[Implantable medical devices].
Medical devices have been individualized to include a category of implantable medical devices, "designed to be totally implanted in the human body or to replace an epithelial surface or a surface of the eye, through surgery, and remain in place after the intervention" (directive 93/42/CEE and decree of 20 April 206). Each implantable medical device has a common name and a commercial name for precise identification of the model (type/references). The users' service and the implanting physician should be clearly identified. There are a number of rules concerning health traceability to rapidly identify patients exposed to risks in which the implantable medical devices of a particular batch or series were used and to monitor the consequences. The traceability data should be preserved 10 years and the patient's medical file for 20 years.
Crickx
B
B
Université Denis-Diderot, Paris 7 et Service de Dermatologie, Groupe hospitalier Bichat-Claude-Bernard, AP-HP, 46 rue Henri Huchard, 75018 Paris, France. beatrice.crickx@bch.aphp.fr
Arrault
X
X
D005602:France; D019981:Health Care Sector / Q000331:legislation & jurisprudence; D006801:Humans; D007883:Legislation, Medical; D008499:Medical Records / Q000331:legislation & jurisprudence; D010820:Physicians / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing / Q000379:methods; D019736:Prostheses and Implants / Q000145:classification; D011996:Records / Q000331:legislation & jurisprudence; D009626:Terminology as Topic