equipment handling and utilization, frequent
power surges, the age of the equipment, lack of operator training, lack of preventive maintenance, lack of spare
parts, lack of maintenance capacity, and minimal knowledge regarding sophisticated equipment, factors which also
contribute to equipment breakdown.
As healthcare delivery continues to expand and improve in Ethiopia, and an increasing number of sophisticated
medical equipment are being introduced, a system capable of supporting and managing these medical technologies
must be in place. It is very crucial to implement Medical Equipment Management operational standards in the
hospitals using its cycle which includes planning and assessment of needs, procurement, training, operation,
maintenance, decommissioning and disposal. Additionally, activities that ensure the successful management of
resources and patient related risks in a healthcare facility need to be implemented.
To improve medical equipment management in all public hospitals, the FMOH has introduced the previous
medical equipment management Guidelines and tried to implement these in some hospitals but the progress has
been slow. The previous chapter has now been revised into this new EHSTG MEM chapter in order to further
improve medical equipment management (MEM) in public hospitals across the country and to include components
of the HSTP agendas.
This chapter outlines procedures that a hospital should undertake to appropriately manage their medical
equipment, allowing for the extension of services while ensuring the safety of its patients.
Figure 1 The Medical Equipment Management Cycle

Source: Bird, Caroline, et al. ‘How to Manage’ Series for Healthcare Technology, Guide 1: How to Organize a
System of Healthcare Technology Management. Hertfordshire, UK: TALC, 2005.

Section 2 Operational Standards for Medical Equipment Management

1. The hospital has in-house Medical Equipment Management unit with an operational plan, required staff and led
by a biomedical personnel.
2. The Hospital has a Medical Equipment Management Committee composed of doctors, nurses, technicians,
pharmacists, and administrative personnel that oversees the medical equipment management programme.
3. The hospital has an appropriately equipped medical equipment maintenance workshop.
4. The Hospital has a paper-based and computer-based or automated inventory management system that tracks all
equipment and spare parts included in the equipment management programme.
5. An Equipment History File is maintained for all medical equipment, containing all key documents for the
equipment.
6. The hospital has policies and procedures in place for acquisition of new medical equipment, commissioning,
decommissioning and disposal of equipment, the receipt of donations, and outsourcing technical services for
medical equipment repair and maintenance.
7. All new equipment undergoes acceptance testing prior to its initial use to ensure the equipment is in good
operating condition, and are installed and commissioned in accordance with the manufacturer’s specifications.

8. All equipment operators and personnel are trained on proper operation, safety, and maintenance of medical
equipment with standard operating procedures readily available to the user.

9. There is a schedule for inspection, testing and preventive maintenance for each piece of equipment as guided by
the manufacturer’s recommendations and that schedule is appropriately implemented.

10. There is a notification and work order system for corrective maintenance and calibration of medical equipment
based on their level of risk.

Section 3 Implementation Guidance

3.1 Medical Equipment Management Unit
Each hospital should establish a medical equipment management unit that is appropriately staffed and led by
trained biomedical personnel including the following:
• The hospital should have a workshop which is equipped with the necessary testing, calibration, measuring
instruments, maintenance tools, computer, printers, reference books, operator and service manuals, and internet
access needed to carry out the overall medical equipment management services. The medical equipment
maintenance workshop should be separate from the general maintenance workshop.
• Establish and maintain the medical equipment inventory.
• Develop and maintain Equipment History Files for all equipment.
• Establish SOPs for equipment use, safety, PPM and troubleshooting procedures.
• Establish PPM schedules.
• Conduct repair of equipment or outsource to an appropriate body when necessary.
• Conduct acceptance testing and installation of new equipment.
• Provide staff in-service training on the correct and safe use of equipment and basic troubleshooting and
preventive maintenance measures.
• Track equipment inventory, service history, and work orders.
• The unit ensures the hospital allocates sufficient funds for regular and incident based maintenance budget,
including spare parts.
• The unit develops and maintains a written procedure describing the processes for managing risk, improving
safety and quality of technologies.
• The unit establishes automated and centralized documentation system that tracks all equipment and spare parts
for planning, budgeting, requisition, reporting and other purposes.
• The unit participates on equipment planning, purchase, installation, maintenance, troubleshooting, and technical
support.
• The unit works towards national and international service accreditations.

The number and skill mix of staff within the medical equipment maintenance unit will depend on the size of the
hospital. Larger hospitals should employ skilled biomedical technicians who are able to undertake corrective
maintenance on both small and larger, more complex equipment. However for smaller hospitals it may be more
cost effective for the equipment maintenance department to perform simple preventive and corrective maintenance
only, and solicit support from the next high level hospital Medical equipment Management unit through the
established referral system for sophisticated and more complex equipment or outsource larger and more complex
maintenance work to an external company.
A well-balanced mix of in-house and external service providers is technically and financially sound, particularly in
settings with limited resources. Even the smallest biomedical maintenance departments should oversee the
condition and operation of all medical equipment, be the contact point for all equipment and maintenance matters,
be responsible for finding the correct solution (calling in technical support from external service providers) and
possibly undertake PPM and repair themselves (if properly trained).
The Head of Medical Equipment management unit should be a member of the hospital senior management team,
participates in the overall hospital planning and performance evaluation, and conducts weekly work-planning
meetings of the medical equipment management unit to assess, prioritize and assign outstanding jobs based on the
Work Order File.
The Medical Equipment Maintenance staff should have a workshop in which to carry out maintenance and repair
activities. Workshops provide the workspace for maintenance and repair procedures, serve as security and storage
areas for tools and supplies, and equipment-related reference materials. Depending on the size of the hospital and
the number of maintenance staff available, hospitals may have a single Maintenance Workshop for the
maintenance of all facility assets (buildings, plumbing, sewage, medical and non-medical equipment), or there
should be a designated Medical Equipment Maintenance Workshop that is separate from the General Maintenance
Workshop.
If a single workshop is used then the area for medical equipment repair must be sectioned off from the rest of the
workshop and must be kept clean and free from dust.
3.2 Medical Equipment Committee
Each hospital should establish a Medical Equipment Committee (MEC) that advices the management of medical
equipment in the facility.
The MEC should be composed of hospital a medical director and presentative of nurses, pharmacists, laboratory,
administrative personnel and biomedical personnel. The MEC is chaired by the medical director of the hospital
and the head of medical equipment management unit should be the secretary. Depending on the equipment being
discussed by the MEC, specialists from the associated department/case team may also participate on an ad hoc
basis. The selection of members of the MEC should be a clear and transparent process. The Committee should
establish Terms of Reference (TOR) that clearly outline the roles and responsibilities of the committee members
and should meet on a regular basis as defined in the TOR and as-needed in emergency situations.
The MEC is responsible to:
a) Oversee establishment of a medical equipment inventory
b) Develop a model medical equipment list
c) Monitor the implementation of policies, standards and guidelines for:
i. procurement of medical equipment
ii. donation of medical equipment
iii. acceptance testing and installation of medical equipment
iv. maintenance of medical equipment, including a list of external suppliers of maintenance services
v. disposal of medical equipment
vi. training of hospital staff on applications and maintenance of medical equipment
d) Review incident reports related to medical equipment

