Amhara Sayint Primary

Hospital
Term of Reference (TOR) For
Healthcare Technology

Management Committee

Prepared By the Hospital Medical

Equipment Maintenance Department

July 2024
 Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

Table of Contents
1. Introduction..............................................................................................................................1
1.1. Definitions.........................................................................................................................3
2. Healthcare technology management committee.......................................................................4
2.1. Committee members.........................................................................................................5
2.2. Vision................................................................................................................................5
2.3. Mission..............................................................................................................................5
2.4. Objective of healthcare technology management committee...........................................6
2.4.1. General objective:......................................................................................................6
2.4.2. Specific objective.......................................................................................................6
2.5. Duties and responsibilities of HTM committee members................................................7
2.6. Role and responsibility of HTM committee in the hospital..............................................7
3. Healthcare technology strategy................................................................................................8
4. Medical equipment inventory...................................................................................................9
4.1. Items included in an inventory........................................................................................10
4.2. Equipment History File...................................................................................................11
4.3. Sample Inventory form...................................................................................................13
5. Medical device risk classification..........................................................................................14
6. Polices and Procedure for Acquisition/Procurement of medical devices...............................15
6.1. Planning and need assessment........................................................................................15
6.2. Medical device development plan...................................................................................16
Existing Medical Equipment’s...................................................................................................17
Additional Equipment Required (Based On The Medical List).............................................17
6.3. Medical device specification...........................................................................................17
6.4. Medical device Procurement...........................................................................................18
6.4.1. Choosing purchase methods....................................................................................18
7. Policies and Procedures in Medical Equipment Acquisition Policies and procedures related
to procurement...............................................................................................................................19
7.1. Sample Procurement Form for medical equipment in Sayint primary hospital..............20
8. Policies and procedures related to donation...........................................................................21

Prepared By the Hospital Medical Equipment Maintenance Department Page i

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

9. Polices and Procedure for medical device installation and commission................................22

8.1. Policies................................................................................................................................22
10. Policies and procedures related to Decommissioning and Disposal..................................23
11. Policies and procedures related to outsourcing Technical Service.....................................24
12. Reference............................................................................................................................26

Prepared By the Hospital Medical Equipment Maintenance Department Page ii

 Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

1. Introduction
Sayint primary hospital is one of the district hospitals in north wollo zone, Amhara region. The
total number of the staff is around 180. The hospital provides majority of medical services
including clinical services (labor and delivery, maternal and child health, major and minor
surgeries, emergency and regular OPDs, IPD, ART, TB, and leprosy treatment and VCT,
laboratory services (serology, bacteriology, immunology, organ function test, parasitology), and
diagnostic service (X-ray and ultrasound).

In Ethiopia, the lack of proper management of medical equipment has limited the capacity of
health institutions to deliver adequate health care. 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 are factors that contribute to equipment breakdowns.

As health care delivery continues, to expand and to improve in Ethiopia and an increasing
number of sophisticated medical equipment is introduced a system capable of supporting and
managing the medical technology must be in place. Medical equipment management defines the
organization and coordination of activities that ensure the successful management of equipment
related to patient care in a health care facility. The medical equipment management cycle
includes planning, assessment of needs procurement, training operation maintenance,
decommissioning and disposal of the item

Prepared By the Hospital Medical Equipment Maintenance Department Page 1

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

Figure: Healthcare technology management cycle

Healthcare technology management Committee (HTMC), which is the bridge between

biomedical department and Senior Management Team (SMT) of the Hospital.

The provision of complete healthcare services by each level of healthcare necessitates is

possible, whenever the availability of safe, effective and affordable medical equipment of the
required quality became effective by taking this fact into consideration.

Sayint primary hospital established healthcare technology management strategy and policy that
governs the overall committee members, biomedical staffs and medical equipment’s user in the
hospital. That is why it is essential that medical equipment should be kept in good management;
operation repairs and is fit for its usage.

