Medical devices for health care

The World Health Organization (WHO) recognizes the importance of medical devices for health care and the improvement of the health of individuals and populations. One of the strategic objectives of WHO is to ensure improved access, quality and use of medical products and health technologies. Without medical devices, many common medical procedures, from bandaging the ankle of a sprained patient to diagnosing HIV/AIDS or implanting a hip prosthesis, would be impossible. At the same time, modern technology is producing an overwhelming abundance of medical devices at such a rate that the newest device quickly becomes obsolete.

Key issues such as the extreme diversity of the medical device sector, in terms of device types, degree of complexity, applications, uses, users and categories, and issues such as the dependence on the context of medical devices and the fact that research on medical devices is often not based on public health needs affect progress in this area.

However, as a crucial element of health care, the effectiveness of medical devices will be maximised if all elements of health care necessary to respond to public health needs are considered: prevention, clinical care (research, diagnosis, treatment and management, follow-up and rehabilitation) and access to adequate health care. Consequently, there is no need to focus on the technological aspects of medical devices, but another goal must be pursued: to improve worldwide access to suitable medical devices. This goal has four key components: availability, accessibility, appropriateness and affordability (known as "the 4 A" as they all start with the letter A). These four components help broaden the scope of the medical device program so that it not only focuses on the preliminary aspect of the innovation effort, but also on choosing which medical devices to purchase rationally, in response to needs, and on ensuring that they are used as effectively as possible to improve health.

Ultimately, this discordance refers to medical devices that are marketed and available on the market and in the public health sector (i.e. that are accessible, affordable and suitable). There is currently no effective counterweight to the many medical devices on the market and many factors contribute to this inappropriate situation.

While industry may be able to provide the medical devices needed worldwide to promote health, prevent, diagnose, treat and manage conditions and diseases, and alleviate the functional problems of people with disabilities, the sector is often saturated with unnecessarily or irrationally acquired medical devices that are not used safely and effectively for their intended purpose or are not even used, and whose specific health outcomes have in too many cases not been adequately evaluated.