Needs assessment for

medical devices
WHO Medical device technical series
Needs assessment for
medical devices
WHO Medical device technical series
 WHO Library Cataloguing-in-Publication Data

Needs assessment for medical devices.

(WHO Medical device technical series)

1.Appropriate technology. 2.Equipment and supplies. 3.Technology assessment,

Biomedical. I.World Health Organization.

ISBN 978 92 4 150138 5 (NLM classification: WX 147)

© World Health Organization 2011

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Design & layout: L’IV Com Sàrl, Le Mont-sur-Lausanne, Switzerland.

iv Needs assessment for medical devices

Contents

Figures and tables 2

Preface 3
Methodology 4
Definitions 5
Acknowledgements 6
Declarations of interests 6
Acronyms and abbreviations 7
Executive Summary 8
1 Introduction 9
2 Purpose 10
3 General approach 11
4 Specific approach 13
4.1 Step I: Baseline information on health service requirements 13
4.2 Step II: Baseline information on health service availability 14
4.3 Step III: Baseline information on medical devices 15
4.4 Step IV: Baseline information on human resources 17
4.5 Step V: Baseline information on finances 17
4.6 Step VI: Analysis and interpretation 18
4.7 Step VII: Prioritization and appraisal of options 18
4.7.1 Prioritization 18
4.7.2 Option appraisal 19
4.7.3 Developing an implementation plan 20
5 Concluding remarks 21
6 Useful resources 22

Appendix A Certificate of need process 24

WHO Medical device technical series 1

 Figures and Tables

Table 1. General needs assessment approach (process) 11

Figure 1. General needs assessment process 12
Table 2. Baseline information on health service requirements 13
Table 3. Baseline information on health service availability 14
Table 4. Baseline information on medical devices 15
Table 5. Baseline information on human resources 17
Table 6. Baseline information on finances 17
Table 7. Plan, Do, Study, Act (PDSA) prioritization matrix 19
Table 8. Key questions for prioritizing and appraisal of options 20

2 Needs assessment for medical devices

Preface

Health technologies are essential for a functioning health system. Medical devices
in particular are crucial in the prevention, diagnosis, and treatment of illness and
disease, as well as patient rehabilitation. Recognizing this important role of health
technologies, the World Health Assembly adopted resolution WHA60.29 in May 2007.
The resolution covers issues arising from the inappropriate deployment and use of health
technologies, and the need to establish priorities in the selection and management of
health technologies, specifically medical devices. By adopting this resolution, delegations
from Member States acknowledged the importance of health technologies for achieving
health-related development goals; urged expansion of expertise in the field of health
technologies, in particular medical devices; and requested that the World Health
Organization (WHO) take specific actions to support Member States.

One of WHO’s strategic objectives is to “ensure improved access, quality and use of
medical products and technologies.” This objective, together with the World Health
Assembly resolution, formed the basis for establishing the Global Initiative on Health
Technologies (GIHT), with funding from the Bill & Melinda Gates Foundation. GIHT
aims to make core health technologies available at an affordable price, particularly
to communities in resource-limited settings, to effectively control important health
problems. It has two specific objectives:

• to challenge the international community to establish a framework for the

development of national essential health technology programmes that will have a
positive impact on the burden of disease and ensure effective use of resources;
• to challenge the business and scientific communities to identify and adapt innovative
technologies that can have a significant impact on public health.

To meet these objectives, WHO and partners have been working towards devising an
agenda, an action plan, tools and guidelines to increase access to appropriate medical
devices. This document is part of a series of reference documents being developed for
use at the country level. The series will include the following subject areas:

• policy framework for health technology

• medical device regulations
• health technology assessment
• health technology management
›› needs assessment of medical devices
›› medical device procurement
›› medical equipment donations
›› medical equipment inventory management
›› medical equipment maintenance
›› computerized maintenance management systems
• medical device data
›› medical device nomenclature
›› medical devices by health-care setting
›› medical devices by clinical procedures
• medical device innovation, research and development.

WHO Medical device technical series 3

 These documents are intended for use by biomedical engineers, health managers,
donors, nongovernmental organizations and academic institutions involved in health
technology at the district, national, regional or global levels.