In this health care technology management strategy we try to include the duty and responsibility
of health care technology management committee, duties and responsibilities of medical
equipment maintenance department/ biomedical workshop/, TOR for healthcare technology
management committee.

Prepared By the Hospital Medical Equipment Maintenance Department Page 2

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

1.1. Definitions
Recognizing that there are multiple interpretations that exist for the terms listed below, they are
defined as follows for the purposes of this Term of Reference (TOR) manual.

Health technology: The application of organized knowledge and skills in the form of
equipment, medicines, vaccines, procedures and systems developed to solve a health problem
and improve quality of life. Used interchangeably with healthcare technology.

Medical device: An article, instrument, apparatus or machine that is used in the prevention,
diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or
modifying the structure or function of the body for some health purpose.

Medical equipment: Medical equipment requiring calibration, maintenance, repair, user

training, and decommissioning – activities usually managed by Biomedical engineers. Medical
equipment used for the specific purposes of diagnosis and treatment of disease or rehabilitation
following disease or injury; it can be used either alone or in combination with any accessory,
consumable, or other piece of medical equipment/equipment. Medical equipment excludes
implantable, disposable or single-use medical equipment.

Outsourcing: Form of contracting with pre-specified terms of financing, monitoring and

supervision. Generally engaged over a longer period, outsourcing is delegation of responsibility
partially or wholly towards performance of a set of activities to achieve pre-specified results
based on a mutually agreed form of reporting, monitoring, evaluation and performance.

Preventive Maintenance: It is an action to eliminate the cause of a potential non-conformity.

The care and servicing by personnel for the purpose of maintaining equipment and facilities in
satisfactory operating condition by providing for systematic inspection, detection, and correction
of incipient failures either before they occur or before they develop into major defects, including
tests, measurements, adjustments, and parts replacement, performed specifically to prevent
faults from occurring.

Corrective Maintenance: It is an action to eliminate the cause of a detected non-conformity. It

is a maintenance task performed to identify, isolate, and rectify a fault so that the failed

Prepared By the Hospital Medical Equipment Maintenance Department Page 3

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

equipment, machine, or system can be restored to an operational condition within the tolerances
or limits established for in-service operations.

Equipment Breakdown Rate: Also known as failure rate it is the frequency with which an
engineered system or component fails. It expressed in failure per equipment per hour /shift/day.

Upkeep time:-

It is the measure of the time a machine has been working or available.

Downtime: - It is the period of time that a maintenance system fails to provide or perform its
primary function in, other words the time for which the dysfunctional equipment remains
dysfunctional.

Maintenance Contracts: It is the legal agreement normally conducted between two parties
where in the latter agrees to render the maintenance service annually to the formal in the
exchange of a nominal amount. It ensures that the latter promises to provide maintenance
services to the former all throughout the year on a regular basis. It includes service charges only.
When charges include spare parts also it is termed as Comprehensive Maintenance Contract.

2. Healthcare technology management committee

Sayint primary hospital has healthcare technology management committee composed of

Chief Clinical officer/ Medical director/ Chief executive director/

Head/Director of health technology management (Secretary).
Head of Pharmacy (member).
Head of laboratory department (member).
Head of Nursing - midwifery service (Matron) (member).
Head/representatives of major clinical departments (internal medicine, surgery,
pediatrics, gyn-Obs (members).
Head of finance department (member).
Head of imaging department.

Prepared By the Hospital Medical Equipment Maintenance Department Page 4

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

No Name Position Responsibility in The HTMC

1. Dr Hunual Adane Medical Director Chairperson
2. Worku Tigetu Head Of Biomedical Department Secretary Of HTMC
3. Dagmawi Kassa Matron Member
4. Worku Tegegne Head Of OPD Department Member
5. Eskadmas Fikru Head Of IPD Department Member
6. Abate Kefyalew Head Of Laboratory Department Member
7. Ademe Techalu Head Of Pharmacy Department Member
8. Samuel Gashaw Head of imaging department Member
9. Geta Workie Head Of MCH Department Member
10. Eyewnsh Adam Biomedical Technician Member
11. Eskedar Alemu Biomedical Technician Member
12. Wodaje Teshome Head Of Finance Department Member
2.1. Committee members

2.2. Vision
To improve medical equipment life cycles by implementing efficient use of modern medical
equipment acquisition, installation, and management in the hospital.

