[Medical devices vigilance].
Within the French Agency for Health Products (AFFSSAPS), there is a section for evaluating medical devices, separate from drug and biological product monitoring. Medical devices vigilance monitors incidents or incident hazards that may result from use of medical devices after they have been put on the market. Anyone, manufacturer, user, or third party who observes or knows of voluntary accident(s) or risk(s) or incidents caused by a medical device, should immediately report to the agency. The dermatologist, for example, is concerned as much by small instrumentation such as lasers and sterilizers, but also implantable medical devices. Each type of report indicates the capacity of the informant, the name of the medical device, as well as its batch and series number, and specifies the incident (date, consequences, and measures taken).
Crickx
B
B
Université Denis-Diderot Paris 7 et Service de Dermatologie, Groupe hospitalier Bichat-Claude-Bernard, AP-HP, 46 rue Henri-Huchard, 75018 Paris. beatrice.crickx@bch.aphp.fr
D001672:Biocompatible Materials; D003880:Dermatology; D004864:Equipment and Supplies; D005602:France; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D019736:Prostheses and Implants
D001672:Biocompatible Materials