The medical device surveillance commission of the French ministry of employment and social affairs. Evaluation and prospect

In France, a national surveillance commission for medical devices ("Commiss ion de Materiovigilance") functions to: a) analyse declarations of incident s/accidents occurring or liable to occur with medical devices; b) propose p reventive measures; c) propose surveys or studies concerning the practice o f materiovigilance. One of the eight sub-commissions is in charge of the pr oblems raised by devices used in anaesthesia and intensive therapy. The commission considered 406 alarm forms in 1996, 986 in 1997 and 1,200 we re expected to arrive in 1998. This strong increase is observed because use rs of medical devices have become aware that declaration of incidents/accid ents has become compulsory and because of the medico-legal risk. With the g eneralisation of local correspondents for materiovigilance and their filter ing office, the amount of significant declarations reaching the national co mmission is expected to decrease. Among the 624 fully processed "alarm forms", at the time of writing this ar ticle, 407 (65%) were incidents without or only with minor consequences, 20 6 (33%) were significant accidents and 11 (2%) were associated with a letha l outcome. Non compliance with the instructions for use and a failure of th e device were the main causes for incidents/accidents. Major corrective mea sures were mainly taken for misconceptions and quality insurance in product ion of the devices. (C) 1999 Elsevier, Paris.