3.3 Medical Equipment Maintenance Workshop

Medical Equipment Maintenance workshop
Each hospital should establish a medical equipment maintenance workshop as per minimum standards for
workshop layout (Appendix M) and includes the following:
a) Automated documentation of the medical equipment inventory
b) Equipment History Files for all equipment
c) SOPs for equipment use, safety, PPM and troubleshooting procedures
d) PPM schedules
e) Necessary tools for repair of equipment when necessary
f) Space for acceptance testing and installation of new equipment
g) Provide staff in-service training on the correct and safe use of equipment and basic troubleshooting and
preventive maintenance measures
h) Track equipment inventory, service history, and work orders

Maintenance workshop including space for:

• Administration offices
• Electrical/Electronic Work Area
• Biomechanical Work Area
• Test and Measurement Store
• Tools, Spare parts, and Personal Protective Devices Store
• Staff Training Room

3.4 Medical Equipment Inventory

An inventory is a list of types of equipment with useful information for each piece of equipment available in the
hospital. A useful inventory tells you:
• What you own (type/sorts)
• How much of it there is (quantity)
• Where it is (location)
• What condition it is in (status)
• How far it is in its lifecycle (age/expected life)

Data included in Hospital medical equipment inventory are:

• Inventory identification number
• Type of equipment/item
• Brief description of item
• Manufacturer
• Model/part number
• Serial number
• Physical location within facility
• Condition/operating status
• Power requirements
• Operation/service requirements
• Date inventory updated
• Maintenance service provider
• Purchase supplier
• Year of Manufacturing and purchased
• Equipment risk classification
• Estimated life span
• Availability of trained user and technicians
• Other info as needed

Before establishing a medical equipment inventory the MEC should determine which items should and should not
be included in the inventory and medical equipment management program. This should be based on the definition
of medical equipment that is presented in Box A. However, the MEC may decide to exclude smaller, less
expensive and easily replaceable items from the medical equipment inventory and program (for example
sphygmomanometers, stethoscopes, etc) since the effort required to record, maintain and repair these smaller items
may not be worth the required manpower and financial resources. The Medical Equipment Strategy should give a
clear definition of medical equipment that should be included in the medical equipment inventory and program,
and should also state exclusion criteria for items that should not be included.
 Box A Definition of Medical Equipment
Medical equipment can be defined as “any instrument, apparatus, implement, machine, appliance, implant, in
vitro reagent or calibrator, software, material or other similar or related article that is used for:
• Diagnosis, prevention, monitoring, treatment or alleviation of disease or injury,
• Investigation, replacement, modification, or support of the anatomy or of a physiological process,
• Supporting or sustaining life,
• Control of conception,
• Disinfection of medical devices,
• Providing information for medical or diagnostic purposes by means of in vitro examination of specimens
derived from the human body, and which does not achieve its primary intended action in or on the human body
by pharmacological, immunological or metabolic means.”

Source: GHTF/SG1/N29R16:2005, Global Harmonization Task Force, 2005.

Each hospital should establish an inventory of all medical equipment (following the inclusion and exclusion
criteria described in the Medical Equipment guidelines. A small team should be established to set up the initial
inventory of medical equipment. The team should be led by the Head of Medical Equipment management who is
ultimately responsible to establish and maintain the equipment inventory. Additional equipment maintenance
personnel or other staff assigned by hospital management should also form part of the inventory team.
Additionally, one or more department/case team representatives should participate in the inventory of their
respective department/case team.
The inventory team is responsible to visit every department and record every item of medical equipment. A sample
Inventory Data Collection Form is presented in Appendix A.
Items that are obsolete, that cannot be repaired or that are not of use to the hospital should be removed and
transferred to a storage area at the time of the inventory and the formal disposal process should be started. An
inventory code number should be assigned to each piece of equipment. This can be done sequentially from number
1 upwards. Each new item is assigned the next number, with no regard to type of equipment, location etc.
Alternatively, a ‘speaking numbers’ inventory system can be used.
This system indicates the location, the type of equipment and the individual number of the equipment. With a
‘speaking number’ system each room/department in the hospital is assigned a location code and each type of
equipment is assigned an equipment type code – for example “T1 99 02” where T1 is Theatre number 1 in the
operating suite, 99 indicates the item is suction pump and 02 is the individual number of machine.
Although the ‘speaking numbers’ inventory system is more complex to establish, it has the advantage that it is
easy to identify the location of each item and to organize the equipment inventory by each department.
An inventory database should be established to record and manage all items of equipment. This can be paper based
or computerized, with paper back up. The following should be documented in the Inventory for each item of
equipment:
• Description or type of the equipment
• Location of equipment (department/section/room)
• Inventory code number
• Name of manufacturer
• Model name and/or number
• Manufacturer’s serial number
• Year manufactured or purchased
• Equipment risk classification
• Estimated total equipment lifespan*
• Current status/condition

*Knowledge of the estimated lifespan of equipment is useful for planning and budgeting purposes. The estimated
lifespan of common hospital equipment items is presented in Appendix B.
Information gathered as part of the inventory of medical equipment should be included in the overall fixed asset
inventory of the hospital. Further guidance on the fixed asset inventory process is provided in Chapter 18 Health
Financing and Asset Management.
The inventory should be reviewed and checked annually, with regular updates during the year when new
equipment arrives or is removed from service. Additional inventory checks may be conducted at regular time
intervals throughout the year, as determined by the MEC and hospital management.
When an item is discarded it should be removed from the Inventory Database. A record should be kept in a
separate file of all discarded equipment for future reference and audit purposes.
All equipment should be labelled with its inventory number preferably using a water proof PVC sticker.
Hospital policy should prohibit use of medical equipment without inventory tags/stickers. This is to ensure that all
equipment in use has undergone ‘acceptance testing’ and receives regular preventive maintenance, hence
minimizing risks to patients and staff from faulty equipment.

3.4.1 Equipment Risk Classification

As part of establishing an inventory an assessment should be undertaken to classify each item of equipment as
‘high’, ‘medium’ or ‘low’ risk. This level of risk determines the priority with which equipment should be repaired
and maintained or replaced if no longer operable. For example if a ‘high risk’ item (such as an anaesthesia
machine) is broken this should generally be repaired before a ‘low risk’ item even if the ‘low risk’ item has been
broken for longer, except under special circumstances.
Additionally, when implementing the guidance in this chapter (such as developing standard operating procedures
(SOPs), setting maintenance schedules, training staff in equipment use etc) the ‘high risk’ items should be dealt
with first.
The assessment of risk should be based on:
 Function of the equipment: For example whether the equipment is used for life support, routine treatment,
and diagnosis or monitoring
 Risk associated with equipment failure
 Preventive maintenance requirements: The frequency with which preventive maintenance is required to
minimize breakdown and ensure safety
 Main area of equipment use: For example use in anesthesia or surgical areas, use in general care areas etc.
 Likelihood of equipment failure: This is measured as the ‘mean time between failures’ calculated from
previous use or service records

Appendix C presents a Sample Medical Equipment Risk Assessment Form for assigning the risk category to
medical equipment.
A Medical Equipment Risk Assessment Form should be completed for all items in the equipment inventory. The
risk category should be entered on the Inventory Index Card, and the Risk Assessment Form should be filed in the
Equipment History File (see Section 3.4 below). Any new item of equipment should be assigned a ‘risk category’
when it is received by the hospital and entered into the inventory.

