2014 - 03 - 31 IUSS Healthcare Technology Proposal

IUSS HEALTH
FACILITY GUIDES
Healthcare
Technology
[Proposal V.1]
28 March 2014
Task Team: C:07
Supported by:
Document tracking
Version Date Name

Version Date Name
Draft 0.1 5 March 2013 R van der Watt
Draft 1.0 26 March 2014 R van der Watt, M Poluta
Edited 28 March 2014 B van Reenen
INFORMATION NOTES
Form: Health facility guides

Status: Proposal V.1, 28 March 2014
Title: Healthcare Technology

Description: “Healthcare Technology” contains guidance in four parts. Part 1 provides a
background to the Health Technology document and its context within the
wider Health Infrastructure domain. Part 2 looks at the entire Lifecycle of
Health Technology and outlines the activities comprising good-practice Health
Technology Management (HTM). Part 3 suggests key Standards that should be
in place in order to ensure a comprehensive HTM Programme. Finally, Part 4
covers a number of examples and usable resources to be used as reference.
Reference: CSIR 59C1119 C:07- 001
Authors: IUSS N and S task group C:07
Stakeholders: National Department of Health, Provincial Departments of Health and Public
Works
Endorsements: The document is endorsed by the CSIR
Endorsements pending:
Submitted to the IUSS Norms and Standards Working Group for endorsement
Supersedes: N/A
Accessing of these guides
This publication is received by the National Department of Health (NDoH), IUSS Steering Committee
Chairman: Dr Massoud Shaker. Use of text, figures or illustrations from this report in any future
documentation, media reports, publications, competition entries and advertising or marketing material is
solely at the discretion of the IUSS Steering Committee and Working Group and should clearly reference
the source. This publication may not be altered without the express permission of the IUSS Steering
Committee and Working Group. Feedback is welcome.
This document (or its updates) is available freely at www.iussonline.co.za
Disclaimer
This is a proposal document and has been prepared in the development of national Norms and Standards
for the NDoH for the benefit of all South Africans involved in the procurement, design, management and
commissioning of healthcare infrastructure across both public and private sectors. Use of the guidance in
this document is at the risk of the implementing party, until endorsed by the National Health Council of
the Department of Health.
Document status
The development process adopted by the IUSS team is to consolidate information from a range of sources
including local and international literature, expert opinion, practice and expert group workshop/s into a
firs- level discussion status document. This will then be released for comment through the iussonline
website and through IUSS, national and provincial channels. Feedback and further development will be
consolidated into a second-level development status document, which again will be released for
comment and more rigorous technical review. Further feedback will be incorporated into proposal
status documents for formal submission to the Department of Health Technical Review Committee. Once
approved, the documents may be submitted for formal approval by the National Health Council, at which
stage documents reach approved status. At all development stages documents may go through various
drafts and the final approved document will be assigned a version number. Documents may be used at
risk for project development at all development stages but will only become mandatory in final approved
status.
Acknowledgements
IUSS Norms and Standards task team. This publication has been funded by the NDoH
Special acknowledgements to Riaan van der Watt, Mladen Poluta, Gift Mphefu, Sam Bakhane, Terry
Downes, Magda Coetzer, Hennie van Tonder
Acknowledgements also to Janine Smit the editor, Sheldon Bole, Claire du Trevou, Kumirai Tichaona and
Mokete Mokete
CONTENTS
OVERVIEW ......................................................................................................................................... 9
PART A - BACKGROUND ........................................................................................................... 11
1. Health technology context ........................................................................................................................11
2. Application of the Guidelines ..................................................................................................................11
3. Associated process and related documents .......................................................................................11
PART B - LIFE CYCLE OF HEALTH TECHNOLOGY............................................................. 12
1. Planning ...........................................................................................................................................................12
1.1. Introduction ......................................................................................................................................................... 12
1.2. Service and related technology planning ................................................................................................ 13
1.3. Planning and budgeting when starting out ............................................................................................ 14
2. Needs assessment ........................................................................................................................................15
2.1. Standard lists of equipment .......................................................................................................................... 15
Usefulness of the standard equipment lists ........................................................................................... 16
2.2. Equipment development plan ..................................................................................................................... 17
Prioritising and appraisal of options....................................................................................................... 17
2.3. Consumables ........................................................................................................................................................ 18
3. Asset management.......................................................................................................................................19
3.1. Inventory ............................................................................................................................................................... 19
3.2. Asset management system ............................................................................................................................ 20
Asset management software ................................................................................................................. 21
4. Budgeting & financing ................................................................................................................................22
4.1. Estimates of budget lines for equipment expenditure...................................................................... 22
4.2. Estimates of maintenance costs for forward planning ..................................................................... 22
4.3. Estimates of consumable operating costs for forward planning ................................................. 24
Specific or annual estimates of consumable operating costs ................................................................ 26
4.4. Estimates of equipment replacement costs ........................................................................................... 26
4.5. Rough estimates of equipment-related administrative costs for forward planning ........... 26
5. Requisitioning ...............................................................................................................................................28
6. Procurement ..................................................................................................................................................29
6.1. Introduction ......................................................................................................................................................... 29
6.2. Preparation of specifications........................................................................................................................ 31
6.3. Evaluation and comparison process ......................................................................................................... 33
6.4. Issues to consider when choosing equipment ...................................................................................... 35
6.5. Donations .............................................................................................................................................................. 38
7. Receipt, testing, installation & commissioning .................................................................................38
7.1. Pre-installation work / site preparation ................................................................................................. 38
7.2. An overview of the acceptance process ................................................................................................... 40
Commissioning ....................................................................................................................................... 41
7.3. Registration and handover ............................................................................................................................ 43
Entering new equipment orders into health facility records ................................................................. 43
Storing manuals ...................................................................................................................................... 44
8. Training ...........................................................................................................................................................44
8.1. Introduction ......................................................................................................................................................... 44
8.2. Correct application ........................................................................................................................................... 45
8.3. Special case: for home-based care or patient-operated devices .................................................. 46
9. Operation ........................................................................................................................................................47
9.1. Introduction ......................................................................................................................................................... 47
INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 1

Health Facility Guides: 28 March 2014
Healthcare Technology [PROPOSAL V.1]
9.2. Care and cleaning .............................................................................................................................................. 48
9.3. Equipment-related infection control ........................................................................................................ 48
9.4. Staff accountability ........................................................................................................................................... 48
10. Maintenance, risk-management and safety .......................................................................................49
10.1. Introduction ......................................................................................................................................................... 49
10.2. Risk-based maintenance strategy .............................................................................................................. 51
Data collection - equipment groups ....................................................................................................... 52
Risk evaluation - factors impacting on risk ............................................................................................. 53
Risk ranking and risk classes ................................................................................................................... 54
Inspection and preventive maintenance planning ................................................................................. 55
Equipment supported ............................................................................................................................ 56
Method - maintenance procedures and intervals .................................................................................. 56
Materials – service required items ......................................................................................................... 57
Staff – human resource requirement ..................................................................................................... 57
Maintenance intensity of specific equipment ........................................................................................ 57
Maintenance trade classification ........................................................................................................... 58
Maintenance labour time requirement ................................................................................................. 59
Outsourcing of maintenance activities ................................................................................................... 59
Implementation of preventative maintenance plan .............................................................................. 60
10.3. Computerised maintenance management system (CMMS) ............................................................ 62
CMMS fields and tables .......................................................................................................................... 63
CMMS modules ...................................................................................................................................... 64
CMMS implementation .......................................................................................................................... 64
10.4. Human resources ............................................................................................................................................... 65
Self-supporting (stand-alone) decentralised departments - tertiary hospitals ...................................... 67
Centralised maintenance units ............................................................................................................... 67
11. Replacement, decommissioning and disposal ..................................................................................69
11.1. Introduction ......................................................................................................................................................... 69
11.2. Replacement of equipment ........................................................................................................................... 70
11.3. Decommissioning and disposal of equipment ...................................................................................... 71
12. Monitoring & evaluation of the HTM system .....................................................................................73
PART C - PART C - ANNEXURES ............................................................................................. 74
1. ANNEX I: Sample Generic Equipment Specification: Infant Incubator .....................................74
2. ANNEX II: Standard device categories and descriptions ...............................................................77
3. ANNEX III: Healthcare technology standards and indicators ......................................................77
3.1. Standards .............................................................................................................................................................. 77
HT Planning (S1) ..................................................................................................................................... 77
HT Inventory (S2) .................................................................................................................................... 77
HT Budgeting and financing (S3) ............................................................................................................ 77
HT Requisition (S4) ................................................................................................................................. 77
HT Procurement (S5) .............................................................................................................................. 77
HT Receipt, testing, installation & commissioning (S6) .......................................................................... 77
HT-related training and skills development (S7) .................................................................................... 78
HT operation (S8) ................................................................................................................................... 78
HT maintenance, risk management and safety (S9) ............................................................................... 78
3.2. Indicators .............................................................................................................................................................. 78
Core indicators (ex WHO) ....................................................................................................................... 78
PART D - REFERENCES AND SELECTED BIBLIOGRAPHY............................................... 82
LIST OF FLOWCHARTS
Flowchart 1: The basic equipment development planning process .............................................................................. 17

Flowchart 2: Establishing usage rates and requirements for equipment-related consumable items ........... 18
Flowchart 3: How to estimate total equipment stock values ........................................................................................... 21
Flowchart 4: How to make rough estimates of maintenance costs for forward planning................................... 24
Flowchart 5: How to make specific or annual estimates of consumable operating costs ................................... 26
Flowchart 6: How to make rough estimates of replacement costs for forward planning ................................... 27
Flowchart 7: How to make specific estimates of assorted equipment-related administrative costs ............. 28
Flowchart 8: Common site preparation steps ......................................................................................................................... 39
Flowchart 9: Key steps in the commissioning process ........................................................................................................ 41
Flowchart 10: Example of prompts showing that training is required ........................................................................ 46
Flowchart 11: Steps in a typical decommissioning process .............................................................................................. 72
LIST OF CHECKLISTS
Checklist 1: Equipment considerations for vision at national level 14
Checklist 2: Key questions for prioritising and appraisal of options 18
Checklist 3: Request to purchase new equipment that is not yet in use at the institution 28
Checklist 4: Request to replace existing equipment 29
Checklist 5: Request to purchase additional equipment similar to equipment already in use 29
Checklist 6: Example of good selection criteria for equipment purchasing 36
Checklist 7: Suggested criteria for evaluating current and past suppliers 37
Checklist 8: Strategies for making staff more accountable 49
LIST OF FIGURES
Figure 1: Distribution of risk for medical devices ................................................................................................................. 51
Figure 2: Risk-based maintenance framework ....................................................................................................................... 52
Figure 3: The maintenance planning process .......................................................................................................................... 55
Figure 4: CMMS planning & implementation process .......................................................................................................... 64
Figure 5: Idealised health technology department structure ........................................................................................... 66
Figure 6: Typical organisational structure for a self-supporting HT maintenance department ...................... 67
Figure 7: Typical structure for a central HT maintenance unit ....................................................................................... 69
LIST OF BOXES
Box 1: The planning and budgeting process (start-up)....................................................................................................... 12
Box 2: Baseline information on medical devices .................................................................................................................... 14
Box 3: Minimum planning and budgeting requirements.................................................................................................... 14
Box 4: Process for Identification of Standard Equipment Lists .............................................................................. 16
Box 5: Inventory-related responsibilities, activities and actors ...................................................................................... 19
Box 6: Process for developing budget lines for equipment expenditure .................................................................... 22
Box 7: Elements of annual maintenance budgets .................................................................................................................. 23
Box 8: Example of valid reasons and order of priority for purchasing of equipment ........................................... 30
Box 9: Planning tools that assist in deciding on procurement ......................................................................................... 30
Box 10: Evaluation information sheets ...................................................................................................................................... 34

Box 11: Summary technical assessment .................................................................................................................................... 35
Box 12. General strategies when operating equipment (for users) ............................................................................... 47
Box 13: Summary of registers, ledgers and files used for maintenance and who keeps them .......................... 50
Box 14: Example of valid reasons for condemning and replacing equipment .......................................................... 71
LIST OF TABLES
Table 1: Example of a core equipment expenditure plan ................................................................................................... 22
Table 2: Rough estimates of consumables’ operating costs for forward planning ................................................. 25
Table 3: Equipment groupings and related risk and maintenance factors ................................................................ 52
Table 4: Maintenance intervals for different equipment types ....................................................................................... 56
Table 5: Grading of equipment service requirements ......................................................................................................... 58
Table 6: Labour hours per service type...................................................................................................................................... 59
Table 7: List of generic fields for a CMMS ................................................................................................................................. 63
Table 8: Typical staff complements (technical) for a self-supporting HT maintenance department ............. 67
Table 9: HT maintenance staffing requirement (regional hospital) .............................................................................. 68
Table 10: HT maintenance staffing requirements (district hospital) ........................................................................... 68
Table 11: HT maintenance staffing requirements (community health centre) ....................................................... 68
Table 12: HT maintenance staffing requirements (large clinic, with maternity) .................................................... 68
GLOSSARY / DEFINITIONS
A detailed inspection performed before a device is put into use either after initial
Acceptance inspection
receipt (i.e. the incoming inspection of new equipment) or following other service
activities (e.g. a major Repair, Modification or Overhaul) as appropriate.
Activities undertaken when equipment arrives at an health facility, at the end of which
Acceptance process
the equipment will be operational and officially belong to the facility, such as receipt,
unpacking, installing, commissioning, initial training, entering into stores and onto
records, payment.
The total cost, including the purchase price, delivery charges, and training and
Acquisition cost
installation costs, to acquire a single piece of equipment.
ANSI is the national organisation that facilitates national standards development by
American standards
accrediting procedures of standardisation organisations. All new medical equipment
has to be approved by the Food and Drug Administration (FDA-approval) before it can
be commercialised.
The number of failures for a device or a group of devices (e.g., a particular model)
Annualised failure rate
divided by the product of the number of years being considered and the number of
devices in use at a facility.
The process of guiding the acquisition, use, safeguarding and disposal of assets to make
Asset management
the most of their service-delivery potential and manage the related risks and costs over
their entire life.
A listing of information pertaining to various aspects of an asset portfolio in a form that
Asset register
allows data to be retrieved and utilised as required.
A reference value for an indicator; it may be established using internal or external
Benchmark
benchmarking or by regulation.
A procedure used to determine a device’s accuracy using test equipment whose own
Calibration
accuracy is appropriate and has been verified and, as needed, adjusting that medical
device to meet the manufacturer’s specifications.

CE markings indicate that a product meets European Union directive standards of
CE mark
performance and safety (see EU Standards below).
Removes visible material (dirt, grease, blood, body fluids, etc.) and reduces the number
Cleaning
of some infectious micro-organisms.
The American College of Clinical Engineering defines a clinical engineer as “a
Clinical engineer
professional who supports and advances patient care by applying engineering and
managerial skills to healthcare technology”.
A specialty within Biomedical Engineering responsible primarily for managing and
Clinical engineering (CE)
maintaining medical equipment/devices and related systems. The scope and location
(within the health service) of Clinical Engineering vary from country to country and
region to region and depend on historical, organisational, service-related and economic
factors, amongst others. CE functions typically include: asset management; risk
management; technology specification, evaluation & commissioning;
inspection/preventive maintenance (IPM); repairs, modifications and limited R&D;
spares inventory management; contract/service provider management; in-service
training; liaison with users and suppliers, etc.
A series of tests and adjustments performed to check whether new equipment is
Commissioning
functioning correctly and safely, and ensure that any necessary adjustments are made,
before the equipment is used.
A legally binding document between the buyer and a supplier for a specified period of
Contract
time, which describes the goods and services being supplied.
Service provided under contract by a manufacturer or independent service
Contracted service
organisation.
Take out of service; dismantle and make safe; or board. The process of condemning or
Decommission
writing off equipment and disposing of it.
The process of making items safe for handling and re-use.
Decontamination
The amount by which the monetary value of an asset is reduced over a period of time
Depreciation
due to its everyday use (“wear and tear”).
The reduction of a population of harmful micro-organisms on any surface without
Disinfection
achieving sterility (in other words, not all bacterial spores present are destroyed).
The time that a device is not available for clinical use because of the need to perform
Downtime
activities such as inspections, preventive maintenance and repairs. Downtime is
specified in hours or as a percentage, typically calculated over a specified “use period”
(based on when a device is scheduled to be available for clinical use or when a
contract’s terms specify that a device will be available).
The guidelines, practices and procedures to ensure that people are protected from the
Electrical safety
fatal electrical risks posed by electrical supplies, installations, and equipment.
These are developed through the organs of EU, EFTA, and the three European
EU standards
standardisation organisations CEN, CENELEC and ETSI. Directives are issued by the EU
authorities and the standardisation organisation prepares the technical standards
according to the directives. There are three main medical devices directives for Europe:
(i) 90/385/EEC for active implantable medical devices; (ii) 93/42/EEC covering vigilance
and compliance in general for medical devices; and (iii) 98/79/EC for in-vitro diagnostic
medical devices.
These allow manufacturers to export equipment that is not manufactured for the
Export certificates
exporting country’s domestic sale or use.
Status of not meeting intended performance or safety requirements, and/or a breach
Failure
of physical integrity that is corrected by repair and/or calibration.
Where this has been introduced, a manufacturer’s Quality System is audited and
Good manufacturing practice
monitored to ensure standards of production and safety are maintained and are
(GMP) consistent.
Any process which examines and reports on healthcare technology properties
Health technology assessment
(evaluative dimensions) such as: safety, efficacy, feasibility, indications for use, cost and
cost-effectiveness, social, economic and/or ethical impacts, and consequences
(whether intended or unintended).
The devices, drugs, medical and surgical procedures - and the knowledge associated
Healthcare technologies
with these – used in the prevention, diagnosis and treatment of disease as well as in
rehabilitation and the organisational and supportive systems within which care is
provided (WHO, 1997).

Optimising the planning, acquisition and utilisation of healthcare technologies to
Healthcare technology
achieve maximum beneficial impact on health outcomes. It includes, after a decision to
management (HTM) acquire a technology has been made (occasionally via a formal technology-assessment
process): selection, procurement, installation, use, maintenance, safeguarding and
disposal of assets to make the most of their service-delivery potential and manage the
related risks and costs over their entire life.
Healthcare technology management service made up of a network of HTM teams and
HTM service
HTM working groups.
A body responsible for the management of equipment, such as an equipment
HTM team
management team, maintenance management team, physical assets management
team. Part of the HTM service.
A working group, or standing committee responsible for making decisions on
HTM working group
healthcare technology management issues; part of the HTM service.
An event implicating a medical device in the injury or potential injury of a person.
Incident (medical device)
A wide range of practices, processes and procedures minimising the risk of cross-
Infection control
infection in health facilities.
The servicing of medical equipment performed by the facility’s own staff.
In-house service
Training, at the time of commissioning and for all medical device/equipment
Initial training
stakeholders, in the range of skills required to make the best use of newly arrived
medical devices/equipment.
A procedure used to verify that the physical integrity, safety, and performance of a
Inspection
device meet the necessary requirements.
The process of fixing equipment into place; this can range from building equipment
Installation
into the fabric of a room to simply connecting it to mains power.
These are international standards for the electrical safety of any electrical and
International Electro-technical
electromechanical equipment. IEC60601-1 is the international standard specifically
Commission (IEC) standards addressing medical electrical safety that manufacturers must conform to if medical
equipment is to be electrically and mechanically safe for use.
A systematic listing of stock (or assets) held. An annual inventory is prepared at the end
Inventory
of each year following a physical inspection and count of all items owned by an
organisation. The list gives details, such as location, reference number, description,
condition, cost, and the date the inventory was taken.
An ISO standard (published in 2003) that represents the requirements for a
ISO 13485
comprehensive management system for the design and manufacture of medical
devices.
An ISO standard (latest revision published in 2007) that represents the requirements
ISO 14971
for a risk management system for medical devices.
A series of standards covering the quality of manufacturing processes, design and
ISO 9000-9004
development, construction, installation, and servicing. ISO standard 13485 was based
on these standards.
The recurrent cost required to keep equipment going throughout its life (for example,
Life-cycle cost
cost of utilities, consumables, upgrades, maintenance, and training).
Lifespan, life expectancy. For equipment, the likely length of time that an item will
Lifetime
work effectively, dependent on the type of technology and parts used in its
manufacture.
A collective term comprising the following activities: acceptance inspection, calibration,
Maintenance
inspection, modification, overhauls, preventive maintenance and repair.
These are validated by the government of the exporting country, confirming that the
Manufacturer’s certificates
exported device is approved for domestic use in the exporting country.
An article, instrument, apparatus or machine that is used in the prevention, diagnosis
Medical device
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. Typically, the
purpose of a medical device is not achieved by pharmacological, immunological or
metabolic means. Medical devices can be used either alone or in combination with
accessories, consumables or other medical devices.
Medical devices requiring calibration, maintenance, repair, user training, and
Medical equipment
decommissioning − activities usually managed by clinical engineers. This term typically
excludes implantable, disposable or single-use medical devices.