Methodology

The documents in this series were written by international experts in their respective
fields, and reviewed by members of the Technical Advisory Group on Health Technology
(TAGHT). The TAGHT was established in 2009 to provide a forum for both experienced
professionals and country representatives to develop and implement the appropriate
tools and documents to meet the objectives of the GIHT. The group has met on three
occasions. The first meeting was held in Geneva in April 2009 to prioritize which tools
and topics most required updating or developing. A second meeting was held in Rio de
Janeiro in November 2009 to share progress on the health technology management tools
under development since April 2009, to review the current challenges and strategies
facing the pilot countries, and to hold an interactive session for the group to present
proposals for new tools, based on information gathered from the earlier presentations
and discussions. The last meeting was held in Cairo in June 2010 to finalize the
documents and to help countries develop action plans for their implementation. In
addition to these meetings, experts and advisers have collaborated through an online
community to provide feedback on the development of the documents. The concepts
were discussed further during the First WHO Global Forum on Medical Devices in
September 2010. Stakeholders from 106 countries made recommendations on how
to implement the information covered in this series of documents at the country level.1

All meeting participants and people involved in the development of these documents
were asked to complete a declaration of interest form, and no conflicts were identified.

1 First WHO Global Forum on Medical Devices: context, outcomes, and future actions is available at: http://www.who.int/medical_devices/gfmd_report_final.pdf (accessed March
2011)

4 Needs assessment for medical devices

Definitions

Recognizing that there are multiple interpretations for the terms listed below, they are
defined as follows for the purposes of this technical series.

Health technology: The application of organized knowledge and skills in the form of
devices, medicines, vaccines, procedures and systems developed to solve a health
problem and improve quality of life.2 It is used interchangeably with health-care
technology.

Medical device: An article, instrument, apparatus or machine that is used in the

prevention, diagnosis or treatment of illness or disease, or for detecting, measuring,
restoring, correcting or modifying the structure or function of the body for some health
purpose. Typically, the purpose of a medical device is not achieved by pharmacological,
immunological or metabolic means.3

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

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

2 World Health Assembly resolution WHA60.29, May 2007 (http://www.who.int/medical_devices/resolution_wha60_29-en1.pdf, accessed March 2011).
3 Information document concerning the definition of the term “medical device”. Global Harmonization Task Force, 2005 (http://www.ghtf.org/documents/sg1/sg1n29r162005.
pdf, accessed March 2011).

WHO Medical device technical series 5

 Acknowledgements

Needs assessment for medical devices was developed under the primary authorship of
Ronald Bauer, Saniplan GmbH, and under the overall direction of Adriana Velazquez-
Berumen, WHO, Geneva, Switzerland as part of the Global Initiative on Health
Technologies project funded by the Bill & Melinda Gates Foundation.

The document outline was reviewed by Andrew Gammie (Fishtail Consulting Ltd.) and
James Wear (consultant), and the draft was reviewed by Jennifer Barragan (WHO),
Adham Ismail (WHO), and was edited by Inis Communication.

We would like to thank Aditi A Sharma for assistance in proofreading and Karina Reyes-
Moya and Gudrun Ingolfsdottir for administrative support throughout the development
of this document.

Declarations of interests

Conflict of interest statements were collected from all contributors to and reviewers of
the document. Ronald Bauer declared his employment at Saniplan GmbH, a firm that
provides technical assistance and consulting services with the aim to improve the quality
and accessibility of health systems and services, and Andrew Gammie his employment
at Fishtail Consulting Ltd., a firm that provides advice in the area of medical devices,
particularly in developing countries, as remuneration from an organization with an
interest related to the subject. None of these declared conflicts influenced the content
of the document.