3.3.2 Spare Parts Inventory

The equipment maintenance department should maintain a stock of the most commonly replaceable spare parts for
the different types of equipment in the hospital. Items should be kept in a locked room with a stock control system
in place. Spare parts should be stored according to manufacturer’s instructions and should not be used beyond the
expiration date.
The inventory of spare parts should be managed using a ‘stock and bin card’ system.
Bin Card:
A Bin Card should be prepared for each spare part stored in the maintenance department. The Bin Card should be
kept with the product inside the store. All transactions of the product to or from the store should be recorded on the
Bin Card. The Bin Card should also include a column for the loss/adjustment of stock and a column for the stock
balance. The stock balance should be updated after each and every transaction or adjustment.
Stock Card:
The Stock Card is similar to the Bin Card but is used to track stock based on issuing and receiving orders. The
Stock Card should be maintained by the Head of the Maintenance Department. Whenever Stock Cards are updated
the totals should be checked against those on the Bin Card and any discrepancies should be investigated.
A combined Bin/Stock Card System provides a measure of internal control that helps to minimize leakages of
stock due to theft or loss.
Paper based or electronic Stock Cards can be used. If an electronic system is installed there should be regular back
up of data.
Sample Bin and Stock Record Cards are presented in Appendices D and E.

3.5 Equipment History File

An individual file/folder should be established for each item of equipment. This file should be held in the
equipment maintenance department. The file should contain:
• Inventory Data Collection Form (Appendix A)
• The address of the manufacturer
• The address of the supplier and local agents
• Details of any maintenance contract and maintenance contractor (if relevant)
• Copy of warranty (if relevant)
• Price paid/Copy of invoice
• List of consumables required to run machine and recommended spare parts
• Acceptance test log sheet (Appendix H)
• Medical Equipment Risk Assessment Form (Appendix C)
• SOPs for operation and maintenance of the item
• Planned preventive maintenance schedule
• Corrective maintenance reports (Appendix K)
Operator, service and other relevant manuals for all equipment items should be stored in the workshop library.
Copies should be made and distributed to users and other interested parties as necessary.
3.6 Model Medical Equipment List
Each hospital should establish a model medical equipment list that describes the ‘ideal’ number and types of
equipment required by the hospital. A multi-disciplinary team brought together from across all the
departments/case teams should develop an outline of the Essential Service Package for the hospital that describes
the core functions and services provided. This Essential Service Package will determine the corresponding Model
Equipment List of all items that are necessary to provide each service. Each discipline will decide the type of
equipment required to provide the healthcare interventions described in the Essential Service Package. National
standards for medical equipment for each type of service or hospital (Primary, General and Specialized), where
these exist, should be the minimum requirements of the Model Equipment List, but these may be expanded upon
as determined by the multi-disciplinary team.
The Model Medical Equipment List should be approved by the MEC.

3.7 Medical Development/Operational Plan

The medical equipment management development/ operation plan should be prepared to define goals for
acquisition, maintenance, and replacement of equipment in the short term and long term. The equipment
management plan should be developed taking into consideration the current equipment inventory and the ‘model
equipment list’.
The medical equipment development/operational plan(ED/OP) brings attention to:
• Current stock and condition of equipment: which pieces need to be replaced or rehabilitated, which pieces need
to be disposed
• Shortfalls in equipment: missing equipment that needs to be purchased
• What action is needed to rehabilitate, replace or purchase equipment?
• Short-term (1 year) and long-term (2-5 year) goals to ensure that the hospital has all necessary equipment for
current and future services
The ED/OP should be developed by the MEU and approved by hospital management. The plan is the basis for the
annual equipment budget .The Head of Equipment Maintenance is responsible to implement the plan, with the
assistance of other departments where relevant (for example administration and finance). He/she should present
quarterly reports to the MEC on the status of implementation of the plan.
The plan should be updated annually. A sample template for an EDP is presented in Table 1 below.

Table 1 Sample Template for Equipment Acquisition Plan

3.8 Procurement of Medical Equipment
The acquisition/procurement of medical equipment should be undertaken in accordance with the MOFED/BOFAD
directives. A hospital may secure medical equipment through one of the following means:
1. Purchasing
2. Donation
3. Leasing and Renting 15-11
4. Cluster based equipment sharing
5. Innovation, refurbished, local production and technology transfer
In Medical equipment procurement/purchasing process the following necessary steps should be considered:
• Need assessments and Justifications,
• Planning and Budgeting
• Technology Assessment and Selection
• Cost of ownership (maintenance, spare parts, consumables, etc.)
• After sale services
• Human resource
• Procurement
When purchasing new equipment enough spare parts and accessories to last at least 2 years should also be
purchased.
Further guidance on the procurement process and development of a procurement policy is presented in Health
Financing and Asset Management Chapter.

3.9 Equipment Donation

The MEU should strictly follow national guidelines (National Donation Directive posted on FMHACA website)
for the receipt of donated medical equipment. The directive describes the conditions under which a donated item
will be accepted by the hospital. For example:
• Donated equipment must be in good working order
• Equipment will only be accepted if the item is needed by the hospital and is described in the Model
Equipment List and associated annual Equipment management Plan
• Instruction manuals, in English, should be supplied with the donation
• Supplies, consumables and spare parts for the equipment should be readily available in Ethiopia. If that is
not possible, at least 1 to 2 years of needed consumables and spare parts should be supplied by the donor
with the donated equipment
• Expertise for the maintenance and repair of the equipment should be available in Ethiopia
• The equipment must be compatible with other medical equipment in the hospital
• The equipment must not require any special storage or operating conditions that the hospital cannot provide
(for example air conditioning, humidity control etc)
• The donor should provide training in the regular use and preventive maintenance of the equipment, if
relevant, and
• The donor should provide follow up support regarding use of the equipment, where necessary
When items are donated the hospital and donor must agree who is responsible for customs clearance, including
approval of the item by the regulatory authority if necessary.
The MEU should establish a list of desired equipment that is based on the Model Equipment List and associated
Equipment annual Plan. The list of desired items and donation policy should be given to all
individuals/organizations that are willing to make a donation to the hospital.
All equipment donations should be reviewed the unit by and approved by the MEC before acceptance.