2.3. Mission
The mission of Sayint primary hospital healthcare technology management committee is to
provide quality, accessible and cost effective health care for the patient by expanding effective
and modernized medical equipment management system.

Prepared By the Hospital Medical Equipment Maintenance Department Page 5

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

2.4. Objective of healthcare technology management committee

When this healthcare management program is established in Sayint primary hospital by the
collaboration effort of the medicals equipment maintenance department and healthcare
technology management committee, it has its own objective as listed below.

2.4.1. General objective:

To facilitate better and cost effective health needs for the community by managing
healthcare technology properly according to the Ethiopian hospital standards or to ensure
that patients are provided with quality and cost effective healthcare through treated with
modern efficient and cost effective medical devices.

2.4.2. Specific objective

To facilitate better and cost effective health needs for the community by managing
healthcare technologies properly according to Ethiopian hospital standards.
To create better environments for health care technology management in the hospital.
To keep any loose of medical equipment from the hospital by preparing medical
equipment inventory with their detail information.
To set up policies and strategies related to acquisition of new medical equipment,
commissioning, decommissioning, and disposal, recipient of donation and out sourcing
technical services.
To set up policies and strategies related to
 Planning and procurement of medical equipment.
 Acquisition of new medical equipment
 Commissioning, decommissioning of medical equipment.
 Recipient of donation and out sourcing technical services.
 Disposal of medical equipment.
 Review incident reports related to medical equipment
To set up SOP/standards operating procedure for medical equipment in the hospital.
To reduce the failure of medical equipment by activating medical equipment
maintenance center/ active biomedical workshop establishment.

Prepared By the Hospital Medical Equipment Maintenance Department Page 6

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

To establish better and effective equipment maintenance program for the medical
equipment maintenance department.
To Monitor establishment of a medical equipment inventory system
To ensure proper utilization of medical device within the health facility.
To Conduct medical device utilization, safety, and need assessment and propose
intervention strategy.

2.5. Duties and responsibilities of HTM committee members

Chairperson: the chair person is appointed by the hospital healthcare technology

management committee.

His/her responsibilities include:

Scheduling meetings and notifying committee members.

Inviting the concerned persons out of HTMC when required by the committee.
Leading and guiding the meeting according to the agenda and time available.
Ensuring all discussion items end with decision, action or specific outcomes.
Review and approve the draft sometime before distribution.

Secretary: is appointed by the hospital healthcare technology management committee and his
or her is responsible to the following tasks.

Prepare agendas and issuing notices for meetings and insuring all necessary documents
requiring discussion or comment that are attached to the agenda.
Distributing the agenda some days prior to the meeting.
Recording notes during meeting and preparing minutes of meeting.

2.6. Role and responsibility of HTM committee in the hospital

Develop and monitor implementation of medical equipment strategy
Oversee establishment of healthcare technology management system.
Establish and monitor the implementation of policies for
 Planning and assessment of medical equipment.
 Technology assessment and selection.

Prepared By the Hospital Medical Equipment Maintenance Department Page 7

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

 Procurement and logistic.

 Installation and commissioning.
 Training and skill development.
 Operation and safety.
 Maintenance and repair.
 Decommissioning and disposal.
 Training biomedical professionals in regional and national training prepared by
Ethiopian ministry of health or other concerned body to improve their skill.
Monitor establishment of a medical equipment inventory system.
Ensure proper utilization of medical device within the health facility.
Conduct medical device utilization, safety, and need assessment and propose
intervention strategy
Determine the annual budget for implementation of medical equipment strategy.
Review incident reports related to healthcare technology.

