WHO Development On Medical Devices

Health technologies are essential for a functioning health system. Medical devices

in particular are crucial in the prevention, diagnosis, and treatment of illness and

disease, as well as patient rehabilitation. Recognizing this important role of health

technologies, the World Health Assembly adopted resolution WHA60.29 in May 2007.

The resolution covers issues arising from the inappropriate deployment and use of health

technologies, and the need to establish priorities in the selection and management of

health technologies, specifically medical devices. By adopting this resolution, delegations

from Member States acknowledged the importance of health technologies for achieving

health-related and medical product development goals; urged expansion of expertise in the field of health technologies, in particular medical devices; and requested that the World Health

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

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

development of national essential health technology programmes that will have a

positive impact on the burden of disease and ensure effective use of resources;

• to challenge the business and scientific communities to identify and adapt innovative

technologies that can have a significant impact on public health.

To meet these objectives, WHO and partners have been working towards devising an

agenda, an action plan, tools and guidelines to increase access to appropriate medical

devices. This document is part of a series of reference documents being developed for

use at the country level. The series will include the following subject areas:

• policy framework for health technology

• medical device regulations

• health technology assessment

• health technology management

    › needs assessment of medical devices

    › medical device procurement

    › medical equipment donations

    › medical equipment inventory management

    › medical equipment maintenance

    › computerized maintenance management systems

• medical device data

    › medical device nomenclature

    › medical devices by health-care setting

    › medical devices by clinical procedures

• medical device innovation, research and development.

These documents are intended for use by biomedical engineers, health managers,

donors, nongovernmental organizations and academic institutions involved in health

technology at the district, national, regional or global levels.

Methodology

The post was originally written by international experts in their respective

fields, and reviewed by members of the Technical Advisory Group on Health Technology

(TAGHT). The TAGHT was established in 2009 to provide a forum for both experienced

professionals and country representatives to develop and implement the appropriate

tools and documents to meet the objectives of the GIHT. The group has met on three

occasions. The first meeting was held in Geneva in April 2009 to prioritize which tools

and topics most required updating or developing. A second meeting was held in Rio de

Janeiro in November 2009 to share progress on the health technology management tools

under development since April 2009, to review the current challenges and strategies

facing the pilot countries, and to hold an interactive session for the group to present

proposals for new tools, based on information gathered from the earlier presentations

and discussions. The last meeting was held in Cairo in June 2010 to finalize the

documents and to help countries develop action plans for their implementation. In

addition to these meetings, experts and advisers have collaborated through an online

community to provide feedback on the development of the documents. The concepts

were discussed further during the First WHO Global Forum on Medical Devices in

September 2010. Stakeholders from 106 countries made recommendations on how

to implement the information covered in this series of documents at the country level.1

All meeting participants and people involved in the development of these documents

were asked to complete a declaration of interest form, and no conflicts were identified.

Definitions

Recognizing that there are multiple interpretations for the terms listed below, they are

defined as follows for the purposes of this technical series.

Health technology: The application of organized knowledge and skills in the form of

devices, medicines, vaccines, procedures and systems developed to solve a health

problem and improve quality of life.2 It is used interchangeably with health-care technology.

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

prevention, diagnosis or treatment of illness or disease, or for detecting, measuring,

restoring, correcting or modifying the structure or function of the body for some health

purpose. Typically, the purpose of a medical device is not achieved by pharmacological,

immunological or metabolic means.3

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

training, and decommissioning − activities usually managed by clinical engineers.

Medical equipment is used for the specific purposes of diagnosis and treatment of

disease or rehabilitation following disease or injury; it can be used either alone or in

combination with any accessory, consumable, or other piece of medical equipment.

Medical equipment excludes implantable, disposable or single-use medical devices.