3.10 Preparing for Equipment Delivery and Commissioning

When an order has been placed to purchase a new item of equipment, or a donation has been accepted,
preparations must be made for receipt of the item. This is to ensure quick and efficient installation, commissioning,
training, and eventually placement into service. Pre-installation work involves the following:
A) Site Preparation
Site preparation is often required to ensure that the location where the new equipment is to be installed is suitable.
This may require new connections for electricity, water, drainage, gas or waste and may even require construction
work.
Preliminary considerations to think about include:
• Is there sufficient access to the room/space (door entry sizes, elevator capacity)?
• Is the room/space large enough?
• Is the position and layout of the room/space suitable?
• Are the required work surfaces and service supply points available?
• Is the environment adequate for the purpose? (Is it dust-free? Away from running water? Air conditioned,
if necessary?)
• Site preparation tasks may include:
• Disposing of the existing item that is to be replaced
• Extending pipelines and supply connections to the site
• Upgrading the type of supply, such as increasing voltage or pipeline diameters
• Providing new surfaces, such as laying concrete or providing new worktops
• Creating the correct installation site, such as digging trenches, building a transformer house or a
compressor building
Appendix F presents a list of Common Site Preparation Steps to follow when preparing a site to receive a new
piece of equipment.
B) Organizing Lifting Equipment
Large or heavy items will need to be lifted and moved upon arrival. Plans should be made ahead of time to arrange
proper lifting/moving equipment before the new equipment arrives.
C) Organizing Warehouse Space
If goods need to be stored before they can be unpacked or installed, space should be made available for these items
before they arrive.
D) Preparation for acceptance testing and installation
Any preparations that need to be made for acceptance testing and installation, including ensuring that appropriately
trained personnel to do the testing are available, gathering or acquiring materials, working/storage space and/or
test instruments should be done before the item arrives.
E) Preparation for User Training
The details of training should already have been decided when drawing up the purchase contract or donation
acceptance document. During delivery time, any preparations that need to be made (including preparation of
training materials, training space, equipment, etc.) should be finalized in order to ensure training can commence
when the equipment is delivered.

3.11 Acceptance Testing and Installation

All medical equipment, purchased or donated, should be inspected upon delivery and tested prior to initial use.
This is known as acceptance testing and ensures that delivered medical equipment is complete, undamaged, in
good operating condition, accompanied by manuals and spare parts, satisfies safety criteria, and meets
specifications of the purchase order. A competent individual must assess the functionality of the equipment to
prevent any harm to the operator or patient upon use. Guidance for unpacking and inspecting equipment is
presented in Appendix G.
The main steps in the Acceptance Testing process are described below:
1) Determine what personnel should be involved by asking the following:
• How complex is the equipment? The more complex the device, the more likely the manufacturer will need to be
involved.
• Do the hospital staffs have the necessary technical skills? If the staff cannot perform the job, then an outside
vendor should be contracted.
• Are you buying a single item or in bulk? If purchasing in bulk, it is often worthwhile to contract the manufacturer
to perform this process on all the equipment. For a single unit, the in-house staff may be able to manage with
guidance from the manufacturer.
2) Isolate the equipment until it has undergone acceptance testing
Once equipment arrives, set it aside by isolating the equipment in a special holding area and by labelling it as “not
for use” to ensure that the equipment will not be used. The only exception is for large items that may be delivered
to where they will be installed but should still be clearly marked as “not for use” until the acceptance process is
completed.
3) Undertake acceptance testing and complete Acceptance Test Log Sheet (see Appendix H)

Acceptance testing should include:

 • A check that the delivered equipment matches the details of the purchasing order (model, vendor, quantity,
technical requirements, etc)
• A check that the equipment is accompanied by operation and service manuals and necessary paperwork
(e.g. warranty, if applicable)
• A check that appropriate spare parts and consumables are included (if applicable)
• Assembly of the equipment if necessary
• Installation and commissioning of the equipment. Installation is the process of fixing the equipment into
place. Depending on the complexity of the equipment, this can range from simply plugging the equipment
into an electrical socket to building it into the fabric of the room. Commissioning is performing a series of
tests and adjustments that will check whether the new equipment is functioning correctly and safely, and
ensuring that any adjustments are made, before the equipment is accepted. 15-14
4) Accept the equipment and Establish Equipment History File
If the equipment passes the safety, calibration and function tests then the hospital can officially accept the
equipment. An Acceptance Test Log Sheet (Appendix H) should be completed and signed and filed in the
Equipment History File.
5) Enter equipment into the equipment inventory
After the item has undergone acceptance testing it should be entered into the hospital inventory. The assigned
inventory number should be marked onto the item of equipment.
6) Prepare Standards Operating Procedures and assign Planned Preventive Maintenance Schedule (see sections
3.11 and 3.12 below)
7) Provide training for equipment users and maintainers as appropriate.
This will ideally occur immediately but sometimes, due to availability of trainers (in-house, vendor, other),
training may occur at a later date. In this case the MEU will have to decide if it is safe to hand over the equipment
before training the staff. Placing the equipment into operation without training should only be done when the
equipment type has been used before and the staffs are familiar with proper operation. Installation and
commissioning should be carried out in the presence of the user as well as engineering support team.
Demonstration of the device indicating all its functions should be carried out to the satisfaction of the user and
biomedical engineering team. Training on operation and maintenance should be included in specifications
indicating the type, duration, location (on-site/off-site, local/overseas), target personnel i.e. doctors, nurses,
maintenance personnel, since differing types and levels of training needs to be provided for each staff category.
User training should be provided by an application specialist, especially training for sophisticated or complex
devices.
8) Handover equipment to appropriate department/users.
9) Make final payment for item
Final payment should be made after the item has undergone acceptance testing and all agreed services (e.g.
installation or training) have been provided.
Payment should be withheld if the equipment does not pass the acceptance test or the services provided are
unsatisfactory. In such circumstances the MEU must work with the supplier to rectify the situation as quickly as
possible.

