Health products policy and standards

Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.

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Strengthening prosthetics and orthotics services

WHO /NOOR / Sebastian Liste

Background

For children, adults, and older people who need them, prostheses (artificial legs and hands) and orthoses (braces and splints) are essential for daily life, such as going to school or work, looking after family, or taking part in community life.

In many countries, only those who can afford high out-of-pocket payments have access to the devices they need. People who use prostheses and orthoses need regular access to prosthetics and orthotics services, staffed by a qualified team and with a well-equipped workshop. These services need to be connected to related health services such as rehabilitation or diabetic foot services. However, there are huge challenges globally in developing and maintaining comprehensive, affordable prosthetics and orthotics services. Key challenges include a lack of policy or strategic planning, a lack of integration into the health system and within universal healthcare schemes, and a lack of a qualified workforce.

WHO Standards for prosthetics and orthotics

In 2017, the World Health Organization (WHO) published the WHO standards for prosthetics and orthotics, comprising Standards (Part 1) and an Implementation manual (Part 2). Developed in collaboration with the International Society for Prosthetics and Orthotics (ISPO), the publication presents standards for countries to use in developing or strengthening high-quality, affordable prosthetics and orthotics services. Implementation of these standards will support governments in fulfilling their obligation to implement the Convention on the Rights of Persons with Disabilities and in meeting the Sustainable Development Goals, in particular Goal 3.

The publication presents 60 standards across four areas: 1) Policy (including leadership, governance, and financing); 2) Products (prostheses and orthoses); 3) Personnel (workforce and training); and 4) Provision of services. The Implementation manual (Part 2) provides information on important considerations and steps that can be taken to implement the standards. For more information and to download the Standards, go to the WHO standards for prosthetics and orthotics webpage.

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

Download

Standards assessment package

The Assessment package has been developed for countries to evaluate the implementation of the WHO Standards for prosthetics and orthotics. It enables identification of areas in need of strengthening and facilitates relevant planning. The complete Assessment package consists of four components:

Assessment guide: gives directions on how to organize and implement the assessment.

Assessment tool: Excel instrument used to carry out assessments and record results.

User manual: explains how the Assessment tool should be used.

Planning document: Excel file into which the recommendations that are generated by the Assessment tool can be pasted for easy use in subsequent planning.

Before undertaking the assessment, stakeholders at the country level should familiarize themselves with the package components and the WHO standards for prosthetics and orthotics (Parts 1 and 2). A PowerPoint presentation describing the assessment process and a video presenting the main assessment steps and key functions of the tool are also available to download from the links below. It is recommended that assessments are undertaken in collaboration with the ministry of health and other ministries responsible for assistive technology, prosthetics and orthotics, and/or rehabilitation.

Background

WHO Standards for prosthetics and orthotics

WHO standards for prosthetics and orthotics

WHO standards for prosthetics and orthotics assessment package: assessment guide

WHO standards for prosthetics and orthotics assessment package: user manual

Standards assessment package