Priority medical devices
In 2007 the World Health Organization (WHO), in collaboration with the Government of the Netherlands, launched the Priority Medical Devices (PMD) project to determine whether medical devices currently on the market were meeting the needs of health care providers and end-users throughout the world and if not, to propose research to identify—and action to remedy—inadequacies or shortcomings. The aim of the project was to bring medical devices to the attention of policy makers and to help guide both industry and government on public health spending.
The main objective of the Priority Medical Devices project was to identify gaps in the availability of preventive, diagnostic, therapeutic and assistive medical devices on the market. Mapping of gaps in the supply of medical devices constitutes a priority for governments and key stakeholders because of the need to treat disease or disability. In addition, the project assessed potential barriers to innovation as well as generated a research agenda and action plan.
The methodology used, took into account of the following key items:
- present burden of disease and disability and the associated clinical guidelines;
- potential future burden of disease and of disability, given the changing demography in many countries;
- cross cutting issues like training design, context, regulatory framework; and
- drivers and barriers to innovation and research.
managing the mismatch
- Dispositifs Médicaux : Comment Résoudre l'Inadequation?
- Устройства Медицинского Назначения: Устранение Несоответствий
- Dispositivos Médicos: La Gestión de la Discordancia
The final report of the project, Medical devices: managing the mismatch was launched on 9 September 2010 at the First WHO Global Forum on Medical Devices.
- A generic methodology to identify "gaps" in the availability of preventive, diagnostic, therapeutic and assistive medical devices. These gaps include medical devices that are or may be:
- currently not available;
- if available, not necessarily used worldwide;
- if used, not to the extent that is desirable; or
- that may be inappropriate for the context in which they are used.
- Identification of the main barriers to innovation and diffusion of medical devices and where possible, suggestion of solutions to either reduce or overcome these.
- A proposed research agenda
- The promotion of medical devices as important tools for improving health care.
This first phase of the PMD project points to the next steps in a continuous process of developing tools for assessing the availability, accessibility and appropriateness of medical devices.
- Methodology briefing paper
- Background paper 1. A stepwise approach to identify gaps in medical devices (availability matrix and survey methodology)
- Background paper 2: Building bridges between diseases, disabilities and assistive devices: linking the GBD, ICF and ISO 9999
- Background paper 3: Clinical evidence for medical devices: regulatory processes focussing on Europe and the United States of America
- Background paper 4: Increasing complexity of medical devices and its consequences for training and outcome of care
- Background paper 5: Context dependency of medical devices
- Background paper 6:Barriers to innovation in the field of medical devices
- Background paper 7: Trends in medical technology and expected impact on public health
- Background paper 8: Future public health needs: communalities and differences between high- and low-resource settings