Part 2: IMPLEMENTATION MANUAL

Part 2: IMPLEMENTATION MANUAL

Technical contribution:
 STANDA RDS F OR PROS T HET ICS AND O RT HO T IC S • PART 2. IM P L E M E N TATION M AN UAL

WHO standards for prosthetics and orthotics

Contents: Part 1. Standards; Part 2. Implementation manual

ISBN 978-92-4-151248-0

© World Health Organization 2017

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Contents
Contents by theme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Contributors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii
Abbreviations and acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Area 1. Policy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1A Stakeholders and their roles. . . . . . . . . . . . . . . . . . . . . . . . . 3
1B Guiding framework. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1C Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1D International support. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1E Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1F Economic benefits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1G Ensuring cost–effectiveness. . . . . . . . . . . . . . . . . . . . . . . . . 14
1H Benefits of early detection and treatment of impairments. . . . . . . . . . . . . 15
1I Prevention of avoidable impairments
. . . . . . . . . . . . . . . . . . . . . . 15
1J Universal health coverage. . . . . . . . . . . . . . . . . . . . . . . . . . 16
1K Financing
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1L Considerations in applying service fees
. . . . . . . . . . . . . . . . . . . . . 21
1M Facilitating access of users
. . . . . . . . . . . . . . . . . . . . . . . . . . 21
1N Assessing the need
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
1O Collection of data . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
1P Data on impact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
1Q Awareness-raising. . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
1R Strengthening the image
. . . . . . . . . . . . . . . . . . . . . . . . . . 30
Area 2. Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
2A Appropriate technology. . . . . . . . . . . . . . . . . . . . . . . . . . 33
2B Overview of product features
. . . . . . . . . . . . . . . . . . . . . . . . 35
2C Prefabricated and custom-made products
. . . . . . . . . . . . . . . . . . . 36
2D Priority assistive products. . . . . . . . . . . . . . . . . . . . . . . . . 37
2E ISO categorization. . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
2F Supply of components and materials
. . . . . . . . . . . . . . . . . . . . . 38
2G Regulation of technical issues
. . . . . . . . . . . . . . . . . . . . . . . . 40
2H Structural and clinical testing
. . . . . . . . . . . . . . . . . . . . . . . . 41
2I Technical and clinical research. . . . . . . . . . . . . . . . . . . . . . . 42
2J Development of affordable products. . . . . . . . . . . . . . . . . . . . . 43

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 STANDA RDS F OR PROS T HET ICS AND O RT HO T IC S • PART 2. IM P L E M E N TATION M AN UAL

Area 3. Personnel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3A Service unit personnel
. . . . . . . . . . . . . . . . . . . . . . . . . . . 45
3B Other professionals on the team . . . . . . . . . . . . . . . . . . . . . . 47
3C Multidisciplinary rehabilitation teams. . . . . . . . . . . . . . . . . . . . 47
3D Training of prosthetics and orthotics personnel
. . . . . . . . . . . . . . . . . 48
3E Training other professionals in prosthetics and orthotics. . . . . . . . . . . . . 53
3F Continuing professional development. . . . . . . . . . . . . . . . . . . . 54
3G Role development. . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
3H Workforce planning
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3I Retention of personnel . . . . . . . . . . . . . . . . . . . . . . . . . . 59
3J Professional regulation . . . . . . . . . . . . . . . . . . . . . . . . . . 60
3K Professional recognition. . . . . . . . . . . . . . . . . . . . . . . . . . 61
3L Professional associations and societies
. . . . . . . . . . . . . . . . . . . . 61

Area 4. Provision of services

. . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4A User policy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4B The user: a central resource in planning and provision of services. . . . . . . . . 64
4C The right of users to choose their service provider and technology
. . . . . . . . . 65
4D Accessible services
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
4E Types of service provider
. . . . . . . . . . . . . . . . . . . . . . . . . . 66
4F Inclusion of prosthetics and orthotics services in the health sector
. . . . . . . . . 67
4G Service delivery systems
. . . . . . . . . . . . . . . . . . . . . . . . . . 68
4H Decentralization of services. . . . . . . . . . . . . . . . . . . . . . . . 71
4I Maintenance and repair services. . . . . . . . . . . . . . . . . . . . . . 78
4J Service provision in disasters. . . . . . . . . . . . . . . . . . . . . . . . 78
4K Exclusive and inclusive service units. . . . . . . . . . . . . . . . . . . . . 80
4L The service unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
4M Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
4N Working environment and safety. . . . . . . . . . . . . . . . . . . . . . 83
4O User identification and referral. . . . . . . . . . . . . . . . . . . . . . . 84
4P The service delivery process. . . . . . . . . . . . . . . . . . . . . . . . 85
4Q Service unit management. . . . . . . . . . . . . . . . . . . . . . . . . 91
4R Quality management. . . . . . . . . . . . . . . . . . . . . . . . . . . 94
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

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Contents by theme
Governance
1A Stakeholders and their roles..................... 3
1B Guiding framework......................... 6
1C Monitoring........................... 8
Finance
1E Costs............................. 9
1F Economic benefits......................... 12
1G Ensuring cost–effectiveness...................... 14
1J Universal health coverage...................... 16
1K Financing............................ 18
1L Considerations in applying service fees................. 21
Data
1N Assessing the need........................ 22
1O Collection of data ......................... 24
1P Data on impact .......................... 27
Awareness-raising
1Q Awareness-raising......................... 27
1R Strengthening the image....................... 30
Early detection/prevention
1H Benefits of early detection and treatment of impairments........... 15
1I Prevention of avoidable impairments.................. 15
Technical issues
2A Appropriate technology....................... 33
2B Overview of product features..................... 35
2C Prefabricated and custom-made products................ 36
2D Priority assistive products...................... 37
2E ISO categorization......................... 38
2F Supply of component and materials................... 38
2G Regulation of technical issues..................... 40
2H Structural and clinical testing..................... 41
2I Technical and clinical research..................... 42
2J Development of affordable products.................. 43
Personnel
3A Service unit personnel........................ 45
3B Other professionals on the team.................... 47
3C Multidisciplinary rehabilitation teams.................. 47
3D Training of prosthetics and orthotics personnel............... 48
3E Training other professionals in prosthetics and orthotics........... 53
3F Continuing professional development.................. 54
3G Role development......................... 55
3H Workforce planning........................ 56
3I Retention of personnel....................... 59
3J Professional regulation....................... 60
3K Professional recognition....................... 61
3L Professional associations and societies.................. 61
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 STANDA RDS F OR PROS T HET ICS AND O RT HO T IC S • PART 2. IM P L E M E N TATION M AN UAL

Service users
4A User policy........................... 63
4B The user: a central resource in planning and provision of services........ 64
4C The right of users to choose their service provider and technology........ 65
1M Facilitating access of users...................... 21
Service systems
4D Accessible services........................ 65
4E Types of service provider....................... 66
4F Inclusion of prosthetics and orthotics services in the health sector........ 67
4G Service delivery systems ...................... 68
4H Decentralization of services ..................... 71
4I Maintenance and repair services.................... 78
The service unit
4K Exclusive and inclusive service units................... 80
4L The service unit.......................... 81
4M Equipment............................ 83
4N Working environment and safety.................... 83
Service processes
4O User identification and referral..................... 84
4P The service delivery process..................... 85
4Q Service unit management...................... 91
Quality management
4R Quality management........................ 94
International issues
1D International support ........................ 8
4J Service provision in disasters..................... 78

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 © Motivation Australia

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 STANDA RDS F OR PROS T HET ICS AND O RT HO T IC S • PART 2. IM P L E M E N TATION M AN UAL

Contributors
WHO steering group Alarcos Cieza, Pauline Kleinitz, Maryam Mallick, Satish
Mishra, Zafar Mirza, Andrea Pupulin, Hala Sakr, Emma
Tebbutt, and Armando Jose Vasquez
Standards development group Girma Bireda Assena, Josephine Bundoc, Mary Anne
Burke, Bishnu Maya Dhungana, Elaine Figgins, Ritu
Ghosh, Allen Ingersoll, Ev Innes, Friedbert Kohler,
Malcolm MacLachlan (Chair), William Neumann, Teap
Odom, Wesley Pryor, Youssef Salam, Daniel Suarez,
Claude Tardif and Nils-Odd Tønnevold
External review group Serap Alsancak, Firoz Ali Alzada, Jonathan Batzdorff,
Lee Brentnall, Helena Burger, Monica Castaneda,
David Condie, Sam Gallop, Olivia Giles, Jacqui Lunday
Johnstone, Jean Kagawa, Peter Kyberd, Aaron Leung,
Bryan Malas, Ana Paulina Chavira Mendoza, Longini
Mtalo, Masse Niang, Samuel Nkhoma, Nerrolyn
Ramstrand, Kerio Rapheal, Christian Schlierf, Pratima
Singh, Mel Stills and Isabelle Urseau
Executive editor Chapal Khasnabis
Lead authors Anders Eklund and Sandra Sexton
Additional contributions Dareen Barbar, Liu Bofei, Björn Ekman, Rajiv Hanspal,
Carson Harte, Kirsti Hoøen, Rob Horvath, V. Jayakodi,
Kylie Mines, Nisarat Opartkiattikul, Vinicius Delgado
Ramos, Albina Shankar, Bengt Söderberg, Camara
Yakouba and Husam Zeino
Systematic reviewers First review group led by Nachiappan Chockalingam and
Aoife Healy. Second review group led by Richard Baker,
Saeed Forghany and Ebrahim Sadeghi-Demneh
Technical editing Elisabeth Heseltine
Proof-reading Diane Bell and Angela Weatherhead
Cover photography China Assistive Devices and Technology Center for
Persons with Disabilities, Mobility India and Royal
National Orthopaedic Hospital-UK
Partner organizations International Society for Prosthetics and Orthotics and
United States Agency for International Development
Financial support Leahy War Victims Fund, United States Agency for
International Development
Administrative support Wendy Hamzai and Rachel McLeod-MacKenzie

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Abbreviations and acronyms
ASCENT Amputee Screening through Cellphone Networking
CBR community-based rehabilitation
CPD continuing professional development
CRPD Convention on the Rights of Persons with Disabilities
GATE Global Cooperation on Assistive Technology
ISO International Organization for Standardization
ISPO International Society for Prosthetics and Orthotics
MSA medical savings account
NGO nongovernmental organization
PHC primary health care
SDG Sustainable Development Goal
USAID United States Agency for International Development
VAT value added tax

H E A LT H CO V
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POLICY PRODUCTS
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Strengthening Improving
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governance, access to
NOL

financing and prostheses

ASSIST

information and orthoses

OGY

systems
R T H OT I C S

PROSTHET

UNIVERS
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Promoting Developing
integrated prosthetics
OVE

prosthetics and and orthotics

DO

orthotics service
ICS

workforce
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delivery capacity
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The four key areas of health systems

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 STANDA RDS F OR PROS T HET ICS AND O RT HO T IC S • PART 2. IM P L E M E N TATION M AN UAL
© ICRC

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Introduction
Purpose of the manual
WHO, in partnership with the International Society for Prosthetics and Orthotics (ISPO) and
the United States Agency for International Development (USAID), has prepared prosthetics
and orthotics standards to guide Member States in improving access to high-quality,
affordable prosthetics and orthotics services, presented in Part 1 of this publication. For more
detailed instructions on “what, why, how, who and when” for each standard, WHO also
prepared this implementation manual. The main purpose of the manual is to support Member
States in analysing the situation of prosthetics and orthotics services in their countries, which,
in turn, helps setting priorities for implementation of the standards. The manual provides
advice on planning, implementing, managing and developing or improving prosthetics and
orthotics services to meet the proposed standards. It is designed to stimulate discussion
on the wide range of issues to be considered in preparing policies and strategic plans and
establishing benchmarks for services. It promotes planning, goal-setting, implementation
and monitoring of services as a joint effort of governments and national stakeholders.

Scope and structure

Like the document on standards, the manual covers the four core areas of prosthetics and
orthotics service: policy (governance, financing and information), products (prostheses
and orthoses), personnel (workforce) and provision of services. Although some sections
are linked, each can be read independently to obtain limited or more specific information.
Several topics are illustrated with brief country examples.

The manual presents the different aspects of prosthetics and orthotics services but does
not provide enough detail to serve as a blueprint for service implementation in all countries.
Plans and priorities differ among and even within countries, depending on the context and
the resources that can be made available.

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 STANDA RDS F OR PROS T HET ICS AND O RT HO T IC S • PART 2. IM P L E M E N TATION M AN UAL
© Chapal Khasnabis/WHO

© Chapal Khasnabis/WHO

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 AR E A 1 . P O L I C Y

Area 1. Policy
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1A Stakeholders and their roles

Many different stakeholders with specific, complementary skills and resources are required
to establish, strengthen and maintain a well-functioning, effective prosthetics and orthotics
service, including:
• users, families and caregivers;
• user groups and disabled people’s organizations;
• national, regional and local governments;
• civil society organizations;
• both public and private prosthetics and orthotics service providers;
• health service providers, including those providing rehabilitation;
• training and academic institutions;
• professional associations;
• manufacturers and suppliers of components, materials and consumables;
• international organizations and agencies; and
• funding agencies.

Service users, families and caregivers

Service users must be at the centre of planning, implementation, monitoring and evaluation
of prosthetics and orthotics services. Not only is this their right, but they are an indispensable
resource in this work (see 4B). Service users should be empowered to engage actively in
service provision, as individuals or as representatives of their organizations.

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 STANDA RDS F OR PROS T HET ICS AND O RT HO T IC S • PART 2. IM P L E M E N TATION M AN UAL

When people have severe physical impairments and rely on assistance for day-to-day
activities, it is important to involve family members, caregivers and others to provide their
perspective on service provision.

User groups and disabled people’s organizations

These groups can participate on behalf of users in planning, implementing, monitoring and
evaluating programmes and may also represent the interests of users on advisory committees.
These organizations often have a wide geographical reach, so that they make important
contributions to awareness-raising and to the identification and referral of potential users.
With the necessary instructions and training, they can work with service providers in peer
counselling, follow-up of individuals, collection of user feedback and impact assessments.

Governments
According to the Convention on the Rights of Persons with Disabilities (CRPD), it is the
responsibility of governments to promote the availability and use of high-quality assistive
devices and technologies, including prostheses and orthoses, at an affordable cost (1).
Governments need not be involved in direct service delivery, but the State – represented
by various ministries – is obliged to enact legislation, formulate policy, prepare national
plans, regulate, finance, raise awareness and generally support and promote prosthetics
and orthotics. Governments can create the circumstances for services to flourish in both the
private and the public sector and bring together the relevant stakeholders. For this purpose,
a national prosthetics and orthotics committee or similar entity could be established within
structures for the coordination of health, rehabilitation and assistive technology (see Box 1).

Box 1. A national prosthetics and orthotics committee

Coordination of prosthetics and orthotics services is strengthened by the creation of a national

prosthetics and orthotics committee or similar entity. This body is best established within existing
structures for the coordination of health, rehabilitation and assistive technology, perhaps as a
subgroup of a broader entity, as long as sufficient attention is given to the details of prosthetics
and orthotics. The structure will depend on the local context. In India, for example, a prosthetics
and orthotics committee has been established within the Rehabilitation Council of India to support
education on these specialties and service delivery.
A committee with varied membership and a prominent role for the government can coordinate the
development of national policies, legislation and strategic plans and monitor services, to ensure
that all stakeholders are working towards the same goals. To be effective, the committee should set
clear aims and objectives for its work and meet regularly, as required by the local situation.

Although many tasks can be delegated by incorporating self-governance and professional

stewardship, the involvement of relevant government offices, at both national and local
levels, may still be required. To give appropriate attention to the sector, governments could
establish an office dedicated to rehabilitation and assistive technology, coordinated by
professional experts.

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 AR E A 1 . P O L I C Y

Civil society organizations

Civil society organizations are important in prosthetics and orthotics services, as they work
with local populations and can help to raise awareness and increase the uptake of treatment
by geographically and culturally diverse populations. Their voices are often the motivation
for policy development and practice.

Prosthetics and orthotics service providers

Service providers, who may be public, private (profit or non-profit), nongovernmental or
philanthropic (see 4E), not only provide direct services but have a significant responsibility
for collecting data for national planning.

Health and rehabilitation services

These services are critical to successful prosthetics and orthotics service provision, and
prosthetics and orthotics services are an important component of the health and rehabilitation
continuum (see 4F and 4G). The involvement of representatives of health and rehabilitation
services is therefore essential in all phases of planning and service development.

Training and academic institutions

National and regional training institutions can ensure that sufficient numbers of competent
prosthetics and orthotics personnel are available to meet the needs of the country. They
are also central to initiating, conducting and promoting research. Training institutions must
be directly involved in workforce planning (see 3H) and sector planning so that the training
issues are well understood and the need for trained personnel is taken into account and met
in a timely manner. In countries where there are no prosthetics or orthotics schools, advice
may be sought from schools and academic institutions in neighbouring countries.

Professional associations
Associations of prosthetists and orthotists, physiotherapists, occupational therapists,
nurses, doctors and other disciplines have collective knowledge that is indispensable for
the planning, development and promotion of prosthetics and orthotics services. Valuable
additional support can also be provided by regional and international associations.

Manufacturers and suppliers of components, materials and consumables

Manufacturers and suppliers should conduct research on, develop, produce, make available
and provide training in good-quality, cost–effective components and materials for the
fabrication of prostheses and orthoses for the full range of treatment in various contexts.

International organizations and agencies

The international prosthetics and orthotics community has an important role in advocacy,
international coordination and exchange of information as well as in the provision of direct
technical support and funding for prosthetics and orthotics development (see 1D).

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 STANDA RDS F OR PROS T HET ICS AND O RT HO T IC S • PART 2. IM P L E M E N TATION M AN UAL

Funding agencies
If prosthetics and orthotics services are to be affordable for all persons in need, they cannot
rely solely on out-of-pocket payments. In most countries, services can be sustained only if
they are subsidized by government funds, insurance, charities, corporate social responsibility
schemes and other sources (see 1J and 1K).

1B Guiding framework
Governments are responsible for establishing a guiding framework for prosthetics and
orthotics services, including national laws, policies, plans, standards, regulations and rules
for licensing service providers and for accreditation of prosthetists and orthotists and their
associates. The framework should be developed and monitored in collaboration with all
national stakeholders.

Legislation
The CRPD, which can serve as a template for formulating national laws and policies, stipulates
that governments should adopt the necessary legislative measures to assure recognized
rights (1). Most countries have laws assuring the rights of people with disabilities, but national
legislation might have to be revised and updated. Governments are equally obliged to make
sure that the laws are enforced.

Policy
Governments, in collaboration with other stakeholders, should formulate a policy for
prosthetics and orthotics services, clearly setting out general principles for the development
and functioning of the services. The policy should ensure that services are affordable,
accessible, effective, efficient, safe and of acceptable quality and adhere to international
standards. As appropriate in the country context, the policy should be integrated into a
broader policy for rehabilitation and/or assistive technology, if the specifics of prosthetics
and orthotics are adequately addressed.

National plan
A national strategic plan for prosthetics and orthotics services should be an integral
component of a national health strategy and linked to national development plans. It
should set detailed goals and concrete steps for establishing, developing and managing
such services. A national plan prepared by all relevant stakeholders can function as a
working document, providing a brief outline of the structures and functions of the service
system, and can gradually incorporate more information, with detailed plans, processes and
standards. The plan may address most of the areas covered in this manual. Each requires
separate discussion but all are interrelated and will have greater impact when linked within
a comprehensive plan.

Standards
Governments, in collaboration with stakeholders, should define standards for working
methods, processes, practices, infrastructure and equipment in prosthetics and orthotics

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 AR E A 1 . P O L I C Y

services. The standards should be framed so that they can be applied to monitoring, auditing
and evaluation of each aspect of services. International standards, such as those in Part 1 of
this publication and those of the International Organization for Standardization (ISO) can
serve as models for preparing national standards. The ISO standards include those for the
provision of prosthetics, orthotics and assistive devices, for rehabilitation (2–5) and general
quality standards (ISO 9000 on the fundamentals of quality management systems and ISO
9001 on the requirements for meeting the standard).

Regulation
To protect the interests and safety of users, regulation should ensure services are provided
in a professional manner by adequately trained personnel following correct procedures and
using reliable materials and equipment. The regulation of prosthetics and orthotics services
should be an integral part of the national health care regulatory system (6), to be established
by governments in collaboration with relevant stakeholders. To ensure a solid foundation for
appropriate, safe service delivery, governments should regulate, for example:
• prosthetics and orthotics training;
• prosthetists, orthotists and their associates (usually as part of regulations on health
professionals, see 3J);
• prosthetics and orthotics services (as part of licensing, see below);
• prosthetic and orthotic products (as part of regulation of health products, see 2G);
• use of prosthetic and orthotic components and materials (usually as part of regulation of
the products);
• the importation and distribution of prosthetic and orthotic components, materials,
prefabricated products, tools, machines and other equipment (as part of customs
regulations, see 2F and 2G);
• financing of prosthetics and orthotics services (see 1K); and
• the issuance of purchase requisitions (as part of financing of services).

Mechanisms should be established for implementation, monitoring and enforcement.

Monitoring is usually conducted by a government office, but responsibility may be delegated
to an independent agency. Enforcement may include legal proceedings. A certain degree of
self-regulation may be applied, such that service providers monitor their own adherence to
national standards.

Licensing of services
Governments are responsible for ensuring that prosthetics and orthotics services are
provided only by qualified providers. This is usually effected by introducing a licensing or
registration system and establishing minimum requirements, including qualification of
personnel; adherence to national standards, rules and regulations; accountability and service
unit infrastructure. Service providers applying for a licence or registration should declare
any conflict of interests, for example with regard to upholding free competition, freedom of
choice and user rights (see 2G and 4C).
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Service providers who meet all the minimum requirements should be registered and given
permission to practise. All licensed services must undertake audits and are expected to
report statistics to the government or a designated office (see 1O). Service providers’ licences
should be renewable after a certain period.

Licensing can be delegated to an independent State regulator but is usually financed by the
government.

Accreditation of prosthetics and orthotics professionals

To ensure the quality of prosthetics and orthotics services and the safety of users, only
professionals who meet national competence standards should be allowed to practise.
Regulation of prosthetists and orthotists should be organized by the government (see 3J),
including mechanisms for withdrawing the accreditation of professionals who make serious
errors in clinical work or are involved in fraudulent activities, putting the safety of users at
risk. The government may delegate accreditation to an independent State regulator.

1C Monitoring
Governments must monitor prosthetics and orthotics services to ensure that they develop
towards the goals set in national policies and plans. Appropriate tools and procedures,
measurable goals and benchmarks and performance indicators should be established
to evaluate outcomes. Monitoring should include data collected from service providers
(see 1O), which indicate the development of services and whether they meet the needs in
terms of both quantity and quality. Monitoring should also include direct, regular auditing
of service providers to verify their adherence to the standards, rules and regulations of the
guiding framework as well as occasional evaluations of quality and also general assistance
to providers in identifying and resolving problems.

Monitoring can be done directly by the government or be delegated to an independent office

or authority, a national prosthetics and orthotics committee or an entity that coordinates and
monitors the broader fields of health, rehabilitation and assistive technology. Evaluations and
audits should be performed by a multidisciplinary team of experts external to the services
being examined.

1D International support
In many low- and middle-income countries, the support of specialized international
organizations is critical for setting up and improving prosthetics and orthotics services.
Frequently, this occurs as a direct response to a disaster (see 4J). Organizations may
contribute financial and technical support for service delivery, professional training, national
policy development and planning and the development of tools and work processes; they may
also directly supply components, materials and equipment. International support contributes

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to raising awareness about the rights of people with disabilities and the need for and benefits
of prosthetics and orthotics services.