6 Needs assessment for medical devices

Acronyms and abbreviations

CENETEC Centro Nacional de Excelencia Tecnológica en Salud (National Center for

Health Technology Excellence)
CMMS computerized maintenance management system
CPG clinical practice guidelines
GIHT Global Initiative on Health Technologies
HIV/AIDS human immunodeficiency virus/acquired immune deficiency syndrome
HTA health technology assessment
HR human resources
iHTP Integrated Healthcare Technology Package
MoH ministry of health
NGO nongovernmental organization
PDSA Plan, Do, Study, Act (prioritization matrix)
SAM Service Availability Mapping
TAGHT Technical Advisory Group on Health Technology
UNICEF United Nations Children’s Fund
WHO World Health Organization

WHO Medical device technical series 7

 Executive Summary

Needs assessment is a complex process, incorporating a number of variables, that

provides decision-makers with the information necessary to prioritize and select
appropriate medical devices at a national, regional or hospital level. This document
describes and illustrates the objective, the general approach and the process of such
a needs assessment. The main section, Specific approach (Section 4), demonstrates
in seven steps how to identify related needs, consider the requirements of baseline
information, analyse the gathered information, appraise the options, and prioritize the
specific requirements. Tools are being continuously developed to support this decision-
making process, and this document also includes information on useful tools that will
help in the execution of these steps.1

1 These links are also found in the section Useful resources.

8 Needs assessment for medical devices

1 Introduction

Needs assessment is a process for deter- A needs assessment can be performed

mining and addressing the gaps between according to different scenarios and un-
the current situation or condition, and the der varying circumstances. It is impor-
desired one. It is a strategic activity and tant to note that this activity is regularly
a part of the planning process that aims performed as part of an effective medical
to improve the current performance or to equipment maintenance programme,1
correct deficiencies. and occurs: when updating a medical
equipment inventory; when re-evaluating
In this particular case, needs assessment services; and/or when replacing equip-
is the identification and definition of ment. A needs assessment is also impor-
prioritized requirements with regard tant prior to the construction of any new
to medical devices. A thorough needs health facility.
assessment includes the potential impact
on performance of medical equipment Furthermore, it can be performed at
users, and on delivery of services within national, regional, local or facility levels.
the context of health system capabilities
and service delivery priorities. It takes It should be noted that ‘needs assessment
into account the overall objectives of of health technology’ differs from ‘health
the institution, existing facilities and technology assessment’ (HTA). HTA is
infrastructures, long-term plan of use, an instrument to analyse the technical,
and human resources (HR) development ethical, social and economical impact,
prior to purchasing a medical device. as well as the clinical effectiveness, of a
specific technology.2
It is also critically important that end-
users are taken into consideration and
are involved in any assessment.

1 Please see Medical equipment maintenance programme overview in this technical

series for more information.
2 Please see Health technology assessment of medical devices in this technical series
for more information.

WHO Medical device technical series 9

 2 Purpose

The main objective of this document is The document can be used for single
to provide Member States with guidance facilities as well as for a network of
for a methodological approach, as well facilities, up to national systems (referral
as tools and references, and examples systems). The tools referred to in this
to conduct a proper assessment of document do, however, need to be
their current situation and future needs properly selected and appropriately
with regard to health technologies applied. The ultimate goal is for countries
– specifically, medical devices – in to use the tools for integration of prioritized
consideration of their country’s health needs into national policies and action
burden and disease data. plans.

Because the characteristics of each Note: The references and links provided
Member State vary enormously, this are not intended to be either complete or
document presents only generic comprehensive, but rather a selection of
principles. However, the resources and documents and tools identified by WHO
examples shown (or referred to) should as sources of information for decision-
enable any country to elaborate or makers.
adapt these principles according to their
particular needs.

10 Needs assessment for medical devices

3 General approach

The general approach in performing a By taking into consideration possible

needs assessment is to examine what is financial and HR restrictions, as well as
available in the facility, region or country, prioritized epidemiological requirements,
and to compare it with what should be a list of the prioritized needs can
available, considering the particular be established. Table 1 and Figure 1
demand and situation of the catchment summarize and visualize the process.
area or target group. Part of this process Table 1 specifically outlines the questions
includes looking at locally- and globally- to be asked, the data required to answer
recognized standards. The identified gap those questions, and the tools available
specifies the overall need. to collect and evaluate the data.

