Health Technology Assessment of Medical Devices

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.

HTA is the systematic evaluation of properties, effects, and/or impacts of health technology. Its main purpose is to inform technology-related policy-making in health care, and thus improve the uptake of cost-effective new technologies and prevent the uptake of technologies that are of doubtful value for the health system. It is one of three complementary functions to ensure the appropriate introduction and use of health technology. The other two components are regulation, which is concerned with safety and efficacy, and assessment of all significant intended as well as unintended consequences of technology use; and management, which is concerned with the procurement and maintenance of the technology during its life-cycle. The performance of health systems is strengthened when the linkages and exchange among these elements are clearly differentiated but mutually supportive.

This document integrates health technology assessment into the WHO framework for evidence-informed policy-making. Health systems are strengthened when HTA is integrated into the human and material resources, data, transparent decision- and policy-making, and linked to the overall vision of equity and accountability. Good governance can rely on health technology assessment to provide a policy approach that is accountable for its decisions to the population.