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Issue2, No.3, 2018.  https://doi.org/10.33137/cpoj.v1i2.31371 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 
 
 

 
 

 

 

 

 

 

PROFESSIONAL OPINION ISSN: 2561-987X 

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Lemaire ED, Supan T, Ortiz M. Global Standards for Prosthetics and Orthotics. Canadian Prosthetics & Orthotics Journal. 
Volume1, Issue2, No.3, 2018.  https://doi.org/10.33137/cpoj.v1i2.31371 

1 

 
OPEN  ACCESS 

GLOBAL STANDARDS FOR PROSTHETICS 

 AND ORTHOTICS 

 

Volume 1, Issue 2, Article No.3, October 2018 

 

 PROFESSIONAL OPINION 

GLOBAL STANDARDS FOR PROSTHETICS AND ORTHOTICS 

 
Lemaire ED1,2*, Supan T3, Ortiz M4  

 
1Ottawa Hospital Research Institute, Centre for Rehabilitation Research and Development, Ottawa, Canada. 
2Faculty of Medicine, University of Ottawa, Ottawa, Canada. 
3Supan Prosthetic Orthotic Consultations, Rochester, Illinois, USA. 
4Ortiz International S.A. Guadalajara, Jalisco, México. 

 

The 60 new global “Standards for Prosthetics and 

Orthotics”1 were developed to: 

• Support countries work to “strengthen and 

extend rehabilitation, habilitation, assistive 

products, support services and community-

based rehabilitation”2, from the “WHO Global 

disability action plan”  

• Achieve the eight recommended areas of 

rehabilitation in health systems from 

“Rehabilitation 2030: Call for action”3  

• Achieve WHO GATE4 initiative goals, to improve 

access to high-quality, affordable assistive 

products globally 

• Realize universal health coverage 

• Support countries implementing CRPD, 

particularly Article 20 (Personal mobility) and 

Article 26 (habilitation and rehabilitation) 

Universal health coverage is often confused with 

fully socialized healthcare. For the standards, the 

WHO definition applies: “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.” This does 

not impose a health service funding or 

organizational model to achieve these goals. 

These standards are for prosthetics and orthotics 

services, using a people centred care perspective. 

Therefore, the scope is beyond the prosthetist and 

orthotist, including devices that may be provided by 

other health care professionals with the right skills 

(i.e., physicians, nurses, physiotherapists, 

occupational therapists, pedorthotists, pedorthists, 

podiatrists). Internal prostheses are not covered 

(e.g., joint implants, dental prostheses). People-

centred care includes psychosocial aspects that 

strengthens personal identity, enhances well-being, 

and recognizes the importance of social 

interactions.  

The Standards are divided into four sections: policy, 

products (prostheses, orthoses), personnel, 

provision of services. Challenges are addressed in 

the standards and implementation manual: 

*CORRESPONDING AUTHOR 

Edward D Lemaire, Ottawa Hospital Research Institute, Centre for Rehabilitation Research and Development, 

505 Smyth Road, Ottawa, ON, Canada, K1H 8M2. 

613-737-7350 x75592  

Email: elemaire@ohri.ca 

DOI: https://doi.org/10.33137/cpoj.v1i2.31371 

CITATION 

Lemaire ED, Supan T, Ortiz M. 

Global Standards for Prosthetics 

and Orthotics. Canadian 

Prosthetics & Orthotics Journal. 

Volume1, Issue2, No.3, 2018. 

https://doi.org/10.33137/cpoj.v1i

2.31371 

KEYWORDS 

Prosthetics, Orthotics, 

Disabilities, World Health 

Organization. 

Over the past decade, essential documents and agreements have emerged to 

help improve the lives of people with physical disabilities. These include 

Convention on the Rights of Persons with Disabilities (CRPD), ratified by more 

than 170 countries, and the World Health Organization (WHO) global disability 

action plan. While the principles in these broad agreements can be applied to 

people who would benefit from assistive technology, specific service standards 

are required to operationalize the CRPD and WHO objectives. Therefore, WHO, 

in partnership with the International Society for Prosthetics and Orthotics (ISPO) 

and the United States Agency for International Development (USAID), prepared 

global standards and an implementation manual to assist Member States in 

setting up, improving, or transforming their systems for delivering appropriate 

prosthetic and orthotic services. 

