title: [Biovigilance, a vigilance exercised on the utilization of products obtained from the human body].
abstract: Organ transplantations and tissue/cells grafts are efficacious in many diseases. Nevertheless, beside the risk due to the technology which permits to carry out transplantations and grafts (surgery, tissue and cells collection, preservation, storage, cell expansion technics, immunosuppressive regimen,...), the microbiology risk must be controlled throughout the process leading to the transplantation or the graft. The structures, the organizations, the procedures, the information network and the controls assure the control of the risk. It is the main objective of human product vigilance. Future regulations will define the objectives of this sanitary vigilance more precisely.
authors.affiliation: CHU de Nice, France. quaranta@chu-nice.fr
authors.forename: J F
authors.initials: JF
authors.lastname: Quaranta
authors.forename: A
authors.initials: A
authors.lastname: Myx-Staccini
mesh_terms: D000465:Algorithms; D017690:Cell Transplantation; D003140:Communicable Disease Control / Q000379:methods / Q000458:organization & administration*; D005568:Forms and Records Control; D005602:France; D006801:Humans; D007256:Information Systems; D011634:Public Health / Q000331:legislation & jurisprudence; D018570:Risk Assessment; D012449:Safety; D014015:Tissue Banks / Q000458:organization & administration / Q000592:standards; D014180:Transplantation / Q000331:legislation & jurisprudence / Q000592:standards*
vernacular_title: La biovigilance, une vigilance exercée sur l'utilisation des produits issus du corps humain.