Material vigilance: vigilance in the use of medical devices

One of the Missions of the Agence Francaise du Sang was to set up a haemovigilance system based on a national network of surveillance and alert, for the whale blood chain from blood collection to receivers' follow-up. This system is now operational and contributes with efficacy to the safety of blood transfusions (see : A quoi sert l'hemovigilance ? Transfus Clin Biol 1998;5: 425-21.). The French law No. 98-535 dated July Ist 1998, whose enforcement orders were published in March 1999, is the legal foundation of the system. In this article the national and regional structures of the national system of sanitary safety are described, and the main guidelines of material vigilance, the last element of this system, is presented. (C) 2000 Editions scientifiques ef medicales Elsevier SAS.