The alteration of a device from its original state to improve performance, reliability, or
Modification
safety or to add new functionality - this includes installing software with new
functionality in accordance with manufacturer’s specifications.
An extensive replacement or rebuilding of worn parts on a device to significantly
Overhaul
extend its life.
A collection of institutions with similar characteristics where it has been established
Peer group
that those characteristics are relevant to the benchmarking indicator.
Number of devices receiving preventive maintenance divided by the number of devices
PM completion rate
scheduled to receive PM (expressed as a percentage).
Planned preventive maintenance protocol, or list of activities, describing the work to be
PPM schedule
carried out on equipment at specified regular intervals, in order to prevent breakdowns
and ensure the equipment is operational and safe.
A routine procedure used to minimise a device’s risk of failure and to ensure its
Preventive maintenance
continued proper operation. Examples of preventive maintenance tasks are lubricating,
adjusting and replacing parts as recommended by the manufacturer.
A legal document between the supplier and the buyer providing a complete breakdown
Pro-forma invoice
of the supplier’s quote and terms for the order, against which payment is made by the
buyer. Most commonly used by buyers to allocate and arrange the transfer of funds via
bank money-transfer to international suppliers. Used by customs in the country of
destination to determine the customs value of imported goods.
A sequentially numbered printed form used by the buyer to place an order with a
Purchase order
supplier, listing the details of all that is required. It is an official and binding document
issued to the supplier, which authorises the expenditure of funds for goods and
services, and acknowledges that payment will follow. Once created, the necessary
funds are dedicated from the relevant budget account (expenditure line) against the
Purchase Order number.
The degree to which health services for individuals and populations increase the
Quality of care
likelihood of desired health outcomes and are consistent with current knowledge (IOM,
2001). Quality healthcare should be safe, effective, patient-centered, timely, efficient
and equitable.
A process used to restore the physical integrity, safety, and performance of a device
Repair (corrective
after a failure.
maintenance)
The hands-on time needed to repair a device and have it ready for return to use.
Repair time
The time from the initiation of a request for service until a service provider solves the
Response time
problem (e.g., by telephone) or arrives to repair a device or to remove it for repair.
A process whereby specific areas of risk are identified through the analysis of pertinent
Risk analysis
recorded data, combined with pre-defined norms and/or experientially based
predictions and/or probabilities.
Ongoing process of identifying risks, assessing their threat, instituting
Risk management
countermeasures, and evaluating countermeasure effectiveness.
These are performed to ensure the device is electrically and mechanically safe. These
Safety inspections
inspections may also include checks for radiation safety or dangerous gas or chemical
pollutants, and/or other environmental impact. When these inspections are done, the
results are compared to country or regional standards as well as to manufacturer’s
specifications. The frequency of safety inspections may be different from planned
maintenance and performance inspections, and are usually based on regulatory
requirements.
A collective term comprising the following activities: acceptance inspection, calibration,
Service
inspection, modification, overhauls, preventive maintenance and repair.
A required or agreed level of quality or attainment set by a recognised authority, used
Standard
as a measure, norm or model for all aspects of health services and healthcare
technology.
Rationalisation, normalisation and harmonisation. In other words, reducing the range
Standardisation
of makes and models of equipment available in stock, by purchasing particular or
named makes and models.
Removes or destroys all living organisms making any surface or fluid free of micro-
Sterilisation
organisms, viruses, and bacterial spores. Sterilisation is absolute, therefore an item
cannot be “nearly” sterile.

Service performed by a manufacturer representative or independent service
Time-and-materials service
organisation and paid for on the basis of the costs of labour, parts and supplies, and
travel time. It may be scheduled or unscheduled.
The total service costs for a single unit or the average per-unit cost for all units of the
Total cost of service
same model; it includes in-house service, contracted service and time-and-materials
service.
The status assigned to a device failure when a service provider finds no problem (e.g.,
Unable to duplicate
when equipment passes inspection) following a report of failure.
The status assigned to a device failure when a service provider finds no problem (e.g.,
Use error
when equipment passes inspection) following a report of failure and the provider
determines that the device or an accessory was used incorrectly.
The servicing of medical equipment performed by staff not employed by the facility,
Vendor service
either under a contract, on a time-and-materials basis, or under a warranty.

OVERVIEW
This document outlines the policy and service context and attempts to illustrate the desired planning
principles and design considerations of Health Technology
PART A outlines the national and provincial service and policy context which are the basic
determinants of the planning and design principles;
PART B Details the health technology life cycle. The section contains guidance for life-cycle stages
from planning through to replacement and decommissioning
PART C - develops these principles into a series of sample standards and specifications;
PART D - contains references and bibliography.
While this document outlines design requirements and acceptance criteria which have an impact on
clinical services, these requirements are prescribed within the framework of the entire IUSS set of
guidance documents and cannot be viewed in isolation.

Table 1 : IUSS:GNS Reference Documents
CLINICAL SUPPORT HEALTHCARE PROCUREMENT&
Recommended
Recommended
Recommended
Recommended
SERVICES SERVICES ENVIRONMENT/ OPERATION
CROSSCUTTING
Essential
Essential
Essential
Essential
ISSUES
Adult Inpatient Administration Generic Room Integrated

Services and Related Requirements infrastructure
Services planning
Clinical and X General Hospital Design Briefing Manual
Specialised Hospital Principles
Diagnostic Support
Laboratory Services
Guidelines
Mental Health Catering Building X Space Guidelines X
Services for Engineering
Hospitals Services
Adult Critical Laundry and Environment and X Cost Guidelines X
care Linen Sustainability
Department
Emergency X Hospital X Materials and Procurement X
Centres Mortuary Finishes
Services
Maternity Care Nursing Future Healthcare Commissioning X
Facilities Education Environments Health Facilities
Institutions
Adult Oncology X Health Facility Healthcare Maintenance X
Facilities Residential Technology
Outpatient X Central Sterile X Inclusive Decommissioning X
Facilities Service Environments
Department
Paediatrics and Training and Infection Capacity
Neonatal Resource Prevention and Development
Facilities Centre Control
Pharmacy Waste Disposal X Information X
Technology and
Infrastructure
Primary Health Regulations
Care Facilities
Diagnostic X
Radiology
Adult Physical X
Rehabilitation
Adult Post-
acute Services
Facilities for X
Surgical
Procedures
TB Services
Colours Legend
Consultants
Administrators
Related documents

PART A - BACKGROUND
1. Health technology context
Health Technology covers a wide range of apparatus, consumables, devices, equipment and instruments
that would require many volumes of documents to cover effectively. This document, as part of the
broader IUSS Norms and Standards project, aims to look at the key elements of Health Technology and its
management as it manifests in healthcare facilities. The document specifically aims at framing the subject
of Health Technology within the infrastructure development and operations domain.
The various definitions of Health Technology are listed in the Glossary but it is important to note that this
document focuses on durable medical equipment and related consumables used in healthcare facilities.
Hospital plant and machinery, normally associated with the building and most often installed as part of
the building, are dealt with in various other documents in the IUSS document bouquet, either under the
respective hospital engineering disciplines or under the respective clinical service area.
2. Application of the Guidelines
This document, published under the Health Facility guides, would be useful for Health Technology
Management (HTM) and Clinical Engineering (CE) practitioners both at the level of an individual facility
and for groups of facilities (for example, in a district), and at any level of care. It will also be a valuable
resource for managers of HTM/CE practitioners, and facility managers in general, who might lack first-
hand experience in this relatively specialised field but may be accountable for the performance of these
practitioners. In many cases the guidelines show the way towards developing specific and applicable
solutions rather than being prescriptive. This approach is necessary to ensure that they remain
sufficiently generic to be applied across a broad spectrum of scenarios.
The document would also be of interest to health infrastructure professionals who might need specific
insight into the domain of Health Technology and its management, recognising that technology and
infrastructure are closely inter-related and will become ever more so in future healthcare systems.
3. Associated process and related documents
This document should be considered in the context of the solid platform provided by the Health
Technology Policy and the Health Facilities Planning Directorates of the National Department of
Health. This includes the Framework for Health Technology Policies which outlines the vision of a
National Health Technology System; the draft Health Technology Management Policy document which
inter alia outlines the organisational and structural requirements at all levels of governance pertaining to
such a system; the Health Technology Strategy which outlines specific objectives and activities, with
associated timeframes, for establishing a National Health Technology System; the Report of the Interim
Steering Committee on Health Technology Assessment, which underlines the importance of having
formal processes in place to assess issues of health technology cost-effectiveness, access, service-fit and
social impact, amongst other “evaluative dimensions”; and lastly the draft Medical Device Regulations
which – in their final form – are likely to fall within the mandate of the new South African Health Products
Regulatory Agency (SAHPRA), to be established under the Medicines and Related Substances Amendment
Act of 2008.

PART B - LIFE CYCLE OF HEALTH TECHNOLOGY
1. Planning
1.1. Introduction
Planning and budgeting are often considered jointly since planning – for it to be effective – needs to take
place within the context of policy, financial, and other constraints. Box 1 shows the overall process.
Box 1: The planning and budgeting process (start-up)

Steps People responsible Actions
Plan and budget within Health service Framework requirements
the framework of managers at follow regulations and standards set by government;
guidance and direction national level in develop a Healthcare Technology Policy including decisions on
from the national level. consultation with standardisation, maintenance provision, finances for HTM activities,
managers at other and the organisational structure for an HTM service;
levels. define the overall “Vision” for healthcare delivery at each level of the
health service;
develop “Standard Equipment Lists” which define the essential
equipment stock for the healthcare to be delivered at each level;
use “Generic Equipment Specifications” for acquisition of equipment;
develop good policies for purchasing, donations, replacement, and
disposal of equipment; and
participate in the planning, equipping and operation of health
facilities.
Increase the availability HTM working Knowing where one is starting from
of planning skills for groups and sub- establish an Equipment Inventory to keep up-to-date records of the
equipment at all service groups. current equipment stock;
levels, by developing estimate the equipment stock values;
planning “tools” through define the usage rates of equipment-related consumable items so
one-off exercises. that realistic estimates can be made of the finances required for
Finance officers. equipment accessories, consumables, and spare parts; and
set up budget lines to record and monitor expenditure on all the
different equipment activities.
Knowing where one is headed
Health develop a library of literature and resources which will help with
management equipment planning and budgeting;
teams. adapt the vision for healthcare delivery at their service level;
adopt good policies for purchasing, donations, replacement, and
disposal of equipment;
adapt the Standard Equipment List for their service level;
HTM working develop generic equipment specifications and technical and
groups and sub- environmental data; and
groups. estimate human resource requirements and associated “acquisition”
and capacity building.
Ensure realistic estimates Capital budget calculations
are made for all HTM working calculate expenditure requirements for replacement items;
equipment-related groups and sub- calculate expenditure requirements for new purchases;
allocations at all service groups. calculate expenditure requirements for support activities linked to
levels, by using budgeting purchases and donations;
“tools” to calculate HTM managers and calculate expenditure requirements for pre-installation work; and
expenditures required. their teams. calculate expenditure requirements for major rehabilitation work.

Steps People responsible Actions
Ensure realistic estimates Recurrent budget calculations
are made for all HTM managers and calculate recurrent expenditure requirements for maintenance;
equipment-related their teams.
allocations at all service Heads of section. calculate recurrent expenditure requirements for consumable
levels, by using budgeting operating costs;
“tools” to calculate HTM working calculate recurrent expenditure requirements for administrative
expenditures required. groups and sub- expenses; and
groups. calculate recurrent expenditure requirements for ongoing training.
Use the tools to make Long-term planning
long-term plans and HTM working establish an Equipment Development Plan covering the priorities for
budgets groups and sub- equipment needs across their service level over time;
groups. establish an Equipment Training Plan to cover the ongoing rolling
programme of training required in relation to equipment activities;
establish a Core Equipment Expenditure Plan which prioritises
equipment spending across the facility over the long term; and
establish a Core Equipment Financing Plan indicating possible sources
of funds and related options.
Review the plans and Annual planning
budgets annually, and HTM teams. update the Equipment Inventory;
monitor progress in order HTM working update the Equipment Development Plan;
to improve planning and groups and sub- update the Equipment Training Plan;
budgeting. groups. cost the capital and recurrent requirements for the current year, and
update the Core Equipment Expenditure Plan and Core Equipment
Financing Plan; and
prioritise across their service level to obtain the annual purchase
activities, annual rehabilitation activities, annual corrective activities,
annual training activities, and thus the annual equipment budget.
Review the plans and Monitoring progress
budgets annually, and HTM working ensure annual plans are implemented;
monitor progress in order groups. study the implications arising from planning and budgeting;
to improve planning and Heads of request help for any deviations from plans such as emergency
budgeting. department and purchases, maintenance and consumable contingencies;
HTM managers. monitor actual expenditure against allocations;
seek the funding identified;
Health consider linking allocation of budgets to whether departments
management achieve their performance targets;
teams. monitor progress through establishing planning and budgeting tools
and associated indicators; and
ensure that the information generated is used to improve stock
control, training, procurement, utilisation, etc.
1.2. Service and related technology planning
For healthcare technology to be managed effectively, a clear idea of healthcare delivery goals and targets
is needed, as well as the context in which the technology is operating. Equipment should not be viewed in
isolation – it is there for a purpose, and must be managed according to set objectives. For effective
planning, access to a wide range of information and reference materials is needed, as well as a clear vision
of the direction in which the health service is headed, plus identification of what equipment is required to
help achieve the health service goals.
To inform the technology part of the debate, the HTM working group (at each level) should consider the
equipment implications of the healthcare interventions suggested, and then offer technical advice to their
health management team. Box 2 and Checklist 1 show some of the issues that the national,
province/district- and facility level HTM working groups, respectively, should consider.

Box 2: Baseline information on medical devices
Medical device situation Considerations Result
 Availability and condition of medical  Medical equipment  Facility map.

devices (including type, number, location inventory including status  Medical equipment
and physical condition). and condition. inventory (quantitative
 Status of electrical, water, and waste  Current health technology and qualitative).
disposal systems related to medical management infrastructure  Outline of health
device use. (or lack thereof). technology management
infrastructure.
Checklist 1: Equipment considerations for vision at national level

Issues Examples
What expansion of  What should be the role of a hospital (central, referral, district) in terms of the
services is necessary or interventions and procedures to be carried out? What does this mean in terms
feasible? of equipment availability?
 What type of care can be offered by rural, district or town health centres? Can
any types of care be transferred over to them? What does this mean in terms of
equipment availability?
 It may be best to locate certain specialised services (such as intensive-care units)
only at certain hospitals. Some specialised services, such as radiotherapy, may
only ever be offered at national level. With pressures to reduce costs, improve
efficiencies, and possibly to reduce staff numbers, can service provision be
rationalised? Is expansion based only on needs that can be realistically met?
What are the  Introducing a new service has knock-on implications for human, material and
implications in terms of financial resources. For example, should eye instruments be bought for a facility
staff, skills, resources, if there is no eye surgeon, or prospects of one becoming available? Or if the
patient referral referral system is such that dialysis is only undertaken and supported at a central
networks? facility, one should think carefully before placing dialysis machines at other
further locations. However, if such expanded “satellite” services are required,
then all the resources required to ensure effective service provision should be
identified, provided and maintained.
Are desired expansions  Although many hospitals may ideally wish to have fluoroscopy facilities (for
financially affordable? example), at a cost of approximately $500 000 per suite, is this a feature each
hospital can necessarily invest in?
Do the services  Is it possible to develop a vision which fits in with the other health service
suggested fit into the provider organisations?
overall health service in
the country?
1.3. Planning and budgeting when starting out
Box 3 shows the minimum requirements for a scenario for an HTM system in its infancy, where the initial
focus is not on long-term forward planning, but concentration on planning and budgeting on a yearly
basis. As the system matures, other elements for forward planning can be added.
Box 3: Minimum planning and budgeting requirements

Planning and budgeting element If just starting out
1. Equipment inventory 1. Essential to have.

2. Stock value estimates 2. Useful to carry out this exercise later on when rough estimates needed
for long-term forward planning.
3. Budget lines for equipment 3. This alteration to budget layout can be done later, but it will help with
expenditures. analysis.

Planning and budgeting element If just starting out
4. Usage rates for equipment-related 4. Useful to do this exercise as it helps with calculation of specific (annual)
consumable items. estimates.
5. Reference materials. 5. These can be developed over time.
6. Developing the vision of service 6. Should have an understanding of this, even if full exercise not
delivery for each facility type. undertaken.
7. Standard Equipment Lists. 7. Initially, list of urgent equipment needs drawn up by departments can
be used. Later on, Standard Equipment Lists obtained elsewhere can be
8. Purchasing, donations, used.
replacement, and disposal policies. 8. Essential to have.
9. Generic equipment specifications 9. Initially learn from others. Later, develop own.
and technical data.
10. Capital budget calculations. 10. Initially learn how to make specific (annual) estimates; only learn the
rough estimation methods when undertaking long-term planning.
11. Recurrent budget calculations. 11. Initially learn how to make specific (annual) estimates. Only learn the
rough estimation methods when undertaking long-term planning.
12. Equipment development plan. 12. Use the basic equipment development planning process only, and only
apply it to the short term.
13. Equipment training plan. 13. Develop a straightforward one for the short term
14. Core equipment expenditure plan. 14. Initially only plan annually (see below).
15. Core equipment financing plan. 15. Initially only plan annually (see below).
16. Annual equipment planning and 16. Create annual actions plans and an equipment budget showing income
budgeting. and expenditure.
17. Monitoring progress. 17. Undertake the basic elements only – progress with annual plans and
tools, coping with emergencies, providing feedback.
2. Needs assessment
2.1. Standard lists of equipment
Once the vision for the direction of health service delivery has been developed, the healthcare
interventions and procedures to be offered will be known. Based on this information, the Essential
Service Packages can be developed; these will translate the vision into:
• human resource requirements, and training needs;

• space requirements, and facility and service installation needs; and
• equipment requirements.
The tool used in the process of defining what equipment is needed for each healthcare intervention is the
Standard Equipment List. This is:
• a list of equipment typically required for each healthcare intervention (such as a healthcare
function, activity, or procedure). For example, health service providers might list all equipment
required for eye-testing, delivering twins, undertaking fluoroscopic examinations, or for testing
blood for malaria;
• organised by activity space or room (such as reception area or treatment room), and by
department;
• developed for every different level of healthcare delivery (such as district, province) since the
equipment needs will differ depending on the vision for each level;
• usually made up of everything including furniture, fittings and fixtures, in order to be useful for
planners, architects, engineers and purchasers, and

• a tool which allows healthcare managers to establish if the Vision is economically viable.
The Standard Equipment List must reflect the level of technology of the equipment. It should describe
only technology that the facility can sustain (in other words, equipment which can be operated and
maintained by existing staff, and for which there are adequate resources for its use). For example a
department could have:
• an electric suction pump or a foot-operated one;

• a hydraulic operating table or an electrically controlled one;
• a computerised laundry system or electro-mechanical machines; and
• disposable syringes or re-usable/sterilisable ones.
It is important that any equipment suggested:
• can fit into the rooms and space available. Reference should therefore be made to any building
norms defining room sizes, flow patterns, and requirements for water, electricity, light levels and
so on;
• has the necessary utilities and associated plant (such as the power, water, waste management
systems) available for it on each site - if such utilities are not available, it is pointless planning to
invest in equipment which requires these utilities in order to work; and
• can be operated and maintained by existing staff and skill levels, or for which the necessary
training is available and affordable.
Usefulness of the standard equipment lists
A Standard Equipment List is an aid to the planning process. In order to plan what equipment to
purchase, awareness of any shortfalls in equipment is needed. To determine such shortfalls, the
Equipment Inventory needs to be compared with the Standard Equipment List. This will indicate whether
any equipment is currently missing or needs to be purchased. Thus, the Standard Equipment List will
assist in determining what equipment, in relation to the Vision for the service, is:
• necessary;
• surplus;
• extravagant; and
• missing
Responsibility for developing the Standard Equipment Lists varies from country to country. It is most
important that this task is undertaken by a multidisciplinary team, so that decisions benefit from the
skills and views of many disciplines, not just one or two. The health service planners at central/national
level should consider developing Standard Equipment Lists in collaboration with staff from each level of
the service, as indicated in Box 4 below.
Box 4: Process for Identification of Standard Equipment Lists
Who/which level? Takes what action?

HTM working group
at each level  Organises special meetings of different types of staff to work on the Standard
Equipment List. Then reports back to the Health Management Teams.
National level  Takes the first step and runs specific exercises to establish the Standard Lists of
Equipment for each clinical and support area, at each operational level.
Province/district level  Takes the second step and adjusts the list on a regional/district basis to cover local
variations.

Who/which level? Takes what action?
Takes the third step and assesses:
- how they can provide the healthcare interventions; and
- what numbers of equipment they require depending on how they organise their
Facility level  work.
Organisational decisions influence the quantity of equipment. For example, the
timing of clinics can reduce or increase the workload in the laboratory. Before
ordering new equipment, its level of use will need to be assessed.
2.2. Equipment development plan
Especially for an HTM system that is not mature, it is important to have an equipment development plan;
one suggestion for the development planning process is presented in Flowchart 1 below.
Flowchart 1: The basic equipment development planning process

Process Activity
HTM manager and his/her team:
Analyse the up-to-date Equipment Inventory to discover the replacement, major
Evaluates the
rehabilitation, maintenance, consumable, training, and administrative requirements.
current equipment Compare the Equipment Inventory with the Standard Equipment List to discover the
stock shortfall of equipment that needs purchasing (If the Standard Equipment List is not
available, compare the inventory to the urgent equipment needs drawn up by
departments).
Evaluates future Study the Vision for the facility to discover any new services planned.
requirements
Compiles the needs List all these requirements.

The HTM working group (or its planning sub-group)
Prioritises the Decide what to attempt:
actions to take, and - as short-term goals (in the coming year or two); and
makes the - as long-term goals (for example, within 3-5 years).
Equipment
Development Plan
Prepares various Creates plans for:

action plans - equipment replacement and new purchases, and any associated support activities;
- major rehabilitation projects; and
- corrective actions (maintenance, consumable needs, training, administrative needs).
Prioritising and appraisal of options
It is equally important, in the context of needs assessment, to critically examine the process and its
outputs and outcomes. Checklist 2 below poses some key questions for consideration by the appropriate
stakeholder/s.

Checklist 2: Key questions for prioritising and appraisal of options
Impact
• Which changes would have the greatest positive impact in meeting needs?
• Do the identified needs relate to a local or a national priority (e.g., maternal and child health, HIV/AIDS, etc.)?
• What would be the implications of not addressing the needs?
Changeability
• Which things can be changed and effectively improved?
• What evidence is there of effective interventions?
• Can negative impacts be stopped or reduced?
• Are there national or local, professional or organisational policies that set out guidelines on what should be done
(e.g. national frameworks, national guidance, etc.)?
Acceptability
• Which of the options for change are likely to be most acceptable to the health service providers, to the target
population, and to the managers?
• What might be the “knock-on” effects, or unintended consequences, of making a change?
Resource feasibility
• Which resources are required to implement the proposed changes?
• Can existing resources be used differently?
• Which resources will be released if ineffective actions are stopped/changed (e.g., proper management of health
technology, etc.)?
• Are there other resources available which have not been given prior consideration (e.g., income generation of
laboratory services, consideration of public-private partnerships, assistance from NGOs, etc.)?
• Which of the actions will achieve the greatest impact for the resources used?
2.3. Consumables
Consumables are a major contributor to equipment-related cost of ownership, and form a significant
portion of recurrent and operational expenditure. It is therefore important to establish the consumables
needs so that adequate provision is made and service delivery is not interrupted. Flowchart 2 below
suggests a process to facilitate the needs assessment related to equipment-related consumables.
Flowchart 2: Establishing usage rates and requirements for equipment-related consumable items
Process Activity
The HTM working group (or its stock sub-group) at facility level:
Undertakes an initial one-off exercise to Investigates the actual annual requirements and rates of use across the
establish usage rates and requirements facility for:
for equipment-related consumable • replacement accessories;
items. • equipment consumables;
• spare parts;
• maintenance materials;
• energy supplies; and
• equipment cleaning materials.
Identifies: By:
• the actual requirements (i.e. the types • consulting with departments;
of items, makes, sources, and • talking to equipment operators and maintainers;
descriptive/identifying part numbers); • referring to departmental statistics and records on patient attendance;
and • referring to stores records; and
• the rates of use for these recurrent • using information from suppliers.
items by department (e.g., quantities
needed per day, week, or month in
order to deliver the required health
service to the patients expected).