Table 1. General needs assessment approach (process)

Questions Data required Toolsa Result

1 What do we want/need in • Population (target • “Certificate of need”
terms of health services? population, catchment area) process, see Appendix A
• Health service provider • Clinical practice guidelines
availability (CPG)
• Epidemiological data • Survey questionnaires
• Standards of level of care
• Integrated Healthcare
Technology Package (iHTP)
2 What do we have? • Health service availability • Service Availability Mapping
(local conditions/ • Lists of available medical (SAM) questionnaires
limitations) devices • Evaluation manuals/tools
• Human resources • Inventory management tool
availability • Computerized maintenance
management system
(CMMS)
3 Which standards/ • Standards/ • (essential) Medical device
recommended best recommendations for health lists; i.e., per facility type
practices exist that could be service delivery coverage and department, or per
applied or adapted? (catchment areas) clinical procedure
• Standards/
recommendations for
medical devices
• Standards/
recommendations for
human resources required
for operation/maintenance/
management of medical
equipment
4=3-2 Overall gap: List of general
needs
5 What financial/human • Budget (capital investment
resources do we have? and operational)
(constraints) • Human resources
6=4-5 Prioritized needs: Prioritized list of
needs
Please refer to Useful resources and appendices included in this document for more information on these tools.
a

WHO Medical device technical series 11

12
Figure 1. General needs assessment process

Generic standards and

examples

Needs assessment for medical devices

Level of care
Clinical practice guidelines
Medical device lists

Prioritization

Budgetary
Overall gap / and HR Prioritized need
Analysing/interpreting need situation

Epidemiological needs/disease priorities

Population data (demography, catchment area, patient
rate)
Service availability and accessibility
Infrastructure situation
Health technology / medical device situation
Human resource situation

Baseline data
4 Specific approach

Expanding upon the general approach, suggestions for analysing and interpreting
this section summarizes the seven spe- the results of Steps I-V. Lastly, Step VII
cific data collection and analysis steps of briefly discusses the issue of prioritization
the needs assessment process. Steps I-III and option appraisal.
refer to the baseline information collection
of health service requirements, health The tables in Steps I-V also summarize
service availability, and health technol- what information is to be collected,
ogy. Steps IV and V refer to the specific the data to be considered during the
situation in terms of human resources collection process, and the desired result
and finances – and possible respective of the process. Due to the cross-cutting
constraints – of the administration of the nature of the process, the same outcomes
facility, region or state. Step VI provides may be mentioned in multiple steps.

4.1 Step I: Baseline information on health service requirements

Table 2. Baseline information on health service requirements

Local geographical and public

Considerations Result
health conditions
• Population of target area, including • Epidemiological needs (disease • Appropriate health service delivery
size of the region/area, number and priorities) requirements
density of population • Population issues (demography /
• Major disease burden catchment area, patient rate)
• CPG/protocols/national or local
recommendations
• Internationally-recognized standards
on diagnosis and treatment of
different diseases
• Health-care issue prioritization

Complete details on Step I are not provided WHO has information available at the
here, as they are outside the scope of this country level while national ministries of
document and the responsibility of the health (MoHs) may have more detailed
GIHT. However, Step I remains critically information.1
important to address, as it directly refers to
the health situation of the target population.
1 WHO country profiles are available at http://www.who.int/countries/en

WHO Medical device technical series 13

 4.2 Step II: Baseline information on health service availability

Table 3. Baseline information on health service availability

Service delivery situation Considerations Result

• Available services (e.g., maternal • Health service availability and • Health service availability map
and child health, HIV/AIDS, surgical, accessibility (overview)
etc.) • Opinions on health service delivery • Facility map
• Facilities (e.g., hospitals, clinics, etc.) from the target population
• Human resources • Opinions on health service delivery
from service providers
• Facility types, numbers, conditions
• Current staffing levels

It is important to assess the current • What is the caseload of staff?