 

 

 

 

 

 

 

https://doi.org/10.33137/cpoj.v1i2.31371
mailto:elemaire@ohri.ca
https://doi.org/10.33137/cpoj.v1i2.31371
https://doi.org/10.33137/cpoj.v1i2.31371
https://doi.org/10.33137/cpoj.v1i2.31371


 
 

 Lemaire ED, Supan T, Ortiz M. Global Standards for Prosthetics and Orthotics. Canadian Prosthetics & Orthotics Journal. 
Volume1, Issue2, No.3, 2018.  https://doi.org/10.33137/cpoj.v1i2.31371 

2 

 
OPEN  ACCESS 

GLOBAL STANDARDS FOR PROSTHETICS 

 AND ORTHOTICS 

 

Volume 1, Issue 2, Article No.3, October 2018 

 

 Policy 

• Absence of policies and national plans for 

prosthetics and orthotics, rehabilitation, and 

assistive technology in most countries 

• Lack of awareness and understanding about the 

role, purpose, and benefits of prosthetics and 

orthotics services 

• Limited funding, with services frequently not 

included in national health and social insurance 

systems 

• Limited data on needs for these services, making 

it difficult to understand the practical and 

financial requirements of providing such services 

for all 

Products 

• Limited availability of appropriate products in 

many countries 

• High price of high-quality prostheses and 

orthoses 

o Even low-cost alternatives may be perceived 

as expensive, particularly in low- and middle-

income countries 

• Lack of national product standards in many 

countries, often resulting in devices that do not 

meet acceptable safety standards 

• Limited evidence of the effectiveness and cost–

effectiveness of products, technologies, and 

working methods 

Personnel 

• Lack of qualified personnel, reducing the quality 

and quantity of services 

• Available personnel are usually found in large 

cities 

• Limited access to schools and training 

opportunities for prosthetics and orthotics 

Provision of Services 

• Unequal service provision, with services are 

frequently available only in capital and other 

large cities and not to poor, isolated populations 

in rural areas 

• Services for the poor are usually provided by 

charities and some Government institutions, 

which may offer poor quality products, while rich 

populations are frequently served by private 

clinics 

• Prosthetics and orthotics services are frequently 

perceived as an expense rather than an 

investment 

 

 

POLICY (15 STANDARDS) 

Governments are encouraged to take a lead role in 

bringing stakeholders together and developing a 

national approach for prosthetics and orthotics 

services, moving beyond policy to include planning, 

implementation, and monitoring. An interesting 

standard (S3) recommends a national prosthetics 

and orthotics committee or similar entity, which 

would benefit both high and low-income countries, 

leading to a national guiding framework (S4). 

Regulation is also recommended (S5), which is 

typically not the situation for prosthetics and 

orthotics (i.e., typically certification, which does not 

have the same legal status, or no legal status). The 

need to monitor and have international sharing of 

experience, data, and research is recognized as 

essential for advancing services globally. Standards 

S13-S14 specifically address the need for data to 

enable decision-making. 

Cost and funding of prosthetics and orthotics are 

addressed in standards S9 to S12. The need to 

have prosthetics and orthotics services considered 

“like other health interventions” is critical to achieve 

appropriate funding, and to enable cost-related 

factors that enable broad access. For example, why 

is prosthetic and orthotic funding considered 

differently from hip and knee replacement funding? 