Meeting

The HTM committee Meeting will conduct regular meeting (at least every two months) and as
needed in urgent situations. The committee decision making process is done if the issue is
supported by majority (more than 50 percent).

3. Healthcare technology strategy

Sayint primary hospital has established healthcare technology management strategy that
addresses the following areas.

Healthcare technology management (HTM) information system

Healthcare technology management (HTM) information system is hardware or software products

intended to transfer, store, convert formats, and display medical device information.

 The major category of information about medical device are:

Prepared By the Hospital Medical Equipment Maintenance Department Page 8

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

 Medical device Inventory.  Risk classification system.

 Bin and stock card.  Spare parts and accessories
 Medical device History file. inventory management.

Medical equipment maintenance.

Medical equipment procurement and disposal.
Planning and budgeting for medical equipment management.
Medical equipment training.
Function of medical equipment maintenance department and others.

4. Medical equipment inventory

Medical device information recording and archiving begins on the day the device is
commissioned and overhanded to the health facility. Medical device inventory is a list of the
technology on hand, including details of the type and quantity of equipment and the current
operating status, preventive maintenance schedules, Accessories, consumables and spare parts.

The inventory provides the basis for effective asset management, including facilitating
scheduling of preventive maintenance and tracking of maintenance, repairs, alerts and recalls.
The inventory can provide financial information to support economic and budget assessments.
The inventory is the foundation needed to organize an effective MDM department.

Items such as equipment history files and logbooks, operating and service manuals, testing and
quality assurance procedures and indicators are created, managed and maintained under the
umbrella of the device inventory. Furthermore, accessories, consumables and spare parts
inventories are directly correlated with the main medical equipment inventory. Before
establishing a medical equipment inventory the MDAC/HTMU should determine which items
should and should not be included in the inventory and medical equipment management program
based on standard inclusion and exclusion criteria. However, the MDAC/HTMU 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
But this smaller equipment’s are included in the management program as medical equipment and
useful properly for the hospital. The effort required to record, maintain and repair this smaller

Prepared By the Hospital Medical Equipment Maintenance Department Page 9

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

items may not be worth the required man power and financial resources. The healthcare
technology management strategy gives clear definition of medical equipment that should be
included in the medical equipment inventory and program and also state exclusion criteria for
items that should not be included.

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 will be
conducted at regular time intervals throughout the year. Additional inventory checks may be
conducted at regular time intervals throughout the year, as determined by the HTMC 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.

4.1. Items included in an inventory

The hospital medical device inventory includes medical equipment’s based on the following
criteria.

1. Function (2-10 pt).

2. Risk (1-5 pts).
3. Maintenance requirement (1- 5 pts).

𝑫𝒆𝒗𝒊𝒄𝒆 𝒎𝒂𝒏𝒂𝒈𝒆𝒎𝒆𝒏𝒕=𝑭𝒖𝒏𝒄𝒕𝒊𝒐𝒏+𝑹𝒊𝒔𝒌+𝑴𝒂𝒊𝒏𝒕𝒆𝒏𝒂𝒏𝒄𝒆
𝑹𝒆𝒒𝒖𝒊𝒓𝒎𝒆𝒏𝒕

Items with score <12 are excluded from inventory

In addition to this include the medical equipment’s by definition.

