Assessment and Non-clinical Impact of Medical Devices - 08/07/16
participants of round table N°4 of Giens XXX:
Alexandre Barna 4, Cédric Carbonneil 5, Karine Chevrie 6, Frédérique Debroucker 7, Anne Grumblat 8, Olivier Grumel 9, Jacques Massol 10, Philippe Maugendre 11, Hubert Méchin 12, David Orlikowski 13, Christophe Roussel 14, Catherine Rumeau-Pichon 15, Jean-Patrick Sales 15, Eric Vicaut 16, †pages | 6 |
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Abstract |
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.
Le texte complet de cet article est disponible en PDF.Keywords : medical devices, assessment, health technology assessment (HTA)
Abbreviations : ASR, AP-HP, CNSA, CEDIT, CEESP, CNEDiMTS, COMEDIMS, EUnetHTA, HAS, HTA, MAST, MD, PRO, SR
Plan
Vol 70 - N° 1
P. 63-68 - janvier 2015 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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