situation in order to identify the difference • How many full-time staff does the
between what is needed and what exists. service employ, and how much time
Taking Table 3 into account, the following do they have available each week for
questions can be asked to retrieve the client appointments?
relevant information: • Is there any information regarding
staff satisfaction or facility-user sat-
• Where is the facility(ies) located? isfaction available by way of surveys?
• Which health services are available • How do existing clients access
at the facility? the facility (e.g., on foot, by public
• What range of clients does the facility transportation, etc.)?
cater to in terms of age, gender, • How accessible is the service by
geographical distribution, etc.? public transportation?
• Which specific needs does the facility
(and its services) meet? Specific tools1 can further assist in the
• How does the facility receive referrals, collection of the appropriate information
and from whom do its referrals come? for this and other steps in the process,
• How many clients does the facility including:
see each week/month/quarter/year?
• On average, how long do clients stay • Service Availability Mapping (SAM)
at the facility, and what are their tool, World Health Organization.
reasons for leaving (e.g., drop-out, • Rapid health facility assessment
onward referral, etc.)? flow chart. International Health
• How many clients each week/month, Facility Assessment Network, 2007.
etc., are referred on to other agen-
cies?
1 Reference information for these tools can be found under Useful Resources.

14 Needs assessment for medical devices

4.3 Step III: Baseline information on medical devices

Table 4. Baseline information on medical devices

Medical device situation Considerations Result

• Availability and condition of medical • Medical equipment inventory • Facility map
devices (including type, number, including status and condition • Medical equipment inventory
location and physical condition) • Current health technology (quantitative and qualitative)
• Status of electrical, water, and waste management infrastructure (or lack • Outline of health technology
disposal systems related to medical thereof) management infrastructure
device use

This is the key step in the process with ›› power supply, electrical connec-
regard to health technology. The main tions and installations (e.g., is an
goal is to identify what is available in emergency generator available?);
terms of medical devices and related ›› waste disposal system (e.g., how
infrastructure, and their condition. It is is waste handled, segregated, and
important to collect as much detailed and disposed of?).
reliable information as possible, because
any change, correction or improvement Medical equipment1
will have a major impact on the financial
and human resources, as well as on the • type and number of equipment
environment. • brand name
• model
A two-step approach can be followed • year of manufacture
where the first step is a neutral, quantitative • date of installation
assessment, and the second, a more de- • location (medical department)
tailed, qualitative assessment. It is up to • physical condition (in operation/out
the implementer to decide if the second of order/repairable)
step is desired or necessary. • spare parts required/available for
repair
Taking Table 4 into account, some of the • tools available for inspection, main-
key information to be collected includes tenance, and repair
the following: • medical equipment history if available
(operation/use time, maintenance/
Infrastructure repair).

• type, size, and position of premise and Health technology management

building(s), including the number and
type of building(s); • Type of existing management struc-
• availability and condition of: ture, including responsibilities.
›› water supply, connections and • Existing policy (if available).
installation (e.g., where does the
water come from?, what is the
quality?, etc); 1 Most of this data is collected in an inventory. Please refer to Introduction to medical
equipment inventory management in this technical series for more details on
developing an inventory.

WHO Medical device technical series 15

 Specific tools2 can further assist in the • Interagency list of essential
collection of the appropriate information medical devices for reproductive
for this and other steps in the process, health. Geneva, World Health
including: Organization, 2008.
• Integrated Management for
• Introduction to medical equipment Emergency and Essential Surgical
inventory management. Geneva, Care (IMEESC) tool kit. Geneva,
World Health Organization, 2011. World Health Organization.
• Computerized maintenance • Surgical care at the district
management system. Geneva, hospital. Geneva, World Health
World Health Organization, 2011. Organization, 2003.
• Integrated Healthcare Technology • Package of essential noncommu-
Package (iHTP). World Health nicable (PEN) disease interventions
Organization.3 for primary health care in low-
• Rapid health facility assessment resource settings. Geneva, World
flow chart. International Health Health Organization, 2010.
Facility Assessment Network, • Medical devices by health-care
2007. facilities (in preparation). Geneva,
• Practical steps for developing World Health Organization, 2011.
health care technology policy. • Medical devices by clinical proce-
Brighton, Institute of Development dures (in preparation). Geneva,
Studies, 2000. World Health Organization, 2011.
• Development of medical device • Models and medical equipment
policies, strategies and action guidelines. Mexico City, Centro
plans. Geneva, World Health Nacional de Excelencia Tecnológica
Organization, 2011. en Salud (CENETEC).
• Primary health care centres
Additionally, the following are some and first referral level hospitals.
available tools on internationally or Planning guide: Equipment and
regionally recognized standards that are renewable resources. New York,
useful for comparison purposes: United Nations Children’s Fund,
2005.

