[Materials surveillance, a surveillance performed on the use of medical devices].
One of the missions of the Agence Française due Sang was to set up a haemovigilance system based on a national network of surveillance and alert, for the whole 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'hémovigilance? Transfus Clin Biol 1998; 5: 415-21.). The French law No. 98-535 dated July 1st 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.
Canivet
N
N
Service biomédical, pharmacie centrale, CHU, Nice, France.
Hollander
K
K
Mousnier
J P
JP
Quaranta
J F
JF
D001793:Blood Preservation / Q000295:instrumentation* / Q000592:standards; D001803:Blood Transfusion / Q000295:instrumentation* / Q000592:standards; D004866:Equipment Contamination; D004868:Equipment Failure; D004869:Equipment Safety; D005568:Forms and Records Control; D005602:France; D006801:Humans; D008499:Medical Records; D011159:Population Surveillance; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D012308:Risk Management / Q000458:organization & administration / Q000592:standards