Numéro |
Therapie
Volume 70, Numéro 1, Janvier-Février 2015
XXXes Rencontres nationales de Pharmacologie et Recherche clinique, pour l’Innovation et l’Évaluation des Technologies de Santé Tables rondes GIENS – 5 au 6 octobre 2014
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Page(s) | 63 - 68 | |
Section | Medical devices / Dispositifs médicaux | |
DOI | https://doi.org/10.2515/therapie/2015004 | |
Publié en ligne | 6 mars 2015 |
Assessment and Non-clinical Impact of Medical Devices
1 Faculté de Médecine,
CHRU, Lille, France
2 Johnson & Johnson Produits de
Santé, Issy-les-Moulineaux, France
3 SNITEM, Courbevoie,
France
4 CEDIT, Paris, France
5 Direction Générale de l’Organisation
des Soins, Ministère des Affaires Sociales, de la Santé et des Droits des
Femmes, Paris,
France
6 EOS Imaging,
Paris,
France
7 Medtronic France,
Boulogne-Billancourt,
France
8 CHU, Besançon,
France
9 Baxter France,
Maurepas,
France
10 Institut Phisquare,
Paris,
France
11 Sanofi France,
Paris,
France
12 Helsia,
Paris,
France
13 Hôpital Universitaire Raymond
Poincaré, Garches,
France
14 3M France,
Paris,
France
15 Haute Autorité de
Santé, Saint-Denis,
France
16 Hôpitaux Universitaires Saint-Louis
Lariboisière, Paris,
France
Correspondence and offprints:
Karine Szwarcensztein, Johnson & Johnson Medical Companies France,
Ethicon SAS, 1 rue Camille Desmoulins - TSA 81 002, 92787 Issy-les-Moulineaux cedex 9,
France. E-mail: kszwarce@its.jnj.com
Received:
8
January
2015
Accepted:
13
January
2015
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.
Key words: medical devices / assessment / health technology assessment (HTA)
© 2015 Société Française de Pharmacologie et de Thérapeutique