Process Activity
Makes use of the information gathered To:
for planning and budgeting purposes. • calculate more realistic annual recurrent funding requirements to cover
consumable items; and
• supply the Health Management Team with sufficient information to set
more realistic budgets.
Provides feedback to the Stores Supply the Stores Controller with sufficient data to:
Controller. • enter onto the Stores” Stock Cards (Bin Cards);
• calculate correct re-ordering quantities and times; and
• make equipment-related consumable items “stockable” items.
Provides feedback to the Specification Provide them with information for more appropriate selection of models
Writing Group and the Tender during procurement.
Committee.
Updates the information regularly. Undertake an annual review as part of the equipment management
activities.
3. Asset management
3.1. Inventory
It is essential that an inventory (asset register) of medical equipment is maintained. However, it is both
costly and time-consuming to include each and every medical device in an asset register. For those items
in an asset register, the following information should be captured and verified:
• Equipment type (an international nomenclature system such as the Universal Medical Device
Nomenclature System (UMDNS) should be used so that all institutions use a common name for
the same type of device).
• Make/manufacturer.
• Model.
• Serial number.
• Date of acquisition.
• Price paid (include any costly accessories).
• Supplier details (name, address, contact person, contact details).
• Location – department or ward where the unit is used.
The responsibilities, activities and role-players relating to equipment inventory are shown in Box 5.
Box 5: Inventory-related responsibilities, activities and actors

Body Responsibility Activity People involved
HTM Creates and updates Organises the gathering of inventory data. Either by:
Service the Equipment  facility staff for their own
Inventory. facility;
 district staff for the facilities
in their district;
 central staff for the health
service as a whole; and
 using specialist help.

Body Responsibility Activity People involved
Inventory Carries out the Visits each department in the health facility, and: Due to the workload and
team Equipment Inventory  looks in all rooms, cupboards, etc.; knowledge required, it is useful
at each facility.  physically checks all equipment for the for the team to be made up of:
details required; and  two maintenance staff (from
 fills in the Equipment Inventory Record the relevant HTM team);
Sheets.  a senior equipment user
from the facility; and
If existing records are available:
 a member of staff from the
 modifies or expands the information as
department being assessed
necessary to cover new items;
(who changes as team
 fills in any gaps; moves from department to
 corrects entries; and department).
 updates data in order to make the
Equipment Inventory as accurate as
possible.
 Enter the data gathered, either onto an
HTM Compile the Make use of trained technical
inventory card or a computer screen, for
teams Equipment Inventory. staff and secretarial/computing
each individual device.
support to assist with data entry.
Make hard copies.  Create summaries, prepare and print out
hard copies.
 Provide a copy of the Equipment

Inventory.to the Stores Controller for
inclusion in the General Inventory held by
stores.
Central- Develops the  Uses computer-based tools required for this Makes use of support from staff
level Equipment Inventory purpose (for example, word-processing trained in keeping computerised
HTM as an active spreadsheets or specific commercial records.
team (regularly updated) inventory products which staff have been
resource. Analyses trained on.
the Equipment
Inventory for planning
purposes.
3.2. Asset management system
Proper asset management requires an appropriate information system which can be used to maintain
data on those items that have been included in the asset register.
Equipment audits provide a snapshot of equipment status in a facility or groups of facilities, and can be
aggregated to reveal the situation at national level. Audit data also serves to inform decision making
related to needs assessment, asset management, maintenance strategies, replacement planning, and so
on.
Also, once an inventory system is up and running, it will be necessary to periodically obtain estimates of
total equipment stock values – this is used, for example, in benchmarking the total expenditure on
maintenance. Flowchart 3 below shows the process for obtain such estimates.

Asset management software
It is essential to adopt and standardise on an appropriate asset management information system. There
are a number of such systems available; serious consideration should be given to open-source solutions
and/or or solutions which are cost-effective and sustainable, requiring minimal support.
Flowchart 3: How to estimate total equipment stock values

Process Activity
The HTM working group (or its pricing sub-group) at facility, district, state or national level:
Use purchase contracts,
Gathers data on current supplier information, data from
equipment prices. service contracts,
manufacturers’ websites, etc.
Compiles a Reference List typical prices for different

Equipment Price List. equipment types.
Makes a stock value Use one of the following three

estimate for the health calculations for the facility:
facility, or each facility
type.
Estimate the major expensive equipment categories (for

To obtain a rough
medical equipment, plant, furniture, etc.) for the health
estimate of the “new”
facility. Then multiply their approximate numbers by the
stock value:
reference prices.
To obtain a more exact Cost the Equipment Inventory, using the reference prices.
estimate:
To obtain an estimate Cost the Standard Equipment List for the facility, using the
for the future: reference prices.
Take the stock value for a facility type and multiply it by the
When making estimates
number of facilities of that type in district, province or
for more than one facility:
organisation.
Improves planning and Ensure the correct stock value is

budgeting. always used for planning and
budgeting purposes.
Ensures the information Revise the prices regularly in

is kept up to date. order to provide a database of
current equipment prices.
Revise the stock values

periodically.

4. Budgeting & financing
4.1. Estimates of budget lines for equipment expenditure
It is essential to have budget lines for health technologies/medical equipment in national, province,
district and facility budgets. A process for developing budget lines is shown in Box 6.
Box 6: Process for developing budget lines for equipment expenditure

People responsible Action
Finance officers, at all Establish different budget lines (sub-divisions) as itemised below:
levels of the health a. capital funds to cover equipment replacement (depreciation);
service (central, province, b. capital funds to cover additional new equipment requirements;
district, facility) c. capital funds to cover support activities which ensure equipment purchases can be used
(installation, commissioning, and initial training);
d. capital funds to cover pre-installation work for equipment purchases;
e. capital funds to cover major rehabilitation projects;
f. recurrent funds to cover equipment maintenance costs, including spare parts, service
contracts, and minor works;
g. recurrent funds to cover equipment operational costs, including consumable items and
worn out accessories;
h. recurrent funds to cover equipment-related administration, including energy
requirements; and
i. recurrent funds to cover ongoing training requirements.
HTM working groups Start using these budget lines to analyse how money is allocated and spent for equipment
purposes.
Health service providers Ensure that budgets are presented by cost centre so that it is clear what allocations are
made between national, provincial, district and facility levels. In this way, it can be seen
what money is spent on equipment activities at each level of the health service. Lobby other
bodies involved (such as Ministries of Finance, Public Works) to also show equipment
expenditures to establish what is allocated by other agencies for equipment activities in the
health service.
The high-level budgets thus obtained can then be “unpacked” into more detailed line expenditures, such
as shown in Table 1 below, with projections covering 3-5-year budget cycles.
4.2. Estimates of maintenance costs for forward planning
An important – and often neglected – expenditure category is that of maintenance, be it for medical
equipment or healthcare technologies and infrastructure in general. Box 7 unpacks the maintenance line
item to indicate the various categories of maintenance-related expenditure for medical equipment, while
Flowchart 4 suggests a process for estimating maintenance costs as part of planning.
Table 2: Example of a core equipment expenditure plan

Capital expenditure Short term Medium term
2012 2013 2014 2015
Replacement
New equipment Use calculations for
Support activities linked to purchases rough estimations (see
Pre-installation Note below)
Rehabilitation
Sub-total
Recurrent expenditure
Equipment maintenance Use calculations for

Capital expenditure Short term Medium term
2012 2013 2014 2015
Consumables rough estimations (see
Administration Note below)
On-going training
Sub-total
Total expenditure
Note: Initially, rough estimates are used for the short- and long-term overview when preparing this Core
Equipment Expenditure Plan. During annual planning the estimates are revised, using calculations for
specific requirements, to obtain the Annual Equipment Budget. The experience gained from that annual
revision process may mean that the long-term estimates in this Core Equipment Expenditure Plan may
have to be altered, so that they are more realistic.
Box 7: Elements of annual maintenance budgets

I. Planned budgets:
These allocate funds for anticipated maintenance costs, which can be derived from the following main areas of
expenditure:
a) spare parts – which are required regularly, determined from previous experience and any planned remedial work;
b) spare parts – which are required according to planned preventive maintenance (PPM) schedules and timetables;
c) maintenance materials – which are required regularly, determined by previous experience and any planned remedial
work;
d) maintenance materials – which are required according to PPM schedules and timetables;
e) service contracts – required for any planned remedial work;
f) service contracts – for breakdowns which are likely to be required, determined from previous experience;
g) service contracts – required for PPM of complex equipment;
h) calibration of workshop test equipment;
i) replacement of tools at the end of their life;
j) office material; and
k) any increased maintenance requirements brought about by planned new equipment purchases under the capital
expenditure budget.
Note: there will be other elements which may fall under other budgets. These could include:
 other administrative costs which are included in budgets held by other departments;
 major repair works – in some cases the planned rehabilitation of equipment which requires major work with the
purchase of substantial amounts of materials or contracts (the large sums of money required for such projects may
have to fall under the capital budget); and
 pre-installation work (such as site-preparation); this often falls under capital funds as it is linked to specific
purchases.
II. Contingency budgets:
In addition to planned budgets, contingency budgets also exist. These allocate funds for unplanned maintenance work,
such as emergencies, or sudden breakdowns which could not be predicted.
[See Section 10 for further discussion on maintenance-related issues].

Flowchart 4: How to make rough estimates of maintenance costs for forward planning
Process Activity
HTM working groups and/or HTM managers:
Refer to existing Use the up-to-date equipment
documents. stock values and equipment
reference price lists.
Calculate adequate Use one of the following

maintenance budget methods, depending on the type
requirements. of financial projections required
in the business plan:
Cost the Standard Equipment List for the specific type of

facility. Then calculate:
• 5-6% of the ideal stock value for medical equipment, for
To obtain an ideal
its maintenance each year;
estimate for a specified
• 1-2% of the ideal construction costs for buildings, for their
type of facility
maintenance each year; and
• 3-4% of the ideal purchase and installation costs for
service supplies and plant, for their maintenance each year.
Cost the existing Equipment Inventory for the health facility.

Then calculate:
• 5-6% of the realistic stock value for medical equipment,
To obtain a more
for its maintenance each year;
realistic estimate based
• 1-2% of the realistic construction costs for buildings, for
on current stock
their maintenance each year; and
• 3-4% of the realistic purchase and installation costs for
Cost the existing Equipment Inventory. Then calculate:

• the percentage which is actually repairable (for example,
20%) to obtain the value of the reduced stock of items
which are worth rehabilitating.
To obtain a reduced
Then calculate:
estimate based on the
• 5-6% of the reduced stock value for medical equipment,
current stock it is
possible to rehabilitate
• 1-2% of the reduced construction costs for buildings, for
• 3-4% of the reduced purchase and installation costs for
Identify and cost only certain equipment areas to

concentrate on, which it is desired to keep functioning over
the next few years. Then calculate:
To obtain a more
• 5-6% of the pragmatic stock value for medical equipment,
pragmatic/practical
estimate for most urgent
• 1-2% of the pragmatic construction costs for buildings, for
needs
• 3-4% of the pragmatic purchase and installation costs for
Feed back the Were reduced or pragmatic If so, increase the replacement budget so that more of the
maintenance maintenance amounts facility's stock can be returned to a working and repairable
assumptions made calculated? (See last two condition.
here to the replacement methods shown above.)
budget calculations.
4.3. Estimates of consumable operating costs for forward planning
In Section A2 (Needs assessment) the importance of consumables for proper functioning and utilisation was
highlighted. Since medical devices cover such a wide spectrum, the related consumables require insight and
good management. A number of alternative approaches are suggested:

i. Consumption depends on the type of equipment used, the service provided, and how many
patients are seen. Therefore, a rough estimation of consumable operating costs can be obtained
by evaluating past usage rates/expenditures, and comparing these with expected patient loads
and specific equipment usage rates per intervention.
ii. If the equipment is part of a “closed” purchasing system, the consumables are only made by one
manufacturer and one is limited to a single supplier; this monopoly often increases the
consumable costs. If the equipment is part of an “open” purchasing system, anyone can supply
the consumables and different manufacturers’ consumables could be used; this competition
brings down costs of consumable. Costs can also be kept down by using items which can be
sterilised/re-used.
iii. Consumable operating costs vary according to equipment type, and can be expressed as a
percentage of purchase cost or stock value, as shown by the examples below. But as the majority
of equipment is likely to be technology that has low to medium consumable costs, one could use
averages of 3% of the stock value for equipment with low consumable usage rates, and for others
as shown in Table 2.
Table 3: Rough estimates of consumables’ operating costs for forward planning

Consumable cost per year (relative
Description
to original purchase cost)
Equipment with high consumable operating costs, such as:
 Haemodialysis machine
 Automatic biochemical analyser
70-120%
 Automatic haematology analyser
 Electrolyte analyser
 Blood gas analyser
Equipment with medium consumable operating costs, such as:
 Conventional x-ray machine 30%
 Anaesthesia machine 20%
 ECG recorder, three-channel
 Ultrasound, medical/obstetric
 Ventilator, ICU 15-25%
 Physiological monitor
 EEG machine
 Autoclave, steam 10-15%
 Incubator, baby, ICU 5-15%
Equipment with low consumable operating costs, such as:
 Centrifuge, electrical 5%
 Suction pump 2-5%
 Delivery bed
 Operating theatre lamp
 Slit lamp 1-2%
 Operating microscope
 Water bath
A different calculation is required when making specific or annual estimates. Annual operating budgets
should be based on more exact estimates. These are not always easy to predict since epidemics,
outbreaks, or surges in workload cannot, in most cases, be anticipated.
Generally with experience, and where standardisation of equipment is in place, the projection for
equipment consumables and spare accessories becomes more predictable.

Specific or annual estimates of consumable operating costs
It is equally important to make provision for consumables on an annual basis. Flowchart 5 suggests how
this could be done.
Flowchart 5: How to make specific or annual estimates of consumable operating costs

Process Activity
Heads of Department, with their teams:
For each different type of equipment, list the consumables and spare accessories
required to operate the equipment in the department, using as guides:
• experience of typical requirements for expected workloads, departmental patient
statistics, data gathered regarding departmental requirements and rates of use;
Evaluate essential
• any new requirements for items being brought back into a working condition (as agreed
consumables and spare
in the “Annual Rehabilitation Activities” and “Annual Corrective Activities”);
accessories required.
• any additional requirements for planned new purchases of equipment from the “Annual
Purchase Activities” in the capital expenditure budget;
• the user planned preventive maintenance schedules and timetables; and
• an allowance for any emergencies.
Cost the consumables and Price the list of consumables and spare accessories for each type of equipment (from
spare accessories above), and multiply the sum by the total numbers of each equipment type involved.
identified above.
Review the total range of costs that have been estimated (from above), and:
Review and prioritise the
• prioritise the needs in order to come up with a consolidated annual estimate of
costs estimated above.
consumable operating needs.
Adjust the figures if there If the annual estimate is too big to be covered:
is a shortage of funds. • ensure that a regular budget is set.
Ensure other budgets are Liaise with other budget holders, and ensure that sufficient estimates are placed in the
set which affect equipment administration budget to cover the requirements of department.
operation.
4.4. Estimates of equipment replacement costs
Equipment replacement needs to be provided for, especially in the case of complex and expensive
equipment, to ensure that adequate resourcing is available at the appropriate time to ensure continuity –
or at least minimal disruption – of service delivery. Flowchart 6 below suggests a process to establish
estimates for replacement costs.
4.5. Rough estimates of equipment-related administrative costs for forward planning
The administrative costs associated with medical equipment are also seldom considered separately, since
they are hidden within general overheads. Different countries suggest alternative approaches:
i. Administrative costs are a small percentage of any operating budget; for example:
• the biggest percentage expense is for staff, taking 50-55%;

• supplies/spares take 35-45%; and
• administration takes only 10-20%.

Thus an equipment-user department could use an average of 15% of its total operating budget for
administrative costs.
ii. For HTM teams and clinical engineering service maintenance workshops, their administrative needs are
not much higher than other administrative units in health facilities. Therefore, a reasonable estimate for
1
the administrative costs for HTM teams could be calculated by taking 10-20% of their total operating
budget.
iii. A starting point is to use 5% of the equipment stock value to cover equipment-related administrative
costs.
Flowchart 6: How to make rough estimates of replacement costs for forward planning
Process Activity
HTM working groups and/or finance officers:
Refer to existing Use the up-to-date equipment
documents. stock values and equipment
reference price lists.
Calculate the annual Use one of the following

replacement equipment methods, depending on the type
budget requirements. of financial projections required
in the business plan:
For an ideal estimate for Cost the Standard Equipment List for the specified type of
a specific type of facility: facility. Then calculate 10% of this ideal value, for the
annual equipment replacement requirement.
For a more realistic Cost the existing Equipment Inventory for the facility. Then
estimate based on calculate 10% of this realistic value, for the annual
current stock: equipment replacement requirement.
For a more pragmatic/ Identify and cost only certain equipment areas to
practical estimate for concentrate on for replacement in the current year. Then,
most urgent needs: calculate the replacement costs for this pragmatic stock
value and their expected lifetimes.
If short of money but As a bare minimum, at least set aside some percentage of
want to start the equipment stock value each year.
somewhere:
Make allowance for the Was maintenance budget based If so, increase the replacement budget, in order to return a
assumptions made only on the small proportion of further proportion of the equipment stock to a repairable
when calculating the current equipment stock which condition.
maintenance budget. can be rehabilitated?
As in the case of consumable-related costs, it is important to determine the annual equipment-related
administrative costs (Flowchart 7).
1It is important to note, nevertheless, the valuable supporting role that administrative personnel play in any maintenance
operation. In situations where technical personnel do not have this support, a significant portion of their time is spent on
administrative duties; this negatively impacts on both their productivity and cost-effectiveness, and increases the number of
technical expert full-time equivalents needed for a specified maintenance load.

Flowchart 7: How to make specific estimates of assorted equipment-related administrative costs
Process Activity
HTM managers:
Evaluate their requirements for administrative costs, such as:
• salaries of the maintenance staff;
• overheads of the workshops, such as electricity;
• fuel allocations;
Identify their needs.
• stationery, forms, records;
• literature, written resources, and subscriptions;
• communications - telephone bills; and
• protective clothing.
Ensure they are reflected Liaise with the relevant budget holders to ensure that they place sufficient estimates
in the relevant budgets. in their budgets for expenditures affecting equipment maintenance work and services.
Heads of equipment-user departments:
Evaluate their requirements for equipment-related administrative costs, such as:
• stationery, forms, records;
Identify their needs. • literature, written resources, and subscriptions;
• protective clothing; and
• fuel allocations.
Ensure they are reflected Liaise with the relevant budget holders to ensure that they place sufficient estimates
in the relevant budgets. in their budgets for expenditures affecting equipment operational services.
5. Requisitioning
The following checklists cover three commonly encountered scenarios:
Checklist 3: Request to purchase new equipment that is not yet in use at the institution
a. Why is it essential to have this equipment and how will it enhance the present patient care. How
was this function performed before and up until this request?
b. Statistics of the patients who will be treated with this equipment.
c. Is this equipment in line with the norms of the service delivery – level of care –of the institution?
d. Accessibility to similar equipment or services in a close proximity to the Institution.
e. Is suitable accommodation available to install the equipment (building and facilities). Is the
structure suitable to carry the additional mass? This to be confirmed by the Engineering Services
Manager, in writing.
f. Are there engineering services available to operate the equipment and has the availability of the
service been confirmed in writing by the Engineering Services Manager, for instance:
g. sufficient water pressure and flow (hot and cold);
h. medical gas and compressed air (at the correct pressures and flow);
i. sufficient power at the correct voltage and current levels;
j. if required, a UPS system with a sufficient capacity;
k. a power line-conditioning unit for sensitive electronic equipment;
l. if required (for example autoclaves), is steam, condensate return and drainage available; and
m. if required, is the ventilation and air-conditioning sufficient.
n. Are proper specifications available from the HTM unit or is suitable equipment available from an
approved period tender? State the tender and the item numbers.
o. Confirmation must be obtained from the Institution that they have a budget (sufficient funds) to
pay for a service contract (where called for), as well as consumables and preventive and
corrective maintenance of the new equipment.
p. Will not having the equipment in any way compromise patient care or safety?

