Viral Safety
This article was originally published in RAJ Devices
Executive Summary
Medical devices containing products of animal origin
Medical devices containing products of animal origin
The French health products safety agency, AFSSaPS (Agence Française de Sécurité Sanitaire des Produits de Santé ), has updated two lists of medical devices for which products of animal origin are used during their manufacturing1. The first concerns bovine, ovine or caprine origin products and the second concerns products of animal origin other than bovine, ovine or caprine. The devices, including aortic or mitral valve replacements and bone substitutes, have received favourable opinions on viral safety and are permitted to be placed on the French market.
The lists are regularly updated based on evaluations conducted by the AFSSaPS group of experts on viral safety. In November 2002 AFSSaPS established a new group of experts to provide opinions on the safety of biological healthcare products including medical devices or those using such biological products during their manufacture, with respect to the transmission of viruses and transmissible agents2.
References
1. Liste des dispositifs médicaux, 9 April 2003, http://agmed.sante.gouv.fr
2.The Regulatory Affairs Journal (Devices), 2003, 11 (2), 97