The support of international organizations and agencies is usually limited in time and
resources. Hence, long-term strategies and implementation plans for prosthetics and
orthotics should be drawn up. Rather than considering international support as an isolated
intervention to maximize immediate service outputs, the interventions should be integrated
into national systems for long-term results. The victims of natural disasters or conflict are
best assisted by strengthening existing service systems, ensuring that they function well in
the long term and are available to all.

With national partners, international organizations may assist in developing effective,

cost–effective models of service delivery at primary, secondary and tertiary levels that are
adapted to the country. International organizations can also help in building local resources
by supporting the establishment of national or regional centres of excellence staffed by well-
trained local experts, which can provide support to other service providers when international
support has ended. This approach has proven effective in many regional training centres and
is important for the development of prosthetics and orthotics services.

1E Costs
The costs of prosthetics and orthotics service provision are not only those for human
resource, components and materials. To ensure provision of good-quality prosthetics and
orthotics services, five main types of cost should be taken into account and covered. Each
is discussed in more detail below.

• service establishment = investment cost

• training human resources

• service providers
= recurrent costs
• service users
• national monitoring

Stakeholders involved in planning, establishing, running and funding prosthetics and orthotics
services should comprehensively and coherently analyse these costs to understand the
financial implications. Each category may require a different type or combination of funding.

Service establishment
Establishment of service units and systems requires capital investment in infrastructure and
hardware, such as buildings, tools and machines. These are essentially one-off investments,
but normal wear and tear will require financial provisions for maintenance, repair and
replacement of items. These expenses are usually included in the costs of the service provider
(see below).
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The establishment of a service is usually financed by the service provider, such as the
government, nongovernmental organizations (NGOs) or private investors. If a service is
established privately, it may be financed by a loan, and the interest and reimbursements are
included in the costs of the service provider.

Training human resource

Prosthetics and orthotics services require well-trained, qualified professionals. Substantial,
continuous financial investment is needed to ensure sufficient numbers of prosthetics and
orthotics personnel and to offer continuing professional development (CPD). With some
exceptions, such training is done in institutions that do not provide regular services, and the
funding sources are usually different from those for service providers. Supervised clinical
placement is usually assured by prosthetics and orthotics services linked to an educational
institution.

Prosthetists and orthotists and other personnel required in these services are usually trained
in public or private institutions. Training is often paid by the students, but frequently with
some type of subsidy from the government or a donor, such as a stipend. Governments
should take responsibility for training and may provide funding if needed.

The costs of training prosthetics and orthotics personnel include those for:
• space, including lecture rooms and sections for practical training;
• tools, machines and other equipment;
• training materials;
• personnel (lecturers and clinical supervisors); and
• users in practical training (allowances).

Countries that do not have prosthetics and orthotics schools but rely on training institutions
abroad have a different set of costs for each individual trained, including for education, study
materials, travel, accommodation and allowances. These costs are sometimes covered by
scholarships from an employer, government, civil society institution or donor.

Service providers
The costs of service providers are the regular expenses paid to deliver services, which may
include:
• material costs, including taxes and charges related to procurement, such as value added
tax (VAT), port charges, clearance and freight costs, importer’s margins and wholesaler
margins;
• personnel costs;
• other running costs, including for telephone, Internet, electricity, water, fuel, cleaning, rent
and insurance;

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• maintenance of building, equipment, etc;

• depreciation (provisions for the replacement of worn-out equipment, vehicles, etc.);
• central, regional and local government taxes;
• interest payments and reimbursement of loans (if applicable); and
• any external service provided by therapists, doctors and other health and rehabilitation
professionals.

In private services, the provider usually sets the prices in order to generate a net profit. This
should be taken into account in calculating costs (see Box 2).

Box 2. Calculation of costs and price of prosthetics and orthotics services

All service providers – public, private, NGO, philanthropic (see 4E) – should know the exact cost of
service delivery and that of each type of treatment offered. Costs and prices can be calculated with
a tool that can also be used to contain costs by identifying areas in which costs can be reduced
and cost–effectiveness improved. The tools include that of ISPO (7). Calculations should take into
account all service-related costs and make provisions for e.g. follow-up, maintenance and repairs.
For public services, salaries and infrastructure costs should also be included in the calculation,
even if these items are covered by separate budgets. If these costs are not included, private service
providers will not be able to compete on an equal basis, as their prices cover all their expenses.
Stakeholders can estimate the cost (or package price) of a complete treatment of a specified type
for one person. This can be based on the prices calculated by service providers but is often higher.
In low-income settings, for example, some of the costs of users might have to be covered in order
to ensure that all people who need services can access them (see Expenses of service users below
and 1M).
In the same way that the price of one vaccination has been calculated for immunization campaigns,
a package price for prosthetics or orthotics treatment can illustrate the amount required to access
the services. This figure is important for raising awareness at policy levels, lobbying for funds and
selling the services. Calculations should preferably be made for each diagnosis, so that the cost
for the entire population can be made on the basis of data on the prevalence of each disability.
Data on costs are also of interest to the international prosthetics and orthotics community, for
making international comparisons and identifying models of cost–effective service delivery. The
support of international bodies might be required in developing and standardizing comprehensive
methods for costing.

Expenses of service users

The expenses that are incurred personally by users when accessing a service unit and the
loss of earnings should be considered in addition to service-related costs in order to derive
the global cost of service delivery. The expenses may include:
• cost of travel to and from the service unit (sometimes requiring special transport);
• cost of accommodation at the service unit location;
• increased cost of meals during treatment;
• loss of earnings while away from work;

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• cost of inability to perform normal activities in the community or household chores;

• cost of an accompanying person or persons (such as parents of children); and
• child care expenses.

Note: Although service fees constitute a major expense for users, they should not be
considered a cost in this context but rather income for the service. (User fees are discussed
in 1K.)

The expenses of users may be higher than the actual cost of service delivery and frequently
constitute just as important a challenge to making services available, in particular in poorer
settings. To facilitate access, user costs might have be subsidized for the people at greatest
risk for exclusion (see 1M).

National monitoring
Monitoring is the least expensive of the five main cost categories if a well-planned service
system is in place. Prosthetics and orthotics services should be monitored to ensure that
they are meeting the needs of the population and are adhering to established standards,
rules and regulations. National monitoring is usually financed by public funding, although
the tasks may be delegated to a nongovernmental agency.

Monitoring costs may include those for:

• a dedicated office or unit for monitoring prosthetics and orthotics services and
• personnel to administer coordination and planning, enforcement of regulations, audits
and evaluation of services and national and international contacts.

1F Economic benefits
Prosthetics and orthotics services generate direct and indirect economic benefits for the
person, the family, the community, society and the country. The services therefore not only
have a cost but are an investment that yields both social and economic returns. Apart from
the moral imperative to make this investment (to ensure that rights are respected and equity
and development are achieved), there is also a clear economic case for financing prosthetics
and orthotics services.

In making a cost–benefit analysis and identifying the economic benefits of these services,
it is important to recognize the high cost of not providing these services to people who
would benefit from them. As a result of treatment, individuals require less assistance from
their families and other caregivers, releasing financial and human resources. The cost of
not providing services may also increase over time, as secondary health conditions may
require more expensive interventions. Gradually, whole families may become at higher risk

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for poverty and more dependent on social support. Aggregated over time, such costs can
soon be higher than the actual cost of treatment. It is therefore important to both provide
the services and ensure that are provided in a timely manner; early interventions significantly
reduce long-term costs (see 1H).

National stakeholders, in coordination with the international prosthetics and orthotics

community and disabled people’s organizations, could conduct more detailed studies to
calculate economic benefits at all levels (from the individual to national) and present policy-
makers and planners with the results.

Direct economic gains at individual, family and community levels

Prosthetics and orthotics services contribute to making individuals more mobile and thereby
more independent, which, in turn, has economic benefits. Rehabilitation of a person can
reduce the costs of care and assistance and, for example, free financial and human resources
in the family and the community, save the cost of institutionalization and reduce spending
on health interventions and hospital visits. Rehabilitation can also result in an income for
individuals and their families (and thereby society), as people who receive prosthetics
and orthotics treatment can return to work or attend school and higher education, thus
increasing their chances of earning an income later; they can also contribute to family tasks
and community work. These benefits may be tangible in poor populations. Thus, prosthetics
and orthotics may help people to escape from extreme poverty and hunger.

Direct economic gains at society and national levels

Benefits at individual, family and community levels will have an accumulated financial
impact. Furthermore, the government will be able to make savings on social welfare, such
as unemployment benefits and disability allowances. Hospital expenses will be reduced,
as prosthetics and orthotics treatment may speed recovery and reduce or shorten hospital
admissions. National health expenditure is decreased, as people with impairments or
functional limitations become more active and healthier and require less health care. In
addition, people who have undergone treatment and have returned to work will increase
their financial contribution to society by paying income tax and generally increasing their
spending. Thus, investments in prosthetics and orthotics services, and thereby in human
capacity, can contribute to national economic growth.

Indirect economic gains at national level

Prosthetics and orthotics services also benefit the national economy indirectly. For example,
service providers, like other employers, contribute to job creation and thereby reduce
unemployment. Staff members, in turn, pay income tax on their salaries, and most services,
particularly when provided privately, are taxable. Some countries also have large prosthetic
and orthotic component industries, which may sell their products on the international market
and generate considerable taxable income and profits.

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1G Ensuring cost–effectiveness
Cost–effectiveness in prosthetics and orthotics services is a measure of responsible use of
the available funds. Services that are cost–effective are more affordable and more widely
available to more users. Efficiency is, therefore, necessary for equity in service delivery.

Measures to ensure cost–effectiveness

Ensuring the cost–effectiveness and growth of services should be part of the regular work
of service providers and of stakeholders who monitor prosthetics and orthotics services.
Several sectors should be analysed to determine where costs can be reduced and efficiency
improved, without compromising quality.

At the service level, providers can investigate ways of reducing costs, by:
• setting realistic treatment goals and making appropriate choices of technologies;
• introducing alternative, cost–effective processes, components and materials (after
appropriate cost–effectiveness analyses);
• ensuring the durability of prostheses and orthoses to reduce the frequency of repairs and renewals;
• providing maintenance and repair services to maximize the lifespan of prostheses and
orthoses (see 4I);
• reducing waste;
• making sure that personnel at all levels and in all functions are well trained and skilled for
the tasks they perform;
• appropriately balancing the ratio of non-clinical personnel per prosthetics and orthotics
clinician (see 3H);
• increasing the specialization of staff members, so that they can gain more experience and
skills in their field (see 3G); and
• task-shifting, so that primary health care (PHC) workers, therapists, social and community
workers and community-based rehabilitation (CBR) workers provide a specific, well-
defined range of prosthetics and orthotics services (see 4G).

A tool for calculating costs can help to identify areas in which costs can be reduced and
cost–effectiveness improved (see Box 2).

Decentralization may increase the overall cost–effectiveness of prosthetics and orthotics

services, including the expenses incurred by users (see 4H, Box 17).

Governments can also significantly reduce the costs of service delivery and make prostheses
and orthoses more affordable, by:
• reducing or waiving import taxes on components, materials, tools, machines and other
equipment used exclusively in prosthetics and orthotics services; and
• reducing or waiving value added tax on these services and products.
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Tax regulations for prosthetics and orthotics services should be the same as for any other
field of assistive technology.

The inclusion of some elements of these services into PHC can save costs due to early detection
of needs, early treatment (see 1H) and the prevention of secondary impairments (see 1I).

1H Benefits of early detection and treatment of impairments

Avoidable impairments must be identified and treated as early as possible. In most cases,
this can be done in PHC programmes, provided the staff have adequate training. Early
interventions not only limit suffering and hardship but are also more economical, reducing
the need for care and consequently the cost for families, caregivers and communities.
When applied early, many prosthetics and orthotics treatments can correct and minimize
deformities, which, if left untreated, would require gradually more complicated interventions
and therefore more resources (see Box 3). The earlier treatment can be started, the sooner
the economic benefits will be seen (see 1F) and the greater the accumulated economic gains.

Box 3. Benefits of early treatment of clubfoot

Some 150 000–200 000 infants are born with clubfoot each year globally (8). If these deformed
feet are identified and treated promptly, the majority can be relatively easily corrected during the
first few months after birth by a combination of manipulation, serial plaster casts, minor surgery
and a brace. The cost of such treatment is low and represents only a fraction of lifelong disability
benefits. If the deformity is not dealt with at an early stage, it will worsen, limiting mobility and
access to education and employment. Eventually, it may lead to discrimination and exclusion from
society. While clubfoot can still be corrected at a late stage, surgery and orthotic fitting are major,
costly interventions, and the function of the foot will still be limited, even if the aesthetics are
improved. Clearly, the cost of not intervening at an early stage is very high.

1I Prevention of avoidable impairments

Prosthetics and orthotics services are important in the prevention of secondary impairments,
through a combination of information, advice and orthotic treatment. Examples include the
care of people with diabetes, who are at risk for amputation as a result of foot ulcers (9)
(see Box 4), management of idiopathic scoliosis during growth (10) and the prevention of
contractures in burns.

Preventing secondary impairments has direct benefits for the person and the health system.
For the person, the absence of functional limitations means a better quality of life, as it is
easier to participate in home, work and family life, and it is less likely that complications will
develop. For the health system, there is less pressure on the resources needed for severe
health conditions.

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Box 4. Prevention of amputation in people with diabetes

People with diabetes may lose sensation in the feet (neuropathy). This, with a poor blood supply
due to restricted blood vessels, increases the risk for damage to the feet and for foot ulcers, which
can lead to infections, amputation or even death.
Diabetes is a sizeable health challenge, as 8.5% of the world’s population have the disease (11),
and people with diabetes have a 12–15% chance of a foot ulcer in their lifetime (9). Strategies to
reduce the risk for foot ulcers include preventive advice, awareness campaigns and identification
of cases of diabetes in the community and primary care settings. Foot ulceration can be prevented
by screening people with diabetes to identify those at risk and showing them proper foot care (12).
For those with foot ulcers, compliance with orthotic treatment and the use of protective footwear
can help to prevent major limb amputation (13).
Prosthetics and orthotics services have a role to play in the prevention and treatment of diabetic foot
ulcers, preferably in a multidisciplinary foot clinic. The principal treatment is mechanical offloading
with total contact plaster casts (14), therapeutic footwear (13) or another orthosis to protect and
stabilize the foot and ankle, depending on the severity of the condition. If limb amputation is
required as a lifesaving measure, these services can offer a prosthesis after amputation. For people
who undergo unilateral amputation because of diabetes, orthoses and special footwear can help
prevent the development of ulcers and later amputation on the sound side.

1J Universal health coverage

The concept
Universal health coverage is defined by WHO as “ensuring that all people can use the
promotive, preventive, curative, rehabilitative and palliative health services they need, of
sufficient quality to be effective, while also ensuring that the use of these services does not
expose the user to financial hardship.” (15).

In this concept, user fees (out-of-pocket payments) are reduced by the use of funds pooled
from various sources, usually including general tax revenues and mandatory earmarked
contributions for health and social insurances (payroll taxes). The services thereby become
affordable for vulnerable and poor populations, who are at risk of sliding into poverty when
they have to pay for health services from their own pockets. Universal health coverage is
therefore a critical component of sustainable development and poverty reduction and a key
element of all efforts to reduce social inequality.

The concept can be illustrated as a three-dimensional box (Fig. 1), which represents the
funds required to provide all health services free of charge to the whole population. Once
a certain level of pooled funding has been secured (the blue volume), policy-makers can
decide how to allocate the money: which sector of the population to insure (dimension 1;
population coverage), which services to include (dimension 2; service coverage) and how
much to charge people for access to those services (dimension 3; financial coverage). To
provide more coverage, either funding or efficiency must be increased. It may not be possible
or even desirable to pool enough funds to fill the larger box; the challenge is allocating the
available funds so that the widest range of services can be provided to the most individuals
in the most equitable way.
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Fig. 1. Three dimensions to be considered when moving towards universal health

coverage

Economy of scale,
partnership and
insurance

Reduce cost
sharing and
fees

Direct costs:
Include proportion of the
other costs covered
Extend to services
non-
covered
Services available Current
at three levels pooled Prosthetics and
funds orthotics services

 
Population: Services:
who is covered? which services are
covered?

WHO generally recommends that countries establish large risk pools by maximizing
mandatory prepayment and use general government revenue to cover people who cannot
afford to contribute. This good practice is based on sound health financing principles.

Prosthetics and orthotics services

Prosthetics and orthotics services constitute an important part of health services and must
therefore be taken into account in moving towards universal health coverage, especially when
the addition of other services is being considered. Like other health services, prosthetics and
orthotics services must be financially accessible for all potential users and should therefore
be included in the benefits package (dimension 2 in Fig. 1).

Certain prosthetics and orthotics treatments may be higher priorities for subsidies than
others. WHO’s “priority assistive products list” (see 2D) serves as a guide for governments,
indicating which products are essential. Where financial resources are limited, governments
– represented by their ministries for health, social welfare and finance and in collaboration
with other stakeholders – will need to determine which products (and their technical features,
see 2B) should be subsidized and to what extent. Therefore, a full economic costing should
be conducted for each product in order to derive the complete cost of delivering the services
(see 1E).

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1K Financing
Health financing is much more than about raising money for health. It is also a matter of
“who is asked to pay”, “when they pay” and “how the money is spent”. The way that money
is raised to cover health costs is usually referred to as “revenue collection” (16).

Experience from the financing of medicines has shown that the critical factors for success
are political commitment, administrative capacity, clear implementation strategies, financial
sustainability, rational selection of products, affordable prices, a reliable supply system, and
low taxes. Inequalities in access to treatments, particularly in resource-poor countries, are
mainly due to inadequate public spending, a lack of adequate health insurance coverage,
poor availability of essential supplies, poor affordability, and high household out-of-pocket
expenditure (17). It may be assumed that the same applies to prosthetics and orthotics
services.

Government commitment is critical to establishing adequate, sustained financing for

prosthetics and orthotics services. With stakeholders, governments can devise financing
models suitable for the country’s institutional, economic and social context, while encouraging
diversity and choice with regard to technologies, components and materials.

Funding resources for prosthetics and orthotics services usually come from general and
specific taxation, public health and social insurance, private insurance and medical savings
accounts, user fees (out-of-pocket payments), donations or a range of less common but still
important sources. Funding is often a mix of these sources, the distribution of which may
differ among countries and change within countries over time. All funding sources must be
explored, in particular in poorer settings, as a single source may not cover all service needs.
Funding mechanisms must always be based on transparency and accountability, with clearly
defined financial procedures and rules, for example in issuing purchase requisitions.

In order to ensure a sustainable financial model, countries are encouraged to move towards
predominant reliance on compulsory funding sources, such as general tax revenues,
earmarked payroll taxes or a combination of both, as typically voluntary mechanisms often
suffer from major shortcomings (18). This strategy contributes to sustainability and including
prosthetics and orthotics services in universal health coverage.

General and specific taxes

In some countries, prosthetics and orthotics services are funded with tax money raised by
national or provincial governments. The taxes may be general income or specific taxes, such
as value added or excise taxes. Tax funds may be channelled through a ministry directly to
prosthetics and orthotics services, or as direct payments or vouchers to the users, who can
obtain the services required for their individual needs.

Governments may use tax funds to subcontract services to private enterprises or NGOs.
Subcontracting should be done by recurrent, open tendering, and services should be

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commissioned to ensure quality and not only advantageous cost. Various cost-sharing
arrangements are possible. For example, government funds might be used to cover the
salaries of the personnel of an NGO, while the NGO pays for the components and materials
and delivers the services.

Public health and social insurance

In many countries, prosthetics and orthotics services are funded through public health and
social insurance systems. In such systems, the country’s entire population is entitled to
health care coverage, usually in a cost-sharing arrangement, with the user paying a service
fee. Insurance is usually financed by compulsory prepayments (social insurance premiums or
other government charges), which are pooled to spread the risks throughout the population
(see 1J). The health and social insurance systems of many countries do not, however, cover
prosthetics and orthotics treatment, and national stakeholders should advocate for the
inclusion of such benefits.

The extra cost of including prosthetics and orthotics services as a component of national
health and social insurance is expected to be comparatively low. The direct results of doing
so may, however, be significant, as coverage may dramatically increase access to services,
thereby contributing to universal health coverage. The costs should be calculated (see 1E)
and compared with the economic benefits for individuals and society (see 1F).

Private health insurance and medical savings accounts

Prosthetics and orthotics services are sometimes funded by private health and accident
insurance, workers’ insurance or similar, which is often co-financed by individuals and their
employers. Such insurance may be compulsory and mandated by law.

In this option, health care is often provided based on the individual’s ability to pay rather
than evaluation of health needs, negatively affecting the unhealthy. The concept of a medical
savings account (MSA) is a mechanism that allows people to save money monthly to spend
in the future on health care. The philosophy behind this concept is that if people are forced
to save their own money to cover costs, they may be more responsible when it comes to
consumption or expenditure (17). In some countries, MSA funds are used to cover the costs
of prostheses and orthoses.

Many countries have private health insurance systems in parallel to the public health
insurance systems. Private health insurance systems usually offer better coverage for people
who can afford it. In countries where private insurance is the sole system, poor people risk
exclusion from the services unless insurance premiums are subsidized by the government (19).
Furthermore, prosthetics and orthotics services are often not included in the benefits package
of many private insurance companies and inclusion may therefore have to be promoted.

User fees
In some circumstances, prosthetics and orthotics services are paid in part or in full by the
service user. Payment in part may be referred to as household out-of-pocket payments and

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is often proportional to the amount of care consumed (17). Overly high service fees have a
direct negative impact on access and the use of services, and many people risk exclusion
(20) (see 1L). Large user fees that lead to catastrophically high expenditure push people,
families or households into debt and poverty cycles. When user fees are the main source of
funding for prosthetics and orthotics services, service providers must make various levels
of technology available, including affordable, low-cost alternatives for people who cannot
pay for an expensive product range.

Donations
In some situations, prosthetics and orthotics services are financed by donations, for example
from charity organizations and NGOs, which may sometimes also provide services. The risk
associated with such an approach is that not enough attention is paid to the outcome of the
service or to sustainability. To ensure quality and user satisfaction, charity services should
be evaluated in the same way as other services.

When services are provided with donated funds, they are often free of charge for the service
user. This can lead to abuse of the system and also seriously undermine the efforts of
providers that do not rely on donors to create sustainable services. Application of a small
service fee can have a positive effect (see 1L). Sometimes, particularly in poorer settings,
donations may include components, materials or second-hand prostheses and orthoses.
If such in-kind contributions are not coordinated, they may be of little help to the service
provider (see discussion on donations and reuse of components in 2F).

Other funding sources

Funding for prosthetics and orthotics services may also come from other, complementary
sources, such as trust funds, credit unions, lotteries, private institutions, multinational
companies, corporate social responsibility initiatives and various types of foundation. In
some instances, local communities may be able to contribute funding to individual service
users, and, in some countries, earmarked funding from a “sin tax” (e.g. a tax on tobacco or
alcohol) may be used.

Service providers can also use a socially oriented system, in which the profits made from
users who can pay the full cost of treatment or who can afford more advanced products
are used to subsidize services for those who have less financial means (cross-subsidized
funding). This is usually the case of private social enterprise organizations, which reinvest
profits into services in order to maximize social well-being.

Another possibility is community health financing, a system comprising consumer payments

such as user fees, pre-payments etc., for community delivered health care, with proceeds
retained and managed within the local health sector. This method often serves as a means
for communities to be active, rather than passive participants in their health system and may
aid in the provision of prostheses or orthoses (17).

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1L Considerations in applying service fees

In some prosthetics and orthotics systems, services are provided free of charge. Although
this may appear to be ideal, in particular in settings with limited financial resources, the
policy must be evaluated carefully.