PRODUCTS (9 STANDARDS) 

This important section addresses prosthetic and 

orthotic products, which is the most visible aspect of 

prosthetic and orthotic care. Standards S16-S18 

include the availability and range of devices 

available in the local region and standards S19-S20 

relate to components and materials. The ongoing 

discussion about the value of reusing components 

leads to the recommendation for regulation by a 

designated authority or “expert group” with no 

conflicts of interest, which would include issues 

such as black markets and resale as new, and 

quality control with documentation. The quality 

control and documentation aspects for reuse is 

often neglected or is handled on the organizational 

or business level instead applying broader 

requirements for audited documentation. 

Technical standards (S21-S22) are important for 

national and international (International 

Organization for Standardization (ISO), etc.) bodies 

to ensure sufficient products quality and safety for 

consumers. National regulation of prosthetic and 

orthotic products, components, and materials is a 

step beyond most country’s approach, where 

https://doi.org/10.33137/cpoj.v1i2.31371


 
 

 Lemaire ED, Supan T, Ortiz M. Global Standards for Prosthetics and Orthotics. Canadian Prosthetics & Orthotics Journal. 
Volume1, Issue2, No.3, 2018.  https://doi.org/10.33137/cpoj.v1i2.31371 

3 

 
OPEN  ACCESS 

GLOBAL STANDARDS FOR PROSTHETICS 

 AND ORTHOTICS 

 

Volume 1, Issue 2, Article No.3, October 2018 

 

 minimal requirements are in place for this medical 

device category and nothing is in place for the 

complete device.  

Research related standards (S23-S24) include the 

need to develop affordable prosthetic and orthotic 

products that are cost–effective, of good quality, 

and context appropriate; which is different from 

trying to make the least expensive device, with 

subsequent lower quality. These research 

standards are related to the policy standards for 

data and sharing knowledge. 

PERSONNEL (12 STANDARDS) 

The personnel standards recognized the 

importance of having appropriate trained and 

competent professionals, within a multidisciplinary 

team for complex cases, provide prosthetic and 

orthotic care. Training should not only be aligned 

nationally but also with international education 

standards. Continuing professional development is 

considered compulsory. To meet this need, widely 

accessible learning opportunities will need to be 

developed, and continually updated, to match the 

pace of assistive technology advancement.  

Workforce planning (S31-S33) should not only deal 

with recruiting and retaining appropriate service 

providers but should recognize “all the disciplines 

required in prosthetics and orthotics services at all 

levels”. This approach moves beyond the simple 

training of prosthetists and orthotists to involving 

national stakeholders to ensure a workforce that 

has local context and can be made available (i.e., 

flexible workforce that adapts to changing 

conditions). This flexibility remains a challenge in 

most regions. 

The standards for professional regulation and 

recognition deal with accountability and career 

structure. As the world moves to address global 

assistive technology issues (fitting 1 billion people in 

need), maintaining quality services will require 

health care professionals, associates, and technical 

personnel with clearly define roles and 

responsibilities. The alignment of prosthetists and 

orthotists within the scope of health professionals 

remains problematics and requires global effort to 

achieve appropriate positioning. This is critical for 

the evolving “associate” level practitioner where 

responsibilities could be expected to vary 

depending on the country and circumstance (i.e., 

larger scope in developing or crisis area). 

PROVISION OF SERVICES (24 
STANDARDS) 

To achieve user-centred service delivery, the 

standards endeavour to promote services where 

“every user with a physical impairment or functional 

limitation can make informed decisions about her or 

his care, services, and service providers”; and 

“services are planned from the perspective of the 

individual user and respond to her or his needs and 

preferences, respecting their dignity, choices and 

rights.” The standards recommend documented 

policy to safeguard the rights of users, involving 

service users and their representatives at all levels, 

and providing choice for service providers and 

technology. 

To achieve this vision, service delivery models 

should facilitate accessibility (S40), be part of the 

health system (S41,S45,S46), be delivered as a 3-

tier system (S42), and consider maintenance and 

repair as part of the service (S43). Standards 47 

and 48 address the service environment, 

recommending service provision in a user-friendly, 

barrier-free, safe, clinical environment that is 

properly equipped. 