3.12 Standard Operating Procedures

To ensure that equipment is used correctly and safely Standard Operating Procedures (SOPs) should be developed
and attached to each item of equipment. The SOP should be a simple ‘how-to’ guide that describes how to use the
equipment, instructions for care of the equipment, and basic safety and troubleshooting procedures. The SOP
should be based on the manufacturer’s user manual (if available). SOPs should be kept attached or adjacent to the
item and a copy should be included in the Equipment History File that is stored in the Medical Equipment
Maintenance Department.
All staff, including maintenance technicians, should be trained to follow the SOPs and should follow infection
prevention procedures when handling medical equipment. (For further guidance on infection prevention see
Infection Prevention and Patient Safety Chapter).
3.13 Calibration Inspection, Testing and Maintenance
Medical devices are assets that directly affect human lives and it is important to have a well-planned and managed
maintenance programme to ensure medical equipment are reliable, safe and available for use when it is needed for
diagnostic procedures, therapy, treatments and monitoring of patients. In addition, such activities prolong the
useful life of the equipment and minimize the repair related cost of equipment.
• Disinfection and sterilization of equipment and tools is required.
• Incident report is performed
• There is a schedule for regular inspection, testing and preventive maintenance for each piece of equipment as per
the manufacturer's service manual.
• Corrective maintenance is performed whenever medical equipment breaks down.
• There is a schedule for calibration of medical equipment (for high risk equipment) as per the manufacturer's
service manual.
A) Planned Preventative Maintenance
All medical equipment should be inspected and tested prior to use (acceptance testing) and thereafter should
undergo regular planned preventative maintenance (PPM) to ensure that the equipment is working properly and to
prolong its expected lifetime. Safety and calibration testing should also be performed regularly to ensure the
equipment is safe to use and is operating within expected specifications (or to adjust if it is not).
Preventing equipment failure is more efficient than repairing equipment after breakdown occurs. PPM should be
carried out by both equipment users (for simple, easy, everyday tasks) as well as biomedical technicians from the
maintenance department (for more complex tasks requiring special skills and/or tools). For some equipment PPM
should only be carried out by certified service engineers.
SOPs for each item of equipment should include instructions on simple PPM and troubleshooting that can be
performed by users of the item.
For each item of equipment there should be a plan for preventive maintenance, safety and calibration testing that is
documented and at a minimum follows manufacturer’s recommendations. If the manufacturer’s manual is not
available then inspection, testing and preventive maintenance should be conducted at a minimum every six
months.
The preventive maintenance plan should include:
• A description of and guidelines for the tasks to be conducted including:
 Care and cleaning
 Safety procedures
 Functional and performance checks
 Calibration testing
 Preventive maintenance checks
• A statement on who is expected to perform each of the above tasks
• The frequency with which each of the tasks should be conducted
For each item of equipment a timetable/schedule for each of the tasks above should be established together with a
log file to document all maintenance activities. The maintenance plan and schedule should be developed
collaboratively between the Medical Equipment Maintenance Department and the Head of the Department/Case
Team where the item is located. The maintenance plan, schedule and log sheet should be attached or kept adjacent
to the equipment item. A copy of the plan and schedule should be kept in the Equipment History File that is held in
the Equipment Maintenance Department.
A sample Preventive Maintenance Log Sheet is presented in Appendix I.
The Head of the Equipment Maintenance Department should establish a system to check all Maintenance Log
Sheets to ensure that all PPM tasks are conducted in accordance with the schedule for each item of equipment, and
should address any instances where PPM is not conducted in accordance with the schedule.
B) Calibration
Some medical equipment, particularly those with therapeutic energy output (e.g. defibrillators, electrosurgical
units, physical therapy stimulators, etc.), needs to be calibrated periodically. This means that energy levels are to
be measured and if there is a discrepancy from the indicated levels, adjustments must be made until the device
functions within specifications. Devices that take measurements (e.g. electrocardiographs, laboratory equipment,
patient scales, pulmonary function analyzers, etc.) also require periodic calibration.
C) Safety inspections
These are performed to ensure the device is electrically and biomechanically safe. These inspections may also
include checks for radiation safety or dangerous gas or chemical pollutants. When these inspections are done, the
results are compared to country or regional standards as well as to the manufacturer’s specifications. The
frequency of safety inspections may be different than planned
Maintenance and performance inspections, and are usually based on regulatory requirements periodic calibration
to ensure accuracy compared to known standards.
D) Corrective Maintenance
Corrective maintenance involves equipment repair and replacement of parts. Instrument operators can follow SOPs
to perform simple corrective maintenance such as replacing blown out fuses or simple troubleshooting. However,
most corrective maintenance must be performed by a qualified technician. A ‘Good Practice Checklist’ for
corrective maintenance technicians is presented in Appendix J.
Whenever corrective maintenance is performed a Corrective Maintenance Report should be completed and stored
in the Equipment History File. A sample Corrective Maintenance Report is presented in Appendix K.
NB: Only engineers that are certified by the supplier can perform corrective maintenance on instruments still under
warranty.
If a large piece of equipment requires major rehabilitation an assessment should be done to determine whether it is
worthwhile repairing the item or whether it would be better to purchase a new one. Generally, if purchasing
separately all the parts that make up a piece of equipment it would cost 3-4 times the price of the equipment.
Rehabilitation may be cheaper in the short term, but if this only adds a short additional lifespan to the item or if it
is continually necessary to replace different parts, then it may be more cost effective to purchase a new item.

E) Work Orders and Reports

Whenever an item of equipment is faulty this should be reported immediately to the medical equipment
maintenance department using a Service Request/Work Order Form. Requests for maintenance to be undertaken
by technicians should also be documented on a Work Order Form. In urgent cases the request for repair can be
made by a telephone call or other verbal means of reporting, however this must always be backed up with a written
request on the Work Order Form. A sample Work Order Form is presented in Appendix L.
Three copies of the Work Order Form should be prepared (using carbon copy paper):
• The first copy should be kept by the user department and filed in a ‘Maintenance Pending File’. This file is best
organized by date submitted, with the most recent request at the top. The ‘Maintenance Pending File’ should be
checked regularly by the Head of Department/Case Team to ensure that Work Orders are being carried out in a
timely manner. When the work is completed and the item is returned to service the Work Order Form should be
signed by the user (Department/Case Team Head or representative) and the Work Order Form should be
transferred to a ‘Maintenance Completed File’.
The second two copies of the Work Order Form should be submitted to the Equipment Maintenance Department
together with the broken item (if it is feasible to move the item). Whenever a Work Order is received by the
Equipment Maintenance Department this should be reviewed by the Department Head and the duty should be
assigned to the appropriate individual (or outside service provider). The name of the person who is assigned to
undertake the repair should be written on both copies of the Work Order Form. In the event that several items
required repair at the same time then ‘High priority’ equipment should be repaired before ‘Medium’ or ‘Low
Priority’ equipment.
• Within the Equipment Maintenance Department one copy of the Work Order should be entered into a ‘Work
Order Pending’ File held by the Head of Equipment Maintenance. This file is best organized by date submitted,
with the most recent request at the top. When the work is completed the Work Order should be transferred to a
‘Work Order Completed’ File and kept as a permanent record of the work undertaken.
• The final copy of the Work Order Form should be given to the responsible medical equipment technician who is
assigned to undertake the repair. Upon completion of the task the final section of the Work Order Form and a
Corrective Maintenance Log should be completed. The item should be returned to the user. The completed Work
Order Form and Corrective Maintenance Log should be filed together in the Equipment History File.
F) Outsourcing of Technical Services
When the equipment maintenance department is unable to perform PPM or corrective maintenance of a particular
item of equipment, support from external maintenance contractors will be required. Work may be outsourced to
the National Scientific Equipment Centre, the manufacturer’s local agent, the manufacturer, private maintenance
companies, individuals such as electricians or plumbers or the Ethiopian Health and Nutrition Research Institute
for laboratory equipment. The Ethiopian Biomedical and Laboratory Equipment Engineers Association could be a
good source for finding qualified individuals or companies. Support may also be provided by the relevant Regional
Health Bureau.
When making the decision to outsource a service, the hospital must consider the task at hand and the qualifications
needed to perform the task. In order to do this, the Medical Equipment Committee should register all potential
individuals and companies that they would consider as a supplier of maintenance services. The MEC should
prepare a list of requirements that each company should meet in order to be 15-18
contracted by the hospital and a team of suitable staff chosen to visit these registered suppliers when possible to
ensure that the suppliers meets the requirements and are qualified to provide the services they offer.
Once the appropriate companies or individuals have been identified and registered, the MEC should determine the
type of arrangement they would like to have with the particular organization. The arrangement used depends on
the sophistication of the equipment and the number of maintenance options available. The most common
arrangements encountered are:
1. Agents’ Maintenance Contracts – typically for sophisticated equipment that is covered by a warranty for a
certain period of time. The contract would be for service post-warranty and negotiated at the time of equipment
purchase.
2. Annual Contracts – for particular types or groups of equipment that can be maintained by an external company
for a period of one year. A formal tendering process should take place to select the best company to provide these
services.
3. Annual Standby Registration – these companies or individuals can be called upon as needed to provide
maintenance services for certain equipment although they must submit tenders at the time a job becomes available
4. One-off Jobs – in this case, the expertise needed may not be on the registered list and the MEC must look for
individuals or companies that might be able to undertake this one-time only task.
Having such arrangements allows the hospital to gain from the benefits of bulk purchasing (e.g. one company can
cover many different maintenance jobs), gain from the benefit of fixed period contracts; ensure that appropriate
contractors are chosen and that the quality of work is high. Therefore, when a repair requiring external support
becomes necessary, the Head of the Equipment Maintenance Department can refer to the registered list of
companies and/or contracts to outsource the work.
The MEU should follow national guidelines for the use of outside contractors including:
• Staff from the maintenance department must accompany outside consultants at all times
• Contractor must provide feedback on progress of job
• Contractor must sign-out after each service visit
• Contractor will provide a report at the completion of the service to be placed in the equipment file
Hospitals may also collaborate together to enter joint service contracts in order to minimize costs and benefit from
bulk purchasing.