The benefits of asking for payment for services include:

• making users more aware of the value of the treatments and more appreciative of the
services;
• allowing users to bargain for better quality;
• encouraging users to maintain the products they receive;
• reducing abuse of services; and
• generating an income that, although perhaps small, helps to sustain the services.

User fees can, however, pose a significant barrier to large sections of the population and
jeopardize the attainment of universal health coverage (see 1J). The right level of fees must
therefore be set. In poor settings, the fee might have to be very low or merely symbolic
for many users. Even a token payment can give rise to most of the positive effects listed
above. The appropriate level of fee might have to be decided case by case by evaluating the
socioeconomic status of individual users.

Caution is required when services are provided from mobile units or in outreach activities,
where it might be particularly difficult to ask for payment, as this might deter people from
using the services.

More evidence is required on the impact of user fees on the use and sustainability of services
in different economic contexts and for different types of service delivery. Research should
be conducted by national and international stakeholders in this area.

1M Facilitating access of users

Travel to a service location and staying throughout treatment sometimes incurs considerable
indirect costs for users (see Expenses of service users in 1E), particularly those who have to
travel a long distance or require assistance and regular appointments. Many users may also
have spent part or all of their savings on surgery and other medical treatment.

In many countries, even if the treatment is free of charge, user expenses may deter people
from seeking the services. In order to minimize travel costs and time spent away from home,
the services should be decentralized as much as possible by their inclusion in health services
(see 4F and 4G) and other means (see 4H). If access is still difficult, the service provider,
government or other stakeholders (including the local community and civil society) might
consider subsidizing travel-related costs for people at greatest risk of not accessing the

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services. Such support should preferably be temporary, so as not to create dependence. If

users are satisfied with the services and experience direct benefits (including financial ones),
they might be readier to find ways to cover travel-related costs the next time they require
the services.

1N Assessing the need

Accurate data on the needs and unmet needs for prosthetics and orthotics are indispensable
for planning and developing services. Information is required, for example, for workforce
planning (see 3H) and for assessing the number of service units to be established in a country
or region (see 4G, Box 15). The need for services can be assessed by using the general WHO
estimate of 0.5% (21), from data on the prevalence of disability, by using data from national
censuses, by analysing service utilization or by conducting a dedicated survey (all discussed
below). Some of these methods also indicate the level of unmet need. As a complement
to these approaches, the demand for services (the number of people actively requesting
assistance) should be considered; however, it is important not to equate demand with need,
as many people who could benefit from these services are unaware of them (see Box 5).

Box 5. Need versus demand

The terms “need” and “demand” should be distinguished. “Need” is the actual number of people
who could benefit from prosthetics and orthotics services, while “demand” is the number of
people who actively request assistance. In many countries, the demand for services is very limited;
frequently, there are no queues outside service units, and waiting lists – if they exist – are often
short. This may give the false impression to decision-makers and other stakeholders that the need
for services has been satisfied, even though the unmet needs may be overwhelming. People who
need services do not demand them because, for example, they may:
• not be aware the services exist (even health care professionals who could refer them to prosthetics
and orthotics services may be unaware of their existence);
• think the services could not help them;
• think they are not entitled to the services;
• find the services inaccessible or too far from their community;
• have had experience of poor service delivery in the past and do not want to try again; or
• be unable to afford the services.
Consequently, governments and other stakeholders cannot rely only on reports of demand. Clear
evidence of need is required to make informed decisions. Services should not be provided only to
those who are vocal or live in large cities.
People’s demand for services is of value for expanding services and making them more accessible.
In countries where many individuals demand these services – by requesting assistance at service
units, hospitals, public offices, etc. – governments are usually more aware of the need for services
and are more likely to take concrete steps to develop them.

Data on national needs and unmet needs for prosthetics and orthotics are often difficult
to obtain, as government data collection methods are not yet sensitive enough to identify
people with all kinds of functional limitation. By building on and improving the methods,

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the international prosthetics and orthotics community could support the development
of a standard needs assessment tool, based on the WHO International Classification of
Functioning, Disability and Health and taking into account existing and emerging data
collection templates (22).

In determining the need for prosthetics and orthotics service, replacements should also
be taken into consideration. The need of many users is lifelong, and their devices must be
replaced regularly as they wear out or no longer fit. The average lifespan of different types
of prostheses and orthoses can be estimated from service data, and this information can
contribute to sector planning.

Calculating need on the basis of the WHO general estimate

WHO estimates that one in every 200 people (or 0.5%) need a prosthesis or orthosis
(21). This is an approximate figure that does not take into account regional differences or
factors that result in higher rates in certain populations, such as war, disabling diseases and
road traffic injuries. Nor does it account for factors that reduce need, such as prevention
programmes and good medical care. It obviously does not indicate the types and numbers of
different prosthetics and orthotics treatments needed or the distribution by gender and age.
It does provide a basis for a first calculation of need and thus of the service system required
to assist the population concerned. The estimate can serve as a starting point for general
planning, to be complemented with more exact assessments later.

Estimating need from data on the prevalence of health conditions

Data on the prevalence of disability, to the degree that they are available, can be used as
a complement to the 0.5% estimate to determine the proportions of different types of
prosthetics and orthotics treatments needed. Epidemiological data on the most common
diseases and diagnoses relevant to prosthetics and orthotics (including diabetes, spinal cord
injury, vascular diseases, cerebral palsy, polio and amputations) can give a general indication
of the numbers and types of treatments and devices needed in a defined geographical
area, which can be extrapolated to national needs. Information for this purpose may be
obtained from the health sector, individual hospitals, national registers (see Box 6, below)
or national records on trauma-related injuries. Similar information can be obtained from CBR
programmes; disabled people’s and user organizations may also be able to provide data on
the impairments commonly seen in their groups.

Estimating need from national census data

In most countries, national population censuses are carried out by the government every 10
years. In some countries, censuses include questions on disability, usually those endorsed by
the Washington Group on Disability Statistics (23). These data are, however, often inaccurate,
as they are obtained from heads of households for all family members and not on first-hand
information. Such statistics, which are usually not specific to prosthetics and orthotics, should
preferably be complemented with data from other sources.

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Estimating minimum needs from service utilization

The utilization of prosthetics and orthotics services is often strongly correlated to the
proximity of those services to potential users. Use is likely to be highest by populations close
to a service unit, in particular if the services are financially accessible, well known and have
a good reputation, such that the need for prosthetics and orthotics services may be almost
met. Data on use of the services in the area will indicate the proportion of the population
that was assisted. Application of this value to other geographical areas can give a preliminary
estimate of the minimum need that can be expected in other regions and in the country. The
calculation can be refined by considering factors that are likely to influence need in different
geographical areas.

Determining need in a dedicated survey

Sample surveys can be conducted to obtain more precise estimates of need and unmet
needs for prosthetics and orthotics in a country or region, thereby also indicating inequity.
Surveys are, however, technically difficult and may also raise expectations in the population
that may not be immediately fulfilled. Unless the purpose of the survey is properly explained
to the people interviewed, it may create frustration and mistrust among individuals who
need assistance. As surveys are expensive, it may be more effective to conduct a small
sample survey in a country where the need is overwhelming and extrapolate the results.
The savings made by not conducting a large data collection exercise can be used to make
services available to more people in need. By keeping accurate records, it will be possible
gradually to understand the extent of the need for services (see previous section).

When a survey is conducted, it should obtain information on all types of prosthetics and
orthotics needs and not any particular need (such as that of people with conflict-related
impairments). When data are sought for one group, a survey usually offers an opportunity
to collect information on other groups too. Attention should be given to ensuring that girls
and women are not neglected.

The personnel conducting screening, assessments and interviewing should have sufficient
training to be able to identify needs. Otherwise the recorded figures may be too low, resulting
in an incorrect assessment of the resources and interventions required to provide appropriate
assistance. As surveys are usually one-off exercises, it may take a long time before flawed
values are corrected.

1O Collection of data
Data to assess the need for prosthetics and orthotics must be collected, analysed, compiled
and used at service and at national and global levels.

Data collection at service level

In order to monitor access to service and successes and challenges, every service provider
should collect basic data on the number of people treated and the type of services they

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received. Consistent recording, monitoring and analysis of data not only provide a picture of
the effectiveness of services but also give an indication of the need for services in the service
unit’s catchment area (see 1N). Service providers should also collect information on who
the users are and how the unit reached different groups, followed up users and ensured the
quality of treatment (Table 1). The purpose of collecting data must be fully understood by
the service providers. Only data that will be used should be collected.

Table 1. Examples of data that can be collected at service level

Data Purpose of data (examples)

Number of people treated and To understand the magnitude and breadth of services
types of treatment provided For planning procurement of components and materials
Socioeconomic status of To ensure that services also reach the most marginalized groups
users
Proportions of women and To determine whether additional measures are needed to target these
children among those groups (such as increasing the number of female personnel)
assisted
Age groups To ensure that children, young people and the elderly are included to the
same extent as other age groups
Geographical origin of users To determine the success of services in reaching remote parts of the
intended catchment area
User experience (from To determine the quality, affordability and accessibility of services and
questionnaires or focus group factors that prevent use and compliance
discussions)
Impact of the services on To determine the usefulness of delivered prostheses and orthoses and their
quality of life, participation contribution to enabling the user to work, go to school, participate in social
and inclusion activities, etc. (see 1P)
Waiting and delivery times To indicate whether the services are user-friendly
Referrals (in and out): by and To determine the success of networking, awareness-raising and
to whom and how mechanisms for referral
Follow-up services: how many To verify that appropriate follow-up services are provided to all users,
and who irrespective of where they live or where they are treated, at a central service
unit or through decentralized services
Repair services: how often To determine the technical quality of delivered products
required, type, reason
Frequency of replacement of To determine the lifespan of products and therefore annual production
prostheses and orthoses needs
Abandonment of prostheses To determine quality issues and areas to be improved
and orthoses, including rates
and reasons
Main causes of disability To determine the main types of treatment needed; monitoring over time will
indicate trends in disability for setting directions for services and predicting
training needs

The collection and analysis of data can be facilitated by ensuring that they are an integral part
of the service unit’s day-to-day work. Full use should be made of service user management
systems so that relevant statistics can be extracted and used (preferably in graphic form

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to illustrate trends over time). The international prosthetics and orthotics community
could facilitate data collection and analysis by developing standard, user-friendly tools and
methods that can be used in services and at national and international levels (see below).
The confidentiality and privacy of users must be respected (24) by anonymizing data collected
for statistical purposes.

Data collection and compilation at national level

National stakeholders require data for monitoring service delivery and for more detailed
planning. Many of the data on services can be compiled to produce national statistics, which
facilitate the analysis of time trends and identification of areas in which action is required
to improve service delivery. Information about service delivery should also be prepared for
decision-makers and others to raise awareness about the achievements, challenges and
general role of prosthetics and orthotics services (see 1Q). Data are also useful for insurance
companies, which might be willing to invest in data collection.

Standardized tools and methods will facilitate data collection and analysis (see previous
section). As at service level, only data that will be used should be collected. Compilation of
data at national level can be facilitated by direct entry of data into a national database, such
as a register (see Box 6). Such a database could be linked to or integrated into the national
health management information system.

Box 6. Use of national registers

A national register is essentially a database to which service providers submit results to provide
a comprehensive view of prosthetics and orthotics services. Regional or provincial registers could
supply data to the national register.
In countries in which there is the risk that users will request subsidized (or even free) services from
several providers, a national register of users and the services provided could facilitate coordination
among units to prevent overlap of supply. This can prevent fraudulent use of services and ensure
that limited resources benefit the maximum number of users.
A national register may be more comprehensive and be used to collect data for planning, monitoring,
evaluating and awareness-raising. All licensed service providers should be expected to submit a
defined set of data to the responsible organization, ministry or office at national level. Decisions
should be made on how the data are to be collected, maintained and retained.
An expanded national register could also include data on processes beyond prosthetics and
orthotics, including cross-sectoral data on interventions throughout the continuum of care, such as
from amputation to prosthetic fitting and complete rehabilitation, as in the Swedish register (25).
Such a register can allow objective evaluation of the quality of the entire rehabilitation process,
providing valid information and recommendations on appropriate treatments. Contribution of data
to the national register might not have to be compulsory, as service providers would usually consider
it an advantage, as the outcome will benefit the whole sector and, ultimately, the user.

Use of data at global level

Data produced at service and national levels is also of interest at global level and can be
collected and compiled by international stakeholders in prosthetics and orthotics. Global
statistics indicate the challenges faced by these services in different parts of the world

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and how they can be met, including examples of successful service delivery systems.
Standardization of tools and methods with ISO terminology for prosthetics and orthotics
(see 4P, Box 26) would facilitate such exchanges.

1P Data on impact
It is important to establish the direct impact of prosthetics and orthotics services on
individuals, i.e. the degree to which the services contributed to improving the quality of
life, social inclusion and economic status of beneficiaries. The availability of standardized
evaluation criteria would facilitate international comparisons.

As most users return at some point to the service unit for repairs or renewal of their devices,
they can be asked about how useful the prosthesis or orthosis is, when it is used, how
much it is used, whether it has enabled the user to work, go to school and participate in
social activities and whether it has improved the user’s self-determination and confidence.
Systematic data collection as part of service delivery is an economical way of assessing
impact.

For a more detailed, scientifically more accurate assessment, an impact study may be
conducted. This may be beyond the capacity of individual service providers, requiring a
commitment from the government or stakeholders and earmarked funding. Verification of
the impact of services is in the interest of all parties, to ensure that the investments generate
good results. Impact studies usually involve visiting beneficiaries in their communities, first
to make a baseline assessment and then to measure change. Studies can be facilitated by
liaising with user groups and community services in health, social or education sectors.

1Q Awareness-raising
Prosthetics and orthotics are relatively unknown, even in the health sector, and the public may
not understand what the services provide (see 1R). More disturbingly, the very people who
could benefit from these services are often unaware of their existence and consequently may
not demand them. This may give the false impression that there is little need for services (see
1N, Box 5). In many countries, therefore, awareness about the need for and benefits of the
services must be raised, from the level of decision-making (policy development and national
planning), to health and social professionals (who refer users) to districts and communities
(where the people who need the services live).

Member States have an obligation to promote use of assistive devices and technologies (1).
With national stakeholders, governments should make prosthetics and orthotics services
known and develop awareness that these services are indispensable and merit investment.
Strategies and tools for awareness-raising should be developed for this purpose as part of
strategies in the broader field of disability.

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Awareness-raising strategies should be based on rights-based arguments (with references

to national laws, decrees and policies and international documents, such as the CRPD and
the SDGs) and also on social and economic arguments of the costs and economic gains at
individual, community and national levels (see 1E and 1F). In some cultures, disability is seen
as a punishment, and people with disabilities are hidden and neglected (26). Such barriers
should be removed to ensure access for all to prosthetics and orthotics services.

User groups have an important role in lobbying and awareness-raising for policies. Demands
by users demonstrate the need for these services and are a complement to collected data.
Their demands sensitize decision-makers to real experiences, so that they will be more
inclined to take action.

At referral level, awareness-raising is best conducted during training of professionals in

health and social sectors. Stakeholders in prosthetics and orthotics should work with relevant
training institutions to ensure that prosthetics and orthotics are appropriately introduced in
the curricula and the role of these services is made clear (see 3E). Awareness should also
be raised by working with stakeholders in referral networks.

At grassroots level, awareness can be raised by liaison with programmes for similar missions
that target similar groups, such as poverty reduction programmes, vaccination campaigns,
civil society actions, disability-inclusive sports and recreation programmes (see Box 7)
and CBR programmes. The availability of good-quality services will, in itself, directly raise
awareness among potential users. When users learn that friendly, reliable services are
available and can make a great difference to their lives, many will tell others. When services
are affordable, easily accessible and of high quality, little awareness-raising will be needed.
Every satisfied user is an ambassador for the prosthetics and orthotics sector.

International awareness-raising activities can support national and local initiatives by

providing guidance and information resources that can be adapted nationally to improve
the efficiency of local campaigns.

A core feature of awareness-raising is information campaigns. Before launching a campaign,

the target groups should be identified (e.g. the general public, decision-makers, health
professionals, social workers, potential users) and the content, mode and medium of
dissemination decided. Information can be disseminated, for example, on television and
radio, in newspapers, on the Internet and in social media, by civil society, faith-based and
humanitarian organizations, at theatres, in schools and on posters and leaflets. Awareness-
raising also includes having good role models, by increasing the visibility of users in everyday
situations, such as in television series and sports events.

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Box 7. Liaising with disability-inclusive sports and recreation programmes

Sports and recreation are generally important for health and well-being and are often beneficial in
rehabilitation. Such activities not only ensure that prosthetics and orthotics service users benefit
from physical training but can also contribute to social inclusion. Many countries have dedicated
sports programmes for people with disabilities – such as track and field, wheelchair basketball and
water sports – some of which are governed by a national paralympic committee. Some athletes with
disabilities are integrated into able-bodied sports organizations. Prosthetics and orthotics service
units could liaise with disability-inclusive sports and recreation programmes and provide technical
support to people with disabilities, at both professional and amateur levels. The provision and
maintenance of prostheses and orthoses may be a precondition for the participation of people with
disabilities. Such support clearly contributes to social inclusion and to raising awareness about the
rights of people with disabilities and the role of prosthetics and orthotics services.

© USAID

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1R Strengthening the image

The challenge
In many countries, the prosthetics and orthotics profession is misunderstood as technical
work that, although it might require certain manual skills, does not require much theoretical
or clinical knowledge. As a consequence, it is often reduced to craft work or as noisy, dusty
work preferably performed in the basement or backyard of a hospital, if at all in a hospital
environment. In poorer settings, a prosthetics and orthotics service may resemble a repair
workshop rather than anything related to clinical work and medical science. As long as this
perception prevails, and even if the professionals are skilled and the results important, it will
be difficult for decision-makers to understand that these services are worth investing in.

National stakeholders should change this perception and make it clear, particularly to
policy- and decision-makers, that this is important work that requires years of training in a
wide range of theoretical subjects. Like other health and rehabilitation professionals, such
as physiotherapists, occupational therapists and podiatrists, prosthetists and orthotists
usually receive training at university, with some continuing to masters and doctorate degrees.
They work closely with doctors, share the same medical language and make an important
contribution to the health sector. This is the image that should be promoted.

Strengthening the image

A number of measures can be taken to strengthen the image of prosthetists and orthotists
among decision-makers, health professionals and rehabilitation professionals in particular.
Many of these measures do not require a large financial investment, especially if they are
considered at the planning stage. Generally, they consist of the way in which the services
are presented and how they interact with other services.

Ensure that prosthetics and orthotics services are an integral part of the health system.
• When possible, prosthetics and orthotics units should be integrated into hospitals, with
close, direct links to orthopaedics, surgery, rehabilitation, physiotherapy and occupational
therapy departments. This will not only make the services more effective but will increase
the perception that the profession is equal to other health professions.

Present positive outcomes of prosthetics and orthotics.

• Demonstrate concrete outcomes in functioning and participation, including socioeconomic
gains, in users, their families, their communities and the whole country.

Promote national recognition.

• If it is not yet the case, work with national authorities and other stakeholders to recognize
prosthetics and orthotics training, the profession, the services and the sector as such.
• Promote the establishment of national prosthetics and orthotics associations or societies.

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Ensure professionalism.
• Make sure all prosthetics and orthotics personnel are well trained and use proven
technologies and working methods based on the best available evidence.

Consider the appearance of the services.

• Make sure that all areas of the service unit have a professional look.
• Make sure that user areas are similar to those of modern hospitals, with a welcoming,
comfortable environment. Waiting rooms and clinical areas should be well separated from
the noisier, dusty activities of the workshop.
• Keep all areas, including assembly and machine rooms, clean, neat and tidy.
• Make sure all personnel are competent in addressing users.
• Make sure a user policy is in place and that services are truly user-oriented and gender-
sensitive (see 4A).
• Promote the wearing of clinical uniforms and name badges by all personnel in contact
with users.
• Always consider dress code when representing the services, in particular for personnel in
direct contact with government agencies or offices.

Carefully consider the choice of terminology.

• Refer to prosthetics and orthotics units as “departments”, “clinics”, “laboratories” or
“centres” and not as “workshops” or “limb-fitting centres”, as these terms perpetuate
the view of prosthetics and orthotics as merely technical work. While “prosthetics and
orthotics workshop” is a valid term, it should be used only when referring to the room or
section of the service unit where prostheses and orthoses are fabricated.
• Use the terms “prostheses and orthoses” and “prosthetic and orthotic products”, and
avoid the terms “calliper” and “appliance”, as these are outdated.

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© Chapal Khasnabis/WHO

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 AR E A 2. P R O D U C T S

Area 2. Products
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2A Appropriate technology
In prosthetics and orthotics, the principal definition of appropriate technology is that of ISPO:

Appropriate technology is a system providing fit and alignment which suits the
needs of the individual and can be sustained by the country at the most economical
price. Proper fit and alignment should be based on sound biomechanical
principles (27).

On the basis of this definition, detailed criteria can be used to evaluate the appropriateness
of technologies, components, materials and working methods locally. Appropriateness can
be considered from three main perspectives: acceptability by users, economic feasibility
and technical suitability. Criteria are proposed in Box 8; however, national prosthetics
and orthotics stakeholders should draw up their own criteria to guide evaluation of the
appropriateness of different technologies (28).

Cost–effectiveness in prosthetics and orthotics services is strongly determined by the

choice of technology and, for that technology, the choice of components and materials. As
components are available from a number of suppliers, with variations in models and prices,
the market must be searched continuously to find the most cost–effective options, while
carefully considering quality, durability and availability.

More than one technology may be appropriate, and several technologies of different levels
of sophistication and price can be used in parallel. Any technology that is requested, paid
for (by the individual, the system or a third party) and does not restrict access to services

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can be viewed as appropriate. This includes expensive and highly sophisticated products for
users who have the financial capacity or insurance coverage to pay for them (and service
providers with the necessary technical capacity to supply them).

Box 8. Criteria for determining the appropriateness of technology

The following criteria may be used to determine the appropriateness of prosthetic and orthotic
technologies, components, materials and working methods.
User-related criteria:
Products should:
• be comfortable, with a well-adapted interface between the body segment and the device;
• be functional;
• be easy to put on and remove;
• not endanger user safety;
• be durable;
• have the best possible cosmetic appearance (e.g. shape, finish, colour);
• be biocompatible (for example, not provoke allergic reactions);
• not be too heavy (in most cases, they should be light);
• be acceptable by and adaptable to the majority of users, i.e. they should:
- generally suit the user’s needs;
- be culturally appropriate, thus, should respect the culture and lifestyle of individuals, which
may include such aspects as walking bare-foot, squatting and sitting cross-legged;
- suit the climate (and, if necessary, be resistant to humid, wet conditions);
- suit the local terrain; and
- suit local working conditions.
Economic criteria:
• Products should be affordable by the system and/or the individual.
• Technologies should be cost-effective; they should be:
- clinically effective;
- allow for rationalization of production methods and swift fabrication;
- not require many tools and machines or very advanced, expensive equipment;
- require low service maintenance;
- generate minimum waste; and
- made of readily available components and materials (on the local market or imported).
• Technologies should promote sustainable development by enhancing local entrepreneurship and
making use of local markets, such as locally produced components or materials.
Technical criteria:
• Technologies and working methods should be of proven, documented efficacy and safety.
• Technologies and working methods should adhere to international standards.
• Technologies should ensure biomechanically correct products that can be given proper alignment.
• Products should be durable and have a long lifespan.
• Products should be easily adjusted, maintained and repaired (as far as possible by the users
themselves).
• Prosthetists and orthotists should have sufficient skill and knowledge to apply technologies and
working methods; if this is not the case, training must be practically feasible and affordable.
• Working methods should not be hazardous to personnel.
• Materials should be easy to store.
The priority of these criteria may vary according to the setting, but all should be considered.