Main medical equipment inventory Data included in Hospital medical equipment inventory
information:

 Inventory number  Brief description of item Physical

 Type of equipment/item location within facility
 Serial number  Condition/operating status
 Operation/service requirements

Prepared By the Hospital Medical Equipment Maintenance Department Page 10

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

 Date inventory updated  Equipment risk classification

 Maintenance service provider  Estimated life span
 Purchase supplier  Availability of trained user and
 Year of Manufacturing and technicians
purchased  Physical location within facility
 Manufacturer  Other information as needed
 Power requirement  Model/part number
4.2. 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 List of consumables required to run
The address of the manufacturer machine and recommended spare
The address of the supplier and local parts
agents Acceptance test log sheet
Details of any maintenance contract Medical device Risk Assessment
and maintenance contractor (if Form
relevant) SOPs for operation and maintenance
Copy of warranty (if relevant) of the item
Price paid/Copy of invoice Planned preventive maintenance
Medical device manual or location of schedule
the manual Corrective maintenance reports
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.

Prepared By the Hospital Medical Equipment Maintenance Department Page 11

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

When new equipment is purchased, donated or received from any agent starting from the
equipment arrived to the hospital the following information will be recorded in the equipment
history file.

The address of supplier and local Acceptance test log sheet.

agents. Medical equipment risk assessment
The address of the manufacturer/ form.
email or cell phone/both. SOPs for operation and maintenance
Detail of any maintenance contract of the item.
and maintenance contractor (if Planned preventive maintenance
relevant). schedule.
Copy of warranty (if relevant). Corrective maintenance reports.
List of consumable required to run
machine and recommended spare
parts.
The history file for all medical equipment’s must be recorded in the following form for
individual equipment’s and the essential information’s are attached in this file.

Prepared By the Hospital Medical Equipment Maintenance Department Page 12

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

4.3. Sample Inventory form

Inventory #: __________________________________________________________________
Type of Equipment: ____________________________________________________________
Manufacturer: _________________________________________________________________
Model: ____________________________ Serial no. _______________________________
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 _____________________
Equipment Users: Doctors Nurses Lab Technicians Students
Equipment owner (department), if any: ___________________________________________
Contact Person and Telephone numbers: __________________________________________
Current location of equipment: __________________________________________________
Will it move from here? No Yes If so, where? _____________________

Prepared By the Hospital Medical Equipment Maintenance Department Page 13

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

5. Medical device 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 anesthesia 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 done based on:
Function of the equipment: For example whether the equipment is used for life support,
routine treatment, diagnosis or monitoring Risk which may associate 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.
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 fled in the medical device history file. Any new item of equipment
should be assigned a ‘risk category’ when it is received by the hospital and entered into the
inventory.

Prepared By the Hospital Medical Equipment Maintenance Department Page 14

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

6. Polices and Procedure for Acquisition/Procurement of medical

devices
Sayint primary hospital has a policy for the acquisition/ procurement for new medical
equipment’s, donations of medical equipment’s/, commissioning \,decommissioning and disposal
of equipment and out sourcing technical services for medical equipment maintenance and
installation. This polices are established by HTMC and medical equipment maintenance
department of the hospital.
The HTMC and administrative bodies of the hospital are the responsible bodies for
implementation of this polices. Any new equipment acquired must be suitable for the hospital’s
mission and improve access to quality healthcare. The HTMU also needs to ensure that
equipment operators have the ability and capacity to absorb, support, and use any technologies
procured. Procurement activity is part of the broader acquisition phase of healthcare technology
management, which also includes planning, need assessment, selection, financing and budgeting.
Purchasing refers to the acquisition of goods or services in return for money or equivalent
payment whereas Procurement is a wider term and refers to the process of obtaining goods and
services in any way, such as through purchase, donation, loan or hire. However, the use of the
terms ‘procurement’ and ‘purchasing’ interchangeably to mean ‘procurement’ is a common and
accepted practice.
6.1. Planning and need assessment
Sayint primary hospital has a policy for Planning and need assessment requires establishment of
Multi-disciplinary Team/HTMC, data gathering and definition of strategic areas, development of
list of required devices, quantities and specifications and specifying of site requirements.
Need assessment is the identification and definition of prioritized requirements with regard to
medical devices. The general approach to conducting a needs assessment is to assess the current
availability of medical equipment in the facility and compare it with what should be available
based on the specific demands and situations of the catchment area or target group. The HTMC
are responsible for planning and need assessment program of the hospital.

