[The Medical Device Surveillance Central Commission. Evaluation and perspectives].
In France, a national surveillance commission for medical devices ("Commission de Matériovigilance") functions to a) analyse declarations of incidents/accidents occurring or liable to occur with medical devices; b) propose preventive measures; c) propose surveys or studies concerning the practice of materiovigilance. One of the eight sub-commissions is in charge of the problems raised by devices used in anaesthesia and intensive therapy. The commission considered 406 alarm forms in 1996, 986 in 1997 and 1,200 were expected to arrive in 1998. This strong increase is observed because users of medical devices have become aware that declaration of incidents/accidents has become compulsory and because of the medico-legal risk. With the generalisation of local correspondents for materiovigilance and their filtering office, the amount of significant declarations reaching the national commission is expected to decrease. Among the 624 fully processed "alarm forms", at the time of writing this article, 407 (65%) were incidents without or only with minor consequences, 206 (33%) were significant accidents and 11 (2%) were associated with a lethal outcome. Non compliance with the instructions for use and a failure of the device were the main causes for incidents/accidents. Major corrective measures were mainly taken for misconceptions and quality insurance in production of the devices.
Cazalaà
J B
JB
Service d'anesthésie-réanimation, hôpital Necker-Enfants-Malades, Paris, France.
D000758:Anesthesia / Q000009:adverse effects* / Q000592:standards; D000776:Anesthesiology / Q000295:instrumentation / Q000592:standards*; D004868:Equipment Failure / Q000706:statistics & numerical data; D004864:Equipment and Supplies / Q000592:standards*; D005602:France; D006801:Humans; D011785:Quality Assurance, Health Care; D012308:Risk Management / Q000706:statistics & numerical data