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2B Overview of product features

The prostheses and orthoses available on the market have various design features. Thus,
the same type of product may be made in different ways with more or less sophisticated
components, materials and techniques. The main criterion for choosing a prosthesis, orthosis
or component part is usually not its degree of sophistication but its general appropriateness
to the needs of the user and the setting in which it is fabricated, fitted, used and financed
(see 2A).

Regardless of the product used, the service is the same (see 4P), with essentially the same
requirements for equipment, tools and trained personnel. The quality requirements should
also be the same. At each level, products should be comfortable and functional. Ideally,
service providers should be able to offer a full range of products, so that all kinds of need and
preference of users can be met. In reality, government funds, insurance and other sources of
funding are unlikely to cover all product types, and priorities should be set (see 1J and 2D).

Four design elements characterize prosthetic and orthotic products: geometric configuration
(shape and alignment), materials, resistance to movement and powering of movement.

Basic prosthetic and orthotic products provide the essential functions and comfort for the
user. They usually are made of a narrow range of materials, such as lightweight thermoplastic,
steel and/or aluminium materials. The components may include single-axis joints and
cushioned-heel feet for prostheses and sidebars for orthoses. Basic prosthetic and orthotic
products are usually of relatively low cost. Such products are needed and appropriate for use
in all countries. In poorer settings, use of basic products is usually a requirement for reaching
large populations in need and serves as a step towards higher levels of product.

Intermediate prosthetic and orthotic products are made of a wider range of materials, such
as thermoplastics, thermosetting (composite) materials, steel, aluminium and/or titanium.
The components may include four-axis knee joints and articulated (single or multi-axis) feet
for lower-limb prostheses and more advanced sidebars and polycentric joints for orthoses.
Supplementary control of joint movement may be powered by the body and/or by more
sophisticated geometric design, friction, pneumatic or hydraulic components. In prosthetics,
for example, pneumatic or hydraulic cylinders are used to control the knee throughout the
swing phase and to control its stability during the stance phase. While this may be the
standard product in most high-income countries, both basic and advanced products can
be used to ensure that services are provided in all settings and are adapted to the financial
resources and needs of individual users.

Advanced prosthetic and orthotic products are made of at least the same range of materials
and components as intermediate products but have additional “smart” controls and/or
materials that capture signals and detect the movements of the user in order to control them
automatically. Examples include: microprocessor-controlled prosthetic knees, which sense
the position of the knee during walking and adjust the settings of pneumatic or hydraulic

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cylinders to provide greater stability; and myoelectric hands, which sense signals across the
surface of the skin and switch on an electric motor to open or close the hand. These products
and working methods usually require a higher level of expertise than basic and intermediate
products. They are also usually more expensive; however, some manufacturers are adopting
more rational production processes in order to reduce overall costs, so that some will become
appropriate for low-income settings.

Working methods are sometimes linked to a certain product level but are usually not. For
example, computer-aided design, manufacturing tools and equipment that allow scanning
of body segments and automated manufacture, such as 3D printing of prostheses, orthoses,
components and models (see Box 9), can be used for products at all three levels. Introduction
into a service of any new product, component, material, equipment or method (at basic,
intermediate or advanced level) must be accompanied by specialized training for both clinical
and technical personnel; without it, the product might not be used to its full potential, the
financial investment might be lost, and the safety of the user might be jeopardized.

Box 9. 3D printing of prostheses and orthoses

Computer-aided design and manufacturing techniques have been used for several decades in
prosthetics and orthotics to design and carve shape-captured models of body segments; however,
“3D printing” has brought new opportunities for upgrading conventional fabrication. Only in the past
two decades has the additive process of printing of thin layers of material (usually thermoplastics)
been applied to prosthetics and orthotics. This is a much cleaner technology, as plaster casts or
moulds are not required. It is less traumatic for users, especially children, and the devices take
less time to produce (29). 3D printing usually involves exposure to a 3D scanner that captures all
the dimensions of the body segment. Pictures from different angles are digitally stitched together
to make a 3D image data file, which can be sent to a 3D printer.
The 3D technique can be used to fabricate custom devices or component parts (29, 30).
Developments in materials and technology mean that prosthetic sockets, orthoses and components
are becoming strong enough to withstand ISO testing and normal day-to-day use; the field of 3D
printers is now large enough to print full-length prostheses and orthoses; and the capital investment
for scanners and printers is falling as the demand increases. This is not, however, the solution for
everyone everywhere. Prosthetics and orthotics clinicians should have a clear understanding of the
use and benefits of 3D printing as compared with the conventional processes for making orthoses
or prostheses.
With training of appropriately skilled personnel and strengthening of all core components of
prosthetics and orthotics services, 3D printing and other technological advances offer solutions
for increasing access to prostheses and orthoses for the nine in ten people who currently have no
access and for increasing user choice and experience in existing services.

2C Prefabricated and custom-made products

Prosthetics and orthotics service providers usually use both prefabricated and custom-made
products. Both types must be fitted and adjusted to conform to the anatomical features
of the user. The choice of product should be guided by an evaluation of the likelihood of
achieving a good fit, comfort, function, safety and quality, as well as cost (as in evaluating
the appropriateness of technologies, see 2A). The choice will be influenced by the economic

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environment in which the services are provided. Both prefabricated and custom-made
products may be basic, intermediate or advanced (see 2B).

Prefabricated products, such as certain ankle–foot and knee orthoses and many spinal and
cervical orthoses, are usually available in different sizes and can be selected according to
clinical criteria and measures of the user’s limb, trunk or neck (31). Many prefabricated products
are designed for temporary, single use. A range of prefabricated, off-the-shelf products is
also available in hospital units (such as emergency, physiotherapy and occupational therapy
and podiatry departments) as well as in PHC services.

Prefabricated products may allow faster fitting and be less expensive than custom-made
devices, but they may also be less effective and should be used only when satisfactory results
can be achieved. Furthermore, in some situations, particularly in low-income settings, the
cost of storing prefabricated products may be prohibitive and it may be more cost–effective
to fabricate devices individually.

Custom-made products include upper- and lower-limb prostheses and orthoses and many
spinal orthoses. Custom-made products are usually chosen when a closer fit, better function
and/or stronger support or correction is required than can be achieved with prefabricated
alternatives or where these alternatives do not exist. Custom-made products can be
constructed from a wide range of materials, including plastics, metals, leather, carbon fibre
and composite materials, and prefabricated components chosen and assembled according
to the user’s needs. Fabrication of these products usually requires a more complete set of
body segment measurements and frequently includes capturing the shape and volume of
the body part and making a plaster mould and/or computer image to serve as a model.

2D Priority assistive products

WHO estimates that over one billion people need one or more assistive products for mobility,
vision, hearing, communication or cognition. To improve access to high-quality, affordable
assistive products in all countries, WHO’s Global Cooperation on Assistive Technology
(“GATE”) initiative prepared a “priority assistive products” list (32) after consultation with a
wide range of experts, users and caregivers. Consensus was reached on a list of 50 products,
including prosthetic and orthotic products, that are considered priorities for maintaining or
improving individual functioning and should be available at a price the community or country
can afford.

The list is not restrictive but provides governments with a model for preparing a national
list. It can act as a catalyst for governments to fulfil their commitment to ensure access
to assistive products at an affordable cost, as mandated by the CRPD. The list can create
public awareness, help in mobilizing resources, guide product development and stimulate
competition and thus contribute to increasing access to assistive products globally. Using this
model, governments can define the prosthetics and orthotics and mobility products and the

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types of technology that are national priorities for meeting local needs. In view of the great
unmet and growing need, such decisions will be important in moving towards universal health
coverage and defining reimbursement policies, including insurance coverage (see 1J and 1K).

Of the 50 assistive products on the list, 16 are mobility devices, including six categories that
reflect the core work of prosthetics and orthotics services (Table 2).

Table 2. The 16 mobility products on WHO’s priority assistive products list

Prosthetic and orthotic products Other mobility products

Lower-limb orthoses Canes and sticks
Upper-limb orthoses Crutches
Spinal orthoses Standing frames
Club foot braces Walking frames and walkers
Lower-limb prostheses Rollators
Therapeutic footwear (diabetic, neuropathic and Tricycles
orthopaedic) Wheelchairs:
• manual for active use
• manual assistant-controlled
• manual with postural support
• electrically powered

2E ISO categorization
ISO is an independent international NGO that brings together experts to prepare international
standards to facilitate international exchange and trade and to ensure quality, safety and
efficiency. ISO standards cover almost every industry, from technology, to food safety, to
agriculture and health care, including standards and classification of assistive products. With
regard to prosthetics and orthotics, ISO standards ISO 8549 Parts 1–3, ISO 13405 Parts 1–3,
ISO 8549 Part 3 and ISO 13404 are particularly important, as they specify methods and
provide terminology for the categorization and description of products and components (33–37).
These standards should be used for any national classification of prosthetic and orthotic
products. (See 4P, Box 26, for other ISO terminology standards.)

2F Supply of components and materials

Procurement of material and logistics are important tasks of a prosthetics and orthotics
service provider and must be well managed to ensure that services are cost–effective and
uninterrupted (38). In large organizations, this work may be done by a dedicated procurement
office; in smaller service units, the responsibility may be delegated to regular staff members.

Importation of material
Components, materials and consumables (including off-the-shelf products) used by a
prosthetics and orthotics service provider may be either imported or purchased locally. While

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many basic materials, such as some plastics, plaster of Paris, wood and leather, are readily
available in most countries, certain components and materials must be imported.

Importation of components and materials for prosthetics and orthotics services is often
difficult, particularly in low- and middle-income countries where customs clearance may be
long and expensive, ultimately reducing the number of people who can be assisted. National
stakeholders should work with relevant authorities and ministries to ensure that components
and materials used exclusively for the fabrication of prostheses and orthoses are exempt
from import taxes and customs fees and that importation procedures are simplified.

National distribution of components and materials

Prosthetic and orthotic components and materials are usually ordered directly from suppliers
by each service provider. In some countries, the existence of a national procurement office
and central store may facilitate the process for individual service units and make it more
cost–effective. When services are integrated into the health system, the central store should
be part of the medical supplies department of the health ministry. In other cases, it may
be an independent entity serving service units in part of the country, the whole country or
several countries. By placing bulk orders to suppliers, a central store can facilitate importation
procedures and reduce costs for individual service units.

Stock management
With appropriate stock management, prosthetics and orthotics service providers can ensure
that service is not interrupted because of a lack of materials or spare parts for machines or
other equipment and can avoid overstockage. Effective planning is needed to ensure that
all materials are in good condition and available when needed. Computer software can be
used to manage stock efficiently, record and analyse stock values, prepare purchase orders
and calculate service costs, including the unit costs of different types of treatment (see 1E,
Box 2). In large and medium-sized service units, the responsibility for stock management
should be assigned to a storekeeper. Stores should be separate from other workshop areas.

Donated components and materials

Some prosthetics and orthotics service providers are supported by organizations or
enterprises, which, instead of making financial contributions, provide in-kind donations
of components and materials for the fabrication of prostheses and orthoses. While such
donations can directly increase productivity, the donated items must meet the standards
of the service provider and be considered the most appropriate. Service providers should
be permitted to influence the types and quantities of components and materials that are
donated to ensure that they correspond to their needs.

Reuse of components
Prosthetic and orthotic components are sometimes reused in order to reduce costs and assist
more people. When this practice is allowed, it should be regulated by the State (see 2G), and
the safety of users must not be jeopardized. Used products should be refurbished by a licensed
operator under controlled conditions, and the items must be decontaminated and approved

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before they are reused. The process should be documented, and users must be informed
when reused components are integrated into their prostheses or orthoses. (Customized
parts, such as prosthetic sockets, should not be reused under any circumstances.)

Donations of used prostheses and orthoses

Service providers in high-income countries sometimes collect old prostheses and orthoses
and donate them to low- and middle-income countries. Although the intention is admirable,
this practice is not always helpful. In the worst case, it may corrupt the efforts of national
stakeholders to establish sustainable and affordable services over which they have control.

As all prostheses and many orthoses are custom-made, it is unlikely that a donated item will
fit another user. While some components of a disassembled device can be reused, they may
be of a different type from those usually used and cannot be combined with local technology.
If technical personnel have not been trained in the new technologies, the service provider
may store components that will never be used and will eventually have to be disposed of,
involving cost, time and resources.

In-kind donations of second-hand prostheses and orthoses will be of value only when
done in a coordinated, professional way. There must be close communication to ensure
that the receiving provider has the capacity to use the technology, the quality of the reused
components must be controlled (see above), complete sets of items should be supplied, and
the results should be followed up. Donations should not undermine the national market or
the work of other service providers who do not receive material for free.

Waste material
Prosthetics and orthotics services, like most manufacturing industries, generate waste, some of
which may be harmful to the environment. Limiting waste material in the production process
is in the economic interest of the service provider and in the environmental interest of society.
Waste products and materials should be properly disposed of according to national rules and
regulations; the handling of hazardous products should be monitored closely. Users should
return their prostheses and orthoses to the service provider when they are no longer using
them. Devices should be disassembled, certain components reused if possible (see above)
and the remainder disposed of according to the recommendations for each type of material.

2G Regulation of technical issues

Prosthetics and orthotics service delivery should be regulated by the State to ensure that users
have access to high-quality products, minimizing the availability of substandard products that
are unsafe or ineffective (see Regulation in 1B). Regulation of the technical aspects of service
delivery includes monitoring the quality of products, materials and equipment. Regulations
should, for example, apply to product and component supply, importation of materials for
prosthetics and orthotics production and reuse of components (according to legislation
for the reuse of health products, see Reuse of components in 2F). Where appropriate, ISO
standards should be applied (see 2H).
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© William Neumann
2H Structural and clinical testing
Prosthetic and orthotic components and materials must be durable, so that sudden,
unexpected failure of a device does not result in injury to the user. Structural and clinical field
tests should be conducted to determine the strength, durability, lifespan and biocompatibility
of components and products.

Structural testing of prosthetic and orthotic components and materials is conducted in a

laboratory environment according to ISO specifications, such as ISO 10328, which lists the
procedures for testing the static and cyclic strength of lower-limb prostheses (39). Use of
standardized procedures allows comparisons of different types of component parts, such as
prosthetic feet, indicating their quality and cost–effectiveness. Components manufacturers
should always test new technologies before placing them on the market in order to
demonstrate their compliance with national and international standards.

Clinical field tests should complement structural testing to determine the strength,
durability, functionality, safety and effectiveness of prosthetic and orthotic components
and products in normal use. The environment in which prostheses and orthoses are used
varies widely throughout the world. The conditions in many low-income settings, with rough
terrain and hot, humid weather, may test components especially. To understand the impact
of such conditions on the strength and durability of a product and to compare alternative
technologies, systematic user trials can be conducted in the field. Clinical testing, like
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structural testing, should adhere to certain rules: user trials should always be undertaken in
accordance with national ethical regulations; participation must be voluntary, with formal
informed consent by the individuals to participate in the test; and tests should follow national
and international scientific standards to ensure the reliability of the results.

In addition to testing, the quality of prosthetic and orthotic products and services should
be ensured by the establishment of quality management systems at service level (see 4R).

2I Technical and clinical research

Research at global level

Research is critical for the development of prosthetics and orthotics services. While
research in this field is conducted continuously, most of it benefits users and services in
high-income countries, while less attention has been paid to the needs in low- and middle-
income countries (see 2J). Furthermore, unlike many other health specialities, relatively little
research is documented or published. There is thus limited evidence for the appropriateness
of prosthetic and orthotic technologies, working methods and treatments, their effectiveness
and cost–effectiveness. While service providers, service users and independent observers
view prosthetics and orthotics treatment as important, considerable research is still required
to verify this view objectively.

WHO has identified five research areas of particular importance for assistive technology
(see Box 10). International organizations and academic institutions working with relevant
national partners should stimulate research in these priority areas. They should also explore
and implement appropriate methods for international exchange, so that results can be shared
and thus benefit services in all parts of the world.

Box 10. WHO global priority research agenda for assistive technology

The WHO Global priority research agenda for improving access to high-quality affordable assistive
technology (40) was prepared by WHO’s GATE initiative with more than 100 experts in assistive
technology. It invites states, researchers, donor agencies, user groups, civil societies and other
stakeholders to initiate and/or support research in five priority areas:
1. Effects, costs and economic impact of assistive technology
2. Assistive technology policies, systems, service delivery models and best practices
3. High-quality, affordable assistive technology
4. Human resources for the assistive technology sector
5. Standards and methods for the assessment of assistive technology need and unmet need
Specific research questions have been identified in each priority area. By addressing these, the
international prosthetics and orthotics community can operationalize targeted research in the field.

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Research at country level

Where relevant, research should be carried out at national centres of excellence, by
establishing links with prosthetics and orthotics training programmes in academic institutions
and coordinating research initiatives with national and international stakeholders. Systems
should be in place to support training in research for relevant personnel at academic
institutions. Prosthetics and orthotics service providers should be expected to gather data
routinely and share them with researchers.

2J Development of affordable products

Components, materials and consumables for prosthetics and orthotics services are produced
by many suppliers in different parts of the world at various operational scales. As in many
other technical fields, most research and development in prosthetics and orthotics is
conducted by enterprises driven by market demand rather than need. While this research
has contributed greatly to improving prosthetic and orthotic technologies over time, the
focus has been on products for high-income settings and less research had been done
on the requirements of low- and middle-income countries, where the financial incentive
is much smaller or inexistent. The sheer size of the market in low- and middle-income
countries should, however, be an incentive for suppliers. Some attempts have been made
by commercial enterprises to develop basic products. International organizations have also
developed more affordable technologies, which are used in many low- and middle-income
countries. In the same regions, some service providers produce affordable components of
similar types.

Nevertheless, there is clearly scope – based on a very tangible global need – for alternative
affordable designs that significantly reduce costs and dramatically increase the number of
people who can be assisted in poorer settings. This could open new business opportunities,
with mass production of cost-effective, good-quality components to meet the global need.
As has been done for medicines, assistive products can be made that are affordable. This will
require the involvement of many national and international stakeholders, including prosthetics
and orthotics experts, private entrepreneurs, governments, service providers, representatives
of users, international organizations, funding agencies and investors.

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© University of Malaya

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Area 3. Personnel
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3A Service unit personnel

The three main categories of prosthetics and orthotics personnel are: prosthetists and
orthotists, associate prosthetists and orthotists and prosthetics and orthotics technicians.
Prosthetists and orthotists and associate prosthetists and orthotists are collectively referred
to as prosthetics and orthotics clinicians, who mainly perform clinical work, while prosthetics
and orthotics technicians and other support personnel are referred to as nonclinicians.

Prosthetists and orthotists

Prosthetists and orthotists are health professionals with overall responsibility for prosthetics
and orthotics treatment, who can supervise and mentor the practice of other personnel.
They are clinicians trained to assess the needs of the user, prescribe treatment, determine
the precise technical specifications of prostheses and orthoses, take measurements and
images of body segments, prepare models for the manufacture and fit of devices and evaluate
treatment outcomes. They should have adequate understanding of the complete fabrication
process in order to guide and supervise the work of prosthetics and orthotics technicians and
support personnel. Prosthetists and orthotists have comprehensive training providing a broad
range of clinical competence. After graduation, they should increase their experience and
expertise in order to assume leadership, advance models of service delivery and participate
in research and evidence-based practice. They may also continue their education to masters
and doctorate levels.

Associate prosthetists and orthotists

Associate prosthetists and orthotists share many of the attributes of prosthetists and
orthotists and do similar clinical work but have more limited competence and conduct less
research and advancement of service delivery methods and models. Associate prosthetists

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and orthotists should be supervised by a prosthetist or orthotist and have a delegated scope
of practice (41). Like prosthetists and orthotists, associates supervise the work of nonclinicians
and should have a thorough understanding of all technical work.

Prosthetics and orthotics technicians

The work of prosthetics and orthotics technicians is to fabricate prostheses and orthoses.
Following the technical specification prepared by the clinician and working under the
clinician’s supervision, the technician processes materials, assembles components, makes
the product ready for fitting and finishes the product for final delivery. Technicians know the
materials, technical processes and safe practice involved in prosthetics and orthotics and
provide repair and maintenance services.

Under controlled circumstances, these technicians may support prosthetists and orthotists
and associates in certain aspects of clinical work in order to increase access to services.
This work must follow an agreed protocol, be done under the close, continuous supervision
of a clinician, within clearly defined limits and only after adequate skills and competence
have been acquired in relevant areas. The technician must know when to refer back to the
supervising clinician for review.

Developing the role of technicians, thereby alleviating clinicians of the work of manufacture,
will reduce bottlenecks in services due to the limited availability of qualified professionals
(see 3G and 3H, Box 12).

Support personnel
Support personnel include workers with no formal training in prosthetics or orthotics, who
have nonclinical duties that are essential for the overall result, such as plastic-forming or
plaster work. Other support personnel include storekeepers, cleaners and maintenance
workers.

Administrative personnel
The care pathway of users involves communication and interactions with reception and
administrative personnel at the first appointment and follow-up of service delivery. While
no specific knowledge in prosthetics and orthotics might be required for this work, reception
personnel must be skilled, competent and at ease with users and caregivers to ensure that
the services are user-centred (see 4A). The way in which users are received can positively
influence their rehabilitation. Long-term service users in particular will become known to
reception personnel over time, and friendly relationships should prevail. Targeted training of
administrative personnel may be required to ensure the highest quality of services.

The appointment of users to administrative roles can be beneficial, as it offers opportunities

for peer support, in particular to first-time users.

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3B Other professionals on the team

Medical specialists often play a central role in the provision of prosthetics and orthotics
services as members of a multidisciplinary rehabilitation team (see 3C) and in referring
users to the services. Of particular importance are physicians specialized in physical
and rehabilitation medicine (particularly for rehabilitation of people with amputations or
in complex care), amputation surgery, orthopaedics, vascular surgery, general surgery,
neurology, rheumatology, plastics and reconstructive surgery, paediatrics and geriatric care.

Physiotherapists and occupational therapists are critical to the outcome of prosthetics

and orthotics service delivery and should be permanent members of the multidisciplinary
rehabilitation team (see 3C). Of particular importance are those specialized in amputation
rehabilitation, stroke, cerebral palsy, clubfoot treatment and spinal conditions. Other allied
health professionals important in prosthetics and orthotics services include podiatrists,
pedorthotists, pedorthists, psychologists, biomedical engineers and pharmacists.

Other personnel – such as health personnel, social workers and CBR workers – may assist in
the provision of services and work within an agreed protocol with appropriate supervision,
provided they have sufficient training. They also frequently refer potential users to prosthetics
and orthotics service units.

3C Multidisciplinary rehabilitation teams

In complex cases and long-term treatment, prosthetics and orthotics services should be
offered by a multidisciplinary rehabilitation team with defined common goals and a shared
team identity. Together, they assess users to determine their needs, prepare holistic treatment
plans and evaluate the outcome of treatment. Multidisciplinary teams should have an
appropriate mix of skills and include a prosthetist or orthotist, a physician, a physiotherapist,
an occupational therapist, a nurse, a psychologist and a social worker. The user (and, where
relevant, families and caregivers) should also be regarded as members of the team and be
allowed to influence any decision taken (see 4A). Ideally, the team members meet at the time
of the assessment and at the end of treatment and carry out agreed interventions according
to their roles. Particularly in poorer settings, the team may be smaller, consisting only of the
user and one rehabilitation professional. While not all prosthetics and orthotics treatments
require interventions by other specialists, efforts should always be made to contact other
specialists in more complex cases.