Prepared By the Hospital Medical Equipment Maintenance Department Page 15

 Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

6.2. Medical device development plan

The Medical Device Development Plan (MDDP) is aimed to define goals for acquisition,
maintenance, and replacement of equipment in the short term and long term. It should be
developed taking into consideration the current devices inventory and the ‘model medical device
list
A Sample template for an EDP is presented in the table below

DEPARTMENT/ ROOM …………………………………………

Prepared by: - ……………………….. Date: - ………………….
Name of Condition Short Term Action Short Longer Term Long Term
Equipme (1 Year) Term Cost Action (2-5 Cost Estimate
nt Estimate Years)
Type For example:- For example:- For example:-
And  age and expected  repair needed;  replacement
Inventory life;  replacement needed,
Number  working needed,  first time
condition (good,  user training purchase
fair, poor, needs needed, needed
repair, damaged  first time
beyond repair, purchase
obsolete) needed
A. Existing Medical Equipment
1. ………….
2. ………...
3. ………….. etc.
B. Additional equipment required (based on the medical list)
1. ………….
2. ………….
3. ………….etc.

Prepared By the Hospital Medical Equipment Maintenance Department Page 16

 Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

Existing Medical Equipment’s

DEPARTMENT/ ROOM………………………………………………..
Prepared by: - ………………………Sign ……. Date: - ………………
Name of Inventory Condition Short term Short Longer term Long
Order

Equipment No, action term cost action term cost

(1 year) estimate (2-5 years) estimate
1.
2.
3.
4.
…

Additional Equipment Required (Based On The Medical List)

DEPARTMENT/ ROOM…………………………………………………………..
Prepared by: - ………………………..… Sign ……… Date: - ………………….
Name of Condition ( problem Short term Short term Longer term Long term
Equipment faced because of item plan (1 cost plan (2-5 cost
Order

absence or less in year) estimate years) estimate

number)
1.
2.
3.
....

6.3. Medical device specification

The specification is the most important document for both the hospital and for the potential
supplier, since it sets out precisely what characteristics are required of the products or services
sought. Often, this is the only chance to detail the selection criteria including requirements for
certain levels of technology, quality, safety, appropriateness, consumable inputs, training, and
technical support. The hospital HTMU should write medical device specifications, so that
whoever is procuring/ providing the goods can conform to the hospital’s requirements. The
specifications provide the detailed technical description of each type of equipment on the Model
Equipment List.

Prepared By the Hospital Medical Equipment Maintenance Department Page 17

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

6.4. Medical device Procurement

Obtaining equipment is intensive work, both in terms of time and resources. It is therefore
required to consider a number of factors before committing to buying, accepting donations, or
hiring equipment. Before carrying out any equipment procurement (through purchases, donations
or rentals), the hospital should already have
An up-to-date equipment inventory A vision for health service delivery
Purchasing, donations, replacement, Model Equipment Lists
and disposal policies

6.4.1. Choosing purchase methods

The hospital HTMC should select the most appropriate method of purchasing method among the
following.
Centralized procurement: procurement takes place centrally, for example at the national level
Group procurement: joint procurement by different health facilities, health authorities (district,
regional) or health service provider organizations (public or private)
Decentralized procurement: health facilities or health authorities to which authority has been
decentralized procure equipment themselves, or health facilities and health authorities with
independent funds undertake their own procurement.
Mixed procurement: a combination of centralization and decentralization whereby some parts
of the procurement process are undertaken centrally and others at district or facility level.
Using procurement agents: private companies being hired to handle procurement.