3.14 Disposal of Medical Equipment

The hospital should establish Medical Equipment Disposal Committee to oversee the disposal of all medical
equipment that are no longer required by the hospital, including medical equipment. Items may be disposed when
they are no longer required by the hospital, cannot be repaired, or have reached the end of their useful lifespan (see
Appendix B). A policy for the disposal of fixed assets should be established by the hospital and approved by
hospital management.
Whenever an item of medical equipment is disposed it should be removed from the hospital inventory and a record
should be entered into the Equipment History File to indicate that the item has been disposed. The Equipment
History File should then be moved to a separate storage location for ‘inactive’ equipment items.
Further guidance on the disposal of hospital assets, including medical equipment is presented in Health Financing
and Asset Management Chapter.

3.15 Training in equipment use and maintenance

Proper use of medical equipment is essential to maintain optimal performance of medical devices and preserve the
safety of patients as well as the staff operating the devices. Given the variation in technical characteristics of
medical equipment, all clinical staff should be trained to operate each medical device that they use. The MEC is
responsible for overseeing all user training for medical devices, whether in-service or conducted by
suppliers/external parties.
Training should be conducted at various times throughout a staff member’s career:
• Induction training – when staff are newly placed in post, move to a new department or facility, or to a new
location with different responsibilities
• Training at the commissioning of equipment – when new equipment first arrives
• Refresher training – to update and renew skills throughout the working life of staff
Building the capacity of biomedical engineers, technologists, and technicians is always one of the major activities
of the Biomedical Engineering Directorate. This can realized through regular short-term training programs,
Supplier Company’s training, and formal credit programs in higher education institutions, local and abroad. All
such training programs are accompanied by certifications.
The hospital plans annually at least one-week long in-house refresher training program for its staffs. Participation
in such refresher programs is mandatory and is part of the annual performance evaluation.
User training should cover:
• Equipment capabilities
 Purpose and capabilities of device
 Awareness of different models and operational differences
 Awareness of the expected life of medical device and need for replacement
 Knowledge of where/how to access user manuals and receive equipment updates
• Operating procedures
 How to assemble the device and connect accessories
 How to operate the device effectively and safely
• How to link device to patient safely, causing minimal discomfort to patient
 How to set/change controls
• Protocol for equipment failure
 How to recognize malfunction (or correct if possible)
 Who to contact to report damage and adverse incidents and to do so promptly
• Emergency and safety procedures
 How to safely shut down/dissemble
 How to clean/decontaminate device and maintain equipment in good operating condition
 Basic safety protocol:
• Always visually inspect equipment before each use. Check for signs of damage or incorrect settings. Make sure
all necessary parts are in place
• Do not use equipment unless properly trained
• Ask senior staff or other trained personnel when in need of assistance
• Maintenance procedures
 How to perform basic, routine maintenance (if applicable)
 How to request equipment maintenance (work order)
 How to keep track of consumables and reorder when necessary
The MEC should establish an Equipment Training Plan that describes the training needs of hospital staff for the
use of medical equipment. Table 2 describes the steps to develop an Equipment Training Plan.

Table 2 Steps to Develop an Equipment Training Plan

Training can be provided either on site or off site. When purchasing new medical equipment, the hospital can
request that suppliers provide in-service training for equipment use, maintenance, and repair. The Hospital can also
send staff to the manufacturer. The MEC should assess the quality of the manufacturer’s user training to ensure it
is practical and provides adequate training for equipment use. The hospital can also send staff to be trained at other
facilities where employees are already trained and using the particular item of medical equipment. The Hospital
can hold in-service trainings if it has staff that are professionally trained to operate and repair the specified medical
equipment and has other needed resources to conduct the training (see below).
For in-service trainings the hospital should provide:
• Trainer (professionally trained expert in use, maintenance, and repair of medical equipment)
• Training materials specific to the piece of medical equipment
• Adequate space to conduct the training
• Sample equipment and supplies to practice/conduct the training
• Test and calibration instruments to test performance and safety
• Spare parts for maintenance training
• User and service manuals
• Formal method of testing and method of certifying trainees (ex. give exam and issue certificate)
The Human Resource Department is responsible for keeping records of all user trainings. Training records should
specify the name of the person trained, the trainer, the date of the training, the medical device for which training
was conducted, its manufacturer, and model. If possible, the content of the training should be appended or briefly
described in the user training form. A sample User Training Verification Form is presented in Appendix M.
3.16 Budgeting for Medical Equipment Management
To effectively manage all medical equipment careful planning and budgeting is essential. As illustrated in Figure 2
below, there are a variety of costs to medical equipment. It is essential that entirety of costs for all medical
equipment—existing and planned purchases—are considered when planning and budgeting.
Figure 2 The Hidden Costs of Medical Equipment Management

Source: Temple-Bird, C., Kaur Manjit, Lenel Andreas, and Willi Kawohl. (2005). Guide 2: How to Plan and Budget for your
Healthcare Technology. In ‘How to Manage’ Series for Healthcare Technology.p.58 Hertfordshire, UK: TALC.

The first step in preparing a budget for the management of medical equipment is to determine the value of existing
stock. This is known as the ‘Stock Value Estimate’. This should indicate the up-to-date replacement cost of all
items in the Equipment Inventory. The up-to-date replacement value can be estimated from purchase contracts,
supplier information, data from service contracts, manufacturer’s websites etc. With the above information it is
possible to calculate an annual equipment budget. This should be based on the Equipment Development Plan and
should include:
• Replacement costs for current equipment
• Maintenance and repair costs
• Costs for new purchases for expansion of services
• Installation costs of new equipment
• Training costs
a) Replacement costs for current equipment
An annual replacement budget covers equipment likely to reach the end of its usefulness by the end of the year. A
quick estimate of an annual replacement budget can be made using the Stock Value Estimate as follows:
Annual replacement budget = Stock Value Estimate/ average lifetime of all equipment
Further guidance on the calculation of replacement costs is presented in Appendix N.
b) Maintenance and repair costs
As an approximation, maintenance and repair costs for medical equipment are generally between 5-6% of the
‘new’ stock value. Hence the Stock Value Estimate can also be used to estimate the budget required for
maintenance and repair.
c) Costs for new purchases for expansion of services
The Equipment Development Plan guides the purchase of new equipment for the hospital. The cost of items that
are due to be purchased in the Financial Year should be calculated and included in the Medical Equipment Budget.
d) Installation costs of new equipment
As described above, there may be costs associated with the installation of new items such as renovation,
installation of plumbing etc. The equipment development plan should include a description of any installation
work that is required. These costs should be estimated and included in the budget.
e) Training costs
The equipment training plan is the basis for the estimate of training costs associated with medical equipment use
and maintenance.