Checklist 4: Request to replace existing equipment
a. Inventory of similar equipment available in the Institution.
b. Inventory of how many pieces of the type of equipment are functional.
c. Inventory of how many pieces of equipment are not functional and the reason thereof.
d. Is this equipment in line with the norms of service delivery – level of care – of the institution?
e. Reason for the condemning of the equipment, supported by a Condemning Certificate.
f. Where the replacement is a fixture for instance an x-ray machine or processor, what engineering
or structural changes will be required?
g. Does the Institution have sufficient funds to purchase the equipment requested?
h. Does the Institution have a budget, sufficient funds to pay for a Comprehensive Service Contract
for the equipment requested?
i. Is suitable accommodation available to install the equipment (building and facilities) and is the
structure suitable to carry the additional mass? This to be confirmed by the Engineering Services
Manager, in writing.
j. Are there engineering services available to operate the equipment and has the availability of the
service been confirmed in writing by the Engineering Services Manager, for instance (as for
above scenario – Checklist 5)?
k. Can this equipment be standardised for the reasons previously stated above?
l. Statistics of patients to be treated with the equipment requested.
m. Are there no other procedures available to treat the patients?
n. Will not having the equipment in any way compromise patient care or safety?
o. Are there proper specifications from the Health Technology Unit available, or is suitable
equipment available from an approved period tender? State the tender and the item numbers.
Checklist 5: Request to purchase additional equipment similar to equipment already in use

a. Inventory of similar equipment available in the Institution.
b. Inventory of how many pieces of the type of equipment are functional.
c. Inventory of how many pieces of the type of equipment are not functional and the reason
therefore.
d. Is this equipment in line with the norms of service delivery – level of care - of the institution?
e. Reason for requesting the additional equipment backed up with patient statistics. Has the
function or status of the Institution changed?
f. Does the institution have sufficient funds to purchase the equipment?
g. Does the institution have a budget, sufficient funds to pay for a comprehensive service contract
for the equipment requested?
h. Can this equipment be standardised for the reasons previously stated?
i. Are there no other procedures available to treat the patients?
j. Will not having the equipment in any way compromise patient care or safety? Are there proper
specifications available from the Health Technology Unit or is suitable equipment available from
an approved period tender. State the tender and item numbers?
6. Procurement
6.1. Introduction
Procurement, from a healthcare service perspective, is probably the most important activity within the
medical equipment life-cycle. If the right (competent) people are driving a transparent, criteria-driven
(not interest-driven) process, it is likely that the healthcare system will avail itself of the technology that

is most appropriate to the intended application, while addressing issues around effectiveness, cost-of-
ownership, institutional fit, technology maturity and compatibility, user competence, maintenance and so
on. In many countries, procurement is being placed in the hands of generic supply-chain management
personnel with little specialised knowledge of medical equipment specifically, and health technologies in
general. It is therefore essential to ensure that a supporting environment is created to minimise the
possibility of sub-optimal procurement outcomes.
Procurement (for capital equipment as opposed to consumables) should be seen as a process with two
phases: one that commences with planning and needs assessment and ends with commissioning, and the
other that extends over its operational lifetime and ensures that the equipment is provided with the
necessary accessories, consumables, maintenance support, and so on.
There are four reasons for procuring equipment, each of which provides a different goal which will
dictate when to acquire equipment. These can be placed in the following order of priority (see Box 8
below). Within each of the four categories shown, priorities will have to be set, and these can be based on
appropriate indicators.
Box 8: Example of valid reasons and order of priority for purchasing of equipment
1. To cover depreciation of Equipment is replaced as it reaches the end of its life and is taken out of service.
equipment. This is necessary in order for the level of healthcare that is currently delivered to
be sustained. [Note: This means that the size of the existing equipment stock
remains the same, and does not imply an expansion of the health service.]
2. To obtain additional equipment Additional equipment may be required in order to provide a basic standard level of
items which are missing from the care. [Note: Missing items are identified by comparing the Equipment Inventory
basic standard requirements. with the Standard Equipment List for the facility.]
3. To obtain additional equipment This is done in order to upgrade the level of health service provided by the
items beyond the basic standard. hospital. For example, new equipment may be needed to provide a new service,
build a new special unit, or increase the level of care offered.
4. To obtain additional equipment This will only be applicable if the additional items have been called for by directives
items outside the facility’s own from the national or provincial ministry, and cannot be stopped/refused for
plans. political reasons, such as “out of the ordinary”, high profile, or political projects.
Of course, procurement is not a self-contained, isolated process but links up with many other equipment-
related processes; these are shown in Box 9 below.
Box 9: Planning tools that assist in deciding on procurement

Planning tools How they help
When replacing items:
Replacement policy Establishing and implementing this tool is much more likely to ensure that the necessary regular
planned replacement of equipment takes place.
Equipment inventory and These tools support identification of the need for replacement equipment at any time. For easy
maintenance record system reference, estimated lifetimes for equipment could be entered into the inventory and could then prompt
one when to purchase. The natural life of equipment is shortened by harsh environment, over-use,
unskilled handling, neglect of maintenance and damage. Equipment malfunction and downtime also
increase with the age of the equipment. Accordingly, cost-effectiveness decreases with age.
Replacement and These assist with judging when equipment has reached the end of its life, and therefore with identifying
condemnation criteria when equipment needs replacing.

Core equipment expenditure Some of the equipment will have to be replaced every year, so it makes sense to spread budgeting for
plan replacement over time. By allocating some money each year, one can avoid facing a large replacement
bill later on. This tool should spread these costs over the long term. Equipment replacement needs can
be estimated each year by assuming that each piece of equipment has an average lifetime of 10 years 2
- this means that on average 10% of equipment stock needs to be replaced each year.
Disposal policy and disposal When equipment is replaced, these tools will assist with the disposal of the old device or system. There
procedures may be government regulations regarding disposal that will provide additional information.
Stock control system Replacement equipment-related supplies should be purchased after an up-to-date stock take. Accurate
stock control systems help with planning and ordering.
When buying additional new items:
Equipment development New equipment should be purchased according to an annual purchase plan (drawn each year from a
plan, and annual purchase long-term equipment development plan). This is based on an up-to-date inventory and Standard
plan Equipment List. Accurate inventory record-keeping helps with planning and ordering.
Package of inputs Planning in advance for what will be needed after the purchase is every bit as important as the
purchase itself. Thus, one must ensure that the package of inputs required to keep equipment
functioning through its life is procured.
Core equipment financing Capital expenditure can only take place once sufficient funding sources have been identified. The long-
plan, and annual budget term Core Equipment Financing Plan and Annual Budget should allocate known and possible sources
of funds against elements of planned expenditure.
Additional items of equipment may need to be procured to accompany/complement the original item, if it
is to function properly in certain environments. For example:
• a voltage stabiliser (surge suppressor plus filter) - this offers protection against power supply
fluctuations, but does not protect against power cuts. It monitors the power supply, removes
surges and spikes, and maintains a continuously regulated alternating current output to the item;
• an uninterruptible power supply - this offers protection against blackouts and power cuts of
limited duration;
• an air-conditioning unit; and
• a water filter or treatment plant.
6.2. Preparation of specifications
Specifications have to be drawn up for every device that is planned to be purchased. Standardised
specifications need to be drawn up for commonly used devices which can then be modified (where
necessary) at institutional level.
General terms and conditions should also be part of specifications, including stipulations like the local
availability of essential spare parts, and the presence of a registered sole agent for the specific brand.
Specifications should be functional specifications and drawn up based on features available in at least a
few brands of the device commonly available in South Africa. Before making a selection the following
may be considered:
• demonstration of devices by supplier;

• trial use of the device in a facility;
• visit to a facility where the device is available;
• verbal presentation on device made by a supplier of the device; and
2 This could be amended as appropriate, for different categories of equipment, and updated as
information on equipment lifetimes is gathered.

• communication with existing users of the device both locally and abroad.
A suggested format for specifications is as follows:
• name of equipment;
• function;
• essential features;
• essential components;
• additional components;
• power supply;
• additional requirements; and
• training – user training, maintenance training.
In order to eliminate the possibility of outdated specifications being used, all specifications should have a
validity date on the document. Specifications that are not valid or have expired should not be used. Copies
of the latest specifications should be obtained from the appropriate HTM unit.
A sample specification (that for an infant incubator) is given in Annex I. For some equipment, such as
sophisticated or imported items, or equipment which is new in the system, it may be necessary to specify
the following item lines:
• Site preparation details – supplier should provide technical instructions and details so that this
work can be planned, either in-house or by contracting out.
• Installation – assistance may be needed.
• Commissioning – assistance may again be required.
• Acceptance – the responsibilities of both the purchaser and supplier with respect to testing
and/or acceptance of the goods must be clearly detailed.
• Training of both users and technicians – help must be obtained if required.
• Maintenance contract (an important part of after-sales support) – help must be requested if it is
required. It will be necessary to agree and stipulate the duration, and whether it should extend
beyond the warranty period, the cost and whether it includes the price of labour and spare parts,
and the responsibilities of the owner and supplier.
There are a number of technical and environmental factors that need to be taken into account. For
example:
• If the area has an unstable power supply, is the supplier able to offer technical solutions (such as
voltage stabilisers, an uninterruptible power supply)?
• Will the geographical location (such as height above sea-level) affect the operation of equipment
(such as motors, pressure vessels)? If so, can the manufacturer adjust the item’s specific needs?
• Extremes of temperature, humidity, and dust may adversely affect equipment operation, and may
require solutions such as air-conditioning, silica gel, polymerised coatings for printed circuit
boards, and filters.
This information can be included within the generic equipment specifications. However, since much of
the information is common to many pieces of equipment, some health service providers have found it
simpler to develop a separate summary Technical and Environmental Data Sheet, which can be referred to
in the purchase documents. This data sheet can be distributed to all suppliers, interested parties, trade
delegations and other relevant bodies. Such a data sheet can be provided regardless of the length of
specification or the procurement method used, ensuring that all parties are kept informed of prevailing
national conditions which could affect the operation of equipment.

The following details should be included in a Technical and Environmental Data Sheet:
• Electricity supply – mains or other supply, voltage and frequency values and fluctuations.
• Water supply – mains or other supply, quality and pressure.
• Environment: height above sea-level; mean temperature and fluctuations; humidity; dust level;
vermin problems, etc.
• Manufacturing quality – international or local standards required.
• Language required – main and secondary.
• Technology level required – manual, electro-mechanical or micro-processor controlled.
6.3. Evaluation and comparison process
The process of evaluation and comparison can often be time consuming. However, it is important to
ensure that decisions for awarding contracts are not made simply on the basis of which items are the
cheapest. During evaluation the items should be assessed against the requirements specified in the
purchase document. The most common way to evaluate offers is to use an elimination process, where
some offers are rejected at each stage. Offers should be judged against the following criteria:
• Compliance with requirements in the purchase document.

• Technical nature of the offer (part of the product selection criteria).
• Financial nature of the offer (part of the product selection criteria).
• Supplier qualification criteria.
By doing this, decisions are based on best value for money for the whole life-cycle cost, rather than simply
being based on the item’s purchase price.
The process of evaluation and comparison must be fair and thorough. To achieve this, the process must
follow a defined pattern to ensure all bids/quotes are dealt with in exactly the same way.
The evaluation process for tenders is similar to that for quotes, although the tender process is normally a
far more comprehensive task and is also regulated by law. The tools for evaluation can be the same, but
the amount of information required is usually much less with quotation methods. Obviously, if only three
quotes are requested for a simple small order, the evaluation process should not take much time. The
following evaluation steps are used, and some bids/quotes are rejected at the end of each step.
Step 1: Checking for compliance

The first step when evaluating offers is to determine which, if any, are not compliant with the technical,
commercial, and other specifications in the purchase document. The procurement unit should be able to
do this. It involves a more detailed examination of the offer to determine the compliance by the bidder
with the requirements specified in the purchase document. This is known in tender processes as the
substantial responsiveness of the bid. This process is more formal and comprehensive for tenders than
for quotations.
A substantially responsive bid is one which:
• conforms to all the terms and conditions; this means that the supplier has responded to all parts
of the schedule of requirements, has filled in all the boxes, and is able to supply all the parts
required; and
• also establishes the bidder’s qualifications to supply and deliver the products within the delivery
schedule; for example, the supplier:

• - has enclosed signed audited accounts, signed company declarations on health, safety, and
environmental activities, certificates of quality manufacturing, and a letter of authorisation from
the manufacturer, and
• - has nominated a representative in the country (if this was one of the compliance criteria).
All non-substantial bids will be rejected as non-responsive and should be excluded from further in-depth
evaluation.
In practice it is found that most bids contain reservations from one or more of the detailed requirements.
If these are just minor adjustments and do not represent a substantial deviation from expressed interests,
one can still conclude that the bid is substantially responsive and therefore should be included. However,
the reservations for closer clarification should be listed.
To assist in this examination one could ask for other clarifications from the bidder. One may also wish to
inspect the quality methods and production methods stated in their documents. This request and
response should be in writing. The bidders, however, are not allowed to make any changes to the
substance or price of their offers. After evaluating the offers for compliance, some offers are discarded as
the suppliers fail. The remaining offers can go forward to be compared in terms of technical performance
(Step 3).
Step 2: Preparing the evaluation information

The procurement unit should collate and compile the information from all the responsive bids into
evaluation information sheets. Box 10 gives an example of the sort of data that needs to be included.
Box 10: Evaluation information sheets

Evaluation Information Sheets present an easy way to compare different bids/quotes. For ease of comparison, it is best
to allocate one page per subject matter (technical product details, price, etc.) and compare the offers side-by-side.
Areas where each offer deviates from the equipment specification should be highlighted. Typical evaluation
information sheets would include the following evaluation criteria:
Technical product data:

 The international/regional standards that the equipment adheres to.
 Whether the operational method used is new, well tried, or old.
 The level of sophistication of the technology and the operating technique.
 Which functions and measurements do not meet the specifications in the purchase document.
 Whether any quality assurance certificates apply to the equipment.
Accessories, consumables, spare parts:
 A list and the cost of accessories included in the offer.
 A list and the cost of consumables included in the offer.
 A list and the cost of spare parts included in the offer.
 The length of time spare parts will be available and their location.
After-sales service:
 Cost of after-sales support.
 Guarantee/warranty periods.
 The details of the after-sales support that can be provided.
Price information:
 The price.
 Delivery arrangements
 Costs to install, commission, and train.
 The life-cycle costs.
Note: this is an example and not a comprehensive list. The information chosen to include will depend upon the
complexity of the equipment purchased – less technical detail is needed for simple equipment or recurrent supplies.

Ideally the evaluation information sheets should allow side-by-side comparison of the offers. For tenders
there are more responses and the orders tend to be more complex, so more paperwork is required to
obtain a true comparison. Usually there is too much information to be compiled in a single sheet, so it may
be better to use:
• one sheet for collating purely technical information about the product;
• one for information on accessories, consumables, and spare parts;
• one for after-sales service; and
• one for price information.
The procurement unit should present the evaluation information sheets to the procurement/tender
committee (for tenders and high-value quotes) or the Procurement Manager (for low-value quotes). They
should be accompanied by an explanation of the requirements, main objectives, and any binding
constraints. Then the technical evaluation process (Step 3) can commence.
Step 3: Carrying out the technical evaluation

The procurement/tender committee should base its decision on advice from members of the group with
professional knowledge relevant to the offer. If appropriate, it should also seek advice from
representatives from the relevant user department and HTM team (for low-value quotes, the
Procurement Manager should also seek advice from these end-users).
The committee should consider the product selection criteria, as set out in the purchase document. It is
essential that the information provided by the supplier is related only to the equipment specification and
the selection criteria listed in the purchase document – any additional information intended to sway the
evaluation can be seen as corruption; hence the importance of detailing requirements adequately in the
purchase document. The better the purchase document, the easier the evaluation process will be. Box 11
lists a few points to remember, relating to the technical aspects of the offer.
Box 11: Summary technical assessment

 If a detailed specification was issued, then every detail of the offer must be closely checked to make sure it conforms
to the original specification.
 If only a brief specification was issued, then the checks should be limited to ensuring the equipment or service
offered meets the requirements.
 Any modifications or alternatives offered must be assessed individually, and decisions made whether any one is
more cost-effective than another.
 The technical assessment includes suitability, safety, ability to commission and train, after-sales support, warranty
arrangements and more – do not simply assess technical data concerning the equipment.
For both quotations and tenders it may be necessary to ask the supplier to clarify any ambiguities or
uncertainties. Alternatively, a shortlist of suppliers can be drawn up and those included can be asked to
demonstrate their equipment, as part of the technical evaluation (this is unlikely to be necessary for very
simple equipment, and may be impossible for many overseas suppliers).
After the technical evaluation, some offers are discarded if they fail to meet the requirements. The
remaining offers can go forward to be compared in terms of financial performance.
6.4. Issues to consider when choosing equipment
Choosing equipment is not easy, due to the wide range of products available. External influences also play
a part. For instance, external support agencies may impose their own conditions regarding suppliers,
which may result in inappropriate equipment being supplied or procured. The acquisition policy should
clearly specify the “good selection criteria” to employ. All equipment should:

• be appropriate to its intended target setting;
• be of assured quality and safety;
• be affordable and cost-effective;
• be easily used and maintained; and
• conform to the existing policies, plans and guidelines.
These criteria, unpacked in Checklist 6 below, should be used during the procurement process when
evaluating and adjudicating between different offers from suppliers.
Checklist 6: Example of good selection criteria for equipment purchasing

Indicators of
Criteria
appropriateness
Appropriate to Equipment should be:
setting  suitable for the level of facility and service provided;
 acceptable to staff and patients;
 suitable for operator skills available;
 suitable for the local maintenance support capabilities;
 compatible with existing equipment and consumable supplies;
 compatible with existing utilities and energy supplies;
 suited to the local climate, geography and conditions; and
 able to be run economically with local resources.
Assured quality and Equipment should be:
safety  of sufficient quality to meet institutional requirements and last a reasonable length of time;
 made of materials that are durable and hard-wearing;
 made from material that can be easily cleaned, disinfected, or sterilised without rusting;
 manufactured to meet internationally recognised safety and performance standards;
 suitably packaged and labelled so that it is not damaged in transit or during storage; and
 provided by reputable, reliable, licensed manufacturers, or registered suppliers.
Affordable and Equipment should be:
cost-effective  available at a price that is cost-effective. Quality and cost often go together (for example, the
cheaper option may be of poor quality and ultimately prove to be a false economy);
 affordable in terms of costs for freight, insurance, import tax, etc.;
 affordable in terms of installation, commissioning, and training of staff to use and maintain
them;
 affordable to operate (for example, cover the costs of consumables, accessories, spare parts
and fuel over its lifetime);
 affordable to maintain and service;
 affordable to dispose of safely;
 affordable in terms of the procurement process (for example the cost of a procurement agent
or foreign exchange); and
 affordable in terms of staffing costs (for example, costs of any additional staff or specialisation
training required).
Ease of use and Equipment should be chosen:

maintenance  for which the necessary skills in terms of operating, cleaning and maintenance are available;
 for which instructions and manuals are available in a suitable language;
 for which staff training is offered by the supplier;
 for which local after-sales support is available with real technical skills;
 which offers the possibility of additional technical assistance through service contracts;
 which comes with a warranty/guarantee, covering a reasonable length of time, for which the
terms are understood (for example, does it cover parts, labour, travel, refunds or replace-
ments?);
 which offers a supply route for equipment-related supplies (for example, consumables,
accessories, spare parts); and
 which offers assured availability of these supplies for a reasonable period (up to 10 years).

Indicators of
Criteria
appropriateness
Conforms to Equipment should be chosen:
existing policies,  according to the purchasing and donations policy;
plans and  according to the standardisation policy;
guidelines  according to the technology level described in the Standard Equipment Lists and Generic
Equipment Specifications;
 which is deemed to be suitable, having studied available literature and compared products;
and
 which is deemed to be suitable, having received feedback regarding previous purchases.
It may also be appropriate to have a set of criteria to evaluate equipment suppliers, both current and past,
as per Checklist 7.
Checklist 7: Suggested criteria for evaluating current and past suppliers

Issue Criteria
Participation  Has the supplier accepted an award of bid/quotation and subsequently failed to deliver?
record  Has the supplier attempted to alter or withdraw bids after submission?
 Has the supplier promised after-sales support, then failed to provide it?
Response to  Has the supplier adequately responded to all enquiries and within a reasonable period of
enquiry time?
 Did the supplier provide regular updates on the status of outstanding orders?
Delivery time (for  What was the supplier’s average promised lead time?
consumables)  What was the actual lead time for the last round of procurement?
 What additional costs were incurred due to late shipments (if applicable)?
Adherence to  Did the shipments arrive under proper shipping conditions?
delivery  Did the supplier send full shipments as requested, or were there partial shipments?
instructions
Provisions of  Were advance copies of documents provided according to contract terms?
documents  Did shipments arrive with all required documents correctly filled out and signed?
 Were adequate site preparation instructions provided?
 Were adequate training materials provided?
 If required documents were omitted, how did the supplier correct the problem?
Packing and  Was labelling complete and adequate for proper use? Was it in the correct language?
labelling (mainly for  Did the supplier ship the correct package size? Were the correct contents and quantities in
consumables) each package?
 Did external packaging protect the product from damage during transport in country?
Product shelf life  Did the products comply with contractual terms for remaining shelf life? If not, how many
(for consumables) were shipped with shelf life less than specified?
 Did the supplier replace items that did not have acceptable remaining shelf life or allow the
return for credit or exchange of goods nearing their expiration date?
Compliance with  Did all invoices comply with contract pricing terms?
contract financial  Were all shipments correctly insured and shipped, according to financial terms in the
terms contract?
 Were there any problems obtaining compensation or reimbursement for lost or damaged
goods?
 Were there any problems obtaining compensation or reimbursement for poor services (such
as commissioning and training)?
Quality of products  Have complaints been received concerning product quality for this supplier?
and services  Did the supplier cooperate in making samples available and paying for any quality-control
tests performed by quality-assurance agencies?
 Have any complaints been received concerning the quality of services provided by this
supplier (such as installation, commissioning, and initial training)?
 Have any complaints been received concerning the quality of after-sales support from this
supplier?
Adapted from: Management Sciences for Health, 2002, “Managing drug supply”, MSH, Boston, USA.

6.5. Donations
Donations are a special case of procurement, and great care needs to be exercised in managing the
procurement process associated with donated equipment. The World Health Organization (WHO)3 and
other bodies have drafted guidelines to facilitate this process.
7. Receipt, testing, installation & commissioning
7.1. Pre-installation work / site preparation
The site at which the device is to be installed has to be adequately prepared, more so in the case of large,
sophisticated devices like x-rays, autoclaves. This has to be coordinated with logistics of the device supply
so that the site is ready when the device is delivered at the institution. The associated utilities like
appropriate power supply, water, compressed air and the like, as well as other appropriate requirements
like radiation protection should also be taken into consideration. In situations where extensive site
preparation is necessary, like in x-rays or CT scans, site works should be included as part of the
acquisition process to ensure comprehensive and coordinated site preparation.
Pre-installation work involves:
• preparing the site ready for equipment when it arrives;

• organising any lifting equipment;
• organising any warehouse (storage) space;
• confirming installation and commissioning details; and
• confirming training details.
In some cases, the pre-installation work required is minimal; in others it requires considerable labour
and finance. As a general guide, site preparation is the work required to ensure that the room or space
where the equipment will be installed is suitable. It often requires the provision of new service supply
connections (for electricity, water, drainage, gas, waste) and may require some construction work. Site
preparation tasks can include:
• disposing of the existing obsolete item (disconnection, removal, cannibalising for parts,
transport, decontamination and disposal);
• extending pipelines and supply connections to the site, from the existing service installations;
• upgrading the type of supply, such as increasing the voltage, or the pipeline diameter;
• providing new surfaces, such as laying concrete, or providing new worktops; and
• creating the correct installation site – for example, digging trenches, building a transformer
house or a compressor housing.
In considering where to position equipment, the following types of questions should be asked:
• Is there sufficient access to the room/space? (Door sizes and elevator capacity are very important
for x-ray and other large machines.)
• Is the room/space large enough?
3 See http://www.who.int/medical_devices/management_use/en/

• 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? (For example, is it air-conditioned? Dust-free?
Away from running water?)
If new buildings or extensions are being constructed, different relevant departments and groups need to
work closely together to design the rooms and plan the service supplies. Planners, users, architects,
service engineers, and equipment engineers need to be consulted.
Site preparation can be carried out by:
• in-house staff (for example, the facility HTM team or a central/regional HTM team);
• maintenance staff from other national agencies (for example, electricians from the Ministry of
Public Works);
• a contractor who has been hired (for example, a private company or an NGO partner); and
• the suppliers or their representative.
When planning and budgeting for the equipment, site-preparation costs should have been estimated for
inclusion in the budget. However, as soon as the order is placed, the HTM working group / procurement
unit should provide the supplier with details of the proposed equipment site and services, and officially
request the necessary site preparation instructions.
Once these are received the HTM manager can plan the work, quantify the needs and costs for materials
and contractors, and apply for a budget allocation. He or she should then oversee the work, and ensure it
is undertaken before the equipment arrives.
Flowchart 8 below shows the common site preparation steps that may be required, depending on the
type of equipment purchased. By the time the goods start to arrive, the site should be ready to receive
them.
Flowchart 8: Common site preparation steps

Step Activity
• Study the manufacturer’s site preparation instructions.

