02 d’abril 2014

Unsafe medical devices regulation

Improving Medical Device Regulation: The United States and Europe in Perspective

The regulatory differences between Europe and US are quite well known since the breast implants scandal. A US citizen was not able to receive such implant because FDA had not approved. The rationale is not related to such a case, it is the current system of notified bodies that really doesn't protect population health. However, US needs also to improve. Milbank Quarterly article says:
Overall, US and European evidence requirements for devices introduce not only risks to patients but also the wrong incentives to generate the needed evidence to better understand and evaluate the benefits and risks of new devices. Considering that manufacturers often take advantage of existing evidence from already marketed devices to gain approval for a new device, they are reluctant to undertake new clinical studies. In addition, because later devices may be able to claim equivalence, the first manufacturer to market does not have a very strong incentive to undertake extensive clinical studies.
The steps to improve regulation are detailed in the article. Surprisingly, notified bodies is again the chosen option in the current review of the legislation. Citizens should know it before voting.

PS. Milbank says it is an original investigation, you may check the same title and authors some months before in Value in Health