3.16.1 Budget Submission

The equipment management budget that is prepared by the MEC should be submitted to the CEO for inclusion in
the hospital’s annual budget plan. The CEO should allocate items to capital or recurrent budget lines as
appropriate.

3.17 Medical Equipment Incident Reporting

The hospital should establish a process to report and investigate all critical incidents, including incidents that arise
from the use of medical equipment. An Incident Officer should be assigned to investigate all incidents and to
ensure that any required follow up action is implemented. Further guidance on Incident Reporting and a sample
Incident Report Form are presented in Clinical Governance and Quality Improvement Chapter.

Section 4 Implementation Checklist and Indicators

4.1 Assessment Tool for Operational Standards
In order to determine if the Operational Standards for Medical Equipment Management have been met by the
hospital an assessment tool has been developed which describes criteria for the attainment of a Standard and a
method of assessment. This tool can be used by hospital management or by an external body such as the RHB or
FMOH to measure attainment of each Operational Standard. The tool is presented in tool is presented in the
Assessment Handbook.

4.2 Implementation Checklist

The following Table can be used as a tool to record whether the main recommendations outlined above have been
implemented by the hospital. The Table does not measure attainment of each Operational Standard but rather
provides a checklist to record implementation activities.
Table 3 Medical Equipment Management Checklist
No Checklist Yes No
1 A Medical Equipment Management Unit has been established.
2 The Medical Equipment Unit has the required staff and led by biomedical personnel.
3 There is an established medical equipment maintenance workshop that meets the layout
minimum standards
4 The medical equipment management unit has development/operational plan
5 Terms of reference for the Medical Equipment Committee are defined and committee
established.
6 The Medical Equipment Committee is established.
7 An inventory management system to manage medical equipment has been established.
8 An inventory management system to manage spare parts of medical equipment has been
established.
9 An Equipment History File system has been established.
10 There are policies and procedures for medical equipment acquisition.
11 There are policies and procedures for medical equipment commissioning and
decommissioning
12 There are policies and procedures for medical equipment donations.
13 There are policies and procedures for medical equipment disposal.
14 There are policies and procedures for outsourcing of medical equipment servicing.
15 A maintenance notification and work order system has been established.
16 Preventive maintenance of medical equipment is scheduled and conducted.
17 Inspection and testing of medical equipment is scheduled and conducted.
18 All new equipment undergoes acceptance testing.
19 There is/are contract(s)/procurement agreement(s) for newly procured medical equipment.
20 Equipment requiring calibration has been identified and calibration carried out as per
manufacturer’s recommendations

4.3 Indicators
In addition, the following indicators may be monitored on a regular basis to assess the effectiveness/outcomes of
implementation of the recommendations provided in this chapter.

Table 4Medical Equipment Management Indicators

N Indicator Formula Frequency Comment
o
1 Percentage of medical equipment Total number of Quarterly
identified on model medical equipment medical equipment
list that is in use at the hospital identified on model
equipment list that
is in use at the
hospital/ Total
number of medical
equipment
identified on model
equipment list *100

2 % functional medical equipment Quarterly

Total number of
medical equipment
that is functional/
total number of
medical equipment
*100

3 a) Number of donated medical a)Total number of Quarterly

equipment donated medical
b) % of donated items that are equipment
functional b) total number of
donated medical
equipment that is
functional/total
number of donated
medical
equipment*100

4 a) Total number of Quarterly

work orders
received for repair
a) Number of work orders received of medical
b) Number work orders completed equipment
c) % of work orders completed b) Total number of
medical equipment
work orders
completed
c) total number of
medical equipment
work orders
completed/ Total
number of work
orders received for
repair of medical
equipment
5 Average time to completion of work Σ of time taken to Quarterly
order complete work
order/ total number
of work orders
completed

6 Actual expenditure on medical Actual expenditure Quarterly

 equipment as % of budget allocated to on medical
medical equipment equipment /total
budget allocated to
medical equipment
*100
Quarterly