Teamwork provides an opportunity for team members to learn from one another. In well-
established multidisciplinary teams, tasks can be shared and shifted among team members
of different professions. This can alleviate the pressures of busy services and make them more
cost–effective. Task-shifting may include having a nurse supply simple ankle foot orthoses,
if the scope of practice has been agreed and sufficient training provided. Personnel must
follow an agreed protocol and be supervised directly or indirectly by a prosthetist or orthotist.

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3D Training of prosthetics and orthotics personnel

Training of new personnel should be dramatically increased to ensure equitable access
for everyone in need, and higher training should be available for those who wish to teach.
Training must be conducted in parallel with expansion of services, so that personnel who
are trained have employment.

The numbers of prosthetics and orthotics courses at different levels and the numbers of
trained professionals have increased significantly during the past few decades, particularly
in low- and middle-income countries. Although courses may not yet be available in all
countries, many prosthetics and orthotics schools have an international intake, so that
professionals from essentially all the countries and areas of the world can be trained. This
important development has been made possible with financial and technical support from
the international community. Although there are still not enough professionals to cover
the need, they represent a foundation for extending high-quality prosthetics and orthotics
services globally.

General aspects
Prosthetics and orthotics training programmes should preferably be an integral part of a
tertiary educational institution in the national health education system and be offered with
courses for other rehabilitation professionals, such as physiotherapists and occupational
therapists. Education in prosthetics and orthotics is a combination of theory and practical
training in the health science and engineering. Typically, theory and technical practice
are taught alternately in a classroom during the first part of the programme, after which,
prosthetist and orthotist and associate prosthetist and orthotist students are usually
introduced to clinical practice with users in a safe, controlled clinical environment in the
educational facility. This practice helps to develop skills in assessment, fitting and alignment
with the latest evidence-based techniques. This phase is followed by supervised practice
placements to further develop practical skills.

The training of prosthetics and orthotics technicians focuses on product preparation and the
use of different materials, tools and machines.

Training levels
To meet national demand and ensure that everyone everywhere has access to prosthetics
and orthotics services, various levels of training should be available in a country. While this
may be difficult in some countries, a cost–effective solution might be for countries in a region
to share opportunities for training.

Prosthetists and orthotists usually have at least a bachelor degree, like other health and
rehabilitation professionals such as physiotherapists and occupational therapists. The entry
requirements should meet national criteria for tertiary education, which should include
completion of secondary education. To further develop the profession, prosthetists and
orthotists should be encouraged to complete post-graduate studies, like their colleagues in
other health and rehabilitation services.
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Associate prosthetists and orthotists should attend training at further education level, with
entry requirements aligned with other vocational training in their country and selection
criteria similar to those of prosthetists and orthotists.

Fully trained prosthetics and orthotics technicians usually attend training at further education
(vocational) level corresponding to the level of health care assistants and assistant therapists
or have equivalent experiential learning.

The training pathway should be planned as a continuum, so that prosthetics and orthotics
personnel can continue to higher levels of training. Thus, talented, dedicated technicians
can progress to clinical positions with more responsibility, and associates can become
prosthetists and orthotists. A few training programmes exist that allow upgrading from one
level to another. More options for academic progression should be in place in each training
institution to increase access to education.

Modes of teaching and learning

The modes and methods of training programmes depend on the local educational culture
and learning environment. The two disciplines – prosthetics and orthotics – are sometimes
taught separately or may be combined, with a joint degree awarded.

Theoretical training is usually provided full-time according to a schedule in a school

environment but is sometimes done part-time or as an online or distance-learning course.
Modular courses, with examinations after each completed module, have proven to be
effective. Training can also be provided by blended learning, which usually includes online
theory and face-to-face technical and clinical practice at a central location, where the
theoretical knowledge can be applied and practical skills developed. This training mode allows
participants to stay on the job and continue service delivery while undergoing training. It can
help practitioners without previous formal training to have a recognized education and others
to upgrade to a higher educational level. This type of training can be particularly useful in
emergency contexts and in countries where there are only a few prosthetics and orthotics
personnel, who cannot be released from their jobs for full-time training.

An interdisciplinary approach to teaching and learning for prosthetics and orthotics, therapy
and medicine in shared training sessions can stimulate teamwork among graduate health
and rehabilitation professionals. This is particularly important in practical clinical training,
especially when students study assessment and prescription and evaluation of treatment,
and can also be used for training in common theory subjects.

Educational standards
Professional standards for prosthetists and orthotists, associates and technicians are well
established, published and upheld by national professional bodies and by ISPO. They can
be used by policy-makers, government ministries, regulatory bodies or funding agents as a
benchmark for education and a guide for curriculum development. WHO, in collaboration
with ISPO, has prepared detailed education and training guidelines for the prosthetics and

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orthotics professions, which are widely accepted by governments and nongovernmental

agencies in the field. To guide the establishment (or restructuring) of prosthetics and orthotics
training courses, ISPO has information packages that describe the learning objectives for
each type of course, with a syllabus and appropriate arrangements for final examination. The
packages also outline arrangements for evaluation and international recognition of prosthetics
and orthotics training programmes.

Course content
Prosthetics and orthotics training should follow the educational standards set at international
and national levels, including those of ISPO. Theoretical training typically includes clinical
subjects, such as anatomy, physiology, prosthetics and orthotics science, pathology and
orthopaedics, as well as technical topics, such as mechanics, biomechanics, materials science
and technology. Practical training usually provides broad understanding of prosthetics and
orthotics technologies, components, materials and clinical work. Instructors should ensure
that the theoretical knowledge is translated into skills in design, production, adaptation and
alignment of prostheses and orthoses, which are directly relevant to the functioning of the
product and the comfort and safety of the user. Quality considerations must be emphasized.

Prosthetics and orthotics students should build problem-solving skills and become reflective
practitioners, willing to learn from their day-to-day and case-by-case experience and to
view continuous learning as part of their professional life. It is also important to emphasize
professional communication skills.

Prosthetics and orthotics courses should also provide fundamental knowledge of:
• the concepts of user-centred care, user policy and user rights (see 4A, 4B and 4C);
• disability issues;
• multidisciplinary teamwork;
• professional codes of conduct and ethics, with clearly definition of the role of the
professional and the limits of appropriate professional behaviour (see Box 11);
• management issues and tools, such as those for cost calculation, cost–benefit analysis,
user management, stock management and quality management;
• work safety;
• referral processes;
• the national health care system and rehabilitation services;
• provision of other mobility assistive products, such as wheelchairs and crutches, which
are often prescribed with prostheses and orthoses;
• clinical research, technical development and innovations; and
• community development in relation to prosthetics and orthotics, rehabilitation and health
care services.

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Box 11. Professional codes of conduct and ethics

All professionals who work with users must have and uphold a professional code of conduct and
ethics. This is true for prosthetists and orthotists and associates. The 15 standards of proficiency
of prosthetists and orthotists of the Health and Care Professions Council of the United Kingdom
(42) provide a good example of professional codes of conduct and ethics.
1. Be able to practise safely and effectively within their scope of practice.
2. Be able to practise within the legal and ethical boundaries of their profession.
3. Be able to maintain fitness to practise.
4. Be able to practise as an autonomous professional, exercising their own professional
judgement.
5. Be aware of the impact of culture, equality and diversity on practice.
6. Be able to practise in a non-discriminatory manner.
7. Understand the importance of and be able to maintain confidentiality.
8. Be able to communicate effectively.
9. Be able to work appropriately with others.
10. Be able to maintain records appropriately.
11. Be able to reflect on and review practice.
12. Be able to assure the quality of their practice.
13. Understand the key concepts of the knowledge base relevant to their profession.
14. Be able to draw on appropriate knowledge and skills to inform practice.
15. Understand the need to establish and maintain a safe practice environment.

Selection of students
Students for professional training in prosthetics and orthotics should be selected transparently,
without discrimination, guided first and foremost by academic criteria. Students must have
sufficient educational qualifications to ensure that they can fully assimilate the course content
and become competent in their profession. A number of further considerations will ensure
that the right individuals are trained. Students should, for example, have an aptitude for
clinical and technical work and have the right values and attitudes to working with people
with disabilities.

Globally, more men than women are trained as prosthetists and orthotists. This risks limiting
the access of women to services. Service units should have balanced numbers of female and
male personnel at all professional levels so that users can choose a female or male clinician
if they so wish. Special initiatives and advocacy may be needed to ensure that sufficient
numbers of women undergo training and have opportunities for employment equal to those
of men.

To ensure access to services by diverse groups, there should be a good balance in the student
intake with regard to culture, ethnicity, faith, gender and other demographic factors. It may
be appropriate to select students from areas where a new workforce is needed, particularly
for remote and rural locations. This will ensure they know the local language and customs
and are motivated to work in such settings. This may generally increase the retention rates
of newly trained individuals (see 3I).

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People with disabilities, users of prosthetics and orthotics services in particular, should be
encouraged to apply for all training, as appropriate. People with experience of disability on the
workforce can provide good role models for users and generally assist in changing negative
attitudes. Their inclusion may require special arrangements: preparatory training may have
to be provided so that people with disabilities can meet the entry requirements; the learning
environment might have to be adjusted; and advocacy may be required to make sure they
have equal opportunities for employment (28).

Newly qualified graduates

After successfully passing the final examination, graduates will usually be awarded proof that
they have completed training for an appropriate qualification. The newly trained professional
will lack experience, which will be built through reflective practice on the job and CPD (see
3F) throughout their working life. Graduates should also either complete an internship or
have extensive supervised clinical practice as part of their training before they obtain national
accreditation and certification and are authorized to practise independently.

During the early years of professional practice, graduates usually provide a defined range
of treatments for users with different diagnoses. Service providers should identify senior
professionals who can assume supervision and mentoring responsibilities, which may require
building these skills.
© WHO/Pakistan

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Training abroad
Prosthetics and orthotics education programmes are not available in all countries, and it may
be difficult to justify the establishment of a school in small countries where only a limited
number of personnel are needed. One solution is to train professionals abroad at a school
with an international intake. Training prosthetics and orthotics personnel abroad is usually
a significant financial investment for a relatively small number of trainees. These individuals
must therefore be selected with care (see above) so that the investment yields long-term
results, in particular if there is a scholarship. Graduates should be able to enter the job
market swiftly on their return home, so there should be jobs for them to return to. This may
require policy-makers to create posts or provide the necessary resources. It is important
that certificates and diplomas obtained abroad are recognized in the home country; national
recognition is often lengthy and might have to be initiated before training commences.

Training abroad has the advantage of exposing students to different contexts and working
methods and providing opportunities for establishing regional and international professional
contacts. It may, however, give limited clinical practice in the context in which the professional
will be working at home. International training institutions should make sure that the skills
that are taught are relevant to different local contexts by including the impairments and
conditions that might be seen in service units in other countries.

New graduates returning from international institutions will require support from more senior,
experienced colleagues to enter the profession fully. Where such professionals are not yet
available, graduates might have to be supported by international prosthetics and orthotics
professionals, for example through volunteer placements, consultancies or work exchange.

3E Training other professionals in prosthetics and orthotics

Prosthetics and orthotics are distinct fields of knowledge that demand specific training
and development for all people involved in service provision and related health care and
rehabilitation. To ensure competence across the workforce, health, allied health and social
care professionals should be given an overview of prosthetics and orthotics subjects in
their professional training programmes. This information should be as pertinent as possible,
and training should preferably include study visits to prosthetics and orthotics service
units. Professionals such as therapists, orthopaedic, neurological and vascular surgeons
and physicians specializing in physical and rehabilitation medicine require more in-depth
knowledge of prosthetics and orthotics. Prosthetists and orthotists should work with medical
faculties and educational institutions to ensure that the course content is appropriate. They
might also be involved in preparing targeted training modules and participate as lecturers
in direct training.

After their graduation, some health, allied health and social care personnel will work with
prosthetics and orthotics service units in the treatment of related diseases and health
conditions, and some will be directly involved in prosthetics and orthotics service delivery.

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They will therefore require more training in these subjects, from basic sensitization to
highly specific knowledge for relevant specialists. This can be provided in special courses
and seminars and by experiential learning, such as in multidisciplinary teamwork, which
allows continuous exchange of information. Prosthetics and orthotics professionals and
service providers should establish regular working contacts with partners in health, social
and education sectors to make sure they have the essential knowledge and skills for referral
and follow-up.

When prosthetics and orthotics services are part of the health care system and certain tasks
are shifted to doctors, nurses and other PHC personnel, these must have sufficient training
and supervision. Training material and tailored courses should be prepared for different
personnel categories, taking into account their professional training and their intended
function in the service delivery system. Prosthetics and orthotics professionals at national
and international levels, with colleagues in health and education sectors, have a significant
role in preparing such training.

3F Continuing professional development

Service providers should ensure that all personnel are given opportunities for CPD to maintain,
update and further strengthen their competence at all levels. This improves the quality,
effectiveness and efficiency of the services and ensures inclusion of new developments in
clinical and technical practice, including new technologies. CPD can also develop the role
of professionals, extending their knowledge into new fields or specializing in more narrow
fields (see 3G).

CPD pathways may be a mixture of formal and informal learning. The formal pathways
include short courses for upgrading personnel from one level to another through a framework
in which training levels are aligned with career progression. Courses may go beyond core
prosthetics and orthotics subjects to include training in related health conditions, such as
diabetes and cardiovascular diseases.

Informal CPD pathways build knowledge, skills and competence in learning that is integral
to professional practice. Informal CPD opportunities include:
• reflective practice (individual reflections on everyday practice);
• sharing experiences with team peers;
• evidence-based practice (learning from audit case series, audit and research results);
• case conferences and ward rounds (multidisciplinary review of single cases);
• reviews or focus groups by users; and
• participation in seminars, conferences and workshops (which may be multidisciplinary,
highlighting the interrelationship between different professions).

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Many experienced clinicians with empirical training or clinicians who are associate prosthetists
and orthotists have not learnt how to find information or appraise research and might require
guidance. To ensure conditions for continuously increasing knowledge, scientific literature
should be accessible in the service, with training in literature searching and appraisal, so
that clinicians can be efficient and self-sufficient in accessing information on which to build
their practice. Until recently, information was found in a library in some service units, but the
Internet makes it possible to access full-text journal articles online or offline with regularly
updated sources, such as the WHO Hinari e-Granary system and open source journals.
Support to ensure that personnel have access to information can be provided in the form of
computer hardware and software. A more vibrant culture of information use can be guided
by sharing evidence-based case studies and developing evidence-based treatment protocols
within the prosthetics and orthotics team.

Service providers can also mentor personnel to increase their competence, either face to
face or through an e-health approach whereby a mentor is matched to selected personnel to
analyse a case study. This kind of CPD can help to embed new skills and knowledge after a
short course; for example, a mentor may continue supervision of a series of prosthetics and
orthotics treatments, until the recipient is competent and confident in the new techniques.

Prosthetics and orthotics personnel should always be willing to learn and be committed
to CPD and reflective practice. A certain amount of CPD per year should be a compulsory
component of their employment. More experienced personnel should participate in annual
professional development planning, when they are given responsibility to identify their CPD
needs and work in partnership with their employers and professional associations to agree
and implement individual professional development plans.

3G Role development
Prosthetics and orthotics training courses can provide the knowledge to start practising the
profession, but no graduate will have all the knowledge and skills required to fully master all
fields and sub-fields. That is learnt by experience in day-to-day practice, with colleagues,
mentors and occasional courses and seminars (as part of CPD, see 3F).

The role of prosthetics and orthotics professionals therefore develops over time; it should
match the needs of the service and the competence of other rehabilitation team members.
Not all personnel in a unit will deliver all types of service. In large units in particular, the
roles of professionals can be differentiated so that they specialize in narrower areas (such as
upper-limb prosthetics, diabetic footwear, sports injuries). This will increase their proficiency
and enable the unit to offer services of higher quality in a wider range of fields while also
minimizing the resources required for additional training, as not all personnel need to be
trained in all fields.

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Roles can be developed within the employee’s usual professional boundaries, by specializing
in distinct fields of prosthetics and orthotics, but also outside these boundaries. Prosthetists
and orthotists can broaden their knowledge by assuming certain tasks in a multidisciplinary
team (see 3C) or by extending their responsibilities to management, such as monitoring
and evaluation, or research. They may also advance their practice with a master’s degree
or doctoral level training. A prosthetics and orthotics technician may be given additional
training to take on some of the role of a prosthetist, orthotist or associate, provided sufficient
monitoring is in place.

Role development can increase productivity and the quality and range of services and can be
a means of distributing tasks across the workforce. This may relieve overloading of personnel
and avoid bottlenecks in service delivery. For the individual, role development may be an
important incentive; he or she may be motivated by having more responsibility or functioning
as the unit’s focal point and specialist for a defined field or in multidisciplinary work, all of
which are signs of recognition.

Role development should be considered when setting goals in professional development plans
(see 3F).

3H Workforce planning
The workforce must be planned to ensure the right numbers of personnel with the right
competence at the primary, secondary and tertiary levels of service delivery. The plan should
guide training, so that adequate numbers of professionals are available; there should not be
more than can be absorbed, as this would waste financial resources, and not too few, which
might result in interruption of services.

Workforce planning involves four steps (Fig. 2): determining the actual size and nature of
service needs, calculating the full need for personnel, profiling the existing workforce and
determining any gaps between future demand and current supply of personnel. The workforce
development plan should be designed to address any gaps.

Fig. 2. The four steps in workforce planning

The four steps in workforce planning

1 2 3 4
Determining Determining Profiling Determining
the need for the need for the existing the need for
services personnel work-force training

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Determining the need for services

The ways in which the need for prosthetics and orthotics services can be determined or
estimated are discussed under 1N. The size, geographical distribution and type of services
needed then form the basis for calculating the required workforce. Future requirements can
be estimated from growth or changing patterns in the population of users, such as how fast
the population is growing, an increase in noncommunicable diseases or a situation of conflict.

Determining the need for personnel

The need for personnel can be calculated from the estimated need for services and local
factors, such as the types of services required and the geographical distribution of service
units. An average country can be expected to require 5–10 prosthetics and orthotics clinicians
per million population and a higher number of nonclinicians (see Box 12).

Box 12. Numbers of prosthetics and orthotics personnel required

The numbers of prosthetics and orthotics clinicians (prosthetists, orthotists and associates) and
nonclinicians (prosthetics and orthotics technicians and support staff) are determined by factors
such as the need; the organization of service systems and units (geographical distribution and
whether services are centre-based or decentralized); the type and range of products provided (e.g.
technology, complexity, proportions of prostheses and orthoses); the knowledge, skills and attitude
of personnel; and the financial context.
Clinicians
On average, a country requires 5–10 prosthetics and orthotics clinicians per million population,
although data and evidence are lacking. In high-income countries, the number of clinicians is
usually higher, at 15–20 per million population or more in some countries. In low-income countries,
the number may be as low as 1 per million population, complicating the provision of sufficient
services of appropriate quality.
In a standard prosthetics and orthotics service unit, a clinician (supported by nonclinical personnel)
can be expected to provide complete services to 300–600 users per year (including first provision,
renewals, follow-up and maintenance and repairs). The number of users who can be assisted
depends on the type and complexity of treatments. International comparative data are needed for
more accurate figures.
Nonclinicians
Each clinician is normally supported by 2 nonclinicians, so that a country would need some
10–20 nonclinicians per million population. Assistance by 4–5 nonclinicians allows more users
to be treated per team, and this is important in settings where there are few trained professionals,
particularly in smaller, decentralized service units. Increasing the ratio of nonclinicians to
clinicians is an economical way of developing services until more clinicians can be trained. In
contrast, for specialized services (at tertiary level or in designated specialist clinics), a lower ratio
of nonclinicians to clinicians, such as 1:1, is usually more appropriate.
Minimum requirements
Each service unit should have at least one qualified prosthetist and orthotist. In countries where
there are few professionals, the quality of clinical services should be assured by an experienced
associate prosthetist or orthotist with the support and supervision of a prosthetist and orthotist.
In workforce planning, the fact that at least two to four times more people require orthotic treatment
than prosthetic treatment (43) should be considered. Clinicians who work in small service units
and are the only qualified professionals available should usually be trained in both disciplines.
In units in which responsibility can be assumed by several clinicians, specialization in either
discipline is usually sufficient.

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Projections should be made for the short and the long term, for example 5, 10 and 15 years
ahead, so that future development is adequately taken into account. Workforce planning
should preferably correspond to the cycle of national population censuses.

For a workforce planned to function at primary, secondary and tertiary levels, calculations
should include other disciplines that contribute to prosthetics and orthotics service delivery,
such as physicians, health and rehabilitation professionals, PHC personnel and others
applicable to the local context.

Profiling the existing workforce

An audit of the entire workforce should be conducted to determine its profile, such as the
numbers, age, gender and professional experience.

Determining the need for training

Training needs can be determined by comparing the numbers and disciplines of the available
personnel with the numbers required, keeping in mind that the workforce should be gender-
balanced. This will reveal the numbers who should be trained, where they are needed and
the type of training required. The estimated numbers will, however, often have to be adapted
© by Otto Bock

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to practical and financial realities. Training must be affordable, and graduates must find a
place in the service system. Thus, often, not all training can be provided at once. There should
be strong links between service providers, training institutions and planners to ensure that
prosthetics and orthotics workforce planning corresponds to that in the general health and
welfare sector.

3I Retention of personnel
As training and mentoring of prosthetics and orthotics personnel is a substantial financial
investment, it should yield long-term results, and strategies are required to motivate
professionals to engage fully in service.

First, the right students should be selected for training and they should be genuinely
interested in working in the profession (see Selection of students in 3D). In addition, the
employer and the service delivery system should provide stimulation. The motivation of the
workforce is linked to, for example:
• proper and equitable recognition of the profession (see 3K),
• career possibilities,
• salary levels and employment benefits,
• working environment,
• the range of responsibilities given,
• possibility of influencing decisions in the work-place,
• positive leadership and
• factors linked to the image of the profession (see 1R).

The migration of prosthetics and orthotics professionals from poor to rich countries and from
rural to urban areas is a particular problem. In low- and middle-income countries especially,
prosthetics and orthotics graduates sponsored by a scholarship may choose to leave their
work place or country for more favourable conditions elsewhere. This can disrupt services,
and, even if the skills of the graduates are used, they will not benefit the intended services.
The situation is sometimes addressed by establishing an “employment bond”, for example
obliging graduates to work for five years with a certain service provider; however, bonds may
be broken and skilled human resources lost. Potential employers of prosthetics and orthotics
personnel in the first five years after graduation should therefore determine whether they
have signed an employment bond. Sponsors, employers and training institutions might jointly
prepare a code of conduct for recruitment and retention of graduates on scholarships to
ensure that the initial investment in a country or region benefits that area.

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Various measures can be taken to stimulate the interest of students and personnel in working
in remote and rural areas and ensuring their retention. Table 3 lists a number of possibilities
that have been proposed.

Table 3. Measures that might improve the retention of prosthetics and orthotics
personnel and make them more interested in working in remote and rural areas

Area Measure
Education • Attract the “right” students.
• Select students from rural areas.
• Train students close to rural communities.
• Facilitate professional development.
Regulatory interventions • Create the conditions for rural health workers to do more.
• Train personnel to meet rural needs.
• Make the most of compulsory service.
• Tie education subsidies to mandatory placements in rural areas.
Financial incentives • Make it worthwhile to move to a remote or rural area.
• Provide additional financial benefits.
Personal and professional • Pay attention to living conditions.
support • Ensure that the work-place is of an acceptable standard.
• Foster interaction between urban and rural personnel.
• Design career ladders for rural personnel.
• Facilitate knowledge exchange.
• Raise the profile of rural personnel.
Source: adapted from reference (44)

3J Professional regulation
As for other health services, professionals working in prosthetics and orthotics services
should be regulated to protect users from harm. Prosthetics and orthotics clinicians can
be regulated as part of the regulation of other health and allied health professionals by an
independent State body, which creates a register of practising professionals. The regulators
may publish an accessible list of registrants, so that users and employers can verify the
status of prosthetics and orthotics clinicians. Regulators expect registrants to uphold the
highest attainable standards of training, professional skills, codes of conduct and ethics. The
registration authority should remove individuals from the register if significant misconduct
is found, in order to reduce the risk of users.