Prepared By the Hospital Medical Equipment Maintenance Department Page 18

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

7. Policies and Procedures in Medical Equipment Acquisition

Policies and procedures related to procurement
 When purchasing new equipment, the purchasing process should be done by the medical
equipment’s specification according to the needs and quality of the equipment to the
hospital.
 The specification for the equipment can be done by the hospitals HTMC or outsourcing
technical services assigned by the hospital.
 When purchasing new equipment enough spare parts and accessories to last at least 1-2
years should also be purchased
 The hospital equipment purchasing committee should bring the original Copy of warranty
Together with the equipment.
 The hospital biomedical engineers and technicians should be participated in the
purchasing process to ensure that the correct specification of the equipment is available.
 The specification should be concerned on the quality of the equipment to ensure its own
perfectness, reliability and durability.

Prepared By the Hospital Medical Equipment Maintenance Department Page 19

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

7.1. Sample Procurement Form for medical equipment in Sayint primary

hospital

Date………………
Rf No…………………
Sayint primary hospital would like to buy the following medical equipment from competent
company.
Equipment name (Item).......................... Model of the equipment ………………….
Manufacturer country (Brand)……………………….
The equipment should fulfill the following minimum requirement.
1. It must be above the specified brand
2. Must Show clear Power capacity
3. Should have clear Date of manufacturing
4. Should have Life span indicator
5. Should have Circuit diagram showing item design
6. Should have Spare parts and accessories with reserves
7. The equipment must have Operation manual and Service manual
8. Should be checked by the hospital assigned biomedical professionals and company
technicians together.
9. Transportation and installation will be conducted by agreement
10. Should be New and packed
11. The company Should give 1 to 2 years’ service Warranty
12. The company should have vat list.
13. The company should have paid the annual tax

Hospital stamp Name and signature of approved person

……………………….. …………………………..
……………………………………….

Notice The hospital have the right to cancel the purchasing process partially or completely if it
is possible to get the best alternative.

Prepared By the Hospital Medical Equipment Maintenance Department Page 20

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

8. Policies and procedures related to donation

The HTMC establish a policy for the receipt of donated medical equipment’s. The policy
describes the conditions under which a donated item will be accepted by the hospital.
Healthcare equipment donations should benefit the hospital /the recipient/ to the
maximum extent possible.
Equipment will only be accepted if the item is needed by the hospital and is described
in the Model Equipment List and associated Equipment Development Plan.
Donated equipment must be in good working order.
Donations should have done the government policies and administrative
arrangements of our country /Ethiopia/ in general and our hospital in particular.
If the quality of an item is unacceptable in the donor country, it is also unacceptable
as a donation.
We accept the donation only if there is effective communication between the donor
and our hospital.
Instruction manuals /service and operation manuals/ in English should be supplied
with the donated equipment.
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.
The donor should provide follow up support regarding use of the equipment, where
necessary.
The equipment must not require any special storage or operating conditions that the
hospital cannot provide (for example air conditioning, humidity control etc.)
The donated medical equipment must have completely full spare parts for their
installation and further use.
The hospital biomedical technicians or other related technicians from the donor
should check up the equipment whenever it is coming to the hospital.
All the equipment donations should be reviewed and approved by the HTMC before
acceptance.

Prepared By the Hospital Medical Equipment Maintenance Department Page 21

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

9. Polices and Procedure for medical device installation and

commission
According to the hospital policy, when new equipment has been purchased or a donation has
been accepted, preparations must be made for receipt of the item. This is to ensure quick and
sufficient installation, commissioning, training, and eventually placement into service
Installation is the process of fixing the equipment into place. Depending on the
complexity of the equipment, this can range from simply plugging into an electrical
socket to building it into the fabric of the room depending on the manufacturer's
recommendation behind installation.
Commissioning is performing a series of tests and adjustments that will check whether
the equipment is functioning correctly and safely, and ensuring that any adjustments are
made before the equipment is accepted.

The equipment that are purchased or accepted from donation may be simple or complex.

