Development of Medical Device Policies

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.

The number of countries with existing health technology policies and with units to implement those policies shows that there is forward movement in the development and implementation of health technology policies. However, because medical devices are complex to select, manage and use, it is important to ensure that new policies are developed appropriately and existing ones are modified as necessary to make them as effective as possible. Proper integration of health technology policies and strategies within the framework of a national health plan has the potential to harness the political support to ensure improved access, quality and use of medical devices, enhance the best use of the resources in a framework of universal coverage, respond to the needs of the population, and ultimately achieve better health outcomes.