Prosthetics and orthotics technicians and other technical personnel should be supervised
by a regulated or certified prosthetics and orthotics clinician, who assumes responsibility
for their conduct.

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3K Professional recognition
Lack of recognition of prosthetics and orthotics personnel can negatively affect their
motivation, retention and professional development, which may limit service development,
particularly in many low- and middle-income countries. Awareness-raising about the nature
and role of these professions is necessary to strengthen recognition (see 1Q). Recognition is
also related to factors such as salary levels, status, profile, protected title, career development
possibilities, certification and registration.

Two aspects of professional recognition should be strengthened:

• recognition that prosthetists and orthotists, associates and technicians have distinct
professional titles and job roles in health care provision; and
• recognition of prosthetics and orthotics professions in local career structures, with
employment conditions aligned with those of other health care professionals, associates
and technical personnel.

3L Professional associations and societies

Professionals working in prosthetics and orthotics are encouraged to be members of and
actively participate in the professional body of their discipline to raise awareness of the
profession. Prosthetics and orthotics clinicians and nonclinicians are encouraged to form
their own professional associations or societies and link them to regional and international
federations and societies.

Professional bodies should support and promote evidence-based practice and develop a
national ethical code of conduct. They may further the development of their profession
by sharing best practice in publications, networks, events and refresher training for their
members. Professional bodies may also engage and advise regulators about their codes of
practice, participate in national planning and promote their professional fields.

Professional societies and associations can also be formed around a topic, health condition or
field of knowledge to bring together an interdisciplinary group of personnel and stakeholders
to share information about treatment of that condition. Such organizations should allow both
professional and user membership.

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© Jacob Simkin/ICRC

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 AR E A 4. P R OV ISION OF S E R VI C E S

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4A User policy
To ensure that prosthetics and orthotics services are user-centred (see Box 13), service
providers should have a written user policy in the local language describing how users and
caregivers should be treated throughout their contact with the service and how their rights
will be upheld. All personnel should be adequately trained in the user policy, and service
providers should be able to present evidence of compliance with the policy.

Box 13. Features of user-centred prosthetics and orthotics services

User-centred prosthetics and orthotics services are planned from the perspective of the users and
respond to their needs, choices and preferences in humane, holistic ways. As a minimum they have
the following features:
User-friendly environment: Service units should be fully accessible and provide a user-friendly
environment. Waiting areas should be clean, quiet and comfortable, with a pleasant temperature,
fresh air, sufficient seating even at peak hours and a television or magazines and play options for
children, to make waiting easier and more comfortable.
Respect: The provider–user relationship should be built on dignity, empathy, mutual respect,
honesty and trust, making sure that the values, needs and wishes of users are taken into account.
Personnel should have a polite, professional attitude and should communicate effectively and
listen attentively to users. The clothing of the personnel should respect the local culture.
Punctuality: Services should be prompt, without unnecessary delays, respecting scheduled
appointment times.
Safety: The safety of users must be ensured in all phases of treatment and in all areas of the
service unit. Safety measures must be in place to protect users against injury (during treatment,
during training with prostheses and orthoses and whenever tools and machines are used), health
hazards (including infections and exposure to potentially dangerous chemicals used in treatment
or production) and verbal and physical violence or abuse.
(Continued over)

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(Box 13. continued)

Special attention must be paid to ensure that women, children and other vulnerable individuals are
protected. The service provider must be able to respond to requests for treatment by personnel of
the same gender and ensure that users can be accompanied if they wish.
Privacy and confidentiality: Privacy should be ensured in all phases of treatment and in all sections
of the service unit. Any personal information collected by the service provider should be treated
as confidential and not be shared without the consent of the user. Service providers should also
ask users to consent to use of pictures or video clips of them before they are used in advertising,
publications, case studies or other contexts.
Information: Service users and caregivers should receive complete information about the treatment
process, suggested interventions, the outcome of assessments, the purpose and function of the
proposed prostheses and orthoses, alternative treatments and cost implications. The expected
outcomes, long-term benefits, possible risks, disadvantages and potential problems should be
clearly explained. Personnel should also advise users and caregivers about the expected timelines
and waiting times. For successful long-term results, personnel must clearly explain follow-up, the
care and maintenance of products and where and how services for maintenance and repair can be
accessed when required. The information should be accessible, for example printed in large format
and in local languages.
Decision-making: Service users should have the final say on what is best for them. Prosthetics
and orthotics personnel should help them in making an informed decision before they consent to
the final treatment plan. Service users and caregivers should be encouraged to participate in the
multidisciplinary team and be given opportunities to raise questions or concerns during and after
treatment. Under no circumstances should users be forced to accept a particular intervention.
They should be free to choose from the available alternatives, including components, materials and
design, and their participation should always be voluntary.
Access to clinical records: In order for users and caregivers to be fully informed about their
treatment and to participate actively in their treatment and decision-making, service providers
must grant them full access to all information pertaining to their care, including their clinical
records, throughout and after treatment.
Complaints and suggestions: Service providers should establish a system whereby users and
caregivers can provide feedback on the services they received and how they were treated. This
should include opportunities for anonymous presentation of concerns, complaints and suggestions.

4B The user: a central resource in planning and provision of

services
Service users must not be regarded merely as recipients of prosthetics and orthotics services
but as partners, who can contribute to improving and sustaining services both locally and
nationally. Users and their families and caregivers are individuals who have knowledge that
is critical to making sure that services are of high quality and well adapted to their needs.
They are, in their own right, experts in prosthetics and orthotics.

Users should, through their representatives (user groups and disabled people’s organizations),
be involved in the planning, implementation, monitoring and evaluation of prosthetics and
orthotics services, at all levels. Their representatives should be on relevant decision-making
committees, including national prosthetics and orthotics committees or similar entities (see
1A, Box 1) and advisory committees of service units (see 4Q, Box 31).

User groups may also be involved in collecting user feedback (see 4R) for quality assurance
of service providers. Feedback is likely to be more sincere and unbiased when collected by

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peers rather than by representatives of the service provider, as users depend on the services
for further assistance. User groups may also be important in referral, peer support (see 4P,
Box 28) and impact assessments (see 1P).

4C The right of users to choose their service provider and

technology
Service users have the right to follow their individual preferences in making the final choice
of which service provider to consult and which prosthetic and orthotic technology to accept.
The right to choose a provider promotes healthy competition, which can improve the quality
and cost–effectiveness of services and make them more affordable.

The right to choose a provider

Users should have the option to choose their provider, if there is no extra cost that is not
covered by either the usual financing system or the users. In order that they can make an
informed decision, those referring them should give them complete information about their
options, including the providers who have the appropriate expertise for the user’s needs,
how the services can be accessed and whether service fees apply or are covered by health
and social insurance.

The right to choose technology and brand

Service users should be given the opportunity to choose the types of components, materials
and design of their prosthesis or orthosis from the options available in the country and within
the limits set for financing or reimbursement, if the technology is consistent with the user’s
needs. Member States should ensure the availability of several technologies to suit different
needs and pockets.

The choice of components and materials must not be the monopoly of any one supplier or
service provider. In many countries, component manufacturers are also service providers. In
these situations, to respect users’ rights and free competition, providers must offer a range
of products in addition to their own. All applicants for licensing should disclose any conflict
of interest (see Licensing of services in 1B).

4D Accessible services
Service providers and national stakeholders should ensure equal access for all people in
need, irrespective of disability, health condition or socioeconomic status. Services must be
financially, physically, geographically, socially, linguistically and organizationally accessible.

Financial access: All people in need should be able to obtain the prosthetics and orthotics
services they require without suffering financial hardship (see 1J). The costs of the product
and service delivery should be affordable for all, including poor and vulnerable people.

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Physical access: Service units should be designed so that people with restricted mobility
(many of whom use wheelchairs or crutches) can readily access all parts of the premises
accessible to users, including the waiting room, treatment sections and toilets. Ramps or lifts
should be installed where steps and stairs constitute physical barriers. Service units should
have ample parking space dedicated for their users.

Geographical access: Services should be available to all users, wherever they live. In most
countries, this will require establishing a network of service units appropriately distributed
throughout the country (see 4G) or decentralization of services (see 4H). Service users and
caregivers may also require financial support for travel to and accommodation at the service
location (see 1M).

Social access: Services should be offered in the same way to all people, irrespective of their
gender, age (with the possible exception of services specifically for children and for the
elderly), social background, ethnicity, cultural values, religion, beliefs, sexual orientation or
refugee or migrant status.

Linguistic access: Service users should be able to communicate with the service provider
in their own language or dialect. All information materials should be available in the local
language and in an accessible format. Sign language interpreters should be available for
people with speech impairments.

Organizational access: Opening hours, waiting times and appointment systems should suit
all users, including those coming from remote locations and those who work during the day.

4E Types of service provider

Prosthetics and orthotics services can be provided by public, private (for profit or not-for-
profit) and nongovernmental and philanthropic organizations. Most countries will require
a combination of different service providers to ensure equitable access to affordable, high-
quality services for all. The advantages may be several sources of funding and a wider reach
of services.

Public service providers

Governments must ensure that high-quality prosthetics and orthotics services are available
at an affordable cost for everyone, everywhere. States can fulfil this responsibility in various
ways, including establishing service units at different levels and providing the services directly.
This may be the case in countries where prosthetics and orthotics service coverage has not
yet been included in national health and social insurance schemes. Public service provision
is often characterized by a long-term commitment.

Public prosthetics and orthotics services may be provided by the ministry of health and
also by ministries for social welfare, education and defence, the last usually being limited

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to military personnel and war veterans. Occasionally, services may be provided by more
than one ministry; this requires close intersectoral collaboration to minimize duplication
and waste of resources. In some countries, funds are provided by one ministry and services
delivered by another.

Private for-profit service providers

In many countries, prosthetics and orthotics services are provided by private enterprises or
commercial establishments. The advantage is that market competition can stimulate the
provision of more cost–effective services, reduce costs and increase quality; however, as
few users are likely to be able to pay the full cost of prosthetics and orthotics treatments
and products, private services will be viable only if the costs are subsidized by the State or
covered by insurance or welfare schemes. Otherwise, the private sector will cater only for
people who can afford their prices. To ensure safety, quality and accountability, the private
service must follow State regulations (see Regulation in 1B).

Private not-for-profit service providers

A private not-for-profit entity or social enterprise is run in most aspects like a commercial
company, with many of its advantages. While a private company’s purpose is usually to make
a profit, however, that of a social enterprise is to maximize improvements in well-being. The
profits are reinvested in services for the benefit of poor users (cross-subsidization) instead
of being paid to the owners or shareholders of the company. As in a private company, a
social enterprise depends on subsidies and insurance coverage, and services must follow
State regulations.

Nongovernmental and philanthropic organizations

In some countries, prosthetics and orthotics services may be provided by not-for-profit
NGOs, such as charities and faith-based organizations. This is more frequent in low-income
settings, where services are often started by NGOs in response to a highly apparent need
that has not been met by public or private services.

NGO services have a social approach similar to that of social enterprises, but services
are often provided free of charge or at a subsidized rate. (For concerns with regard to free
services, see 1L.) NGO services often rely on private donations and funds from philanthropies
or corporate social responsibility initiatives but may also be financed by the government or
insurance funds. Services are often provided within a project, which may place them at risk
for funding cuts. Like other entities, NGOs must comply with State regulations.

4F Inclusion of prosthetics and orthotics services in the health

sector
Prosthetics and orthotics services are best positioned within the health ministry and
integrated and mainstreamed into the national health care system. The benefits include
the fact that these specialized health services provide interventions for a range of health
conditions, contributing to better health outcomes and furthering universal health coverage.

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Prosthetics and orthotics treatments are usually provided in conjunction and collaboration
with other health services such as surgery and rehabilitation, and close linkage is critical for
the outcomes (see Box 14); these treatments can also reduce health costs (see 1F).

Box 14. Mutual benefits of including prosthetics and orthotics services in the
health sector

Many prosthetics and orthotics service users require medical treatment, wound healing, X-ray,
surgery, therapy and other interventions during treatment. The entry point of prosthetics and
orthotics services is often general health services. For example, a prosthetic fitting is required
after amputation, an orthosis after surgery or paralysis, and diabetic conditions often require
special footwear. Many prosthetics and orthotics service users are hospital inpatients or have
just been discharged. Prosthetics and orthotics service providers, irrespective of their affiliation,
should therefore work with hospital departments, including orthopaedics, rehabilitation, diabetes,
neurology, paediatrics, geriatrics and emergency. When the prosthetics and orthotics services are
not in the same building or campus, providers can maintain contacts by holding consultations
within hospitals and clinics.
Collaboration between prosthetics and orthotics services and decentralized health services is
of particular importance, as district hospitals and PHC and community health programmes can
identify, refer and follow up users. As part of the health sector, prosthetics and orthotics services
can make use of established networks to reach people in need everywhere in the country. This also
benefits the health services, as it can strengthen the continuum of care and increase the range of
services available. Such collaboration can ensure that health conditions requiring prosthetics and
orthotics treatment are identified and treated at an early stage (see 1H).

The inclusion of prosthetics and orthotics services in the health sector contributes to
the provision of inclusive health services for all, including people with disabilities. It also
reinforces the continuum of care, from preventive, promotive, curative, rehabilitative, assistive
interventions to palliative care.

While the ministry of health is usually the lead ministry for prosthetics and orthotics
services, others may make important contributions, by direct service delivery, by their part
in the rehabilitation continuum and in areas such as education, economic empowerment
and social integration. In particular, there should be strong links between health, education,
employment and social sectors.

4G Service delivery systems

The distribution of prosthetics and orthotics services should match overall need and the
population distribution in the country. Most countries will require several service units (see
Box 15) of different capacity, at different levels and in various geographical areas.

Ideally, all service units should provide the full range of services. In many contexts and
particularly in poorer settings, however, this may not be practically or financially possible,
as it would require comprehensive service units and specialized personnel for treating rare
and complex cases at all locations. Responsibilities can be distributed to different service

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levels with slightly different tasks. Together, the system will provide all the types of service
needed, with the expectation that the widest possible range of services is offered as close
as possible to potential users.

Box 15. Numbers of prosthetics and orthotics service units required

The number of service units required to cover the needs for prosthetics and orthotics in a country
depends on the geographical setting, the types of service provided in each unit and their size and
location. This varies widely by country.
On average, a country will require one to three prosthetics and orthotics service units per 1 million
population, on the assumption that each unit can assist 1500–2000 users per year (covering all
types of intervention). More precise figures from national and international studies and research
should be made available to determine the precise numbers of units required in different countries.

The three-level prosthetics and orthotics service delivery system

Like the three-level health care system and preferably integrated within it, a system of
primary, secondary and tertiary services can be used to organize prosthetics and orthotics
services (Fig. 3).

Fig. 3. Three-level delivery system for prosthetics and orthotics services;

exclusive and inclusive approaches

Exclusive prosthetics and Inclusive health system

orthotics approach approach

Specialized
prosthetics and
orthotics centres
Tertiary
Tertiary
Standard prosthetics
and orthotics units
Ref thwa
pa

Decentralized Secondary
err ys

Secondary
al

services

Primary
Primary- Mainstreaming Community
Community
within PHC services Identification, referral and follow-up

At primary level, to ensure that the widest range of services can be provided as close as
possible to the users, services can be extended from the exclusive prosthetics and orthotics
approach to an integrated approach involving other health and rehabilitation sectors in
identification, referral and follow-up and in the provision of a limited range of very basic
prosthetics and orthotics treatments, as decided by the tertiary and secondary services (the
inclusive health system approach).

At secondary level, standard prosthetics and orthotics units provide a range of the most
commonly required treatments for people in provinces and districts, including those referred

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from primary level. These units, preferably integrated into hospitals, should have established
links and standardized referral pathways to tertiary level services for rare conditions, complex
cases, advice and second opinions.

At tertiary level, specialized services are provided by, for example, national or regional
centres with the full range of specialist prosthetics and orthotics services or by specialist
clinics designated to provide comprehensive, multidisciplinary treatment for rare and complex
conditions, such as congenital limb deficiency, antenatal care and complex amputation
surgery and prosthetic fitting. Tertiary level centres are expected to be centres of excellence
that provide national or regional leadership, best practices, research, support and/or training
in particular areas. They should be able to offer a wide range of technology to meet specific
needs and should have access to inpatient rehabilitation beds for complex cases.

After treatment at secondary and/or tertiary levels, users can be followed up at primary level,
as close as possible to their homes.

Technical support and monitoring should be provided throughout the system to ensure that
high quality is maintained at all levels and in all types of service. Particular attention must
be paid to quality at primary level where personnel have less specialized training.

In large countries, there may be more than one service unit for specialized services at the
tertiary level, and some countries may also have standard prosthetics and orthotics units at
the primary level (see Box 16).

Country example
Box 16. A decentralized prosthetics and orthotics service
delivery system in China

Access to prosthetics and orthotics services can be improved by decentralized provision through a
close-knit network of service units. An estimated 24 million people in China experience physical
disability (45). Of these, 2.3 million are amputees who need prostheses or other mobility aids;
others have physical impairments, most of whom require orthoses, wheelchairs and other mobility
aids. To address this huge need, the China Disabled Persons’ Federation established a nationwide
network of permanent prosthetics and orthotics service units at all levels. Currently, the Federation
has 180 service units in the provinces and cities and nearly 1000 units of different scales and
sizes in counties. These units, with mobile and outreach service facilities, go towards ensuring
that prosthetics and orthotics services are available in most parts of the country. Within the
Cheung Kong New Milestone programme, a longstanding collaboration between the China Disabled
Persons’ Federation and the Li Ka-shing Foundation, China continuously upgrades and strengthens
the capacity of the decentralized prosthetics and orthotics service system.

Systems of private prosthetics and orthotics service providers

In countries where citizens are effectively covered by public or private insurance, the
advantage of private prosthetics and orthotics services is that they tend to be distributed
according to the demand for services and correspondingly have a financial incentive to
provide services. A private actor will be interested in establishing a prosthetics and orthotics

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© ICRC
unit of the appropriate size and with suitable specialization in a country in which there is a
favourable environment for private business.

Private services may be provided by stand-alone units or, more typically, by enterprises
that have branches in various cities and largely function as separate service systems. While
collaboration with other service providers (which would be seen as competitors) may be
limited, there is a strong financial incentive for private service providers to collaborate with
the health sector, which can increase both client numbers and income.

4H Decentralization of services
Although it would be financially impossible to have complete prosthetics and orthotics
service units in all cities and communities in a country, the services must be made accessible
for people in remote and rural areas. A service unit can serve as a hub for the provision of
decentralized services through, for example, satellite units, mobile units, outreach services
or liaison with community programmes and outreach campaigns. Each of these approaches
has its advantages and disadvantages (Table 4). All depend on services and support from a
prosthetics and orthotics unit, and most face challenges in assuring the quality of treatments
and products. Decentralized services must therefore be monitored closely and the results
carefully followed up and evaluated.

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Table 4. Advantages and disadvantages of different means of providing

decentralized prosthetics and orthotics services

Means of
decentralization Advantages Disdvantages
Satellite services • Can provide the same range of services as • The degree of decentralization is
the main service unit more limited than that of outreach
• Can maintain the same quality standards and mobile services but can be
as the main service unit increased by establishment of
• Can be integrated into a health facility and several units.
stimulate collaboration with the health
sector
• Can become a permanently staffed service
unit
Mobile services • Can reach the least centralized parts of a • Complicated cases and those
country requiring long training must be
• Are less dependent than outreach services referred to a main service unit.
on the main service unit and can be • The range of treatments and
operational for longer products that can be provided
• Can be efficient and assist a large number without compromising quality may
of users be limited.
• Can play an important role in identification • Cost–effectiveness may be low.
and referral of potential users
• Can assure a broad range of repair and
maintenance work
• Can raise awareness about disability
issues, prosthetics and orthotics needs
and the role and benefits of the services
Outreach services • Can reach the least centralized parts of a • Depend on the main service unit
country for fabrication of all custom-made
• Can identify and refer potential users products
• Can assist some users • Insufficient time for the treatment of
most users, who must be referred to
a service unit
• High risk that the quality of
treatment is below acceptable levels
• Only a limited range of treatments
and products can be provided.
Linkage with • Facilitates early identification and • A very limited range of treatments
CBR and other intervention can be provided; the vast majority
community • Can refer potential users and follow them of users have to travel to the service
programmes up after treatment unit.
• Little cost for the prosthetics and orthotics • The quality of treatments may be
service provider poor.
• May increase the probability of co-
financing services for community members
• Can do repairs and maintenance
Linkage with • Can identify and refer potential users • Cannot provide prosthetics and
community • Little cost for the prosthetics and orthotics orthotics treatment; all users have
outreach service provider to be referred to a service unit
campaigns

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While decentralization of prosthetics and orthotics services usually incurs significant extra
costs for the service provider, who must consider the cost–effectiveness of services, it can
result in considerable savings for the user and may therefore be economically justifiable
(see Box 17). In many countries, decentralization may be the only way of reaching all people
in need. People who need more advanced treatment than can be offered in decentralized
services can be identified and referred to the right level in the service system.

Box 17. Decentralization of services: not only a cost but an investment that
can generate savings

The provision of prosthetics and orthotics services involves costs in five categories (see 1E). The
two main categories are the cost of the service provider and the expenses of the user (including, for
example, the costs of travelling to and from the service location and staying throughout treatment).
While decentralization of services increases the costs for the service provider (and donor agencies,
the government, insurance systems), users can make large savings and increase their earnings, as
they will have to travel less and spend less time away from home or a job.
These aspects must be considered when analysing the overall cost of decentralizing services. Not
only is it more practical for users to have the services closer (instead of having large numbers of
people travelling to centrally located service units), it may also have economic benefits for society.
In addition, decentralized services can ensure better repair and maintenance services, which can
increase the lifespan of prostheses and orthoses and reduce the cost of renewals.

Satellite services
A satellite service unit is a small facility in a suitable decentralized location, preferably
integrated into a hospital or a health centre facility where collaboration can be established
with health personnel. The unit may not be permanently staffed initially but visited
regularly, perhaps every 2–3 weeks, by personnel from a main service unit. The satellite
has the equipment necessary for taking measurements and casts and fitting, repairing and
maintaining prostheses and orthoses but relies on the main centre for fabrication.

Starting at a very small scale, a satellite unit can grow and the frequency of visits increase
as it becomes better known in the area and the demand for services rises. Eventually, the
services may become permanent (see Box 18). At an intermediate stage, the unit may be
staffed by a physiotherapist, occupational therapist, nurse or trained CBR worker, who can
conduct the first screening and prepare users for treatment, and/or by a prosthetics and
orthotics technician, who can make repairs and maintain prostheses, orthoses and other
mobility products. To increase decentralization, a main unit may have several satellites. Except
for staffing, satellite units should adhere to the same standards as the overall service system.

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Country example
Box 18. Satellite prosthetics and orthotics service
provision in Sweden

The Swedish island of Gotland is located in the Baltic Sea some 100 km off the mainland, a
3-h ferry ride away. With a population of nearly 60 000, it has only recently been provided with
permanent prosthetics and orthotics services. Until the 1970s, the only prosthetics and orthotics
services offered were those of a shoemaker. In the 1980s, a service provider on the mainland
started to make monthly visits to the island’s main hospital, where measurements and casts were
taken and prostheses and orthoses fitted and delivered. As the demand grew and visits became
more frequent, it was decided in the 1990s to establish a permanent service unit. With two
prosthetics and orthotics personnel, this unit is now a provincial centre that can provide a wide
range of treatments, and only a few people have to travel to the mainland for specialized services.