Review technical needs
• Use experience and common sense.
Remove existing • Cut supply connections and remove the existing item.
equipment (if applicable) • Cannibalise the existing item for parts.
• Build any special construction required, such as a transformer housing, lead

screening, room extension.
Construct or alter building • Make any special modifications necessary, such as enlarging the doorway, or building
a worktop.
• Remove any scrap or other items from the room.
Undertake the work required to provide (as necessary):

• a new transformer;
• a new or upgraded generator;
Provide electrical
• a single phase or three-phase supply at the site of installation;
requirements
• a special circuit breaker;
• a special socket outlet; and
• an electrical circuit with sufficient capacity.

Step Activity
Ensure the electricity Ensure that all relevant electrical installations are properly grounded and tested and do
installation is safe any remedial work as required.

• adequate water pressure;
Provide water and • water treatment;
drainage requirements • increased pipeline diameter;
• proper drainage; and
• appropriate connection points.

• a steam supply at the proposed site;
Provide steam supply
• increased pipeline diameter;
requirements
• a boiler which can accommodate the increased load; and

Provide gas supply
• relevant gas supplies at the proposed site; and
requirements
Depending on specific guidelines for certain types of equipment (as detailed by the
Provide extra specific equipment supplier), provide:
requirements for installing • bolts in the ceiling for attaching operating lights in theatres;
the equipment • trenches for supply lines to dental suites; and
• trenches for wastewater from washing machines, etc.
Provide any additional Provide any associated items as necessary for the equipment or installation, such as an
equipment needs air-conditioning unit, an uninterruptible power supply (UPS) and/or a water pump.
7.2. An overview of the acceptance process
Each health facility should have an official acceptance process for equipment that arrives on site (a
simpler process is used when equipment-related supplies arrive on their own). During the acceptance
process, the following should be established:
• the complete order has arrived;

• installation, commissioning, and initial training has taken place;
• the equipment is mechanically and electrically safe for users and patients and is functioning
properly; and
• the equipment is entered into the health facility inventory.
A simple way to carry out these activities is to fill in a standard Acceptance Test Logsheet. This form is
specially designed to make checking easier and to help to avoid mistakes. It is an important document
since it is the first record to be placed in the equipment file and provides all relevant details of the start of
the equipment’s life at the health facility, and commences the service history of the equipment. The
Acceptance Test Logsheet has sections that cover all the components of the acceptance process, including:
• delivery/receipt of the equipment on site;

• unpacking and checking for damage and for the complete order;
• assembly;
• installation;
• commissioning and safety testing;

• official acceptance;
• initial training;
• registration – entering stocks into stores and onto records; and
• handover.
Each of these sections in the logsheet needs to be completed and signed off to indicate that the activity
has been successfully completed. Once the logsheet has been fully completed, it is signed off to certify that
the equipment and services are satisfactory. Only then should payment be made.
If there are problems with goods or services, the Acceptance Test Logsheet should not be signed; instead
a fault report on the equipment’s shortcomings should be logged, outlining the problems encountered and
advising that payment be withheld until the problems have been addressed.
The equipment is not normally put into routine use until the complaints have been resolved, the logsheet
finally signed off, and the payments made. The acceptance process is straightforward for common low-
complexity items of equipment that are simple to use. Installation, commissioning, and initial training are
not major activities and can happen all at once – e.g. for a mobile examination lamp:
• Installation involves using a test meter to check the electricity supply of the socket outlet, and
then simply plugging in the lamp.
• Commissioning involves using a test meter to check the electrical safety of the lamp so that it will
not give the operator an electric shock.
• Initial training involves ensuring the operator knows where the on/off switch is, how to handle
the light bulb, and how to alter the angle of the head without pulling the lamp over.
Commissioning
Commissioning usually, but not always, takes place straight after installation. The technical and safety
aspects of the equipment should already have been specified and considered during the selection process.
However, it is also essential to carry out performance and safety tests on each piece of equipment. Such
tests validate that each piece of equipment is safe and is capable of performing its intended function.
Performance and safety tests should be carried out regardless of whether equipment is purchased,
donated, leased or borrowed by the health facility. The commissioning team and any visiting installers are
responsible for ensuring these tests take place. The steps in the commissioning process are shown in
Flowchart 9.
Flowchart 9: Key steps in the commissioning process

Step Activity
• Make sure all the relevant documentation is available (for example, manuals, instructions).
Check the • Place it where staff can easily gain access to it during commissioning.
documentation • During commissioning check that everything that is mentioned in the documentation is
available and functioning on the machine.
• Fit the correct mains plug to the mains lead.

• Attach any accessories
• Carry out any relevant warm-up processes.
Prepare the
• Where applicable, allow the equipment to go through any built-in self-check or test
equipment for use
programmes on start-up (such as infant resuscitation tables, bench-top autoclaves, diathermy
units).
• Where applicable, place the equipment “on-charge” (such as defibrillators).

Step Activity
• Ensure all electrical equipment is tested for adequate insulation and earth connections.
• Ensure all electro-medical equipment is tested for compliance with IEC 60101 electrical and
medical safety standards to guarantee patient and operator safety. This is particularly
Undertake safety tests important if there has been a significant time lapse since installation.
• Consider mechanical safety aspects, visually inspect the equipment, and study drawings.
• If harmful radiation is produced (β, γ or x-rays), carry out tests to ensure correct calibration
and safe use.
• Adjust the equipment to prevailing conditions (climate, electricity supply, altitude, etc.) so the
readings are true.
Initial calibration For example: adjust laboratory counters to give reliable readings; adjust air-conditioners to the
right setting for cooling rooms; provide x-ray units with sufficient power output to provide the
required dosage to patients.
• Ensure that the equipment provides dependable and accurate results. If calibration is not
done, the equipment may not function properly. For instance, an autoclave could go through
its operational cycle without reaching the correct temperature to sterilise.
Calibration
• Ongoing re-calibration is required throughout the life of the equipment to ensure that it is in a
proper, accurate working condition. These tasks could eventually be carried out by users and
maintenance technicians, depending on the equipment model type and its sophistication.
• For larger or complex equipment like autoclaves, laboratory analysers or x-ray machines, run
the manufacturer’s recommended methods/protocols on phantoms or known samples to
Function tests ensure the method is adequate and the results are acceptable and stable over time.
• Process a few control samples, or samples of known value, to make sure the equipment is
functioning properly.
• Both maintenance staff and operators should cooperate in performing such tests.
• Keep records of all test results in the Equipment File.

• Note and record any technical issues in the Equipment File.
Record the results
• Fill in the relevant sections of the Acceptance Test Logsheet, when the work has been
completed satisfactorily and all tests have been passed.
Once the equipment has passed its safety, calibration, and function tests, the commissioning team is in a
position to:
• officially accept that the equipment has been received in a satisfactory condition, and
• officially accept the equipment as the institution/department’s property.
This could trigger the payment for the goods only. Payment for services can only occur when the training
is finished, if it was part of the purchase contract. If the equipment has not passed the tests, negotiations
would be commenced with the supplier and complaints procedures initiated. The equipment should not
be accepted or used until these issues have been resolved. Once the equipment is accepted, staff can be
trained in its operation and maintenance.
Note: The concepts discussed here relate to commissioning of Health Technology specifically.
Commissioning is the subject of a separate IUSS Health Facility Guide. For a thorough discussion
on Commissioning of an entire facility and how Health Technology integrates with other
disciplines during commissioning, please refer to the said guide.

7.3. Registration and handover
Once equipment and supplies have been officially accepted, they can be registered in various health
facility records and systems, process them, and stored or used as appropriate. The commissioning team is
responsible for ensuring that all these activities take place.
Entering new equipment orders into health facility records
All equipment and equipment-related supplies need to be entered into the health facility’s records and
systems. The most common records and systems are the:
• Equipment Inventory (manual or computerised). The HTM manager should enter new major
pieces of equipment onto the Equipment Inventory. The type of information recorded should
identify the particular piece of equipment, its manufacturer and location. The HTM manager can
gather this information from the Acceptance Test Logsheet and the Register of New Stocks form.
In addition, the HTM manager should allocate a unique inventory code number to each piece of
equipment and ensure the equipment is labelled/marked with this code number.
• Equipment File (manual or computerised). This acts as a service history for a particular piece of
equipment. The HTM manager should open a new Equipment File for each piece of equipment,
and label the file with the equipment’s inventory code number. The type of information recorded
in this file at the acceptance stage should include details of the manufacturer/supplier and
purchase contract terms. Much of this information will be contained in the completed Acceptance
Test Logsheet, which should be the first document placed in this file with supplementary data as
required. Subsequent records placed in the Equipment File are of any maintenance work carried
out so that the file becomes the equipment’s service history.
• Planned preventive maintenance (PPM) programme. The HTM manager should register
equipment for any PPM carried out by maintenance staff (if it is taking place), and enter it onto
their PPM timetable so that it gets attention at regular intervals. On handover of the equipment
to the user, the HTM manager should liaise with the head of the user department (or person
responsible for equipment in that department) regarding any PPM that could be performed by
users, and entering this onto their user PPM timetable [see Section 10.2 for further discussion
on maintenance].
• Equipment card. This is a piece of card or laminated sheet that is permanently kept with the
equipment. It can provide users with a summary of the equipment care instructions and a
summary service history, such as dates when routine inspections, testing, and servicing took
place.
• Register of New Stocks form. This provides the Stores Controller with all the information
required for entering each new piece of equipment and its supplies into the stores stock control
system. The commissioning team should (partially) complete this form by gathering information
from the available contract, packing lists, or invoice, according to a standard format. The type of
information should identify the manufacturer/supplier’s order codes, description, and batch
sizes of the equipment, consumables, accessories, and spare parts. The Stores Controller finishes
completing the form by allocating and recording each item’s unique stores code. The Stores
Controller provides copies of the finalised forms to the user departments and HTM team so they
can order the correct replacement items in future. The HTM manager keeps this form in the
relevant Equipment File.
• Registering warranties. The guarantee or warranty of the equipment (if applicable) needs to be
registered. The date of commencement and the period of the warranty which have been agreed
with the supplier must be entered into all relevant procurement, finance, and maintenance
records.

• Note: Once the equipment has been checked and is confirmed as safe and ready for use, it is sensible
to highlight this fact. Use a simple strip of tape placed across the main controls of the apparatus to
clearly show that it has been tested. It is preferable to use printed warning notice tape, but other
types could be used.
Storing manuals
Operator and service manuals should be supplied with the equipment, according to the purchase
document. It is important to make sure that manuals are kept in a safe place, and are not lost by staff. It is
also important to make them widely available for use among users and maintenance staff. This can be
done by:
• Storing the original copies in a safe place, such as the clinical engineering workshop library, the
main stores office, or the HTM service library.
• Making two photocopies of all operator manuals received, and giving one set to the head of the
relevant user department, and the other to the HTM team or workshop responsible for the
equipment’s maintenance.
• Making one photocopy of the service manuals received, and giving it to the HTM team or
workshop responsible for the equipment’s maintenance.
• Asking for manuals or their content in other formats, such as CD-Rom, video, DVD.
• Scanning the printed documents into a computer to convert them into electronic copies, and
making them easily available to maintenance staff at many locations.
• Recording in the Equipment File how the manuals were distributed. This helps with monitoring
and updating the manuals in future.
8. Training
8.1. Introduction
After successful installation and commissioning, the users and maintainers need training on the type of
equipment and the model purchased. This training can take place straight after commissioning, with the
installation team acting as the trainers. However, the training team often involves different people, such
as those with clinical or training skills. In this case, the training may take place sometime later when the
training team has assembled.
Ideally, the initial training occurs straight after commissioning. After the training, the equipment can be
handed over to the user department for regular use. However, if there is a delay before training can take
place, one may have to consider whether to hand over the equipment before training staff. We recognise
that there will be pressure to do this as all staff want to start using new equipment as soon as possible.
However, this should only be done if:
• the equipment is a type that has been used before;

• the staff are familiar with the equipment; and
• experienced staff members are in charge of its use, until the remaining staff can be trained.
Note: Anyone using or working on equipment without proper training or authority whose actions result
in an accident is likely to be found negligent.

Depending on the complexity of the equipment and the staff’s previous experience of it, initial training
can include:
• good practice when handling the equipment;

• basic “dos and don’ts”;
• how to operate the equipment (along with familiarisation with the symbols and markings on the
machine);
• the correct application of the equipment;
• care, cleaning, and decontamination;
• safety procedures;
• planned preventive maintenance (PPM) for users; and
• PPM and repair for maintainers.
The level and nature of training provided depends on whether the equipment is:
• A standard make and model. If staff are familiar with the equipment, in-house staff could train
new users and provide refresher training for other staff. The training sub-group should produce
suitable and necessary training resources and hand-outs for the trainees, using the operator and
service manuals, and any videos available.
• A new make or model. If the equipment is unfamiliar, training should be carried out by the
supplier or their representative, or by a central training team with knowledge of the equipment.
The training sub-group should observe the training session, obtain copies of any overheads or
hand-outs used, and compile its own training pack for future training.
Sometimes in-depth training is given only to very few staff members who, at a later stage, will train the
rest of the users. In this case, a training timetable is needed to ensure the ongoing training occurs.
Note:
• One should ensure that the chosen trainees turn up for the training sessions, and maintain
records of the training that individual staff members have received.
• A library of the training resources developed should be established.
• The representatives of both the commissioning team and visiting training team should sign the
Acceptance Test Logsheet, to avoid later disputes.
8.2. Correct application
Staff may feel confident about how to operate equipment, but it is imperative that they also know the
correct “application” for the equipment. Staff need to be able to apply their taught (clinical) procedures
correctly, and to employ the correct methods of application so that equipment is used to its fullest
capacity.
Staff will need to be trained in order to fully appreciate when and how to use equipment. They will need
to know:
• when different features will be employed for different patients or uses the range of assistance a
machine can offer them;
• how to alter the relationship between the machine and the patient, or sample, for different
purposes; and
• the different procedures to pursue for different disorders or treatments.

They will also need to understand the safety precautions they must take. Traditionally, colleges offering
basic training for health are responsible for teaching clinical procedures. Thus, they must have access to
the necessary equipment for this purpose, both in their teaching rooms and at suitable clinical locations
such as hospitals.
It is important to note that training is an ongoing endeavour. Staff come and go, and even staff who have
received initial training on an item of equipment may need refresher training. It is therefore useful to
have a mechanism that will trigger training interventions. Flowchart 10 suggests appropriate triggers.
Flowchart 10: Example of prompts showing that training is required

Process Activity
Staff newly arrived at a facility, or In-service training co-ordinator organises induction training on equipment-related
transferred between skills.
departments.
Staff admit that they need any They request it from their head of section.
type of equipment-related
training.
Heads of section see that staff They request the necessary training from the HTM working group (or its training
are short of particular equipment- sub-group).
related skills.
Maintenance staff identify user- They report this to the HTM manager.
related problems with equipment.
New equipment arrives at the The training sub-group / commissioning team organises this.
health facility.
The HTM working group, or its safety sub-groups, decides if extra training is the
An incident report is submitted.
appropriate solution.
Skill shortages are discovered Managers agree with the individual which training would be the best development
during the staff appraisal strategy, and request it from the Human Resources Department / training sub-
process. group.
When the device is removed from service, professional users should know how to clean it and to organise
decontamination.
8.3. Special case: for home-based care or patient-operated devices
Professional users, clinical supervisors and prescribers need to make sure that training for end-users
enables them to use a medical device/equipment safely and effectively, and to perform routine
maintenance as appropriate for the medical device/equipment. For example, end-users of ambulatory
infusion pumps should be aware of how the medical device works, including special features such as
bolus delivery, and the risks of siphoning if a syringe is removed from a driver. It is also essential that
end-users are provided with information contained in manufacturer’s instructions and that it is explained
and, where necessary, expanded upon. Where possible, user organisations should provide the same
standards of equipment and training for end-users as they do for staff.

9. Operation
9.1. Introduction
“Operation” of equipment means using the correct physical methods to get the equipment to work. In
order to do this successfully, the user needs to know:
• the specific operating characteristics of the equipment;

• the operational procedures that make the machine work;
• how to use its various functions;
• how to make it perform its customary cycles and routines; and
• how to change the bulb, paper roll, batteries, etc.
The equipment manufacturer’s user manual is often the best source of this information. Other sources
include:
• written resources from staff training sessions;

• experienced colleagues; and
• a wide range of reference material.
Box 12 provides some examples of general strategies when operating equipment
Box 12. General strategies when operating equipment (for users)

 Make sure you have the authority and knowledge to operate equipment before you start;
 Refer to the manufacturer’s operating manual for correct advice.
 Always follow the safety procedures specific to the machine.
 Only connect a machine to an electrical socket outlet which has been checked by the electrician for proper
grounding, and only use the correct plug for the socket (for example, never put a two-pin plug into a three-pin
socket).
 Do not start equipment that requires water for its operation without checking that the water supply is available.
 Use equipment/machinery only with the correct type and quantities of water, oil, fuel, etc.
 Always handle accessories carefully as these are the most easily damaged component of equipment.
 Always use the correct consumables without wasting them.
 Always respond to alarms, and check what is causing them.
 Ensure that the relevant waste pipeline is not blocked, before allowing equipment to discharge its contents into the
waste water/sewage system or special container for hazardous material.
 If the electricity power supply is cut off, switch off all electrical equipment to protect it from electrical surges which
may occur when the power is restored; once power is returned, ensure that vital equipment (such as refrigerators) is
switched back on.
 Ensure that any mains-powered equipment which will be required to work off batteries during a power failure
(defibrillator, vital signs monitor, ICU ventilator, etc.) is always plugged into a live socket and left switched on so that
its batteries are continuously charged.
 When oxygen and other gases are no longer required, turn off the supply so that gas is not discharged into the
atmosphere and wasted.
Each type of equipment has specific operating instructions. When operating equipment, it is also essential
to follow good strategies for using consumable materials.
Equipment users should only operate equipment for which they are suitably qualified. Clinical meetings,
committee meetings, departmental meetings, or specifically organised training sessions can all be used to
provide application training (as appropriate).
For specialised devices e.g. autoclave, x-rays, the right type of personnel are required to operate these
devices. Certification may be a requirement for some specialised devices. Regular monitoring has to be

carried out for certain specialised devices (e.g. radiation safety monitoring for x-ray machines). User
manuals should be provided for all devices to enable users to operate all devices safely and effectively, as
well as for trouble-shooting for simple problems encountered with devices.
9.2. Care and cleaning
To maximise the life of equipment, it is necessary that equipment users and maintainers know how to
look after the equipment and clean it. Users must care for and clean equipment regularly, to a given
timetable. It is beneficial to do this because:
• it is easier to see faults (such as damaged suction pump tubing) when the equipment is clean;
• it prolongs the life of equipment (for example, protecting electronic parts from damage by dust,
protecting metal from corrosion by liquids or chemicals, protecting rubber seals from
degradation by greases);
• it protects the operator and patient from infections (from microscope eyepieces, for example);
and
• it improves the performance of equipment (clean probes for ultrasound, clean seals on fridge
doors, etc.).
The best information regarding the care and cleaning of equipment is usually contained in the
manufacturer’s user manual and/or service manual. In addition, staff should have written resources from
their training sessions and, in some cases, posters which provide the guidance and experience of their
colleagues.
9.3. Equipment-related infection control
Internationally, the term “infection control” has come to mean control of a wide range of practices,
processes and procedures in the clinical work of the health facility as a whole. Proper infection control
(relating to equipment) can be achieved by making decisions about a number of different issues:
• decontamination, through appropriate use of cleaning, disinfection, and sterilisation methods, as

well as monitoring sterility;
• linen handling; and
• ensuring the workplace is clean.
Information and advice must be sought from the relevant national body that is responsible for infection
control, since national policies should have been established to ensure that risks are reduced. It is
suggested that the central HTM working group, or its smaller sub-group, the infection control committee,
should be responsible for establishing policies and guidelines to prevent contamination through exposure
to blood, body fluids, body parts, and infectious agents.
9.4. Staff accountability
Finally, the issue of staff accountability should be addressed. Checklist 8 includes checks for different
role-players as part of a systemic approach.

Checklist 8: Strategies for making staff more accountable
Type of Staff Strategies
Heads of section - given overall responsibility for the equipment in their section, according to their
inventory and undertake regular inventory checks to look for missing equipment and
accessories;
- made responsible for conforming to the local security regulations for the facility and
its site; and
- ensure their staff have sufficient skills to operate and care for equipment correctly
and safely, and help them to access appropriate training or reference materials.
Operators-in-charge - during every shift, made responsible for undertaking functional checks on the
equipment as part of user planned preventive maintenance (PPM) schedules.
Equipment users - made responsible for the state of the equipment, accessories and consumables they
handle and use;
- take personal responsibility for ensuring they operate equipment correctly, and that
they know the correct operating techniques and applications;
- take personal responsibility for using the correct consumables in a non-wasteful way;
- take personal responsibility for ensuring they operate equipment safely, and knowing
the proper safety procedures;
- made responsible for the daily care and cleaning of the equipment they use with the
correct cleaning chemicals;
- made responsible for monitoring that equipment is functioning properly and is
providing the type of results expected, and reporting any faults immediately to the
HTM team through their head of section;
- ensure they have been specifically trained to undertake these tasks, and if they
require further skill-development put in a request to their head of section; and
- take responsibility for conforming to the local security regulations for the facility and
its site.
purchasing and supplies - made responsible for purchasing the correct consumables and cleaning chemicals.
officers
Stores controllers - made responsible for keeping track of stocks of consumables and materials in the
various stores.
Health management teams - develop a suitable working environment where managers are seen to be present, and
performing well themselves;
- consider positive strategies with bonuses and rewards for good behaviour with
equipment, as incentives for making staff more responsible and accountable; and
- consider disciplinary mechanisms so that staff are charged for intentional loss of, or
damage to equipment and accessories, to make them more accountable for their
actions.
10. Maintenance, risk-management and safety
10.1. Introduction
An effective medical equipment maintenance programme consists of adequate planning, management

and implementation. Planning considers the financial, physical and human resources required to
adequately implement the maintenance activities. Once the programme has been defined, financial,
personnel and operational aspects are continually examined and managed to ensure the programme
continues uninterrupted and improves as necessary. Ultimately, proper implementation of the
programme is key to ensuring optimal equipment functionality. Box 13 lists the some of the
responsibilities and tools typically associated with a medical equipment maintenance system.

