Évaluation de la procédure de mise à disposition des dispositifs médicaux stériles innovants à l'AP-HP : bilan de trois ans de fonctionnement

The aim of the study is to evaluate, after three years of activity, the procedure set up to assess innovative and expansive medical devices (MD) submitted to the Medical Devices Assessment Committee (CODIMS) ; in particular, to discern which step of the medical device assessment procedure is more preponderant (internal and external assessments or the synthesis presented in CODIMS). For each medical device, the following items are noted : quality of available clinical studies based on evidence-based-medecine standards, quality of the information transmitted by the company to assess the hospital medical advantage of the product, approval of the French medical devices assessment commission (CEPP) for reimbursment, quality of assessment reports from physicians considered as referents and final CODIMS decision. Nine of the 19 MD have been rejected by CODIMS. This is often correlated to poor quality of clinical studies, insufficient information transmitted by the company and the lack of CEPP approval. Results of final CODIMS opinion (MD accepted or rejected) are concordant with those of the specialists asked for advice for two thirds of the MD. Internal expertise must offer a clear-cut opinion in the event of a disagreement between CODIMS's members and the experts. In order to help the evaluation of MD in the hospital setting, future developments should be highly desirable : additional clinical investigational regulations asked for european MD approval and continuing education differents actors involved in the process.