2 Reference information for these tools can be found under Useful Resources.
3 Tool requires technical support from WHO before use.

16 Needs assessment for medical devices

4.4 Step IV: Baseline information on human resources

Table 5. Baseline information on human resources

Human resources Considerations Result

Qualification and number of human • Availability, capacity, and capability • Human resource data information
resources required to cover the required of current human resources (staffing plan)
health-care demand (as defined by • Education and training map
results of Step I)

The minimum information that should be ›› on-the-job training

available for collection and assessment is: ›› human resources planning.

• existing posts and job descriptions Further details on Step IV are not provided
• number of vacant posts here, as this is outside the scope of
• status and availability of: this document and the responsibility of
›› basic, higher or vocational educa- the GIHT. This information should be
tion available at the HR department of your
›› continuous training administration.

4.5 Step V: Baseline information on finances

Table 6. Baseline information on finances

Financial situation Considerations Result

Capacity to finance overall facility • Financial resources • Budget
operations, including health services,
health technology, and infrastructure
(Steps II and III above).

The minimum information that should be Further details on Step V are not provided
available for collection and assessment is: here, as this is outside the scope of
this document and the responsibility of
• budget and expenses from previous the GIHT. This information should be
periods available at the financial department of
• current budget your administration.
• system of monitoring/controlling
budget.

WHO Medical device technical series 17

 4.6 Step VI: Analysis and interpretation

Once all the information is gathered, III above) with an internationally- or

it is possible to analyse, interpret and regionally-recognized standard for the
draw conclusions. The analysis and type of facility and/or intervention being
interpretation should be based directly reviewed, and assess the respective gap.
on the information gathered in the Using spreadsheets in a programme such
manner outlined in previous steps. as Excel can be helpful, but if there is a
Therefore, keep in mind that the use large amount of data to compare, it may
of poor methodology in the information- be best to use the inventory section of a
gathering stages will undermine the ability CMMS, if available, for such purposes.
to develop valid interpretations of the
situation. In the end, this will affect the The recent WHO background paper
quality of the conclusions and resulting entitled: A stepwise approach to identify
recommendations targeting the needs of gaps in medical devices (availability
the population. matrix and survey methodology), is a
result of the Priority Medical Devices
Specifically for analysing medical device project, and it might be a helpful tool
needs, it is necessary to compare the during this stage of the process.
current inventory list (results of Step

4.7 Step VII: Prioritization and appraisal of options

After having analysed the information • Implementation: When agreement

gathered in the earlier steps of the needs has been reached about how the
assessment process, and having drawn needs are to be met, an action plan
conclusions, there should now be a and timetable should be drawn
reasonably clear picture of the needs of up, including a plan for resource
the target population. Decisions regarding allocation.
the actions to take will depend on several
crucial and closely connected activities. In practice, the tasks of prioritization and
These include: option appraisal are directly linked. Both
must be considered together.
• Prioritization: If there are insufficient
resources to meet all the identified 4.7.1 Prioritization
needs, it may be necessary to rank When sufficient resources are not
them in order to decide which needs available to meet all the identified needs
should be met first and which will be (which is the case in most circumstances),
met later. it is important for prioritization to occur.
• Option appraisal: There may be more Prioritization is a strategic process,
than one way of meeting the needs undertaken by those responsible for
identified. Various options should the commissioning of services. Those
be considered, and the evidence in involved in prioritizing should also
favour of each should be weighed consider the opinions of service users
carefully. and service providers regarding how to

18 Needs assessment for medical devices

prioritize needs. However, they may not required (in terms of medical devices) in
always agree, so priority is best given to order to render the required services that
those areas where they do. will allow these priorities to be realized.