8.1. Policies
 For the purpose of installation, the appropriate. Safe Sufficient and clear place should be
selected. This place can be selected by the person who conducts the installation by taking the
hospitals place and area into consideration.
 If the equipment that is purchased or accepted from donors are somewhat complex and
computerized the installation and commissioning should be conducted by the technicians
from the purchasing or donation company together with the hospital biomedical technicians.
 Installation and commissioning out of the above point can be conducted by the hospital
biomedical technicians.
 When the equipment become perfect in its own desired function after the completion of
Installation and commissioning, the person who conducts the Installation and Commissioning
should train the users for its proper operation.

Prepared By the Hospital Medical Equipment Maintenance Department Page 22

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

 At the end of Installation and commissioning the hospital biomedical maintenance

department should do the following task.
 Accept the equipment and establish Equipment History File including the
essential information that should be included in the Equipment History File.
 Enter equipment into the equipment inventory /the hospitals inventory/
 Prepare Standards Operating Procedures and assign Planned Preventive
Maintenance Schedule
 Provide training for equipment users and maintainers as appropriate
 Handover equipment to appropriate department ‘users/.
 Keep the List of consumables required to run machine and recommended spare
parts in protected place until they are required by the machine.
 Keep the operation and service manuals of the machine in a protected place.

10. Policies and procedures related to Decommissioning and

Disposal
 When the life span of particular medical equipment is finished and stops completely its
proper function the equipment should be decommissioned and finally disposed based
following policies.

 Before decommissioning the hospital biomedical department or Sourcing personnel that

are assigned by the hospital should check the total the status of the machine.

 The hospital will establish a Disposal Committee composed of HTMC and other bodies if
required.

 This established committee oversees the disposal of all fixed assets 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 as checked by the
manufacturer's recommendation, assigned technicians or Engineers.

Prepared By the Hospital Medical Equipment Maintenance Department Page 23

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

 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 F1le to
indicate that the item has been disposed.

 The Equipment History File should then be moved to a separate storage location for the
indication of, inactive equipment items.

11. Policies and procedures related to outsourcing Technical

Service
 When the equipment maintenance / Planed Preventive Maintenance or corrective
maintenance/, installation, commissioning, decommissioning and general operations are
beyond hospital's medical equipment maintenance department the hospital can assign an out
sourcing technical service based on the following policies.

The hospitals administrator and HTMC must look for individuals or companies that might be
able to undertake this task effectively and select qualified individuals or companies according
to the requirement set up by the HTMC of the hospital.

The hospital can assign out sourced technical service from:

 Ethiopian Biomedical and Laboratory Equipment Engineers Association.

 The medical equipment manufacturer’s local agent.

 The National Scientific Equipment Centre.

 Private maintenance companies.

 From any volunteer national or foreign company that can assist the hospital.

 The Ethiopian Health and Nutrition Research Institute for laboratory equipment.

 Individuals such as electricians or plumbers.

 Any qualified technicians, Engineers from government institutions or NGOS that the
hospitals persuade them.

Prepared By the Hospital Medical Equipment Maintenance Department Page 24

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

Out sourcing technical Support may also be provided by the relevant Regional or federal
health institutions whenever required by the hospital.

When making the decision to outsource a service, the hospital will consider the task at hand
to be the performed and the qualification needed to perform the task.

The time duration of the outsourcing technical support will be determined by the HTMC
depend on the sophistication of the equipment, the number of maintenance, installation and
tasks to be done generally. The time may be for short period of time, annual contracts or
beyond this one.

There should be service warranty between the hospital and the bodies that provide the
outsourcing technical service.

Prepared By the Hospital Medical Equipment Maintenance Department Page 25

Amhara Sayint Primary Hospital Term of Reference (TOR) for HTM

12. Reference

1. The Ethiopian Hospital Services information Guidelines (ESHIG)

2. Biomedical Equipment Maintenance and Management Program Text Book

Prepared By the Hospital Medical Equipment Maintenance Department Page 26