Organisational impact: Definition and assessment methods for medical devices
| Autor: | Karine Szwarcensztein, Christophe Roussel, Antoine Audry, André Tanti, Hubert Méchin, Nicolas Martelli, Sandrine Fare, Stéphane Burtey, Emmanuel Luigi, Frédéric Rupprecht, François Langevin, Stéphane Laroche, Cédric Carbonneil, Grégoire Mercier, Sébastien Woynar, Catherine Zaidman |
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| Přispěvatelé: | Institut des Sciences Moléculaires de Marseille (ISM2), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)-École Centrale de Marseille (ECM)-Institut de Chimie du CNRS (INC), Chirurgie urologique et transplantation rénale [Hôpital de la Conception - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Vascular research center of Marseille (VRCM), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), École des Hautes Études en Santé Publique [EHESP] (EHESP), Institut du Management (IDM), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Groupe de Recherche et d'Accueil en Droit et Economie de la Santé (GRADES), Université Paris-Saclay, Aix Marseille Université (AMU)-École Centrale de Marseille (ECM)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS) |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Value (ethics)
Technology Assessment Biomedical Organisational innovation Biomedical Computer science Process (engineering) Cost-Benefit Analysis [SDV]Life Sciences [q-bio] Guidelines as Topic Efficiency Technology assessment 030226 pharmacology & pharmacy Organizational 03 medical and health sciences 0302 clinical medicine MESH: Technology Assessment Biomedical Humans Pharmacology (medical) MESH: Humans Cost–benefit analysis 030503 health policy & services MESH: Guidelines as Topic Health technology MESH: Equipment and Supplies Benchmarking Risk analysis (engineering) Work (electrical) Equipment and supplies [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie 0305 other medical science Medical literature MESH: Cost-Benefit Analysis |
| Zdroj: | Thérapie Thérapie, EDP Sciences, 2016, 71, pp.69-96. ⟨10.1016/j.therap.2016.01.003⟩ Thérapie, EDP Sciences, 2016, 71 (1), pp.83-96. ⟨10.1016/j.therap.2016.01.003⟩ Thérapie, 2016, 71, pp.69-96. ⟨10.1016/j.therap.2016.01.003⟩ |
| ISSN: | 0040-5957 1958-5578 |
| DOI: | 10.1016/j.therap.2016.01.003⟩ |
| Popis: | International audience; Health technology assessment (HTA) is a rapidly developing area and the value of taking non-clinical fields into consideration is growing. Although the health-economic aspect is commonly recognised, evaluating organisational impact has not been studied nearly as much. The goal of this work was to provide a definition of organisational impact in the sector of medical devices by defining its contours and exploring the evaluation methods specific to this field. Following an analysis of the literature concerning the impact of technologies on organisations as well as the medical literature, and also after reviewing the regulatory texts in this respect, the group of experts identified 12 types of organisational impact. A number of medical devices were carefully screened using the criteria grid, which proved to be operational and to differentiate properly. From the analysis of the practice and of the methods described, the group was then able to derive a few guidelines to successfully evaluate organisational impact. This work shows that taking organisational impact into consideration may be critical alongside of the other criteria currently in favour (clinically and economically). What remains is to confer a role in the decision-making process on this factor and one that meets the economic efficiency principle. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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