Assessment and non-clinical impact of medical devices.
Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.
Faculté de Médecine, CHRU, Lille, France.
Benoît
B
Dervaux
Johnson & Johnson Produits de Santé, Issy-les-Moulineaux, France.
Karine
K
Szwarcensztein
SNITEM, Courbevoie, France.
Anne
A
Josseran
CEDIT, Paris, France.
Alexandre
A
Barna
Direction Générale de l'Organisation des Soins, Ministère des Affaires Sociales, de la Santé et des Droits des Femmes, Paris, France.
Cédric
C
Carbonneil
EOS Imaging, Paris, France.
Karine
K
Chevrie
Medtronic France, Boulogne-Billancourt, France.
Frédérique
F
Debroucker
CHU, Besançon, France.
Anne
A
Grumblat
Baxter France, Maurepas, France.
Olivier
O
Grumel
Institut Phisquare, Paris, France.
Jacques
J
Massol
Sanofi France, Paris, France.
Philippe
P
Maugendre
Helsia, Paris, France.
Hubert
H
Méchin
Hôpital Universitaire Raymond Poincaré, Garches, France.
David
D
Orlikowski
3M France, Paris, France.
Christophe
C
Roussel
Haute Autorité de Santé, Saint-Denis, France.
Catherine
C
Rumeau-Pichon
Haute Autorité de Santé, Saint-Denis, France.
Jean-Patrick
JP
Sales
Hôpitaux Universitaires Saint-Louis Lariboisière, Paris, France.
Eric
E
Vicaut
D015415:Biomarkers; D003362:Cost-Benefit Analysis; D019091:Critical Pathways; D003663:Decision Trees; D004864:Equipment and Supplies / Q000009:adverse effects / Q000191:economics / Q000592:standards*; D005602:France; D006801:Humans; D007349:Insurance, Health, Reimbursement; D062069:Inventions; D062307:Medical Device Legislation; D009313:National Health Programs; D013673:Technology Assessment, Biomedical / Q000458:organization & administration / Q000592:standards*
D015415:Biomarkers