Mobile services
A mobile unit is essentially a prosthetics and orthotics service facility on wheels or, in some
countries, a boat. It is equipped with the tools and machinery required to produce a certain
range of prostheses and orthoses and is staffed by a team ideally including prosthetics and
orthotics specialists, doctors, therapists and social and CBR workers. The unit can be used
in remote areas, preferably in collaboration with a district or sub-district hospital and PHC
centre, to identify needs, directly deliver services, refer users to secondary units, follow-up
and carry out maintenance and repair work. It can also raising awareness of prosthetics and
orthotics services, which may increase demand and thus favour establishment of permanent
service units.

A mobile unit can work independently in a wide area for long periods, up to several weeks or
even months, if there are sufficient materials and staff can be compensated for the particular
work conditions. This can ensure efficient service delivery.

The provision of mobile services is often more expensive than in a prosthetics and orthotics
facility because of vehicle costs and higher personnel costs for allowances and accommodation
during field visits. To be cost–effective, a unit should therefore remain at a location for only
as long as its capacity is fully used but long enough to ensure that all treatments adhere to
standard procedures. These considerations affect the extent to which the needs in a location
can be covered. Some cases will have to be referred to a main unit, because they are too
complicated or require very lengthy treatment.

Mobile services should not be second-rate services for rural populations but should adhere to
the same standards as the main prosthetics and orthotics unit and follow well-defined quality
requirements for that type of service. Ensuring the quality of services is more challenging in
a mobile unit than at a main unit, and the types of treatments that can be provided are likely
to be more limited. On the basis of evaluations of treatment results, the service provider
can define the range of treatments that can be provided without compromising quality. Such
evaluations must be objective and evidence-based and not based only on users’ opinion, as
users in remote areas may not know what they should expect from the services and may
have low expectations of fit, function and comfort.
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Mobile prosthetics and orthotics services are usually a temporary approach for raising
awareness about needs, increasing access to services and paving the way for establishment
of a less centralized network of secondary level service units (see Box 19). In some countries,
mobile services may be the only way of reaching populations scattered over large areas that
are difficult to access (such as deserts, islands and mountainous areas). Mobile services
should be considered an important element in the service delivery system and may be critical
for providing services to all the people who need them.

Country example
Box 19. Mobile prosthetics and orthotics services in Brazil

In 2008, the São Paulo State Government in Brazil initiated a network of 20 permanent rehabilitation
facilities. While the first service facilities were being built, equipped and staffed, a mobile unit was
created to provide decentralized services, build the capacity of local professionals, raise awareness
about the right of people with disabilities to access appropriate services and collect data on service
needs. The mobile unit was introduced in 2009 and was operational until 2011. It consisted of
a 15.4-m long, 2.5-m wide fit-for-purpose tractor–trailer with rooms for waiting, consultation,
therapy, fitting, assembly, machine work, plaster work and administrative support. The unit was
staffed by a team of prosthetics and orthotics personnel, doctors, physiotherapists, occupational
therapists, nurses, administrative officers and a bioengineer. This allowed both assisting users and
training local rehabilitation professionals.
The mobile unit provided services in nine of the State’s 17 regional health departments, with three
visits in each location. The users were referred from surrounding areas by local health authorities,
who also coordinated follow-up. On the first visit, assessments and prescriptions were made and
measurements taken, followed by fitting, training and delivery of prostheses and orthoses on
subsequent visits. During the three years in which the mobile unit was operational, more than
3300 assistive products were delivered, including lower- and upper-limb orthoses and prostheses,
shoes and insoles, canes, crutches and walking frames, benefitting some 1800 users. Increasing
numbers have since been assisted at the permanent rehabilitation facilities that were established
in some of the regions visited by the mobile unit. The mobile service thereby led the establishment
of new services in parts of the State that had previously not been catered for.
Data collected by the mobile unit were used to project the requirements for assistive products in
each region and indicated further action, including the establishment of more service units and
training of personnel (46).

Outreach services
Exceptionally, such as in emergencies or to reach very remote populations, prosthetics and
orthotics units can organize outreach services (see Box 20). These services usually consist
of a series of visits to a location, preferably organized in collaboration with a district or sub-
district hospital or a PHC centre, possibly as part of a health outreach activity.

Outreach services are provided by a team similar to that of a mobile unit (see above) but
without most of its tools and machines. Each visit may last one or several days, depending
on the size of the targeted population and the distance. On the first visit, potential users are
screened, then people who require prosthetics and orthotics are fully assessed and measured,
with casts made, or prefabricated devices or mobility assistive products are provided. After
the first visit, the team returns to the service unit for fabrication of custom-made products,
which are fitted on the second visit. Follow-up visits can be made, or follow-up can be
conducted by community workers. Visits may also include a limited range of maintenance

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and repair of devices. In some countries, very simple prosthetic and orthotic products might
be manufactured at the outreach location.

The challenge of this type of service is guaranteeing the quality of treatment and products,
as the service is often provided under considerable time pressure, without access to the full
range of equipment and tools required and in an environment that may not readily allow
use of standard procedures or ensure the privacy of users. Such services should be provided
only when monitoring, evaluation and follow-up of treatment and products verify that they
meet the quality requirements. Only a limited range of treatments can be provided in the
field, as most users (particularly those who require training and close follow-up) are referred
to a service unit.

Country example
Box 20. Outreach prosthetics and orthotics services in Nepal

Nepal has a population of 27 million, distributed over an area of 150 000 km2 in three distinct
physiographic areas: the Terai (lowlands), the Hills and the Mountains. Prosthetics and orthotics
facilities are located mainly in the lowlands (with the exception of those in the two main cities,
Kathmandu and Pokhara), and access to services is difficult for people in vast parts of the Hill and
Mountain regions. To ensure rehabilitation of people in these areas, most service providers offer
outreach services, potentially reaching all the country’s 75 districts.
Providing outreach services often involves travelling 10–15 hours to reach a district, from which
several locations can be visited; usually, 1–2 days are spent at each site. Potential users, who
may arrive by foot (or be carried) from places many hours away, are referred by village leaders and
personnel in local health, social and education offices and institutions.
The multidisciplinary team of the outreach service makes assessments and provides rehabilitation
services on site, where some prefabricated orthoses and mobility aids can be provided. Measurements
are taken for some users, who receive custom-built products on a second visit; however, users are
referred to the service facility for most treatment. Outreach services significantly increase service
use, and screening of potential users ensures that people do not travel to the service unit in vain.
Outreach service providers usually work with community disability workers in the district, who help
in organizing visits and are instrumental in following up users and communicating with service
facility staff when adjustments, repairs and renewals are needed.

Linkage with CBR and other community programmes

In addition to collaborating with PHC services at primary level within the three-level service
delivery system (see 4G, Fig. 3), prosthetics and orthotics services can link with community
programmes, such as social and CBR programmes (see Box 21), to identify and refer people
who require prostheses and orthoses to service units and to follow them up on their return.
Developments in information and communications technology can facilitate this work (see
Box 22). Some communities may be able to provide funding for users referred to services
at secondary and tertiary levels. Basic prosthetics and orthotics treatment may be provided,
but only if community workers have received sufficient training and their work is closely
supervised. It is important to clearly define what community workers can and cannot do and
the circumstances in which they should consult specialists at the prosthetics and orthotics unit.

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Box 21. Community-based rehabilitation

CBR can ensure that a large proportion of people with disabilities receive rehabilitation in
their communities. CBR workers can identify people with disabilities, conduct basic functional
assessments, provide simple rehabilitation treatment, train family members to support and assist
a person with a disability, provide information about the types of services available, facilitate
referrals to more specialized rehabilitation at secondary and tertiary levels, including prosthetics
and orthotics services, and follow up users on their return. CBR programmes can raise awareness
in a community about disability, rehabilitation and prosthetics and orthotics services and are
important partners of these service providers (47).

Country example
Box 22. Telemedicine and telerehabilitation to facilitate
prosthetics and orthotics service provision in the Philippines

“Telemedicine”, “telehealth”, “e-health” and “mHealth” are terms used interchangeably to

describe clinical services that are provided by use of information and communication technology.
Where great distances make face-to-face consultations difficult and expensive, these services can
facilitate access to generalists or specialists. They can also be used by health personnel who need
specialist advice on rare or complex conditions in order to intervene locally. Images and data can
be stored before they are transmitted, or consultations can be made in real time (live streaming).
Telerehabilitation is the application of information and communication technology in the field of
rehabilitation services and is used to improve access to services for people with physical impairments
or functional limitations, so that more people can be assisted and more specialized interventions
and follow-up are available at local level. To be effective, telerehabilitation technology should be
“lightweight”, with a simple interface, and should allow real-time communication (48). Lessons
learnt from telemedicine and telerehabilitation can be applied to the provision of prosthetics
and orthotics services. Areas to be developed include outreach screening, provision of specialist
assessment and advice and follow up of users.
In view of the challenge of reaching remote, underserved communities on the many islands of
the Philippines, the Department of Rehabilitation Medicine at the Philippine General Hospital
initiated a programme, Amputee Screening through Cellphone Networking (ASCENT), in which
medical doctors, students and health workers screen amputees in the community. Cell phones are
used to record the medical history and transmit the data to a centralized web-based database, with
photographs and videos taken with the cell phone camera.
ASCENT has created a registry of amputees, provided a tool for screening the parameters of
prosthesis use, identifies amputees at risk of a second amputation and enhances the role of the
rehabilitation team. The registry provided the data necessary for creation and implementation of the
Philippine Health Insurance Commission Prostheses Benefit Package. ASCENT overcomes many
challenges by making evaluation paperless and user-friendly and facilitating access to prosthetics
services in rural and geographically remote areas.

Linkage with community outreach campaigns

Governments and NGOs sometimes provide direct support to communities in, for example,
vaccination campaigns, HIV/AIDS awareness-raising projects, registration of voters and
literacy campaigns. These outreach interventions, even though they are temporary, offer
opportunities for raising awareness about prosthetics and orthotics and identifying and
referring people who need such treatment. Prosthetics and orthotics service providers can
link with such initiatives in order to increase service coverage.

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4I Maintenance and repair services

For prostheses and orthoses to remain useful, they require regular maintenance and
occasional repairs. Sometimes, adjustments are required to ensure that the products remain
comfortable and functional. An amputation stump, for example, may gradually become
smaller as a natural result of atrophying muscles, or it might become larger due to oedema
or weight gain; this will affect the fit of the prosthesis. Similar changes can influence the fit,
comfort and function of orthoses. Adjustments, maintenance and repair, although often small,
can ensure that prostheses and orthoses have a long lifespan; they are critical for the users’
comfort and to maintain their confidence in the services. Maintenance and repair may also
save costs for users, service providers and society.

Maintenance and repair services should be an integral part of a prosthetics and orthotics
service system and should be provided as close as possible to users, by the service unit
itself and through decentralized services (see 4H). They can also be provided by dedicated,
decentralized maintenance and repair facilities, perhaps providing similar services for
mobility and assistive products in general. This may involve working with others in wider
fields, such as CBR workers. In all cases, concerned individuals should be trained. The range
of maintenance and repairs that can be done by workers with no formal prosthetics and
orthotics training should be carefully defined. The repairs are likely to include minor (but,
for the user, important) interventions, such as replacing straps and providing spare socks.

4J Service provision in disasters

Prosthetics and orthotics services are often needed after natural and manmade disasters,
such as earthquakes and civil conflict, with increasing numbers of people with acquired
impairments such as spinal cord injury, traumatic brain injury, limb amputation, fracture,
peripheral nerve injury and crush injury (49, 50). Some of these victims will require immediate
prosthetics and orthotics treatment. Often, the local services for assisting these victims
are also affected by the disaster, and international support may be required to rebuild and
strengthen them.

International support often involves establishing clusters for coordinating and channelling
work to different sectors. Prosthetics and orthotics are usually part of the health sector
response and are coordinated by a health cluster, preferably in a sub-cluster for rehabilitation.
Governments should be encouraged to play a leading role in coordination. If there is a national
prosthetics and orthotics committee or similar (see 1A, Box 1), it is usually well placed to
assume coordination and planning, with the involvement and support of relevant international
actors. Coordination is critical from an early stage to ensure that all national and international
stakeholders work towards a common goal, which should correspond to the national long-
term goals. International support projects must conform to national strategies, such as for
use of technology and training of personnel, so that services can be sustained by national
stakeholders when the support ends.

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In disasters, it is particularly important to protect vulnerable groups such as people with

disabilities (especially children and women). Their rights, as outlined in the CRPD, must be
respected, including ensuring access to rehabilitation services. The aftermath of a disaster
may highlight rehabilitation needs and provide an opportunity to raise disability issues on
the national agenda.

Support for victims of a disaster who need prostheses and orthoses involves the actions
shown in Fig. 4.

Fig. 4. Phases of the prosthetics and orthotics rehabilitation continuum in

disaster contexts

Rehabilitation continuum in disaster contexts

Emergency phase Reconstruction Long term
• Triage phase • Capacity-building
• Provision of a limited range • Systems strengthening
of mobility devices • Prosthetics and orthotics • Training of personnel
• Advice to health and service delivery • Strengthening of service
rehabilitation personnel • Follow-up units
• Data collection • Long-term planning
• Planning • Policy development

Source: adapted from reference (49)

Emergency phase
Prostheses and orthoses do not usually save lives, but services must be planned in the
immediate emergency phase without delay. Information should be collected on the number
of victims who need prosthetics and orthotics treatment, the capacity of local services, the
personnel available and the technical and material support that may be required to restore
and strengthen existing services to provide sufficient assistance.

In the emergency phase, victims might need some orthoses (such as off-the-shelf products to
stabilize limbs and spinal fractures) and mobility products (such as wheelchairs and crutches)
to prevent secondary impairment and to facilitate mobility. Prosthetics and orthotics
specialists should work with surgeons, therapists and other health personnel in assessing
victims and give advice on, for example, amputation levels, prosthetic considerations, type
of baseline data to be collected, referral processes and prevention of secondary impairment
(49–51). Planning of subsequent service delivery should start in parallel to ensure that the
materials and working methods are compatible with those to be used in the long term.

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Reconstruction phase
Fitting of prostheses and orthoses should start as soon as the healing of injuries and
the security situation allow. It will be increasingly difficult to achieve good rehabilitation
outcomes if services are not provided promptly. New service units might have to be set up
to complement or replace inoperational services. All activities should be conducted with a
view to the long term.

Long-term provision
Service users who are assisted during the reconstruction phase must have ensured access
to reliable long-term services, as should all people who need prostheses and orthoses.
The provision of long-term, sustainable services may require strengthening the capacity of
service units and investing in training of personnel. This must be considered in planning and
budgeting international support.

Disaster preparedness
Countries that are particularly prone to disasters can make preparations to ensure that
prosthetics and orthotics treatment can be provided with other rehabilitation services at
an early stage. They might set up stocks of essential orthoses and mobility devices and
add prosthetics and orthotics to the disaster preparedness training of health personnel and
community workers.

4K Exclusive and inclusive service units

A prosthetics and orthotics service unit may be an exclusive, stand-alone entity or it may be
an integrated part of a health, rehabilitation or assistive products provision facility. Prosthetics
and orthotics services that are integrated into the national health care system (see 4F) are
usually in hospitals and rehabilitation facilities. Exceptionally, these units may specialize in
only one discipline – prosthetics or orthotics – or even in one subfield, such as spinal orthoses.

Exclusive service units

An exclusive, stand-alone prosthetics and orthotics unit is not part of a larger service facility.
It may still be part of a wider network of service providers, such as one of several units of
a ministry or a commercial company. The advantage of an exclusive unit is that it is more
flexible in terms of location, making it easier for users to access. Exclusive units may, however,
have more difficulty in establishing direct links with hospitals and other rehabilitation services;
and many users may find it inconvenient and expensive to attend multiple appointments for
different health needs at different locations.

Inclusive service units

Prosthetics and orthotics units are frequently integrated into larger health service facilities,
which may be advantageous for both the service unit and the larger facility, as direct contact
between prosthetics and orthotics personnel and other health personnel can facilitate inter-
referral and generally improve the results of health and rehabilitation services (see 4F). Any
type of prosthetics and orthotics service provider – public, private or NGO – can be integrated

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into a larger health structure; the integrated service unit is not necessarily part of the same
organization as the larger facility. Private prosthetics and orthotics units, for example, are
often integrated into public hospitals.

Integrated services for mobility and assistive products

Prosthetics and orthotics services may be part of a facility that provides mobility products,
including crutches, walking frames, wheelchairs and special seating (see Box 23), or of a
facility for even broader assistive technology, including vision and hearing aids. This may be
an approach for establishing decentralized maintenance and repair services. As certain staff
skills, equipment, tools and service systems are common to the different fields, services may
become more economical when resources are shared.

Country example
Box 23. An inclusive approach to provision of assistive
products in Samoa

Combining different assistive technologies in one service unit is an effective way to improve access
to these technologies, including prostheses and orthoses. Samoa Integrated Mobility Device
Services is a collaboration between the Samoa National Health Service, Nuanua O Le Alofa, and
Motivation Australia, to ensure consistent, reliable, equitable, sustainable access to appropriate
mobility devices. A new facility has been built, which is staffed by trained personnel who are working
towards new careers in allied health services for Samoans. Services for wheelchairs, supportive
seating, prostheses, orthoses and walking aids are combined into one mobility device department.

Segregated services
Very exceptionally, service units that target a well-defined group of users (such as children
with amputations or neurological disorders and people with spinal impairments) provide
services in only prosthetics or orthotics. While this may be justified in some cases, it is
more practical and cost–effective to provide both services in one place. The tools, machines,
equipment and raw materials used are similar, and the professionals have similar training,
so that savings can be made on investment and running costs.

4L The service unit

Prosthetics and orthotics services are provided in facilities that are designed and adapted
for people who need these devices. A typical service unit consists of four areas: a reception
and waiting area, a clinical area, a workshop and rooms for administration (see Box 24). The
layout and size of the unit should be suitable for the intended workload and the types of
services to be provided. For example, if prostheses and orthoses are fabricated at a central
facility shared by several units, only a small workshop area will be required in the service unit.

Users should have direct, easy access to the reception and waiting area and relevant clinical
areas. All user areas, including toilets, should be physically accessible and ergonomically
designed. Waiting rooms and clinical areas should be separated from the workshop to
minimize the risk for injury and exposure to loud noise, dust and the fumes of (potentially
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harmful) chemicals used in the manufacture of prostheses and orthoses. User areas should
be friendly and have a clinical appearance (see 4A, Box 13, and 1R). As required in the local
context, the possibility of treating girls, boys, women and men separately should be offered.

Box 24. The four main areas of a prosthetics and orthotics service unit

Service user areas Staff areas

1 2 3 4
Reception/waiting area Clinical area Workshop area Personnel area
• Waiting room • Assessment room • Assembly room(s), • Administration
• Reception • Casting/measuring laboratory(s) • Staff offices
• Toilets room • Plaster modification • Library/meeting
• Fitting room room room
• Gait training area • Plastic room • Changing room
• Physiotherapy • Machine room • Shower room
• Shower room • Store • Toilets
• In larger service
units, facilities for
a wider range of
services may be
available.
© Royal National Orthopaedic Hospital – UK

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4M Equipment
The equipment usually used in a service unit comprises general craftsman’s tools and
more specific tools for the fabrication of prostheses and orthoses (see examples in Box
25). The numbers and sets of equipment depend on the size of the unit and the types of
service provided. The choice of equipment has a direct bearing on the cost–effectiveness
of services. The market should be searched for the most appropriate tools, machines and
other equipment, with a careful comparison of prices, quality and availability. Investing in
good-quality equipment, even if it is initially more expensive, can reduce maintenance and
replacement costs, making the prostheses and orthoses more affordable in the long term.
All items should be maintained regularly according to the recommendations of the supplier
or manufacturer, and there should be a plan for machine replacement.

As for prosthetic and orthotic components and materials (see 2F), national stakeholders
should work with relevant authorities and ministries to ensure that tools, machines and other
equipment used exclusively for the fabrication of prostheses and orthoses are exempt from
import taxes and customs fees.

Box 25. Examples of equipment used in a prosthetics and orthotics service unit

Section Equipment
Assessment room Record-keeping tools; tools and equipment for assessing users
Casting and measuring Shape capture equipment; measurement tools
room
Plaster modification room Mould modification tools and equipment
Plastic room Equipment for thermoplastic forming and/or laminating (e.g. oven,
vacuum machine)
Assembly room Hand tools, drilling machine, sewing machine, etc.
Machine room Socket router, heavy-duty drill, etc.
Therapy and gait training Therapy equipment, parallel bars, mirrors, etc.

4N Working environment and safety

The provision of prosthetics and orthotics is clinical work, done in an environment similar
to that of a medical facility, but certain technical tasks are performed in a workshop. Some
of the tools and machines used are noisy, produce dust and may cause physical injury;
frequently, the chemicals used are hazardous to the skin and lungs. To protect the safety
and health of both users and personnel, prosthetics and orthotics service units should have
documented safety rules, with visible health and safety notices explaining the rules and the
potential dangers in each section of the unit. Fire extinguishers, first aid kits and eyewash
stations should be easily accessible, and smoking should not be allowed. Personnel should
receive adequate training in the rules and procedures in the case of accidents, fire or another

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emergency. All personnel must adhere to the rules. In the event of an accident, users and
personnel should be covered by relevant insurance policies.

In the workshop area, workers’ health and safety should be protected by ensuring, for
example, that:
• protective gear, such as gloves, masks, goggles and ear protection, are used for hazardous
work (as defined by safety rules);
• effective systems are in place to exhaust dust and fumes from workshop areas;
• noisy machines are used only in dedicated, preferably sound-isolated rooms;
• machines are correctly installed, with ample space around them and according to the
instructions of the supplier or manufacturer, so they can be used without risk of accidents;
• tools and machines are regularly maintained and in good order; and
• all technical personnel are trained in the safe use of tools, machines and materials.

Monitoring safety
Safety should be monitored by collecting and analysing data on adverse incidents in service
delivery, including data on accidents, near-accidents, injuries, infections, irregularities,
misbehaviour of personnel or other faults that might jeopardize the safety of users and
personnel or have negative implications for the service. Such events should be carefully
followed up and recurrence prevented. Protocols should be in place to minimize adverse
incidents. User feedback should be encouraged to ensure that all incidents are recorded.

4O User identification and referral

Identification and referral of users is important to ensure that those who need services can
be directed to a unit where the services can be delivered (see 4P).

Identification of need
A person’s need for prosthetics or orthotics service is often identified in the health sector, for
example when the person seeks assistance at a hospital or clinic for a chronic condition or
impairment-related problem, or as the immediate result of a medical intervention, such as
amputation. Often, however, people who need prosthetics or orthotics services are unaware
of the availability and benefits of these services. This is likely to be a problem, particularly in
poorer settings, where health services may be less developed, few professionals are trained
to identify needs and less is known about referral possibilities. In such settings, people are
commonly referred to prosthetics and orthotics services by peers and user groups.

To ensure that people in need are referred to the appropriate services, personnel in the health
and social sectors should be made aware of the availability of the services and how to access
them as part of usual awareness-raising activities (see 1Q), possibly in combination with
targeted training in identification.

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Referral
The precise rules and customs for referral to a prosthetics and orthotics service depend on
the country and local service and financing systems. Referral processes should be established
and included in service policies at national, local or service unit level, depending on the
context. They should include processes for both self-referral and referral by health and other
professionals, with the information required for the referral to be acted upon.