Box 13: Summary of registers, ledgers and files used for maintenance and who keeps them
Equipment users - Work request/job forms used for recording the details of the request for maintenance
and managers support and also used by maintainers to record the work done.
- User department maintenance files to keep track of the requests made and their progress.
- User PPM schedules for each type of equipment, PPM timetables and wall calendars.
- Equipment cards attached to/kept with all pieces of equipment, showing user PPM and care
instructions and service due dates.
Maintainers - Work request/job forms submitted by equipment users and used by the maintainers for
recording the details of the work undertaken.
4
- Personal record books to keep track of special problems and successes with work, which
help to identify skill development needs.
- PPM schedules for each type of equipment.
- Equipment cards attached to/kept with all pieces of equipment used by the maintainers for
recording dates when routine inspections, testing, and servicing took place, and are next due.
HTM manager (and - Inventories of equipment, furniture, buildings, tools, etc.
possibly a clerk) - PPM timetables and wall calendars showing when PPM was undertaken on different devices.
- Job pending files and job completed files kept by the HTM team to keep track of the requests
received and their progress.
- A contractors’ record book/file to record which contractor undertook which job, and their
performance.
- Equipment files and section files which create service histories.
- Statistics forms and statistics folders for keeping various statistical records for analysis and
for compiling written reports for management.
HTM team’s stores- - A tools ledger in order to keep a record of: the tools owned, which staff members were
person allocated which tools, and the return of the tools at the end of the day.
- Stock cards used by the HTM team’s stores-person to record and keep track of the different
items stocked in the storeroom.
- A stock control ledger kept by the HTM team in order to monitor the quantities of parts and
materials used and kept in stock.
• Simple repairs should be carried out by users. Other repairs should be carried out by clinical
engineering personnel. Specialised or complex repairs should be carried out by suppliers.
• Planned preventive maintenance should be carried out to minimise down-time of devices (e.g. to
replace x-ray tube at time period recommended by manufacturer rather than when tube fails).
• Calibration and testing should be carried out at regular intervals, as recommended by the
manufacturer, by users or clinical engineering personnel – depending on the complexity of the
device.
• Records of maintenance and repairs of devices should be documented in a maintenance log,
while a plant register is to be maintained for sophisticated or specialised devices.
•
A maintenance strategy includes procedures for inspection, as well as preventive and corrective
maintenance. Performance inspections ensure that equipment is operating correctly, safety inspections
ensure the equipment is safe for both patients and operators, and preventive maintenance (PM) aims to
extend the life of the equipment and reduce failure rates. Additionally, some hidden problems may be
4
How much each person records will vary, but when a maintenance task is completed the following could be recorded: strengths (special
solutions found for problems; hints and tips; what made things turn out better); weaknesses (special problems encountered; difficult
maintenance tasks which could not be solved; methods that failed); possible solutions (training wishes; additional resources required;
altered working practices) and response to inputs (training or help received, and what they thought of it; opportunities to meet colleagues
or discuss issues, and what they thought of them).

discovered during a scheduled inspection. However, performing inspections of equipment only ensures
that the device is in good operating condition at the time of inspection and cannot eliminate the
possibility of failure during future use; the nature of most electrical and mechanical components is that
they can potentially fail at any time. Corrective maintenance (CM) restores the function of a failed device
and allows it to be put back into service.
10.2. Risk-based maintenance strategy
A risk-based maintenance strategy prioritises maintenance resources toward assets that carry the most
risk if they were to fail. It is a methodology for determining the most economical use of maintenance
resources. This is done so that the maintenance effort across a facility is optimised to minimise the total
risk of failure.
A risk-based maintenance strategy is based on two main phases:
• Risk assessment.
• Maintenance planning based on the risk.
The maintenance frequency and type are prioritised based on the risk of failure. Assets that have a
greater risk and consequence of failure are maintained and monitored more frequently. Assets that carry
a lower risk are subjected to a less stringent maintenance programme. By this process, the total risk of
failure is minimised across the facility in the most economical way.
Risk is adopted as an index for clarifying priority; that risk can be given as the product of the probability
of failure occurring to the inspected area and the consequence of failure to the surroundings. In other
words, risk is the expected value of the degree of impact. Figure 1 shows the concept of distribution of
risk held by devices in a system.
Figure 1: Distribution of risk for medical devices

A to S on the horizontal axis are the devices in
a system and the vertical axis is the relative
risk each device holds. The graph shows that
80% of the total risk of the system is
concentrated in just 20% of the devices. In
that case, it would be irrational to inspect all
devices with the same level of priority. It is
thus important to identify the 20% of devices
and raise their priority level in the inspection
programme. That is the basic concept of risk
maintenance technology.
A framework for determining risk in the

health industry should be implemented in
the following manner:

Figure 2: Risk-based maintenance framework
Data collection - equipment groups
For each risk that has been identified data about the risk needs to be collected. In the equipment scenario
it is always advisable to group equipment with the same nature and/or function, instead of focusing on
individual items. Information per equipment group will include information about the risk, its general
consequences and the general methods used to mitigate and predict the risk.
In a model developed as part of the IUSS project the main equipment groups identified are shown in Table
3 (also shown are other factors to be discussed later).
Table 4: Equipment groupings and related risk and maintenance factors

GRP Defined Total risk % Maint. of
GROUP DESCRIPTION
CODE risk Factor (%) repl. value
CAUCLE Auxiliary Cleaning/Sterilising Equipment B-Medium 56% 3.5%

CAUOTH Auxiliary Other Specialised Equipment B-Medium 52% 5.5%
CAUSPE Auxiliary Special Medical furniture B-Medium 68% 3.0%
CAUMED Auxiliary General Medical furniture C-Low 20% 3.0%
CAUTES Auxiliary Test Equipment B-Medium 74% 5.5%
CAUFUR Auxiliary General Administrative Furniture C-Low 18% 2.5%
CAUAPP Auxiliary General Appliances C-Low 20% 3.0%
CAUSOF Auxiliary Software and Communication Systems B-Medium 74% 12.0%
CBDAUD Diagnostic Audiology B-Medium 72% 5.5%
CBDFLE Diagnostic Flexible Endoscopes B-Medium 74% 5.5%
CBDMIC Diagnostic Microscopes B-Medium 74% 5.5%
CBDPAT Diagnostic Pathology Devices B-Medium 66% 5.5%
CBDRIG Diagnostic Rigid Scopes B-Medium 62% 5.5%
CBDSCA Diagnostic Scales C-Low 48% 5.5%
CBDSUR Diagnostic Surgical Lights B-Medium 74% 3.0%
CBDVID Diagnostic Video/Data Devices B-Medium 50% 5.5%
CBDOPT Diagnostic Ophthalmology B-Medium 72% 5.5%
CBLANA Life Support Anaesthesia Units A-High 100% 5.5%
CBLBAL Life Support IABP A-High 100% 5.5%
CBLDEF Life Support Cardioversion Devices A-High 88% 5.5%
CBLHRT Life Support Heart-Lung Bypass Units A-High 96% 5.5%
CBLVEN Life Support Ventilators A-High 88% 5.5%
CBMCAP Monitoring Capnography B-Medium 72% 5.5%
CBMCEN Monitoring Central Stations B-Medium 60% 3.0%
CBMECG Monitoring ECG B-Medium 60% 5.5%
CBMMUL Monitoring Multi-Parameter Monitors B-Medium 66% 5.5%
CBMOTH Monitoring Other Patient Parameters B-Medium 64% 5.5%
CBMPRE Monitoring Pressures B-Medium 60% 5.5%

GRP Defined Total risk % Maint. of
GROUP DESCRIPTION
CODE risk Factor (%) repl. value
CBMSAT Monitoring Saturation B-Medium 60% 5.5%

CBMTEM Monitoring Temperature B-Medium 60% 5.5%
CBTBEU Therapeutic Neuromuscular Stimulators A-High 76% 5.5%
CBTBRE Therapeutic Breast Pumps C-Low 40% 5.5%
CBTHEM Therapeutic Hemofiltration Units A-High 76% 5.5%
CBTINC Therapeutic Infant Warming and Phototherapy A-High 88% 5.5%
CBTINF Therapeutic Infusion Devices B-Medium 64% 5.5%
CBTINS Therapeutic Inspired Gas Conditioning Devices B-Medium 64% 5.5%
CBTLAZ Therapeutic Lasers A-High 82% 5.5%
CBTWAR Therapeutic Warmers Patient/Blood/Solution B-Medium 74%. 5.5%
CBTDEN Therapeutic Dental Equipment B-Medium 60% 5.5%
CBTPHY Therapeutic Physiotherapy Equipment B-Medium 64% 5.5%
CINELE Instruments Electric B-Medium 74% 5.5%
CINMAN Instruments Manual B-Medium 62% 2.0%
CINPHN Instruments Pneumatic B-Medium 74% 5.5%
CINHOL Instruments Hollow ware & General Stainless ware C-Low 20% 2.0%
CRDAUX Radiology Digital Auxiliary Equipment B-Medium 72% 9.0%
CRDBDE Radiology Digital Bone Densitometers A-High 80% 5.5%
CRDCAT Radiology Digital Computed Tomography A-High 84% 9.0%
CRDDEN Radiology Digital Radiographic Units Dental A-High 80% 9.0%
CRDMRI Radiology Digital Magnetic Resonance Imaging A-High 84% 9.0%
Radiology Digital Radiographic/Fluoroscopic
CRDRFS A-High 84% 9.0%
Systems
CRDRSD Radiology Digital Radiographic Systems A-High 80% 9.0%
CRDULT Radiology Digital Ultrasonic Scanning Systems A-High 76% 6.0%
CRDNUC Radiology Nuclear Medicine Equipment A-High 84% 9.0%
Risk evaluation - factors impacting on risk
At the risk-evaluation stage, both the probability of the risk and the consequence of the risk are quantified
in the context of the equipment group under consideration. For this specific model, more emphasis has
been placed on risk factors impacting directly on the maintenance function.
Volume
Availability of alternative devices to perform the same required function
Score Intensity
5 - Very low volume (only one per hospital)
4 - Low volume
3 - Medium (loan units available)
2 - Moderate (some duplication exists)
1 - High volume (high numbers per unit)
Function
Equipment function has a direct impact on the risk associated with the equipment:
Score Function
5 – Life-support
4.5 - Surgical and intensive care Therapeutic equipment
4 - Physical therapy and treatment

3.5 - Surgical and intensive care monitoring Diagnostic equipment
3 - Additional physiological monitoring and diagnostic
2.5 - Analytical laboratory

2 - Laboratory accessories Analytical equipment
1.5 - Computer and related
Miscellaneous equipment
1 - Patient Related Furniture and Other
Physical risk
The risk associated with equipment failure and/or misuse measured by the impact on patient and/or staff
injury
Score Risk
5 - Patient death
4 - Patient or operator injury
3 - Inappropriate therapy or misdiagnosis
2 - Operational risk
1 - No significant risk
Maintenance intensity
Maintenance intensity in the operational environment also impacts on the risk model due to the specific
requirements placed on scarce resources such as technical staff and financial constraints.
Score Intensity
5 - Extensive and costly with highly skilled technical staff involved.
4 - Moderate skilled technical resources required but still costly.
3 - Average skilled technical resources required with low cost associated.
2 - Low technical skill required with low cost.
1 - Minimal maintenance required.
Technology intensity
This is the risk associated with the requirements placed on the operator due to the nature and technology
level of the equipment. Qualified operators and trained staff remain a scarce resource in the medical
device industry.
Score Intensity
5 - Operator-certified and specialised training required.
4 - Specialist nursing training required.
3 - Average training required.
2 - Very low skill level required.
1 - No training required.
Risk ranking and risk classes
With the risk evaluation complete, the probability and consequence are combined to determine the total
risk. This total risk is ranked against pre-determined levels of risk. As a result, the risk is either acceptable
or unacceptable.
Equipment groups can therefore be divided into three major classes according to the risk evaluation
outcome:

High-risk equipment – risk score of 75% and higher
 Risk is not acceptable and preventive maintenance and condition monitoring is highly advised.
 This category includes all life-support devices, key resuscitation devices, and other devices whose
failure or misuse is reasonably likely to result in serious injury to patients or staff.
 High impact on hospital operational activities.
 Low volume of items increases risk.
 Device history could increase or reduce risk.
Medium-risk equipment – risk score of 50% to 75%
 Risk is not acceptable and preventive maintenance and/or condition monitoring advised.
 This category includes devices whose misuse, failure, or absence would have significant impact on
patient care, but would not likely cause immediate serious injury.
 Medium impact on hospital operational activities.
 Low volume of devices raises risk.
 Device history could increase or reduce risk.
Low-risk equipment – risk score of 50% and lower
 Risk is acceptable and very low level of preventive maintenance – if any maintenance is advised.
 This category includes devices whose failure or misuse is unlikely to have serious consequences.
 Very low impact on hospital operational activities.
 High volume of devices reduces risk.
Inspection and preventive maintenance planning
Maintenance planning should always start with a basic approach where only staff and maintenance
material are required, and further evolve to a more advanced approach where the specific asset and
method required for the asset are addressed. This also forms the basis for the maintenance excellence
hierarchy. The preventative maintenance planning is based on the following diagram:
Figure 3: The maintenance planning process

Equipment supported
The starting point for any advanced maintenance approach is to know exactly what is being maintained.
The model therefore makes use of Standard Equipment List(s) obtained from NDoH. The Standard
Equipment List (SEL) per level of care is a list of the medical equipment in the various nursing
departments and provides detail per room level. The SELs for the various levels of care are combined in
the model and standardised according to Universal Medical Device Nomenclature System™ (UMDNS).
The combined equipment list is grouped according to the various equipment groups and the risk model
applied.
Final quantities of equipment determined by number of facilities to achieve a theoretical equipment list
per province/district. This theoretical HT Asset Register can now be further manipulated to accept
changes made to quantities of specific unique items.
Method - maintenance procedures and intervals
Maintenance procedures and intervals are determined by the manufacturer and/or legal requirements.
There are international minimum accepted norms available to determine not only the service/inspection
interval (Table 4) but also the minimum procedure to be performed (NB for Table 4: All other types: once
a year).
Table 5: Maintenance intervals for different equipment types

Interval Interval
Equipment type Equipment type
p.a. p.a.
Anaesthesia Unit Vaporisers 2 Infusion Devices 1
Anaesthesia Unit Ventilators 2 Intra-Aortic Balloon Pumps 2
Anaesthesia Units 2 Isolated Power Systems 2
Apnoea Monitors 1 Laparoscopic Insufflators 1
Argon-Enhanced Coagulation Units 1 Mammography Units 2
Argon Surgical Lasers 2 Medical Gas/Vacuum Systems 1
Aspirators, Emergency and Tracheal 2 Mini C-arms 2
Automated External Defibrillators 2 Mobile C-arms 2
Autotransfusion Units 2 Mobile High-Efficiency-Filter Air Cleaners 4
Beds, Electric 1 Mobile x-ray Units 2
Blood Pressure Monitors, Electronic Indirect 1 Nd:YAG Surgical Lasers 2
Blood Pressure Monitors, Invasive 1 Oxygen-Air Proportioners 1
Blood/Solution Warmers 1 Oxygen Analysers 1
Capnometers and Multiple Medical Gas Monitors 1 Oxygen Concentrators 4
Carbon Dioxide Surgical Lasers 2 Pacemakers, External Invasive 1
Cardiac Resuscitators 2 Pacemakers, External Non-invasive 2
Centrifuges 1 Peritoneal Dialysis Units 2
Circulating-Fluid Pumps 1 Phototherapy Units 1
Circumcision Clamps 1 Physical Therapy Ultrasound Units 1
Conductive Furniture and Floors 12 Pneumatic Tourniquets 2
Critical Care Ventilators 2 Portable Ventilators 2
Cryosurgical Units 1 Pressure Transducers 2
Defibrillators 2 Pulmonary Resuscitators, Gas-Powered 1
ECG Monitors 1 Pulmonary Resuscitators, Manual 1
Electrical Receptacles 1 Pulse Oximeters 1
Electrocardiographs 1 Radiant Warmers 1
Electrosurgical Units 2 Radiographic Units, General Purpose 2
Radiographic/Fluoroscopic Units, General-
Fetal Monitors 1 2
Purpose

Interval Interval
p.a. p.a.
Frequency-Doubled Nd:YAG Surgical Lasers 2 Smoke Evacuators 1
Heart-Lung Bypass Units 4 Sphygmomanometers 1
*
Heated Humidifiers 1 Suction Regulators, Tracheal 2
Hemodialysis Units 4 Temperature Monitors 1
Ho:YAG Surgical Lasers 2 Traction Units 1
Hypo/Hyperthermia Units 1 Transcutaneous O2/CO2 Monitors 1
Infant Incubators 1 Ultrasound Scanners 1
Materials – service required items
Material required for preventive maintenance is very device- and manufacturer-specific and cannot be
generalised or averaged to be used in the model. The majority of the maintenance and repair workload is
simple tasks requiring common spare parts. Therefore, try to remember that more than 80% of all spare
parts needed (in theory), represent less than 20% of the overall spare parts cost. In other words, only
20% of your maintenance and repair tasks can eat up 80% of your spare parts budget, because the
equipment is complex and expensive.
Staff – human resource requirement
The maintenance and repair requirements of healthcare facilities are more demanding than those of most
other facilities. The high intensity of use, long operating hours (24-hours per day for most primary care
hospitals) and high-technology specialised equipment all lead to a relatively high maintenance workload
usually fulfilled by a combination of internal staff and external service providers.
There are a number of statistical models to determine the ideal staff level but most fail owing to the
complexity of the different variables:
• Technology level of hospital.

• Availability of internal maintenance specialisation.
• Internal vs outsourced maintenance combination.
• Cost constraints.
• Etc.
To get a better estimation of staff levels as well as the impact of outsourced maintenance, this model takes
a number of specific factors related to staff into consideration:
Maintenance intensity of specific equipment
The combined theoretical equipment list contains a total of 768 unique equipment descriptions. Each
equipment type has been graded according to the service requirement assigned by the service procedure
and interval, as follows:

Table 6: Grading of equipment service requirements
Major Minor Predictive Reactive
Verification
Level Service Service Inspection Maintenance
1 XXX XXX XXX XXX XXX
2 XXX XXX XXX XXX
3 XXX XXX XXX
4 XXX XXX
5 XXX
 Major service
A service that normally requires the replacement of parts as well as consumable service items.
 Minor service
A service that normally only requires the replacement of consumable service items.
 Verification
The verification of equipment performance to a standard in the form of a performance analyser and/or
simulator.
 Predictive inspection
The inspection of equipment to a set list. No tools and/or verification equipment required.
 Reactive maintenance
Only reactive work performed on equipment breakdown and/or failure.
The specific level of maintenance is always determined by the highest service requirement and may not
always include the lower service requirements. A device that requires a major service but no minor
services or verification will therefore be graded as Level 1 maintenance intensity, although not all
services are required.
Maintenance trade classification
The specific staff skill required as well as the skill level is assigned to the service requirement of every
unique equipment description.
 Electronic high
Electronically qualified person with specialisation on specific equipment.
 Electronic medium
Electronically qualified person without specialisation on specific equipment.
 Electronic low
Person with electronic background but no formal tertiary qualification.
 Mechanical high
Mechanically qualified person with specialisation on specific equipment.
 Mechanical medium
Mechanically qualified person without specialisation on specific equipment.
 Mechanical low
Person with mechanical background but no formal tertiary qualification.