Service delivery is divided into four steps 

(assessment, fabrication and fitting, user training 

and product delivery, follow-up) that are covered in 

nine standards. Evidence based practice and care 

documentation are essential. User centre care 

principles are included throughout these four steps. 

Quality management approaches should be used, 

with  annual  and  long-term  planning  supported  

by continuous  monitoring  of  performance  

indicators. 

Consideration prostheses and orthoses in disaster 

conditions (S44) is an interesting standard since the 

attention to services may not be included in many 

country’s disaster plans, especially since prosthetic 

and orthotic care is a long-term (lifetime) service 

requirement and thereby requires different planning 

considerations than acute care needs. 

IMPLEMENTATION 

The accompanying Implementation Manual 

provides detailed ideas and examples of how each 

standard can be operationalized. Of these, the 

following items are of particular interest: 

Stakeholders: A broad approach should be 

considered when engaging people and groups. A 

list of stakeholders and their roles are provided, and 

https://doi.org/10.33137/cpoj.v1i2.31371


 
 

 Lemaire ED, Supan T, Ortiz M. Global Standards for Prosthetics and Orthotics. Canadian Prosthetics & Orthotics Journal. 
Volume1, Issue2, No.3, 2018.  https://doi.org/10.33137/cpoj.v1i2.31371 

4 

 
OPEN  ACCESS 

GLOBAL STANDARDS FOR PROSTHETICS 

 AND ORTHOTICS 

 

Volume 1, Issue 2, Article No.3, October 2018 

 

 can be used to engage with these people or groups 

(i.e., ask why a group is not engaged when they are 

identified in the standards) 

National approach: In most countries, at least one 

of the standards or implementation ideas is likely 

lacking; for example, having a government 

supported prosthetic and orthotic committee with a 

5–10-year plan that is specific, measurable, 

achievable, realistic, and timely 

A national audit of how each country currently 

adheres to the standard, with global reporting to 

allow for inter-country benchmarking, is an 

important step to understand deficiencies and 

successes. This information will empower country 

and global regions to advocate and achieve positive 

change for prosthetic and orthotic services 

Data and Evidence: Implementing positive change 

requires solid evidence. With the many players 

involved with provision (public, private, hospital, 

military, etc.) and funding, new strategies are 

required to obtain quantitative evidence on costs 

and economic impact; best practices; products; 

human resources; unmet needs 

Research: The need for continued research is 

apparent, but the standards reiterate the need for 

global collaboration (project formulation, multi-

country studies, etc.) and sharing to make the best 

use of this research, thereby expanding the 

evidence base on prosthetics and orthotics 

services. These global factors include identifying 

and standardizing research questions, using 

standardized tools, increasing research-related 

investment, and broadening the range of experts 

involved with prosthetic and orthotic related 

research (e.g., health economists, human rights 

experts, policy analysts, etc.). 
 

These WHO global standards for prosthetic and 

orthotic services are important for enhancing 

understanding of the expectation for appropriate 

care, regardless of the person’s location or 

economic status. As with any standards, success is 

directly related to how they are applied. With local, 

national, and international efforts, positive change 

can be realized to deal with the current state of only 

1 in 10 people in need having access to assistive 

products, thereby “helping people to become more 

active and to live healthy, productive, independent, 

dignified lives and to participate in education, the 

labour market and social life”. 

 

REFERENCES 

1. WHO standards for prosthetics and orthotics. Geneva: 

World Health Organization; 2017 

(http://www.who.int/rehabilitation/prosthetics-and-orthotics-

standards/en/, accessed 31 October 2018). 
 

2. WHO global disability action plan 2014–2021. Better 

health for all people with disability. Geneva: World Health 

Organization; 2015 

(http://www.who.int/disabilities/actionplan/en/, accessed 31 

October 2018). 
 

3. Rehabilitation 2030. A call for action. Geneva: World 

Health Organization; 2017 

(http://www.who.int/disabilities/care/rehab-2030/en/, 

accessed 31 October 2018). 
 