The way in which decisions are made 4.7.2 Option appraisal

with regard to identified priorities will In most cases, there will be more than
depend on local circumstances. National one way of responding to the needs which
priorities and the availability of required have been identified. The options you
resources are often what prompts the choose will depend on several factors,
needs assessment process. Therefore, including:
the purpose of this step is to determine
specifically what should be done, how, • how the needs are prioritized
and in what order. For example, national • what the likely impact of each option
and local policy may require that services will be
should be provided for maternal and • the availability of resources.
child health. In this case, the local needs
assessment will focus on identifying Table 7 provides one way of thinking
the specific needs of women/mothers about the options for change following a
and newborns in the local area, their needs assessment.
prioritization, and what is particularly

Table 7. Plan, Do, Study, Act (PDSA) prioritization matrix

Finances/resources required to implement Likely impact of change

change Low High
Low Soft target: Wait Win: Go!
High Refrain or Wait Challenging: Wait

The aim will be to give first priority to having little impact. It may be tempting/
actions that will have the highest positive attractive to go ahead with these actions,
impact on the ability to provide optimal but they can prove to be a distraction
services to the target population, as well from the more high-impact actions. For
as require the fewest additional resources. this reason, it is usually better to wait until
the ‘quick wins’ have been successfully
At the other extreme, it is better to avoid implemented first.
making changes that are likely to have a
low impact but which require a high level Hooper and Longworth (2002) suggest
of resources. In between are those actions that a number of key questions should be
that are likely to have a high impact, addressed when appraising the options
but will also demand high resources. In and prioritizing the needs following a
most circumstances, these would not be needs assessment exercise. These
selected for immediate action either, but questions focus on the issues of impact,
rather, considered as long-term options. changeability, acceptability and resource
feasibility, and are adapted here for the
Similarly, so called ‘soft targets’ are those application of needs assessment of health
actions requiring few resources but technology.

WHO Medical device technical series 19

 Table 8. Key questions for prioritizing and appraisal of options

Key questions to ask when appraising the options and prioritizing

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 organizational 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?

4.7.3 Developing an implementation the specific steps and milestones

plan required to achieve it;
Once priorities and the ways to address • the names of the individuals
these priorities are agreed upon, the responsible for carrying out each part
next step is to develop an action plan of the plan, what they will do and
for implementation. An implementation when, and the skills and training they
plan should be realistic, achievable and will need (in particular, with a focus
adequately fundable, while at the same on health technology management,
time able to clearly outline the various policy and structure);
stages of the implementation process. • details of the resources that will
be required (including devices,
It is important that health service providers and if applicable, administrative,
are included in discussions regarding the managerial, and IT systems), and
implementation plan – and are supportive where they will come from;
of it – because at an operational level, • a clear understanding of how the
they will be directly involved in the plan will be kept on track, how the
implementation and introduction of the implementation of each component
agreed changes to existing services. of the plan will be measured, and
how the relevant people will be kept
A good implementation plan includes: motivated and involved.

• a statement of the aims and objec-

tives of the planned action, and

20 Needs assessment for medical devices

5 Concluding remarks

The needs assessment process is a Determining how to best use the

powerful tool for determining medical resources available to fill that gap will
device needs at the facility, regional and/ lead to a prioritization of activities that
or country level. By collecting baseline can eventually lead to a more efficient
information and comparing it to a provision of health services and better
desired standard, the existing gap can quality of care.
be identified.

WHO Medical device technical series 21

 6 Useful resources

All URLs accessed 30th March 2011

For these and more resources, please visit the World Health Organization Library
Information System (WHOLIS) at http://dosei.who.int, or the e-Documentation centre
for WHO Health Technologies/Medical devices at http://hinfo.humaninfo.ro/gsdl/
healthtechdocs.

Medical equipment maintenance programme overview. Geneva, World Health

Organization, 2011.

Health technology assessment of medical devices. Geneva, World Health Organization,

2011.

Service Availability Mapping (SAM), World Health Organization (http://www.who.int/

healthinfo/systems/serviceavailabilitymapping/en).

Rapid health facility assessment flow chart. New York, International Health Facility
Assessment Network, 2007 (http://ihfan.org/home/docs/attachments/ms-08-28_
flowchart.pdf).

Introduction to medical equipment inventory management. Geneva, World Health

Organization, 2011.

Computerized maintenance management system. Geneva, World Health Organization,

2011.

Integrated Healthcare Technology Package (iHTP), World Health Organization (http://

www.ihtp.info).

Temple-Bird C. Practical steps for developing health care technology policy. Brighton,
Institute of Development Studies, 2000.