Maintenance labour time requirement
An average of labour time per unique equipment description is calculated based on equipment group risk
(maintenance intensity) and assigns the following values per service type:
Table 7: Labour hours per service type
Maintenance intensity risk score

Labour hours
Service type 1 2 3 4 5
Major service 1 1.5 2.5 3.5 4.5
Minor service 0.5 0.75 1.25 1.75 2.25
Verification 0.5 0.5 0.5 0.5 0.5
Predictive maintenance 0.25 0.25 0.25 0.25 0.25
The only equipment group that does not form part of the above table is radiology equipment, where
equipment verification has been extended to an average of two hours per verification.
Outsourcing of maintenance activities
Many equipment types require very specialised training and tools for preventative as well as reactive
maintenance. This high specialisation requirement on the maintenance often leads to the outsourcing of
maintenance. Outsourcing could occur per equipment group or per unique device (manufacturer
specific).
This model incorporates three different categories that can be user selected per unique equipment type:
 Outsourced
All maintenance activities related to the specific equipment are performed by outsourced service
providers.
 Combined
The major and minor services as well as reactive maintenance are performed by outsourced service
providers and verification and predictive maintenance are performed by internal staff. As a norm, the
ratio of outsourced labour to internal labour is set at 70% to 30%. The ratio can be changed to
accommodate various scenarios.
 Internal
All maintenance activities performed by internal staff with the exception of some reactive maintenance
outsourced (unique cases).
The various types of outsourcing contracts include:
• Full coverage contracts shall be considered contracts which include both unscheduled
(emergency repair) and scheduled (preventive/interval) maintenance. This type of coverage will
involve the least amount of work for the operator and the Health Technology/Clinical
Engineering Department, as it will be up to the vendor to complete all maintenance of the
equipment. The time invested in the management of the contract will involve the most effort by
the Health Technology Department as the billing will have to be monitored and the contract will

need to be overseen to ensure that all provisions of the contract(s) are being carried out in a
timely manner.
• Unscheduled maintenance only (emergency repair) contracts are desirable where the ability to
perform the scheduled maintenance programme exists within the hospital. Each item of
equipment should receive a minimum of one (1) preventive maintenance inspection per year by
the internal staff.
• Scheduled maintenance only (preventive/interval maintenance inspection) contracts shall be
considered cost-effective where the need for expensive specialised test equipment is needed and
is not owned by the hospital, and/or where the reliability of the equipment is such that the
unscheduled downtime of the equipment does not warrant the need for full coverage. Cost-
effectiveness shall be a major part in this decision.
• Parts only contracts shall be considered where the expertise to perform the work required is
contained within the facility but the cost of parts is expensive. The decision to acquire this type
of contract shall be supported by documentation to the cost of parts and the capability of the
Clinical Engineering staff.
• Variations of and combinations of the aforementioned are another possibility. Where
documentation is present, it is possible to decide the most cost-effective method of coverage for
each piece of equipment. The extent of coverage and any portion of the workload which can be
performed by the in-house staff shall be prime consideration to the exact type of coverage
required.
Implementation of preventative maintenance plan
There are various combinations of outsourced maintenance and the planner needs to be very aware of
the different impact these combinations might have on internal staffing levels. A phased approach
according to equipment risk level should form the baseline for implementation.
It would be impractical and not cost-effective to include all equipment in a preventive maintenance plan;
if the risk is acceptable then the specific equipment should not form part of an IPM plan and only reactive
maintenance should be performed. We can divide the equipment list into groups for specific action, as
shown below (sub-types have been removed, e.g. ‘Radiographic Units, Dental, Extraoral’ and ‘Radiographic
Units, Dental, Intraoral’ are covered by the term ‘Radiographic Units, Dental’) for the sake of brevity; the
full lists are available on request. For each equipment type, there are established procedures and
protocols for what needs to be done – these are available from organisations such as ECRI.
A. High-risk with high maintenance intensity – typical outsourcing with comprehensive service
contracts and short-term implementation:
o Anesthesia Units
o Angioplasty Systems
o Apheresis Units
o Autotransfusion Units
o Brachytherapy Systems
o Circulatory Assist Units, Cardiac, Intra-Aortic Balloon
o Collimators, Radiographic
o Densitometers, Bone
o Heart-Lung Bypass Units
o Heat Exchangers, Heart-Lung Bypass
o Hemodialysis Units
o Peritoneal Dialysis Units
o Positive Airway Pressure Units, Continuous
o Pulsatile Pressure Generators, Heart-Lung Bypass
o Radiographic Systems/Units

o Radiographic/Fluoroscopic Systems/Units
o Radiotherapy Beam Block Shaping Systems
o Radiotherapy Simulation Systems
o Radiotherapy Systems, Linear Accelerator
o Scanning Systems, Computed Tomography
o Scanning Systems, Gamma Camera
o Scanning Systems, Magnetic Resonance Imaging
o Stereotactic Systems
o Ventilators.
B. High-risk with medium maintenance intensity – typical outsourcing of major services, verification
and inspections performed by internal staff and short-term implementation:
o Defibrillators
o Echocardiographs
o Incubators
o Inflators, Angioplasty Balloon
o Lasers
o Pacemakers, Cardiac, External, Invasive Electrodes
o Phototherapy Units
o Programmer/Testers, Implantable Cardiac Pacemaker
o Scanning Systems, Ultrasonic
o Phantoms, Computed Tomography
o Nerve Locators
o Stimulators, Electrical
o Valves, Positive End-Expiratory Pressure.
C. High, high risk with low maintenance intensity – typical reactive maintenance performed by internal
staff with parts-only contracts as possibility and medium- to long-term implementation:
o Angioscopes
o Brachytherapy Applicators/Sources
o Extractors, Plasma
o Masks, Resuscitator
o Radioisotope Transfer Units
o Resuscitators, Pulmonary, Manual, Reusable
o Transducers, Ultrasonic.
D. Medium-risk with high maintenance intensity - typical outsourcing of major services, verification and
inspections performed by internal staff and medium- to long-term implementation:
o Aerators, Ethylene Oxide
o Analysers, Laboratory
o Cabinets, Biological Safety
o Cameras, Identification
o Chromatography Systems
o Cleaners, Bedpan
o Compressors
o Computer Aided Detection Systems, Papanicolaou Smear
o Detectors, Air Bubble/Foam, Heart-Lung Bypass Unit
o Disinfecting Units, Liquid, Flexible Endoscope
o Injectors, Contrast Media
o Laminar Air Flow Units
o Lithotripters
o Microscopes, Light, Operating
o Microwave Therapy Systems, Tissue Ablation, Prostatic
o Pill Counters, Automatic
o Printers, Dry-Processing
o Radiofrequency Therapy Systems

o Sterilising Units
o Stools, Adjustable, Dentistry
o Tables, Imaging, Ultrasound
o Tables, Operating
o Telemanipulation Systems, Surgical
o Thrombometers
o Tissue Processors
o Urodynamic Measurement Systems.
E. Medium-risk with medium/low maintenance intensity - typical maintenance performed by internal

staff and long-term implementation.
F. All low-risk equipment – reactive maintenance only.
10.3. Computerised maintenance management system (CMMS)
In most modern health-care facilities, the number of pieces of medical equipment and the number of
service events are so large that keeping and organising this information can only be done by a computer
system. Thus, a computerised maintenance management system (CMMS) can be very useful in managing
the medical equipment maintenance programme.
A CMMS is made up of fields, tables and modules populated with data from the clinical engineering or
medical equipment department of a given facility. Using a CMMS, critical data can be accessed,
manipulated and analysed using user-friendly interfaces. Reports can be generated from the system to
help policy-makers reach decisions regarding health technologies. However, it is important to take into
consideration multiple factors when deciding to adopt and develop a CMMS. Factors such as financial and
technical resources are important when determining whether to purchase a commercial product, use
open-source software, or to develop a system locally. Implementation requires proceeding through a
number of phases that will allow the system to be planned comprehensively. By completing this multistep
process, the options for deployment will be thoroughly evaluated; a suitable package will be selected,
installed and customised; data will be entered; and training on the CMMS will be provided.
For organisations with the appropriate resources to implement this tool, a CMMS can be very beneficial. It
is a highly flexible tool that when properly implemented has the ability to transform the management of
medical equipment while also improving the availability and functionality of the technology required to
prevent, diagnose and treat illness.
A CMMS can be used to:
• standardise and harmonise information within a HTM programme;

• assist in the planning and monitoring of inspection and preventive maintenance, and schedule
and track repairs;
• monitor equipment performance indicators such as mean time between failures, downtime and
maintenance costs for individual or equipment groups of the same model, type or manufacturer;
• monitor clinical engineering staff performance indicators such as repeated repairs by the same
staff member for the same problem, average downtime associated with individuals, and
productive work time for individuals or groups;
• generate reports that can be used to plan user training programmes based on equipment failure
trends in certain departments or health facilities;
• host libraries of regulatory requirements and safety information;

• generate the appropriate documentation for accreditation by regulatory and standard
organisations; and
• generate reports to assist in the monitoring and improvement of the productivity, effectiveness
and performance of HTM
CMMS fields and tables
A field is a single piece of information, for example an “equipment serial number”. A table is a collection of
related fields; for example, an equipment location table might be made up of the fields “building”,
“department” and “room” where a piece of equipment is stored.
To avoid long descriptive text, it is useful to develop a comprehensive, consistent and simple coding
system for the various activities of the database. A single code is a field, and a collection of fields can be
organised into tables. Coding of tables can be developed for equipment inventory, personnel,
maintenance procedures and equipment locations.
Commercial CMMS packages normally have a set of generic codes that can be adapted or customised
according to the needs of the health facility. For “equipment type” coding, standard nomenclature such as
the Universal Medical Device Nomenclature System and the Global Medical Device Nomenclature System
should be considered. Implementing appropriate nomenclature can also facilitate the management of
alerts and vigilance reports. A generic list of fields that are commonly included in a CMMS is provided in
Table 7.
Table 8: List of generic fields for a CMMS

Item Fields
Inspection and preventive
maintenance (IPM) procedures
IPM frequency
Risk level
Responsible staff
Equipment model Model number
Serial number
Parts list
Parts code and name
IPM procedures
Manufacturer Manufacturer code and name
Supplier code and name
Manufacturer email, telephone and address
Supplier email, telephone and address
Manufacturer contact name
Supplier contact name
Stores/spares Store code and name
Parts code and name
Parts order number
Staff Employee code
Employee name
Employee position
Access level
Training details
Maintenance Inventory number
Work order number
Service provider

Item Fields
Service engineer code
Training details
Service IPM procedures
IPM interval
Service provider
Training details
Health facility Facility code and name
Area
Department
CMMS modules
A module is a collection of tables and data screens. The inventory module, for example, is made up of the
“equipment type” table, the “manufacturer information” table and the “equipment location” table. The
following lists the basic modules of a CMMS package:
I. Equipment inventory module.

II. Spare parts inventory and management module.
III. Maintenance (repair) module.
IV. Contract management module.
V. Preventive maintenance module.
VI. Reporting module.
CMMS implementation
Clinical engineering staff must be included in the entire CMMS planning and implementation process, as
shown in Figure 4 below and described thereafter.
Figure 4: CMMS planning & implementation process
Phase 1 - Evaluation

It is important to conduct a feasibility study to evaluate and assess the need for a CMMS. During this
phase, a complete analysis is conducted and the scope of the system is defined.
Phase 2 - Selection
Once specifications for a system have been identified, an appropriate package can be selected. It may be
one that is commercially available, customised to the health facility’s needs or designed specifically for
the user.
Phase 3 – Data collection
A comprehensive survey and analysis of all available data should be conducted before implementing the
CMMS. Complete and current inventory lists as well as all other tables required by the CMMS must be
available to avoid costly data collection processes. Most CMMS solutions fail due to inaccurate and
incomplete data collection.
Phase 4 – Installation
The CMMS can be implemented as a complete system, by individual modules, by equipment type or by
location. This is the decision of the clinical engineering department and will depend on the resources
available and hardware configuration.
Phase 5 – Configuration and customisation
Configuration of the system could cover areas such as simple workflow, access and security, and user
preferences. Customisation refers to the technical functional requirements of the system including
custom screens and tables, facility-specific workflow and additional data fields.
Phase 6 – Data entry
Initial data entry comprises common fields such as equipment model number, inventory code, human
resources, equipment locations, manufacturer information and nomenclature classifications. User
security levels and associated passwords, access levels and access types are also set at this stage.
Phase 7 – Training
Basic and advanced functional training can now be performed. It is important that each staff member of
the clinical engineering department is fully confident and familiar with all functions of the CMMS and
specific level of functionality assigned to him/her. It is useful to begin staff training in the early stages of
implementation to increase staff buy-in and improve confidence.
Phase 8 – Follow up and performance monitoring
Continuous monitoring of the system is conducted to ensure that it is directly contributing to the
improvement and effective running of the HTM programme.
10.4. Human resources
To develop an appropriate and complete staff establishment in order to achieve the objectives of the
maintenance strategy is challenging and an ongoing optimisation process – even more so under a future
NHI dispensation. The model presented here can be used to determine staff requirements and plan for
future development; however, actual implementation will highly depend on the following factors:

• Equipment included in preventative maintenance plan.
• Mixture of in- and outsourced maintenance.
• Availability of operational technically qualified staff.
• Availability of management and support staff.
• Specific health technology department structure; centralised vs decentralised structures.
• Funds available to acquire resources.
The provincial reviews have indicated that most provinces follow a combination approach between
Centralised and Decentralised Health Technology Department structures, idealised in Figure 5 below.
The Central Maintenance Unit(s) provide a single contact point to Health Facilities while decentralised HT
Departments service across multiple Health Facility Locations. The Tertiary Hospital in most cases being
the exception to the rule where the HT Department services the Tertiary Hospital only and form a self-
supporting unit.
The Central Maintenance Units are responsible for management responsibilities which includes client
relationship management, regulatory compliance, uniform standards of delivery and management of
human and financial resources.
Figure 5: Idealised health technology department structure

Self-supporting (stand-alone) decentralised departments - tertiary hospitals
Properties:
• Tertiary hospitals normally have intra-hospital HT departments without provincial support.

• Flat management structure – not included in staff complement above.
• Manage own service contracts and spare parts.
• High level of specialisation.
A suggested staff complement is shown in Table 8 (this assumes a typical asset inventory and allows for
two-thirds of available time spent on maintenance), and a suggested organisational structure is shown in
Figure 6 below.
Table 9: Typical staff complements (technical) for a self-supporting HT maintenance department

Equipment risk level
Resource C-Low B-Medium A-High Combined
Electronic high 0.00 3.82 5.68 9.50
Electronic medium 0.44 4.28 0.81 5.53
Electronic low 0.03 0.02 0.04
Mechanical high 1.14 0.01 1.15
Mechanical medium 1.09 3.12 0.01 4.22
Mechanical low 0.28 0.06 0.34
Total 20.79
Figure 6: Typical organisational structure for a self-supporting HT maintenance department
Centralised maintenance units
There are a number of variations on the structure and function of Central Maintenance Units, all
depending on the specific size of the area serviced:

• Provincial HT maintenance units.
• Servicing all levels of facilities across various districts.
• District HT maintenance units.
• Servicing all levels of facilities within a specific district.
• Facility HT maintenance units.
• Servicing a single facility where it’s based and a couple of smaller facilities in the direct
surrounding area.
The typical staffing complement will depend on the type and quantity of the facilities supported by the
central HT maintenance unit. Typical staffing levels per facility based on the variables in the model are
suggested in Tables 9-12 below, and the typical structure of a central HT maintenance unit is shown in
Figure 7.
Table 10: HT maintenance staffing requirement (regional hospital)

Equipment risk level
Electronic High 0.42 0.78 1.20
Electronic Medium 0.08 1.01 0.18 1.27
Electronic Low 0.01 0.01
Mechanical High 0.32 0.32
Mechanical Medium 0.34 0.26 0.60
Mechanical Low 0.06 0.01 0.08
Total 3.47
Table 11: HT maintenance staffing requirements (district hospital)

Equipment Risk Level
Electronic Low 0.01
Mechanical Low 0.03 0.01 0.04
Total 2.25
Table 12: HT maintenance staffing requirements (community health centre)

Electronic Low 0.01
Mechanical Low 0.10 0.11
Total 0.88
Table 13: HT maintenance staffing requirements (large clinic, with maternity)


Electronic Low
Mechanical Low 0.02 0.02
Total 0.23
Figure 7: Typical structure for a central HT maintenance unit
Properties:
• Size depends on number of facilities.

• Specialisation not as advanced as in tertiary structure.
• Staff at central location and/or remote locations.
• Specific functions at central to support remote staff.
• Resources at remote locations can be increased with staff from central location to relieve short
period demand(s).
• Administration and planning of all activities from central location.
11. Replacement, decommissioning and disposal
11.1. Introduction
• Planning for replacement of a device should commence almost at the time of the original
purchase to allow adequate time for budgeting and to prevent interruptions or disruption of
services. Planned replacement can be based on the projected life-span of the device locally.
• Decommissioning should be carried out systematically with set procedures and processes of
certification, also ensuring that services are not interrupted.

• Disposal of devices should be carried out systematically with set procedures and processes, with
safety being a prime concern.
• Additional precautions must be taken for disposal of special devices, e.g. radioactive devices.
11.2. Replacement of equipment
Replacement is necessary because all equipment has a finite life expectancy. This lifespan will depend
upon the type of equipment, and the types of technology contained within it. For example, five years
might be the typical life for an ECG monitor, 10 years for a suction pump, 15 years for an operating table,
and 20 years for an electricity generator. Once the equipment reaches the end of its life no amount of
intervention (such as maintenance) will be effective, and the only option will be to replace it.
International guidance on equipment lifetimes is available, but experience has shown that lifetimes for
individual items are crucially dependent on their utilisation, care and maintenance.
If replacement of equipment is not planned for, the health service delivered to the public may deteriorate.
If equipment is not replaced at the end of its life, there will be:
• an uneven standard of reliability among the equipment in a facility or service, and

• a general deterioration in:
o - performance;
o - safety;
o - dependability; and
o - availability for use.
For all medical devices and equipment, a stage is reached at which replacement must be considered. If
any of the following seven criteria apply, the medical device/equipment is no longer serviceable:
• Worn out beyond economic repair.

• Damaged beyond economic repair.
• Unreliable (check service history).
• Clinically or technically obsolete.
• Spare parts no longer available.
• More cost-effective or clinically effective medical devices/equipment have become available.
• Unable to be cleaned effectively prior to disinfection and/or sterilisation.
If the medical device/equipment survives this test, a date should be set for re-testing (e.g. in a year's
time).
Each facility should replace equipment for valid reasons only, which should be defined. Box 14 lists some
such reasons and suggests criteria for condemning and replacing equipment. Equipment must NOT be
condemned and/or disposed of on the strength of a Report or Certificate issued by the manufacturer,
agent, supplier or contractor.

Box 14: Example of valid reasons for condemning and replacing equipment
Valid replacement criteria
i. Equipment will be replaced only when one of the following valid reasons has been fulfilled:
a. it is worn out beyond repair (has reached the end of its natural life);
b. it is damaged beyond repair;
c. it is unreliable – faulty, old, unsafe;
d. it is clinically or technically obsolete;
e. spare parts are no longer available; and
f. it is no longer economical to repair.
and one of the following valid reasons has also been fulfilled:
g. utilisation statistics are available to show that it is still required; and
h. a demonstrated clinical or operational need still exists.
ii. Equipment will not be replaced simply because:

 it is old;
 staff do not like it; and
 a newer model has arrived on the market.
Judging when it is time to condemn equipment

Senior maintenance staff need to study the equipment, and judge:
 whether the equipment fulfils any of the valid replacement criteria (see above);
 whether the equipment has outlived its (internationally/locally) advised typical “lifetime”;
 the equipment’s track record and state of health, as documented in its service history records; and
 whether it will be necessary to override the average expected lifespan and condemn the equipment early, or
even to extend the lifespan of the equipment.
For expensive equipment, it may be helpful to obtain an evaluation from the supplier.
11.3. Decommissioning and disposal of equipment
Formal procedures must exist for condemning and disposal of equipment. Failure to dispose of
equipment properly could result in the following:
• graveyards of abandoned equipment piling up around health facilities;

• departments, store rooms, cupboards, and workshops full of old equipment; and
• previously condemned equipment ending up back on the wards and being re-used.
Once equipment has been condemned, a formal policy is needed to oversee its disposal. This should
cover:
• how it should be disposed of safely;

• how it can be disposed of as promptly as possible;
• how it can be disposed of in an environmentally sound way according to a “waste management
and hygiene plan”; and
• how useful spare parts can be stripped off before the equipment is disposed of.
Note: The practice of selling intact condemned medical equipment to contractors is strongly discouraged.
Where possible and appropriate, the condemned medical equipment must be destroyed and sold as scrap
to a metal dealer.

Flowchart 11 below describes the typical decommissioning process.
The condemning and disposal of equipment should trigger the purchase of a replacement piece of
equipment. It is preferable to plan for replacements before they are needed and, where possible, likely
replacement needs should be identified within the annual equipment inventory update and annual plans.
These activities should be timed to take place ahead of the next procurement cycle, which usually takes
place annually.
In summary, to replace and dispose of equipment it is necessary to have the following:
• technical skills to identify those items ready for replacement;

• good procurement practices which enable financing and purchase of replacement items in good
time;
• courage and determination to take equipment out of service when necessary, even if the users
want to keep using it;
• a formal method for condemning equipment;
• a formal method for disposing of the equipment, safely and in an environmentally sound way;
and
• a formal method so that the disposal of equipment triggers the purchase of a replacement item.
Flowchart 11: Steps in a typical decommissioning process

Steps Activities
Senior maintenance staff technically evaluate equipment to assess its fitness to continue in service. This can happen at any
• when there is a fault;
Timing
• during the annual equipment inventory updating process; and
• during the equipment development planning (EDP) process.
Senior maintenance staff from the local workshop consider four issues and judge:
• whether the equipment fulfils any of the valid replacement criteria defined in the replacement
policy;
• the (internationally advised) typical life-time for the equipment;
Judgement
• the equipment's track record and state of health as documented in its service history records; and
• whether it will be necessary to override the average expected lifespan and condemn early, or even
to extend the lifespan.
For expensive equipment, it may be helpful to obtain an evaluation from the supplier.
If the equipment is condemned because it is unreliable, damaged, or in any way unsafe, the
maintenance staff:
• take it out of service immediately for safety reasons and to prevent its return to use;
Technical • inform the head of the user department;
action • take unsafe moveable items to the maintenance workshop, or arrange for unsafe fixed equipment
to be disassembled; and
• if there is to be a delay with either of these actions, leave notices on the equipment and make it
inoperable (for example, by removing the accessories, or the mains connection).
The HTM manager of the local workshop:

• writes a technical report explaining why the equipment should be officially condemned and
• submits this report to the:
– health management team and relevant user department, for information and discussion at
Reporting
management meetings;
– purchasing and supplies manager, who starts the official process; and
– HTM working group, so that the condemnation triggers a replacement in the annual equipment
development planning process.

Steps Activities
The purchasing and supplies manager completes a form, such as a List of Expendables to be
Written Off form, and submits it to the relevant:
Administration
• financial head office of the organisation (for example, the Ministry of Finance); and
• local Board of Survey, whether it is a facility or district branch.
Official The Board of Survey scrutinises the report, visits the facility, and condemns the equipment, thereby
response providing the HTM service with authority to remove the equipment from service.
The HTM team from the local workshop cannibalises the equipment by:
• removing any useful components and parts from the condemned equipment, for use on other
equipment;
• storing these components and parts in the facility stores and maintenance sub-stores (depending
on their size and number);
Technical • ensuring that any hazardous components or parts (such as radioactive sources, asbestos,
action mercury, etc.) are disposed of in a safe manner according to the waste management & hygiene
plan, taking advice from the Infection Control Committee and any other relevant safety sub-group of
the HTM team; and
• placing the remaining (unusable) parts of the equipment outside at a specially designated site
within the grounds of the health facility or workshop, which is a secure site that is fenced-off and
locked.
The HTM manager ensures that the record of the written-off items:
• is removed from the equipment inventory;
Record-keeping
• is removed from the maintenance files; and
• is used to update the equipment development plan.
The local Board of Survey auctions off:

Official action • only the remaining equipment items which are safe to re-use; and
• any remaining materials for which scrap value can be obtained (for example, scrap metal).
12. Monitoring & evaluation of the HTM system
This document has outlined the building blocks of an effective, evidence-based and responsive Health
Technology Management (HTM) system. This system – in its pivotal contributing role to safe, cost-
effective, accessible and quality healthcare service delivery - needs to be monitored and evaluated on an
ongoing basis at all levels of care delivery.
Annex III suggests a set of Standards that align with the sections in this document; they also underline
the need for a clear statement of vision and intended performance. They also indirectly point to the need
for adequate and proper resourcing – at all levels of delivery – of the structures, processes, activities and
human capital that together constitute an HTM system.
Annex III also contains a list of HT-related Indicators that could be used to measure/assess compliance
with these Standards as well as indicate levels of performance in their own right.
These HT-related Standards and Indicators are particularly relevant with respect to the newly established
Office of Standards Compliance of the Department of Health and the associated National Core Standards
for Health Facilities. They will also be very useful as bridging links between the public and the private
sectors as we move towards an NHI dispensation.

