Overview of Medical

Equipment Management
(EHSTG)
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  Chapter Objective:
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At the end of this chapter the participants will be able to
describe medical equipment management standards.
 Enabling Objectives: At the end of this chapter,
participants will be able to:
Identify hospital medical equipment management
operational standards
Describe implementation guidance medical equipment
management operational standards
 Chapter Outline:
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 Introduction
 Medical equipment management operational standards
 Implementation guidance for medical equipment management
operational standards
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Introduction
 In Ethiopia, lack of proper management of medical equipment has
limited the capacity of health institutions to deliver adequate
health care.
 It is very crucial to implement Medical Equipment Management in
the hospitals to manage and coordinate the medical equipment
management cycle which includes
 Planning and assessment of needs,
 Procurement, training, operation, maintenance,
 Decommissioning and disposal.
 a. Medical Equipment Management Unit
5  Each Hospital should establish a medical equipment management unit that is
appropriately staffed and led by trained biomedical personnel with activities
like;
 maintenance workshop equipped with the necessary materials
 Establish and maintain the medical equipment inventory and History Files
for all equipment
 Conduct acceptance testing and installation of new equipment
 Provide staff in-service training on the correct and safe use of equipment
 Track equipment inventory, service history, and work orders
 Ensures sufficient funds for regular and incident based maintenance
budget, including spare parts.
 Develops and maintains a procedure describing the processes for risk
managing, improving safety and quality.
 Establishes automated and centralized documentation system that tracks
all equipment and spare parts
 b. Medical Equipment Committee

6  Each hospital should establish Medical Equipment Committee (MEC)

that advices the management of medical equipment in the facility.
 The MEC is chaired by the medical director of the hospital and the head
of medical equipment management unit should be the secretary.
 The MEC should be composed of hospital a medical director and
representative of nurses, pharmacists, laboratory, administrative
personnel and biomedical personnel basis.
 The MEC is responsible to:
 Oversee establishment of a medical equipment inventory
 Develop a model medical equipment list
 Monitor the implementation of policies, standards and guidelines for:
 Planning and procurement of medical equipment
 Donation of medical equipment
 Disposal of medical equipment
 Review incident reports related to medical equipment
 c. Medical Equipment Maintenance
workshop
Hospitals should establish a medical equipment maintenance workshop based on their level
7  Maintenance workshop including space for:
 Administration offices
 Electrical/Electronic Work Area
 Biomechanical Work Area
 Test , Measuring equipment, Tools, Spare parts, and Personal Protective Devices Store
 Staff Training Room

d. Medical Equipment Inventory

 Medical equipment inventory is a list of the technology on hand, including details of the type and
quantity of equipment and the current operating status.
 Accessories, consumables and spare parts inventories are directly correlated with the main medical
equipment inventory.
 The Medical Equipment strategy should give a clear definition of medical equipment that should be
included in the medical equipment inventory
 A small team should be established for the inventory of medical equipment.
 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 inventory should be reviewed and checked annually, with regular updates during the year when
new equipment arrives or is removed from service.
 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.
 e. Equipment History File
 An individual file/folder should be established for each item of equipment.
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 This file should be held in the equipment maintenance department.
 The file should contain:
 Inventory Data Collection Form
 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
 Medical Equipment Risk Assessment Form
 SOPs for operation and maintenance of the item
 Planned preventive maintenance schedule
 Corrective maintenance reports
 f. Model Medical Equipment List
9  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 will determine Model Equipment List of all items that are
necessary to provide essential service.

g. Medical Equipment Development Plan

 is a plan to define goals for acquisition, maintenance, and replacement of equipment
in the short term and long term.
 The medical equipment development plan (EDP) 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 EDP should be developed by the MEMU and approved by hospital management.
 h. Accusation /Procurement of Medical
10 Equipment
In Medical equipment Procurement process the following steps should
be considered.
 Need assessments and Justifications,
 Planning and Budgeting
 Technology Assessment, preparation of technical specification and
Selection
 Cost of ownership( Maintenance, Spare part, consumable etc) costs
 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.
 The hospital MEMU should strictly follow National Medical Equipment
Donation Directive for the receipt of donated medical equipment.
 i. Preparing for Equipment Delivery and
 Commissioning
When an order has been placed to purchase a new item of equipment, or a
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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:
 Site Preparation
 Organizing Lifting Equipment
 Organizing Warehouse Space
 Preparation for acceptance testing and installation
 Preparation for User Training

j. Acceptance Testing and Installation

 All medical equipment, purchased or donated, should be inspected upon delivery and
tested prior to initial use.
 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.
 Final payment should be made after the item has undergone acceptance testing,
commissioned and all agreed services (e.g. installation or training) have been provided..
 k. Standard Operating Procedures
 A guide that describes how to use the equipment, instructions for care of the equipment,
12 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

l. Calibration, Inspection, Testing and Maintenance

 To ensure medical equipment are reliable, safe and available all time when it is needed
for diagnostic procedures, therapy, treatments and monitoring of patients.
 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.
 m. Disposal of Medical Equipment
13  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.
 A policy for the disposal of fixed assets should be established
by the hospital and approved by hospital management.
n. Training in equipment use and maintenance
 all clinical staff should be trained to operate each medical
device that they use.
 The MEMU is responsible for overseeing all user training for
medical devices, whether in-service or conducted by
suppliers/external parties.
 The Human Resource Department and MEMU are responsible
for keeping records of all
 O. Budgeting for Medical Equipment Management
 To effectively manage all medical equipment careful planning and budgeting is
14 essential.
 It is essential that entirety of costs for all medical equipment—existing and
planned purchases—are
P. 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.