Development of medical device policies, strategies and action plans. Geneva, World
Health Organization, 2011.

Interagency list of essential medical devices for reproductive health. Geneva, World
Health Organization, 2008 (http://whqlibdoc.who.int/hq/2008/WHO_PSM_PAR_2008.1_
eng.pdf).

Integrated Management for Emergency and Essential Surgical Care (IMEESC) tool.
Geneva, World Health Organization (http://www.who.int/surgery/publications/imeesc/
en/index.html).

22 Needs assessment for medical devices

Surgical care at the district hospital. Geneva, World Health Organization, 2003 (http://
www.who.int/surgery/publications/scdh_manual/en).

Package of essential noncommunicable (PEN) disease interventions for primary

health care in low-resource settings. Geneva, World Health Organization, 2010 (http://
whqlibdoc.who.int/publications/2010/9789241598996_eng.pdf).

Medical devices by health-care facilities (in preparation). Geneva, World Health

Organization, 2011.

Medical devices by clinical procedures (in preparation). Geneva, World Health

Organization, 2011.

Models and medical equipment guidelines. Mexico City, Centro Nacional de Excelencia
Tecnológica en Salud (CENETEC) (http://www.cenetec.salud.gob.mx/interior/modelos_
equip.html).

Primary health care centres and first referral level hospitals. Planning guide: Equipment
and renewable resources. New York, United Nations Children’s Fund, 2005 (http://
www.unicef.org/supply/files/050307PlanningGuideHandbookAug2005%281%29.pdf).

A stepwise approach to identify gaps in medical devices (availability matrix and survey
methodology). Background paper 1. Geneva, World Health Organization, 2010 (http://
whqlibdoc.who.int/hq/2010/WHO_HSS_EHT_DIM_10.1_eng.pdf).

Priority medical devices project. World Health Organization (http://www.who.int/medi-

cal_devices/access/en/index.html).

Hooper J and Longworth P. (2002). Health needs assessment workbook. Health

Development Agency, 2002 (http://www.nice.org.uk/niceMedia/documents/hna.pdf).

Certificado de Necesidad (Certificate of Need). Mexico City, Centro Nacional de

Excelencia Tecnológica en Salud (CENETEC) (http://www.cenetec.salud.gob.mx/interior/
cert_nec.html).

‘How to Manage’ series of health care technology guides. St Albans, Ziken International
(Health Partners International), 2005 (http://www.healthpartners-int.co.uk/our_expertise/
how_to_manage_series.html).

Liu, X. Policy tools for allocative efficiency of health services. Geneva, World Health
Organization, 2003 (http://whqlibdoc.who.int/publications/2003/9241562528.pdf).

WHO Medical device technical series 23

 Appendix A
Certificate of need process

The Certificate of Need is a planning • Description of need

tool used to support decision-makers ›› Service characteristics
in evaluating investments of highly- ›› Clinical procedures required
specialized and expensive medical ›› Number of referred patients to
equipment, based on technical, another site
epidemiological, and cost-benefit criteria ›› Other available equipment in the
in order to best optimize resources. 1 area.
Many countries do not have this process
in place but may be something decision- • Proposal
makers may want to consider. For those ›› Medical equipment
countries who have or will implement ›› Staff
this process, it is important to take into ›› Infrastructure.
consideration the following when applying
for a certificate of need. • Resources needed
›› Investment
• General Data ›› Operational costs
›› Place ›› Sources of financing.
›› Catchment area
›› Epidemiology information
›› Mortality/morbidity
›› Applicants data.

1 CENETEC definition translated from Spanish (http://www.cenetec.salud.gob.mx/

interior/cert_nec.html)

24 Needs assessment for medical devices

The flow chart below demonstrates the process for obtaining a certificate of need.

Fill in application for

certificate of need

Pre-assessment
>1 million USD?
study
No

Yes
Evaluation

Approval? Certificate of need

Yes

WHO Medical device technical series 25

 ISBN 978 92 4 150138 5
Department of Essential Health Technologies
World Health Organization
20 Avenue Appia
CH-1211 Geneva 27
Switzerland
Tel: +41 22 791 21 11
E-mail: [email protected]
http://www.who.int/medical_devices/en/