Rev Epidemiol Sante
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Rev Epidemiol Sante · Apr 2013
[Introduction of innovative high-risk medical devices in Europe: are clinical efficacy and safety guaranteed?].
Innovative high-risk medical devices, such as new types of heart valves or hip prostheses, become available on the European market more rapidly than in USA. This is due to the European legislation allowing early marketing of innovative high-risk medical devices before high-quality clinical evidence is obtained from randomized controlled trials. ⋯ For innovative high-risk devices, and while awaiting a reworked Medical Device Directive, patient risk should be minimized by limiting the market introduction of novel high-risk devices with minimal clinical data to physicians with the necessary training and expertise. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.
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Rev Epidemiol Sante · Apr 2013
Review[Experience feedback committee: a method for patient safety improvement].
An experience feedback committee (CREX, Comité de Retour d'EXpérience) is a method which contributes to the management of safety of care in a medical unit. Originally used for security systems of civil aviation, the method has been adapted to health care facilities and successfully implemented in radiotherapy units and in other specialties. ⋯ Safety of care has become a priority of health systems. In this context, the CREX can be a useful vehicle for the implementation of a safety culture in medical units.