4. Global cooperation on assistive technology (GATE). 

Geneva: World Health Organization; 2016 

(http://www.who.int/phi/implementation/assistive_technolo

gy/phi_gate/en/, accessed 31 October 2018). 

 

AUTHORS BIOGRAPHY  

Professor Edward Lemaire, President-elect of ISPO 

Edward Lemaire, PhD, is actively involved with research on 

technologies that improve mobility for people with physical 

disabilities. He is a Senior 

Investigator at The Ottawa 

Hospital Research Institute’s 

Centre for Rehabilitation 

Research and Development; 

Professor at the University of 

Ottawa Faculty of Medicine; and 

Adjunct Professor in Human 

Kinetics, Mechanical Engineering, 

and Systems Design Engineering. 

He is also active with the 

International Society of 

Prosthetics and Orthotics, as a board member, international 

congress chairman, and incoming president. Dr. Lemaire’s 

research has resulted in over 450 published papers and 

presentations that include intelligent prosthetics and orthotics, 

biomechanical walking analysis in 3D virtual environments, 

smartphone approaches to improve decision-making, and 

eHealth technology to enhance access to education and 

rehabilitation services. 

 

Terry J Supan, CPO, LPO, FISPO, FAAOP 
Terry J. Supan, is President and CEO of Supan Prosthetic 

Orthotic Consultations. He is a Clinical Professor (Retired) at 

Southern Illinois University School 

of Medicine and a former Chair of 

the Illinois Orthotic, Prosthetic and 

Pedorthic Licensure Board. He is a 

licensed and board certified 

orthotist and prosthetist that 

specialized in upper limb 

amputations, cerebral palsy, 

scoliosis, polio, stroke, and other 

rehabilitation for persons with 

physical disabilities. He is an 

internationally known speaker in those areas as well as lower 

https://doi.org/10.33137/cpoj.v1i2.31371


 
 

 Lemaire ED, Supan T, Ortiz M. Global Standards for Prosthetics and Orthotics. Canadian Prosthetics & Orthotics Journal. 
Volume1, Issue2, No.3, 2018.  https://doi.org/10.33137/cpoj.v1i2.31371 

5 

 
OPEN  ACCESS 

GLOBAL STANDARDS FOR PROSTHETICS 

 AND ORTHOTICS 

 

Volume 1, Issue 2, Article No.3, October 2018 

 

 limb prosthetics; biomechanics/gait analysis; prosthetic/orthotic 

education; state O&P practice acts; and governmental 

regulations. Mr. Supan served as the President of the American 

Academy of Orthotists and Prosthetists’ (AAOP) in 1990 -1991. 

On March 22nd, 2012 the Academy bestowed the Titus-

Ferguson Lifetime Achievement Award on Mr. Supan. He is a 

Fellow of both the AAOP and the ISPO. In June of 2015 he was 

appointed to the International Society for Prosthetics and 

Orthotics Executive Board and serves as the Treasurer of ISPO. 

He was re-elected as ISPO Treasurer in 2017 and will serve in 

that capacity until 2019. 

 
Marlo Ortiz 

Marlo Ortiz graduated as an 

Engineer in 1977 from University of 

Guadalajara, Mexico and later 

undertook courses in Prosthetics 

and Orthotics until 1979, when he 

began to practice as a certified 

clinical prosthetist (Barra Mexicana 

de Certificacion en Ortesis y 

Protesis A.C.). He was recipient of 

the “Clinical Creativity” Prize 

presented at the 2005 AAOP 

meeting in Orlando and “Blatchford 

Prize” for Best “Prosthetic Technology” at the ISPO 2007 World 

Congress in Vancouver. Marlo Ortiz is an international speaker 

with O&P presentations at meetings in many countries for over 

20 years. He is also National Coordinator of Uniting Frontiers 

Regional Board, International Representative of ISPO Mexico 

National Member Society, and member of the Executive Board of 

ISPO International. 

 

 

 

 

https://doi.org/10.33137/cpoj.v1i2.31371

