But doctor, it's my hip!: the fate of failed medical devices.
It is difficult to study failed medical devices because of a lack of data. Routine device retrieval and analysis (DRA) is essential to performance evaluation, which, in turn, is essential to good patient care. We argue for the development of a national DRA program and medical device database and discuss the major ethical and policy issues associated with this proposal.
Fielder
J H
JH
Villanova University, PA, USA.
Black
J
J
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D016208:Databases, Factual; D030881:Disclosure; D004868:Equipment Failure; D004869:Equipment Safety; D004992:Ethics, Medical; D035082:Federal Government; D033161:Government Regulation; D006801:Humans; D011358:Product Surveillance, Postmarketing; D016730:Program Development; D019736:Prostheses and Implants / Q000009:adverse effects / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration; D035141:Voluntary Programs