PART C - ANNEXURES
1. ANNEX I: Sample Generic Equipment Specification: Infant Incubator
NB: The specification is intended to indicate the range of issues addressed as well as the level of detail, clarity
of language and formatting/layout typically associated with a good technical specification; however, since
this is being used for illustrative purposes, many clauses have been omitted for the sake of brevity.
1. APPLICABLE DOCUMENTS
The specification should be read in conjunction with the “Technical and Environmental Data Sheet”, and
all goods offered must conform to the details specified in it and be able to function in the prevailing
conditions described.
2. REQUIREMENTS
2.1 GENERAL DESCRIPTION
To supply: ONE unit to provide a suitable environment conducive for nursing ill, premature, and
underweight babies.
2.2 OPERATIONAL REQUIREMENTS

Note: supplier to complete “Reply” and “Remarks” sections.
2.2.1 There shall be a trolley base with four swivel wheels, at least two lockable.
2.2.2 The incubator shall fit securely onto the trolley.
2.2.3 The incubator base shall house the power compartment, fan and humidifier tank.
2.2.4 The infant compartment shall have a base, mounted above the humidifier tank and fan, which is
large enough to allow the unimpeded handling of the infant. Base shall have smooth, easy to
clean surfaces.
2.2.5 The baby tray shall be mounted on the infant compartment base and shall be tiltable.
…
2.2.8 The infant compartment shall have a transparent canopy that forms four sides and the roof.
2.2.9 The canopy shall be hinged along one side so that it can be swung up to provide free access to
the bed.
…
2.2.15 The air shall be drawn into the incubator through an easily removable bacteria filter capable of
removing, with an efficiency of 99%, particles of the size down to 0.5 micron diameter.
2.2.16 The air shall be circulated by means of a fan.
2.2.17 The circulated air shall maintain slight positive pressure in the infant compartment such that
enough stale air escapes from the hood to prevent an undesirable and dangerous carbon
dioxide accumulation inside blood.
2.2.18 The hood shall have inlet holes for access by oxygen and feeding tubes.
…
2.2.21 There shall be an air temperature sensor mounted on the inside of the canopy.
2.2.22 The incubator shall be equipped with heating elements of the totally enclosed metal-clad type
and a thermostat capable of controlling the temperature in the infant compartment over a
specific temperature range.
2.2.23 The incubator shall be equipped with a reliable pre-set high-temperature cut-out that operates
completely independently from the thermostat and that disconnects the heating circuit from
the electricity supply if, as a result of heating from any source (including direct sunlight or
nearby heaters), the temperature in the infant compartment exceeds 39˚C. Any relay forming
part of this circuit shall be arranged to be fail-safe.
2.2.24 Temperature range of 34-39 degrees Celsius, in increments of 0.1 degree.

2.2.26 The airflow alarm shall be activated if the airflow is obstructed (due to fan failure or total air
circulation failure). The activation of the alarm shall cause a cut off of the heating elements. It shall be
mains operated audible and visual.
2.2.27 The high temperature alarm shall be activated if air temperature in the canopy exceeds 39˚C. It
shall be mains operated audible and visual.
2.2.28 The power failure alarm shall give warning of any interruption of the electric power supply to
the incubator. The alarm shall be operated from a battery of the nickel cadmium type that is
housed in the power compartment and is continuously trickle-charged when the power is
switched on. The alarm shall be audible and visual.
2.2.29 Single-phase power supply of 220-240 Vac, 50Hz.
2.2.30 To be able to withstand mains supply voltage fluctuations of +/- 10%, and mains supply
frequency fluctuations of +/- 10%.
2.2.31 The incubator shall be equipped with a 3-metre non-kinking type flexible mains lead, fitted with
a three-pin (square) 13A plug. The mains connector to be detachable locking type.
2.2.32 The humidifier tank will consist of a water reservoir, water inlet port, and water outlet drain
constructed in such a way that once drained a residue puddle of water cannot remain in the
reservoir.
2.3 PHYSICAL CHARACTERISTICS

2.3.1 The trolley to be of metallic tubular frame of such dimensions and wall thickness as to give
acceptable strength and rigidity. It shall have a polyester powder coating finish.
2.3.2 The casters will be of a minimum size of 100mm.
2.3.3 The incubator base shall be of metal construction with a polyester powder coating finish.
2.3.4 The power compartment shall be of metal and so designed that the mechanical and electrical
equipment within it is adequately protected against mechanical damage and the ingress of
water and cleaning fluids.
…
2.3.7 The bed tray and support shall be of corrosion-resistant material.
…
2.3.10 It should be possible to fully dismantle the equipment for cleaning purposes; and all parts will
be easily cleaned.
2.4 SAFETY FEATURES

2.4.1 The unit must be manufactured to conform to the IEC safety standard 60101 for medical
electrical equipment 2.4.2 Safety Classification: Type B.
3. ACCESSORIES AND CONSUMABLES

3.1 The trolley base to contain a storage compartment with latching doors.
3.2 An IV pole shall be attached to the trolley.
3.3 An oxygen cylinder holder shall be attached to the trolley.
…
3.6 Supply all necessaries for the unit to function as described.
3.7 A list of each accessory and its cost must be stated.
3.8 State all consumables necessary for the unit to function for two years.
3.9 A list of each consumable and its cost must be stated.
4. DOCUMENTATION
4.1 Supply an operating manual in English for the machine.
4.2 Supply a service manual in English for the machine.
4.3 Supply a list of recommended spare parts required for the maintenance of the machine,
5. SPARE PARTS
5.1 Supply a set of only the recommended essential spare parts for 24 months for maintenance and
repair.
5.2 A list of each part and its price must be attached to this bid.

6. DELIVERY
6.3 The cost of freighting the goods by sea and road (alt: air and road) to health facility X must be
stated.
7. INSTALLATION/COMMISSIONING/TRAINING
7.1 Full assembly and commissioning instructions must be provided for assembly and commissioning
by the client, in a written format and as a video if available.
7.2 The cost of commissioning by the supplier or representative must be stated.
7.3 State the cost of the supplier or representative undertaking training and providing written
guidelines:
- in operation – for users;
- in care and cleaning – for users;
- in PPM – for maintenance technicians; and
- in repair – for maintenance technicians
8. WARRANTY
8.1 A guarantee period must be stated (a minimum of 12 months from the date of commissioning).
9. AFTER-SALES SUPPORT
9.1 After-sales support must be available, with maintenance capabilities and facilities, and spare parts
stock holdings.
9.2 Details of the availability and location of spare parts must be stated.
9.3 Details of the availability and location of maintenance facilities must be stated.
9.4 The cost of the annual maintenance contract must be stated, detailing the range/scope of such
maintenance work.
10. SUMMARY OF PRICES (detailed as follows: total prices, showing options and alternatives):
1. Basic unit.
2. Accessories as detailed.
3. Optional accessories.
4. Consumables.
5. Documentation.
6. Spare parts for maintenance and repair for 24 months.
7. Crating, delivery, insurance.
8. Commissioning, training.
9. Annual maintenance contract.

2. ANNEX II: Standard device categories and descriptions
(See: Standard Device - Lookup v3.pdf)
(See: Standard Device - Description v3.pdf)
3. ANNEX III: Healthcare technology standards and indicators
3.1. Standards
The following standards are suggested in alignment with some of the key building blocks of an HTM
System.
HT Planning (S1)
There is a system in place which ensures that health technologies are properly planned and provided for
in response to disease burden profiles and healthcare needs of populations served, in alignment with
service delivery needs and in compliance with organisational and financial constraints.
HT Inventory (S2)
There is a system in place which ensures that appropriate and adequate information on health
technology/ medical device assets is maintained, and that this information is validated, regularly updated
and accessible to HTM-related decision-making structures and processes at all levels of healthcare
delivery.
HT Budgeting and financing (S3)
There is a system in place which ensures that health technologies and related expenditures are properly
budgeted for and appropriately and sustainably financed, in accordance with prescribed regulations and
organisational policies.
HT Requisition (S4)
There is a system in place which ensures that health technology requests at all levels are properly
initiated, screened and collated, according to established criteria and in compliance with specified
formats and processes.
HT Procurement (S5)
There is a system in place which ensures that health technology requests, if properly drafted and
considered, are translated into a transparent, criteria-driven process that ensures the acquisition of the
best technology solution with due consideration of organisational needs and preferences and related
criteria.
HT Receipt, testing, installation & commissioning (S6)
There is a system in place which ensures that medical equipment, as part of the procurement process, is
properly received, tested, installed and commissioned prior to use in the healthcare environment, in
accordance with laid-down procedures and accepted good practice. Pre-installation site preparation or
modification may be required.

HT-related training and skills development (S7)
There is a system in place which ensures that both medical equipment users and maintenance personnel
receive appropriate and ongoing training and skill development, so that healthcare interventions and
procedures requiring medical equipment, devices and/or instruments are delivered safely and effectively.
HT operation (S8)
There is a system in place which ensures that health technologies are utilised and managed optimally so
as to achieve maximal benefit in terms of health outcomes, as part of quality healthcare delivery.
HT maintenance, risk management and safety (S9)
There is a maintenance and risk management system in place that, in keeping with international and
national standards and practice, ensures safety of staff and patients.
3.2. Indicators
Core indicators (ex WHO)
I. Inputs and processes
1. Procurement budget
Description: Total budget spent on new acquisitions in relation to total current asset
replacement value (%).
Rationale: A sufficient budget allocation is necessary in order to replace outdated assets and
keep pace with rapid developments in new medical procedures and changing
trends in technology. The total budget combines new acquisitions (additions to
the existing asset base) and funds for the replacement of outdated and obsolete
assets. The total budget combines funding from all sources. Benchmark/Target:
10% or higher.
Measurement: Evaluation of budgets, at national, sub-national or facility level, extracting the
budget spent on new acquisitions, in relation to the total asset replacement value.
Effort level: Low to medium.
Numerator: Total budget spent on new acquisitions per annum.
Denominator: Total current asset replacement value.
Data collection methods/sources:
Statistics to be provided by the health institutions administration, technical
department and/or MoH.
Periodicity: Annual.
2. Maintenance budget
Description: Total combined budget spent on maintenance and training in relation to
total current asset replacement value (%).
Rationale: Proper maintenance of assets and training of support staff in the use and
maintenance of assets is a prerequisite for effective asset management. The
budget spent on maintenance and training has to be in a sound relation to the total
asset replacement value. Benchmark/Target: 6% or higher.

Measurement: Evaluation of budgets, at national, sub-national or facility level, extracting the
budget spent on maintenance and training, in relation to the total asset
replacement value.
Numerator: Total budget spent on maintenance and training.
Denominator: Total current asset replacement value.
3. Workforce
Description: Number of trained technical support staff related to number of devices.
Rationale: Only with a sufficient number of qualified managerial, engineering and technical
staff can adequate, high-quality health infrastructure and technology management,
and thus high quality healthcare, be sustained. Benchmark: ratio in countries with
high-quality CE services.
Measurement: The number of trained technical support staff per 1 000 medical devices.
Effort level: Low.
Numerator: The number of trained technical support (CE) staff.
Denominator: Total number of medical devices supported.
II. Outputs
4. Asset quality
Description: Proportion of assets ready for service delivery in a reliable and safe manner
(%).
Rationale: At any given time, all assets should be in working and safe condition and be used
to their full capacity. There should be no defective, unsafe or outdated assets.
Benchmark: 100%.
Measurement: Inspection (audit) of all assets in regular intervals and maintaining a checklist
indicating working condition, safety and usage.
Numerator: Number of assets ready for service delivery - i.e. reliable and safe.
Denominator: Total number of assets.
5. Asset downtime
Description: Average downtime of assets following breakdown or failure (days).

Rationale: The period of time that it takes the service department to restore defective assets
in health facilities to their original working state should be kept to a reasonable
and feasible minimum. Benchmark/Target: Minimum period of time (days).
Measurement: Statistics on downtime of all equipment (by major category/type).
Effort level: Low.
Numerator: Average downtime of assets following breakdown or failure (in days).
III. Outcomes
6. Service access
Description: Percentage of HIT-related patient referrals.
Rationale: Unnecessary referrals to other, normally higher-level facilities, as a result of asset-
related problems, delay the treatment of patients and cause additional costs, thus
negatively reflecting on the quality of healthcare. Benchmark/Target: No referrals
(0%).
Measurement: Statistics on the total number of patients and the number of health infrastructure-
and technology-related referrals.
Effort level: Low.
Numerator: Number of patients being referred to another facility due to asset problems (lack
of equipment or consumables, equipment out of order, etc.).
Denominator: Total number of patients making use of facility (as either out- or inpatients).
Statistics to be provided by the health institutions, healthcare providers and MoH.
7. Service delay
Description: Percentage of patients unduly delayed due to asset failure.
Rationale: With adequate implementation of proper management processes, patient wait
times due to asset failure will be kept to a minimum. Benchmark/Target: No
delays (0%).
Measurement: Statistics on asset failure and the number of patients delayed by these failures.
Effort level: Medium.
Numerator: Number of patients with delayed diagnosis or treatment due to asset failure.
Statistics to be provided by the health centres and MoH.
IV. Impact
8. Patient safety
Description: Rate of adverse events due to asset failure.

Rationale: HIT-related incidents and accidents sharply decrease with improving the quality
of the technical support services. Asset-related adverse events can affect both
staff and patients and must be notified. Benchmark/Target: No adverse events
during the period of assessment.
Measurement: Evaluation of accident and incident reports.
Effort level: Medium, decreasing to low with the introduction of an accident and incident
notification system.
Numerator: Number of HIT-related accidents and incidents for the institution or level
assessed.
Statistics to be provided by the health centres and MoH. Statistics from the
accident and incident reporting system. Statistics from the WHO safe surgery
checklist.
9. Staff satisfaction
Description: Degree of satisfaction of health workers with asset performance.
Rationale: Staff satisfaction is to a large extent related to the positive or negative
contribution of asset performance to the effectiveness and efficiency of healthcare
delivery. Benchmark/Target: High degree of satisfaction.
Measurement: Evaluation of questionnaires. A representative sample of health workers
expresses their level of satisfaction on a scale of 1-5: (1) Very poor, (2) Poor, (3)
Reasonable, (4 ) Good, (5) Excellent.
Effort level: Medium.
Numerator: Satisfaction score (average and range) as per agreed grading system.
Questionnaires to be answered by a representative sample of health workers in
the health institutions.
Periodicity: Annual
10. Financial risk

Description: Proportion of assets in good working condition, but not used.
Rationale: With appropriate management, all assets should be used up to their full capacity.
In cases were assets are in good working condition, but not fully utilised, this is
seen as a financial waste. Benchmark/Target: 0%.
Measurement: Inspection of all assets at regular intervals and maintaining a checklist indicating
their use.
Effort level: Low.
Numerator: Number of assets not used (or used to less than 50% of expected capability),
though in good working condition.
Denominator: Total number of assets.
Statistics to be provided by the health institution administration, technical

PART D - REFERENCES AND SELECTED BIBLIOGRAPHY
1. Banta D, Luce B (1993). Health Care Technology and its Assessment: An International
Perspective. Oxford University Press.
2. Department of Health, Republic of South Africa (2000). A Framework for Health Technology
Policies.
3. Department of Health, Republic of South Africa (2004). Health Technology Assessment:
Discussion Document on a Strategy for the Future. Report of Interim Steering Committee on
Health Technology Assessment.
4. Department of Health, Republic of South Africa (2005). National Health Technology
Management Policy (draft).
5. Federal Ministry of Health, Republic of Sudan (2011). Health Technology Management Policy
(Medical Devices)
6. Locke GP (2000). Safety and Risk Management. Course Notes, Healthcare Technology
Management (HTM) Programme, University of Cape Town.
7. Ministry of Health, Republic of Uganda (2009). National Medical Equipment Policy (4th
edition).
8. Nunziata E (2003). Workshops overview. Basic Principles and Implementation Strategy.
9. Nunziata E, Poluta M (2006). Health Technology Unit: Framework for Establishment of
Regional Workshops. Consultancy Report.
10. Nunziata E, Poluta M (2006). Medical Device Acquisition and Procurement Policy: Draft and
Background Document. Consultancy Report.
11. Nunziata E, Poluta M (2012). Procedures, Standards and Norms for Healthcare Technology
Lifecycle Management. Consultancy Report.
12. Panerai R, Mohr B (1989). HTA Methodologies for Developing Countries. PAHO.
13. Poluta M (2013). Course Notes (various), Healthcare Technology Management (HTM)
Programme, University of Cape Town.
14. Ridgway M, Atles LR, Subhan A (2009). Reducing Equipment Downtime - A New Line of
Attack. J of Clin Eng, Oct/Dec issue, pp 200-4.
15. Rosen R, Gabbay J (1999). Linking health technology assessment to practice. BMJ vol. 319.
16. Stevens A, Milne R, Lilford R, Gabbay J (1999). Keeping pace with new technologies: systems
needed to identify and evaluate them. BMJ vol. 319, Nov.
17. Temple-Bird C (2000). Practical Steps for Developing Health Care Technology Policy. Institute
of Development Studies, Brighton.
18. Wang B, Fedele J, Pridgen B et al (2010). Evidence-Based Maintenance (Part I): Measuring
Maintenance Effectiveness with Failure Codes. J of Clin Eng, Jul/Sep issue pp 132-144.
19. WHO (1989). Manpower Development for a Health Care Technical Service – Report of WHO
Inter-regional Meeting, Campinas, Brazil.
20. WHO (1997). Guidelines for Healthcare Equipment Donations.
21. WHO (1998). Final Report of the WHO Consultation on Physical Infrastructure and
Technology.
22. WHO (2001). Report of Technical Consultation on Effective Coverage in Health Systems
WHO/EIP/OSD/10.01.
23. WHO (2002). Safe Medical Devices. Aide-Memoire for National Medical Device
Administrations.
24. WHO (2008a). Strengthening Healthcare Infrastructure and Technology Management for
Optimized Health Service Delivery. Luxembourg – WHO Project Technical Document.
25. WHO (2008b). Measuring Health Systems Strengthening and Trends: A Toolkit for Countries.
26. WHO (2010a). A Framework for National Health Policies, Strategies and Plans. Consultation
Document (draft 3).
27. WHO Collaborating Centre for Essential Technologies in Health (1998). The Essential
Technology Package – a decision-support tool for selection and codification of equipment

based on identified health interventions and delineated procedures.
28. WHO. Towards a WHO Model List of Essential Medical Devices. Dept. of Essential Health
Technologies.
29. WHO/World Bank/GAVI/Global Fund (2009). Monitoring and Evaluation of Health Systems
Strengthening – An Operational Framework.
30. WHO-AFRO (1998). Guidelines for the Formulation of a National Equipment Policy.
31. WHO-AFRO (1999). Health Technology Policy in the African Region – Horizon 2010.
32. WHO-EMRO (1997). Resolution EM/RC44/R3 on Appropriate Health Technology.
33. WHO-EMRO (2001a). Eastern Mediterranean Regional Strategy for Appropriate Health Care
Technology. No. 2 in Series on Health Care Technology Management.
34. WHO-EMRO (2001b). Health Care Technology Policy Formulation and Implementation. No. 3
in Series on Health Care Technology Management.
35. WHO-EMRO (2001c). Health Care Technology Policy Framework. No. 1 in Series on Health
Care Technology Management.
36. Ziken International (2005). “How to Manage” Series for Healthcare Technology. DFID KaR
Programme
37. WHO Medical Device Technical Series (2011) includes:
i. WHO EHT Computerised Maintenance Management System Guide
ii. WHO EHT Donations Guide
iii. WHO EHT HTA Guide
iv. WHO EHT Inventory Management Guide
v. WHO EHT Maintenance Guide
vi. WHO EHT Needs Assessment for Medical Devices
vii. WHO EHT Procurement Process Guide

Available at http://www.who.int/medical_devices/management_use/en/


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INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 1

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 2

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 3

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 4

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 5

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 6

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 7

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 8

PART D - contains references and bibliography.

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 9

CLINICAL SUPPORT HEALTHCARE PROCUREMENT&

Adult Inpatient Administration Generic Room Integrated

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 10

1. Health technology context

2. Application of the Guidelines

3. Associated process and related documents

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 11

Box 1: The planning and budgeting process (start-up)

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 12

1.2. Service and related technology planning

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 13

 Availability and condition of medical  Medical equipment  Facility map.

Checklist 1: Equipment considerations for vision at national level

1.3. Planning and budgeting when starting out

Box 3: Minimum planning and budgeting requirements

1. Equipment inventory 1. Essential to have.

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 14

2.1. Standard lists of equipment

• human resource requirements, and training needs;

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 15

• an electric suction pump or a foot-operated one;

It is important that any equipment suggested:

Usefulness of the standard equipment lists

Box 4: Process for Identification of Standard Equipment Lists

Who/which level? Takes what action?

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 16

2.2. Equipment development plan

Flowchart 1: The basic equipment development planning process

Compiles the needs List all these requirements.

Prepares various Creates plans for:

Prioritising and appraisal of options

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 17

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 18

Box 5: Inventory-related responsibilities, activities and actors

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 19

 Provide a copy of the Equipment

3.2. Asset management system

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 20

Flowchart 3: How to estimate total equipment stock values

Compiles a Reference List typical prices for different

Makes a stock value Use one of the following three

Estimate the major expensive equipment categories (for

Improves planning and Ensure the correct stock value is

Ensures the information Revise the prices regularly in

Revise the stock values

INFRASTRUCTURE UNIT SUPPORT SYSTEMS (IUSS) 21

4.1. Estimates of budget lines for equipment expenditure

Box 6: Process for developing budget lines for equipment expenditure