title: Scientific evaluation and pricing of medical devices and associated procedures in France.
abstract: Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.
authors: Centre Hospitalier Universitaire La Cavale Blanche, Brest, France.
authors: Martine
authors: M
authors: Gilard
authors: Frederique
authors: F
authors: Debroucker
authors: Claude
authors: C
authors: Dubray
authors: Yves
authors: Y
authors: Allioux
authors: Eliane
authors: E
authors: Aper
authors: Valérie
authors: V
authors: Barat-Leonhardt
authors: Michèle
authors: M
authors: Brami
authors: Cédric
authors: C
authors: Carbonneil
authors: Emmanuel
authors: E
authors: Chartier-Kastler
authors: Claire
authors: C
authors: Coqueblin
authors: Sandrine
authors: S
authors: Fare
authors: Isabelle
authors: I
authors: Giri
authors: Jean-Marie
authors: JM
authors: Goehrs
authors: Karine
authors: K
authors: Levesque
authors: Philippe
authors: P
authors: Maugendre
authors: François
authors: F
authors: Parquin
authors: Jean-Patrick
authors: JP
authors: Sales
authors: Karine
authors: K
authors: Szwarcensztein
mesh_terms: D003362:Cost-Benefit Analysis; D004864:Equipment and Supplies / Q000191:economics / Q000592:standards; D005069:Evaluation Studies as Topic; D005602:France; D006801:Humans; D062069:Inventions / Q000191:economics / Q000592:standards; D062307:Medical Device Legislation / Q000191:economics; D019919:Prosthesis Implantation / Q000295:instrumentation / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D013514:Surgical Procedures, Operative / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards