Le retraitement des dispositifs médicaux à usage unique, éléments de réflexion concernant les achats

Abstract : As today, French regulation requires, for the single use devices, a single use for a single patient, and then, elimination by a specific way (Wastes from clinical activities with infectious hazards). In the United States and Germany in particular, the same references of sterile medical devices may be reused under certain conditions. After identifying the reasons that led to the emergence in these countries of a practice now banned in France (reasons like regulatory frameworks, sometimes under the same guidelines, and technical, clinical and ethical factors) the economical impact is positive. For hospitals purchasers, if reuse became possible in France, it would be a potential source of savings for hospitals, where medical devices expenses dramatically increases. This work evaluate, for only one category of medical devices which can be reprocessed (interventional cardiology medical devices), savings of a range from 45 000 euros for a hospital center with 1300 beds to 340 000 euros for an university teaching hospital with 1950 beds, using available data from the literature and real data from hospitals members of GCS UniHA. This work was done in partnership between GCS UniHA and Vanguard Medical Services (Grenoble), French subsidiary of European reprocessing leader. Those findings allowed us to think that reprocessing might be an innovating solution for cost reducing in an hospital, but only after validation of equivalency of sterile medical devices reprocessed according to the highest quality process, ensuring security for patients, users and third parties; together with a regulation adaptation framing practice and risk management.
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Master Thesis
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Submitted on : Wednesday, January 9, 2019 - 11:42:14 AM
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  • HAL Id : dumas-01975166, version 1


Baptiste Campillo. Le retraitement des dispositifs médicaux à usage unique, éléments de réflexion concernant les achats. Sciences pharmaceutiques. 2011. ⟨dumas-01975166⟩



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