In many countries, to benefit from insurance coverage, a user must see a doctor, who makes
a first general assessment and prescribes a prosthesis or orthosis. The doctor should be
specialized in physical and rehabilitation medicine or orthopaedics, with adequate knowledge
of prosthetics and orthotics and be authorized by the insurance office – public or private – to
issue purchase requisitions payable to the service provider.

In many other countries, there is no insurance coverage for prosthetics and orthotics services,
and there may be few doctors, especially doctors who are specialized in rehabilitation.
Targeted training could be provided to general practitioners or other rehabilitation specialists,
who can issue purchase requisitions.

Self-referrals are common in many countries, particularly for the renewal of prostheses and
orthoses. Renewals can usually be done with the original purchase requisition, if there is an
agreement between the service provider and the paying office on how often and under what
circumstances a new product can be provided.

4P The service delivery process

The complete service delivery process is usually done in the service unit, although certain
aspects of the services may be delivered outside this. For example, measuring, cast-taking
and the trial and delivery of a prosthesis or orthosis may be done at decentralized service
locations (see 4H) or when personnel from the unit visit a hospital, and the fabrication of
prostheses and orthoses may be done at a centralized location shared by several service units.

Service delivery consists of four steps: (1) assessment, (2) fabrication and fitting, (3) user
training and (4) product delivery and follow-up, each of which can be divided into sub-
activities (Fig. 5). Many ISO standards that define prosthetics and orthotics terminology,
users and methods can be used in formulating and documenting procedures in service
delivery (see Box 26).

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Fig. 5. The prosthetics and orthotics service delivery process

Service delivery process

1 2 3 4
Assessment Fabrication and User training Product delivery
fitting and follow-up
• Appointment • Therapy
• Assessment • Measuring • Gait training • Product delivery
• Prescription • Fabrication • Training to acquire • Outcome evaluation
daily living skills • Follow-up
• Goal-setting • Fitting and • Maintenance and
customization repair

1 Assessment
Appointment
Once the user is in contact with a prosthetics and orthotics service unit, an appointment
is made to assess the individual’s precise needs. Both the user and caregivers should be
informed about all the practical issues in the treatment process and the cost implications,
if any. If the unit has a large workload and a waiting list, appointments for certain groups
of users, such as children, should be prioritized, and guidelines should be in place for
prioritization. Appointment systems should allow for emergency situations.

Then, a named prosthetics and orthotics professional should be appointed as the treating
clinician and the main contact for the user.

Assessment
Treatment usually starts with a thorough assessment of the user. When required and possible,
this is done by a multidisciplinary team of different rehabilitation professionals (see 3C).
With a holistic focus and considering the user and caregivers as members of the team, the
assessment should define the person’s need by considering body structure and function,
activity and participation. The results of the assessment should be shared with the user and
caregivers.

Prescription
On the basis of the assessment and after consultation between the multidisciplinary team
and the user and caregivers, an informed decision can be made about the most appropriate
treatment. Prescribers should check the biomedical and psychosocial goals to be achieved
when prescribing a prosthetic or orthotic product as these influence fit (62). The prescription
should specify the design and technical specification of the product to be provided according
to the country’s standard classification of prostheses and orthoses (which, in turn should

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be based on an ISO standard, see Box 26 and 2E). It should also describe the technology,
including components and materials, to be used and any special requirements (such as non-
standard designs or components).

Box 26. ISO standard terminology for prosthetics and orthotics

ISO Technical Committee 168 on prosthetics and orthotics has prepared standards for:
• the terminology to be used to describe the users of prostheses and orthoses and the devices they
use,
• the methods for assessing users and prescribing devices and
• describing the outcomes of treatment.
ISO standards for prosthetics:
• ISO 8548 Part 1 specifies a method for describing deficiencies present at birth (33).
• ISO 8549 Part 4 specifies terms relating to limb amputation (52).
• ISO 8548 Parts 2–5 specify methods for describing lower limb amputation stumps, upper limb
amputation stumps, the causal conditions for amputation and the clinical condition of people who
have had an amputation (35, 53–55).
• ISO 29782 describes factors to be considered in specifying a prosthesis for a person with a lower
limb amputation (56).
• ISO 8549 Part 2 specifies terms relating to external limb prostheses and the wearers of these
prostheses (34).
• ISO 13405 Parts 1–3 specify a method for classifying and describing prosthetic components (37).
• ISO 29781 specifies factors to be included in describing the physical activity of a person with a
lower limb amputation(s) or a deficiency of a lower limb segment(s) present at birth (57).
• ISO 29783 Parts 1 and 2 provide terminology to describe normal gait and prosthetic gait (58, 59).
ISO standards for orthotics:
• ISO 8551 specifies terminology for describing people to be treated with an orthosis, the clinical
objectives of treatment and the functional requirements of the orthosis (60).
• ISO 8549 Part 3 specifies terms relating to external orthoses (33).
• ISO 13404 specifies a method for categorizing and describing external orthoses and orthotic
components (37).
• ISO 29783 Part 3 describes a method for describing pathological gait (excluding prosthetic gait)
(61).

Depending on the needs identified in the assessment, the prescription may also include other
types of mobility assistive products (see Box 27), preparatory physiotherapy and occupational
therapy training, surgery, pain management and psychosocial support.

Box 27. Combined needs for mobility assistive products

In their overall care plan, users often need other mobility products, in addition to their prosthesis or
orthosis, such as a cane or stick, crutches, a standing frame, a walking frame or a wheelchair. This
need may be temporary (during their rehabilitation) or permanent. Many users with degenerative
conditions will gradually need additional mobility products to maintain their independence. In the
overall treatment plan and prescription of mobility products, care should be taken to ensure that
products are combined to the best effect.

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Frequently, users and caregivers are directed to appropriate user groups for peer support
and counselling (see Box 28).

Box 28. Peer support and counselling

Service users benefit from exchanging experiences, knowledge, emotions and thoughts on social
or practical issues with people who are in a similar situation or who have gone through a similar
experience. In a relationship of equality and peer support, the user can understand how others
managed to adjust to their new situation after, for example, trauma or disease. This can give them
hope and help them move past the difficulties created in their lives.
Peer support can take different forms, including mentoring, counselling and listening. It can be
formal or informal and can be done face-to-face, by telephone or on online forums, in groups or
individually. Support can be provided by peers with or without training, by volunteers or by salaried
peer counsellors.
All prosthetics and orthotics users should have the opportunity to access peer support, as
appropriate to their needs. When relevant, this should also involve families and caregivers. Informal
peer support may be offered within normal services, with referral to user groups or organizations
experienced in providing such services, as needed. Although peer support is voluntary, it should
be encouraged by service providers, as it can increase the user’s motivation, thereby speeding up
treatment and contributing to better results overall.

Some assessments lead to a decision not to prescribe a prosthesis or orthosis, for example,
if it is deemed that the fitting is not viable or would not benefit the user. The reasons should
be fully explained and justified to the user and caregivers and an alternative treatment plan
proposed, such as prescription of a wheelchair or therapy. Occasionally, purchase requisitions
are inaccurate or inappropriate, and users might have to be referred back to the person who
referred them originally.

Goal-setting
In collaboration with the user and caregivers, a personalized treatment plan should be
prepared and documented, including individual and realistic goal-setting (see Box 29).
Short- and long-term goals should be set, regularly reviewed and adapted to the progress
made. This may mean modifying the treatment plan.

Box 29. SMART goals

Prosthetics and orthotics clinicians, in consultation with the user and caregivers, should set
appropriate goals for treatment. Goal-setting should be guided by specific, measurable, achievable,
relevant, time-bound (“SMART”) criteria, which, in the context of prosthetics and orthotics
treatment, are as follows.
Specific: The goals must not be too general but should target well-defined areas for
improvement.
Measurable: The goals must be measurable, with indicators to quantify and verify improvements.
Achievable: The goals must be realistic and attainable, given the potential of the user (as defined
in the assessment) and the resources that are available.
Relevant: The goals must be relevant to the needs and expectations of the user and caregivers
and must be adapted individually.
Time-bound: The goals must include target dates and specify the time within which improvements
should be achieved.
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2 Fabrication and fitting

Measuring
Fitting of a prosthesis or orthosis usually begins with a set of body segment measurements.
For prefabricated products (see 2C), it is usually enough to measure certain lengths and
circumferences, which are then used to select a device of appropriate size. (The product may
still have to be adapted to the person’s anatomical features; see Fitting and customization
below.) When custom-made products are used, measurement often also includes capturing
the shape and making a model of the body segment, such as a plaster mould and/or a
computer-generated digital picture, which is used in fabricating the device.

Fabrication
Fabrication usually consists of shaping and assembling different components and materials
– many of them prefabricated and available in different models and sizes. This may be
done while the user is waiting, but a completely customized device usually requires a new
appointment.

Prosthetics and orthotics personnel must follow the manufacturers’ instructions and
guidelines to ensure full usage of components and to minimize potential risks to users and
personnel. Any deviations from standard practice must be fully documented. Manufacturers
and suppliers of prosthetic and orthotic components, materials and consumables should
inform and train personnel about the best clinical application of their products.

Fitting and customization

Next, the device can be tried on the user and be fully adapted to the body’s anatomical
features and movement patterns. Individual customization is required for fit and alignment
in order to achieve optimum comfort, function and appearance, thus ensuring that the
product can be used effectively. This is done in parallel with user training (see next section).
Depending on the type and complexity of the device, customization may be immediate, as
is the case with many prefabricated products, or it may require work over several sessions.
In some cases, customization may take days or weeks or, exceptionally, even months.

3 User training
Training
Training of users must be an integral part of prosthetics and orthotics service delivery.
Many users have to undergo preparatory training to strengthen their muscles and increase
the range of movement in their joints before a prosthesis or orthosis can be fitted. In the
fitting process, they should be provided with sufficient functional training to ensure that
they become accustomed to the new device, are able to put it on and take it off, can use it
effectively and safely and can control its features and functions fully.

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Training may be given under the supervision of the prosthetics and orthotics clinician or
by a physiotherapist or occupational therapist (see Box 30). Further adjustments can be
made to the device, as needed and according to the progress of the user (see Fitting and
customization above). Most users require considerably less training when a prosthesis or
orthosis is renewed. For users who require regular support in their daily activities, family
members and caregivers should be involved in all steps of training.

Box 30. Therapy interventions in the prosthetics and orthotics service delivery
process

Physiotherapy and occupational therapy interventions are often needed in preparatory training
and in the fitting phase (functional training) and are particularly important for users undergoing
their first treatment. Physiotherapists and occupational therapists are central members of the
multidisciplinary team.
The aim of preparatory training is to ensure that individuals are physically ready for the prosthesis or
orthosis fitting. The interventions may include strengthening muscles, joints and other structures
by direct manipulation or supervised exercises. They may also include massage and, occasionally,
electrotherapy and heat treatments.
Functional training is begun at the time of the first trials with the prosthesis or orthosis in order
to optimize the fit and function. Functional training includes guiding users in moving with the
new device, supervising gait training and supporting functional activities to make sure that the
individual can use the device in daily life.
Therapy is critical to the overall treatment result and should be an integral part of prosthetics
and orthotics service delivery, ideally by including therapists in the service unit. Often, however,
they are external resources, either in dedicated physiotherapy and occupational therapy hospital
departments or in independent, private entities.

4 Product delivery and follow-up

Product delivery
Once the fit, function and comfort of the prosthesis or orthosis is deemed optimal and the
user is confident in its use, all its features should be checked thoroughly by the responsible
prosthetics and orthotics clinician before it is finalized. Users and caregivers should have the
final say on the acceptability of fit, function and appearance.

At delivery of the prosthesis or orthosis, the responsible clinician should make a last check
of all the essential treatment criteria, by a standard protocol, in consultation with the user
and caregivers. If applicable, the results should be reported to the relevant insurance office.
The user and caregivers must know how to use and maintain the device (including how to
store it when it is not used), when to return to the service provider for follow-up and when
and where to go for maintenance and repair (see below). The user is responsible for adhering
to these instructions. Users should have an appointment for the first follow-up visit when
they leave the service unit. These arrangements should be documented.

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Outcome evaluation
At product delivery and in follow-up sessions, the outcome of treatment should be evaluated
against the agreed treatment goals with appropriately selected, validated outcome measures,
when available. The technical results and direct improvements in the user’s functioning,
mobility, dexterity and activity should be evaluated and documented, as well as the impact
on participation, such as return to work, education, social inclusion and other aspects of
quality of life (see 1P).

Follow-up
After treatment has been finalized, the user must be followed up at certain intervals and the
results reviewed. Follow-up should be individualized and should take into account the type
of intervention and the age of the user; children should be followed up at least twice a year.
Users are followed up to verify that the products are useful and there are no problems with
fit, comfort or function and to provide maintenance and repair as required. Follow-up is as
important as any other step in the delivery process.

Follow-up appointments also offer an opportunity to collect data for quality assurance and
evidence on measures to improve the quality of treatments, products and services (see 4R).

If users miss appointments, service providers should find out why. They have a responsibility
to ensure that the devices they provide do not fail the user.

Maintenance and repair

To increase the lifespan of prostheses and orthoses, maintenance and repair services must
be provided by the service unit or by collaborating units (see 4I).

4Q Service unit management

A director, manager or management team has the overall responsibility for the operation
of the prosthetics and orthotics service unit, while responsibilities for day-to-day activities
and supervision should be delegated to appointed heads of section or department (such
as administration, finance and manufacturing) and then cascaded to other staff members.
Management duties include planning, monitoring, financial work, stock management, material
procurement, human resources management, data collection and quality management.

Planning
Planning should be done at unit level but may involve offices at higher levels if the unit is part
of a larger organization. Both long-term and annual strategic and operational plans should be
in place. Plans should set clear aims (stating, for example, the number of users to be treated
and the quality targets to be reached), with benchmarks and performance indicators, so that
the results can be readily monitored and evaluated.

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Monitoring and evaluation

The activities of a prosthetics and orthotics service unit must be monitored continuously and
the results evaluated regularly to ensure that the services are achieving their goals efficiently.

Monitoring is done internally by the unit’s management team (or by offices at higher levels
in the organization). Monitoring involves regular collection and analysis of data (including
certain service data, see Table 1 in 1O) to make sure that activities are progressing according
to plan. A checklist can be used of the goals set for running and developing the services. By
comparing service data and other achievements with the checklist, the progress (or delay)
in the activities can be determined, and the management can correct any shortcomings.

Evaluation is an objective examination, usually by external specialists (from higher levels in

the organization or from outside), of the relevance, effectiveness, efficiency and impact of
the unit’s activities and services. The purpose is to identify any deviation from the planned
direction, so that it can be corrected and the unit’s work be strengthened. Evaluation
complements regular monitoring. It is usually a single event, which may be repeated as
needed to ensure that the work is on track. An evaluation may also be a means for reporting
to a donor about the outcome of a supported project and for demonstrating that the funds
were well managed and spent.

Collaboration
Management of a service unit also includes setting directions for and coordinating
collaboration with other stakeholders, such as:
• service user groups;
• health and rehabilitation services;
• social, education and livelihood services;
• CBR programmes;
• disability-inclusive sports and recreation programmes (see 1Q, Box 7);
• local government;
• civil society;
• the business community; and
• donors, investors and insurance agencies.

Although the frequency of collaboration will vary, from day-to-day contact with some
partners to annual meetings with others, these contacts are all vital. To be effective, working
relations should be formalized, which implies regular meetings and setting common goals
and mechanisms for collaboration. To use the knowledge of partners and their advice in
planning and running of services further, service units should consider establishing an
advisory committee with their membership (see Box 31).

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Box 31. Prosthetics and orthotics advisory committee

Prosthetics and orthotics service units can find support in planning, raising resources, monitoring
and evaluation by establishing a prosthetics and orthotics advisory committee, with representatives
of the most important collaborating partners, which have a direct interest in and can contribute to
ensuring well-functioning services. As they may have somewhat different interests in the services,
partners can contribute a variety of valuable, complementary suggestions on how the service can
be improved, contributing to its general development.
Representatives of users should be members of the committee, giving them opportunities to
influence local service design and service delivery (see 4B).
The advisory committee not only safeguards the mission of the programme but also offers
opportunities for awareness-raising and promotion of prosthetics and orthotics (see 1Q).

Financial management
A prosthetics and orthotics service provider has various expenses, such as salaries, materials,
consumables, rent and telephone and electricity bills. Funds may come from different
sources, such as government contributions, insurance payments, donations or user fees (or
combinations, see 1K). Good financial management includes planning, procuring, using and
controlling the unit’s financial resources to ensure that the services have a solid foundation,
can grow gradually and have an important long-term impact. Financial management should
be transparent and follow the standard practices of the country.

Stock management and material procurement

A range of components and materials are used in the manufacture of prostheses and
orthoses. Service providers should carefully plan the purchase, storage and use of these items
so that services are cost–effective, affordable for the user and not interrupted because of a
shortage of materials (see 2F). The use of stock management software for procurement and
disbursement should be explored.

Human resources management

Prosthetics and orthotics service units should apply and adhere to the staff management
procedures used in the public, private or NGO sector of the country. If the unit is large or
is part of a wider system of service providers, staff management is usually assured by a
specialized human resources department. Typical staff management issues include defining
and paying salaries, controlling staff members’ hours and managing personnel insurance
(work, accident, sickness, social and other). Important issues are workforce planning (see
3H), recruitment, CPD (3F), staff satisfaction and staff retention (3I). Annual performance
appraisals should be conducted to compare the work performance and productivity of
individual employees with the agreed objectives.

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Data management
Prosthetics and orthotics service providers should collect data on the services delivered and
on users, as this information is useful for planning, budgeting, monitoring and evaluating
at both service delivery and national levels. Data should also be reviewed for quality
management. Consistent collection and analysis of data provides a detailed picture of how
successful the services are, for example in terms of productivity and in reaching certain target
groups in different geographical areas (see 1O and 1P). Anonymized data should be sent to
central level for analyses of national needs and service availability.

For effective analysis of data, service providers should have integrated computerized systems
for storing and managing information and use electronic clinical records. The computer
programs should allow easy access to data for reporting.

4R Quality management
Prosthetics and orthotics service providers must ensure that the quality of the products
and treatments meets set requirements. A quality assurance system should therefore be in
place, not only for the technical quality of prostheses and orthoses but also for the extent to
which the services as a whole meet the needs of users (see Box 32). Quality management
comprises measuring, monitoring and improving the quality of products and services (see
Box 33). This corresponds to a clinical audit of health care services.

Box 32. Technical quality versus quality of services

The “quality” of a prosthetic or orthotic product might have slightly different meanings according
to by whom and in which context it is used. In simple terms, a high-quality prosthesis or orthosis
is one that is durable and safe and has excellent performance. From the perspective of the user,
high-quality products not only meet those criteria but are comfortable, functional, aesthetically
acceptable and meet their needs and expectations. From the economic point of view, a high-quality
prosthesis or orthosis is a product that is durable and cost–effective. These criteria, with others,
essentially define appropriate technology (see 2A).
The concept of quality should not be applied only to technical work but also to prosthetics and orthotics
services in the broader sense. Services are of good quality when they are centred on the user, they
are physically and financially accessible and free of other barriers, users feel they have been politely
attended to, waiting times are short, few visits are needed, safety is ensured, the working processes
are appropriate, the technical quality of the products is good and the continuity of services is ensured
(including follow-up, maintenance, renewal of products and referral to other services). These aspects
of service delivery all influence the trust of beneficiaries in the services, their willingness to seek
assistance and to return to the centre if needed and their motivation to recommend the services to
others. This, in turn, influences the overall outcome and impact of services.

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Box 33. Quality management in prosthetics and orthotics services

Quality management comprises all the actions taken by a prosthetics and orthotics service provider
to measure, monitor and improve the quality of products and services and to make sure that all
the requirements of adequate service delivery are fulfilled. Quality management includes definition
of quality indicators, which are measures of the quality achieved for each feature. It also involves
definition of quality standards, which are the requirements to be met. Quality standards can be
set by individual service providers but should be based on the best available evidence and in
accordance with standards set at higher levels in the national system or, when applicable, by
international bodies, such as ISO, WHO and ISPO. Quality standards should be realistic, so that
the goals are attainable; they must therefore reflect the context in which the services are provided.
Benchmarks may be set to measure the gradual improvements in quality that are to be expected
over time.
Quality can be measured and monitored by, for example, structural and clinical testing (for
technical quality, see 2H), analysing user satisfaction from questionnaires (to measure service
quality), analysing service data and statistics (see 1O) or occasional quality controls by external
experts. Measurement and monitoring of quality can reveal quality-related problems and the
actions required for quality improvement. The actions may include reviewing manufacturing
processes (to make a product more resistant and durable) or changing appointment procedures and
schedules (to reduce waiting times for users).
Any system that affects the quality of products
Fig. 6. The quality management Prepare plan
and services, including management, (quality control) cycle
administration, financial procedures, material
procurement (including component choice),
stock management and professional training, Define quality
indicators
might have to be changed. Take action to improve quality
Quality assurance is not a one-off task but
continuous work performed in a cycle (Fig.
6). Once problems are identified and actions Define standards
taken to solve them, quality should be Identify problems
measured again to verify the improvements.
Occasionally, quality indicators might have to
be redefined to ensure that all the necessary
Measure quality
aspects of quality are captured correctly. Monitor
Similarly, standards may be adjusted gradually
as quality improves.

Prosthetics and orthotics quality management should be an integral part of service provision.
The responsibility for this work should be assigned to a clinical or technical staff member (in
small units) or to a quality management team with representatives from various sections of
the service. The opinions of users and caregivers should be carefully solicited to measure the
quality of services, and feedback should be collected systematically from representative users,
for example from questionnaires or focus group discussions. Service user representatives
and disabled people’s organizations can play an important role in facilitating this work.

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(http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=36652, accessed 11
January 2017).
56. ISO 29782: Prostheses and orthoses – Factors to be considered when specifying a prosthesis for a person
who has had a lower limb amputation. Geneva: International Organization for Standardization; 2008
(https://www.iso.org/standard/45682.html?browse=tc, accessed 11 January 2017).
57. ISO 29781: Prostheses and orthoses – Factors to be included when describing physical activity of a person
who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present at
birth. Geneva: International Organization for Standardization; 2008 (http://www.iso.org/iso/home/store/
catalogue_tc/catalogue_detail.htm?csnumber=45681, accessed 11 January 2017).
58. ISO 29783-1: Prosthetics and orthotics – Vocabulary – Part 1: Normal gait. Geneva: International
Organization for Standardization; 2008 (https://www.iso.org/standard/45683.html, accessed 11 January
2017).
59. ISO 29783-2: Prosthetics and orthotics – Vocabulary – Part 2: Prosthetic gait. Geneva: International
Organization for Standardization; 2015 (http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.
htm?csnumber=63539, accessed 11 January 2017).
60. ISO 8551: Prosthetics and orthotics – Functional deficiencies – Description of the person to be treated
with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis. Geneva:
International Organization for Standardization; 2003 (http://www.iso.org/iso/home/store/catalogue_tc/
catalogue_detail.htm?csnumber=38506, accessed 11 January 2017).
61. ISO 29783-3: Prosthetics and orthotics – Vocabulary – Part 3: Pathological gait (excluding prosthetic
gait). Geneva: International Organization for Standardization; 2016 (http://www.iso.org/iso/home/store/
catalogue_tc/catalogue_detail.htm?csnumber=66398, accessed 11 January 2017).
62. Baars EC, Schrier E, Geertzen JH, Dijkstra PU. Biomedical and psychosocial factors influencing transtibial
prosthesis fit: a Delphi survey among health care professionals. Disabil Rehabil 2015;37:1946–1954.

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