7 Number of incident reports related to Total number of Quarterly

medical equipment malfunction incident reports
received related to
medical equipment
malfunction
Source Documents
1. Abington Memorial Hospital Department of Biomedical Engineering, Medical Equipment Management
Program. Abington Memorial Hospital Policy and Procedure for Biomedical Equipment Class/Risk Classification.
2. Association for the Advancement of Medical Instrumentation. AAMI Equipment Management Committee.
(1999). ANSI/AAMI EQ56: 1999. Recommended practice for a medical equipment management program.
Arlington, VA.
3. The Australian Council on Healthcare Standards. EQuIP Standards, 3rd Edition. Safe Practice and Environment,
pp. 4.
4. Baldinger, P. and Ratterman, W. (2008). Powering Health. Options for Improving Energy Services at Health
Facilities in Ethiopia. Washington DC: United States Agency for International Aid.
5. Bekele, H. (2008, August). Assessment on Medical Equipment Conditions. Ethiopian Science and Technology
Agency. National Scientific Equipment Centre.
6. Egyptian Ministry of Health and Partners for Health Reformplus. (2004, December). Egyptian Hospital
Accreditation Program: Standards. 6. Environmental Safety, pp. 31.
7. Hospital Standards for Accreditation for Afghanistan. Section 5: Administration and Management. Maintenance
of Hospital Facilities and Equipment.
8. Joint Commission International. Joint Commission International Accreditation Standards for Hospitals, 2nd
Edition. Facility Management and Safety. pp. 135, 140-1.
9. Mavalankar, D., Raman, P., Dwivedi, H., Jain, M.L. (2004). Managing Equipment for Emergency Obstetric
Care in Rural Hospitals. International Journal of Gynecology and Obstetrics. (87): 88-97.
10. Temple-Bird, C., Kaur Manjit, Lenel Andreas, and Willi Kawohl. (2005). Guide 1: How to Organize a System
of Healthcare Technology Management. In ‘How to Manage’ Series for Healthcare Technology. Hertfordshire,
UK: TALC.
11. Temple-Bird, C., Kaur Manjit, Lenel Andreas, and Willi Kawohl. (2005). Guide 2: How to Plan and Budget
for your Healthcare Technology. In ‘How to Manage’ Series for Healthcare Technology. Hertfordshire, UK:
TALC.
12. Temple-Bird, C., Kaur Manjit, Lenel Andreas, Trond Fagerli, and Willi Kawohl. (2005). Guide 3: How to
Procure and Commission Your Healthcare Technology. In ‘How to Manage’ Series for Healthcare Technology.
Hertfordshire, UK: TALC.
13. Temple-Bird, C., Kaur Manjit, Lenel Andreas, and Willi Kawohl. (2005). Guide 4: How to operate your
healthcare technology effectively and safely. Management Procedures for Health Facilities and District
Authorities. In‘How to Manage’ Series for Healthcare Technology. Hertfordshire, UK: TALC.
14. Temple-Bird, C., Kaur Manjit, Lenel Andreas, and Willi Kawohl. (2005). Guide 5. How to organize the
maintenance of your healthcare technology. Management Procedures for Health Facilities and District Authorities.
In ‘How to Manage’ Series for Healthcare Technology. Hertfordshire, UK: TALC.
15. Wang, B. (2003). A Framework for Health Equipment Management in Developing Countries. Business
Briefing: In Hospital Engineering & Facilities Management. International Federation of Hospital Engineering.
Retrieved from:
15-27
http://www.abeclin.org.br/comissoes_arquivos/A%20Framework%20for%20Health%20Equipment
%20Management%20in%20Developing%20Countries.pdf.
16. World Health Organization Regional Office for the Western Pacific. (1998). Section 2.6.Training of
Technicians for Medical Equipment Maintenance. In District Health Facilities: Guidelines for Development and
Operations. WHO Regional Publications, Western Pacific Series No. 22. Retrieved from:
www.wpro.who.int/internet/files/pub/297/part1_2.6.pdf.
17. World Health Organization. (1998). District Health Facilities Guidelines for Development and Operations. Part
1, section 2.4 Management of Medical Equipment pgs.150-154. WHO Regional Publications, Western Pacific
Series No. 22, pp 150-3.
18. World Health Organization. (2000). Guidelines for Health Care Equipment Donations. WHO/ARA/97.3.
Geneva: World Health Organization.
19. Doncaster and Basset Law Hospitals. NHS Foundation Trust. Medical Equipment Training for Trust Staff.
Volume 3. Retrieved from: http://www.dbh.nhs.uk/Library/Corporate_Policies/CORP%20RISK%202%20v.3%20-
%20Medical%20Equip%20Training%20for%20Staff.pdf.
20. Duke University Clinical Engineering Policy CE-020. (2007, January). Retrieved from:
http://clinicalengineering.duhs.duke.edu/wysiwyg/downloads/CE020-Equipment_Management_Program.pdf.
Appendix A Sample Inventory Data Collection Form
Inventory # ________________________
Type of Equipment: __________________________________
Manufacturer: _____________________________
Model: ____________________________ Serial #: ___________________________
Country of Origin: ____________________ Year of Manufacture: __________
Power Requirement: 220V 110V
Current State/Condition: Operable and in service
Operable and out of service
Reason out of service: ______________________
Needs maintenance
Not repairable
Needs to be discarded? Yes No
Spare parts available? Yes No
If yes, what, how many, and where are they located? __________________________
________________________________________________________________________
Manuals Available: User manual # of copies _______ Location ____________
Service manual # of copies _______ Location ____________
Other (specify) # of copies _______ Location ____________
Equipment Users:
Doctors Nurses Lab Technicians
Students Residents Other (specify) _______________________________
Equipment owner (department), if any: _____________________________________
Contact Person and Telephone numbers: _______________________________________________
Current location of equipment: ____________________________________________
Will it move from here? No Yes If so, where? ______________________
Other notes (use back of paper if more room is needed:
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________
_________________________________________
Appendix B Typical Equipment Lifespan
The following is a list of typical equipment lifetimes developed by the American Hospital Association. The list
reflects how equipment lasts within the United States healthcare system, whether it was manufactured in the U.S.
or abroad. While this may not be directly applicable to the Ethiopian context, it is useful to have and use as a
reference.
Diagnostic and Treatment Departments
 Appendix C Sample Medical Equipment Risk Assessment Form
All medical equipment should be assessed to determine the risk associated with equipment use and failure. This
guides the priority that should be assigned to each item for maintenance and repair and replacement when the item
can no longer be repaired.
Step 1 Assign a score to each item of equipment
Each item of equipment should be scored in each of 5 categories:
Category A Equipment function
Category B Risk associated with equipment failure
Category C Preventive maintenance requirements
Category D Main area of equipment use
Category E Likelihood of equipment failure (mean time between failures)
Note: Category E, the ‘mean time between failures’ can be calculated based on equipment service and incident
history. If this is not known then an estimate should be made.
Step 2 Calculate Total Score and Risk Category
The most important categories in the assessment are (A) Equipment Function and (B) Risk Associated with
Equipment Use. Because these are the most important categories these are given greater weight when the total
score is calculated. Hence the total score is calculated as follows:
Total score = A + B + (C+D+E)/3
The total score will range from 3 to 20.
Medical equipment should be categorized as follows:
High risk (score 18 – 20):
Equipment should be tested at least twice per year and should be given highest priority for repair and routine
testing and calibration.
Medium risk (score 15 – 17):
Equipment should be tested at least annually and should be repaired or undergo routine testing and calibration after
this has been done for ‘high priority’ equipment.
Low risk (score 12 -14):
Equipment should be tested at least annually and should be repaired or undergo routine testing and calibration after
this has been done for ‘high and medium risk’ equipment.
Hazard surveillance (<12):
Equipment in this category should undergo annual inspection.
 Medical equipment risk assessment form
Equipment type Inventory number
Name and signature of assessor: Date of assessment

Assessment criteria Score ( circle as appropriate)

A. equipment function
Therapeutic- life support 10
Therapeutic-surgical or intensive 9
care
Therapeutic- physical therapy or 8
treatment
Diagnostic- surgical or intensive 7
care-monitoring
Diagnostic-other physiological 6
monitoring
Analytical- laboratory analytical 5
Analytical- laboratory accessories 4
Analytical-computer and related 3
Miscellaneous-patient related 2
Miscellaneous-non-patient related 1
B. risk associated with
equipment failure
Potential patient death 5
Potential patient injury 4
Inappropriate therapy or 3
misdiagnosis
Equipment damage 2
No significant identified risk 1
C. preventive maintenance
requirement
Monthly 5
Quarterly 4
Semi-Annually 3
Annually 2
Not required 1
D. main area of equipment use
Anesthesia/ surgical care locations 5
Critical/ intensive care locations 4
Labs/ exam areas 3
General care areas 2
Non- patient areas 1
E. likelihood of failure
Less than three months 5
Approximately 4-6 months 4
Approximately 7-12 months 3
Approximately 1 to 3 years 2
Approximately >3 years 1

Total score= A+B+(C+D+E)/3

Inventory classification result (tick appropriate box below)

High risk(score 18-20)
Medium risk(score 15-17)
Low risk(score 12-14)
Hazard surveillance(score <12)
 Appendix D Sample Bin Record Card for Spare Parts
Item Description: Item Code Number:

Date Doc. No( Received QUANTITY Batch no Expiry date Remarks

receiving from or Receive Issued Loss/ Balance
or issued to d Adj
issuing)