Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform: Report of a policy conference of the European Society of Cardiology
| Autor: | Fraser AG, Daubert JC, Van de Werf F, Estes NA 3rd, Smith SC Jr, Krucoff MW, Vardas PE, Komajda M, Anker S, Auricchio A, Bailey S, Bonhoeffer P, Borggrefe M, Brodin LA, Bruining N, Buser P, Butchart E, Calle Gordo J, Cleland J, Danchin N, Degertekin M, Demade I, Denjoy N, Derumeaux G, di Mario C, Dickstein K, Dudek D, Farb A, Flotats A, Gueret P, Israel C, James S, Kautzner J, Lombardi M, Marwick T, Mioulet M, O'Kelly S, Rosano G, Rosenhek R, Sabate M, Swahn E, Tavazzi L, van der Velde E, van Herwerden L, Voigt JU, Weaver D, Wilmshurst P., PERRONE FILARDI, PASQUALE |
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| Přispěvatelé: | Fraser, Ag, Daubert, Jc, Van de Werf, F, Estes NA, 3rd, Smith SC, Jr, Krucoff, Mw, Vardas, Pe, Komajda, M, Anker, S, Auricchio, A, Bailey, S, Bonhoeffer, P, Borggrefe, M, Brodin, La, Bruining, N, Buser, P, Butchart, E, Calle Gordo, J, Cleland, J, Danchin, N, Degertekin, M, Demade, I, Denjoy, N, Derumeaux, G, di Mario, C, Dickstein, K, Dudek, D, Farb, A, Flotats, A, Gueret, P, Israel, C, James, S, Kautzner, J, Lombardi, M, Marwick, T, Mioulet, M, O'Kelly, S, PERRONE FILARDI, Pasquale, Rosano, G, Rosenhek, R, Sabate, M, Swahn, E, Tavazzi, L, van der Velde, E, van Herwerden, L, Voigt, Ju, Weaver, D, Wilmshurst, P., Société Européenne de Cardiologie (ESC), Société Européenne de Cardiologie (ESC)-The European Heart House |
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Legislation
Medical Health Care Sector MESH: Equipment Failure Regulatory reform 030204 cardiovascular system & hematology Premarket approval 0302 clinical medicine Medicine 030212 general & internal medicine Post-marketing surveillance MESH: Equipment and Supplies Equipment Design MESH: Cardiology 3. Good health Equipment and Supplies MESH: Patient Safety Medical devices Engineering ethics Professional association Equipment Failure [SDV.IB]Life Sciences [q-bio]/Bioengineering Patient Safety Cardiology and Cardiovascular Medicine Clinical evaluation Diagnostic Imaging medicine.medical_specialty Process (engineering) Interprofessional Relations Biomedical Technology Cardiology Postmarketing surveillance Legislation Context (language use) MESH: Diffusion of Innovation European device directives 03 medical and health sciences [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system MESH: Interprofessional Relations MESH: United States MESH: European Union Humans European Union Psychiatry Pace MESH: Humans business.industry MESH: Diagnostic Imaging MESH: Health Care Sector MESH: Legislation Medical United States Recast of legislation Diffusion of Innovation business MESH: Biomedical Technology MESH: Equipment Design |
| Zdroj: | European Heart Journal European Heart Journal, Oxford University Press (OUP): Policy B, 2011, 32 (13), pp.1673-86. ⟨10.1093/eurheartj/ehr171⟩ |
| ISSN: | 0195-668X 1522-9645 |
| Popis: | International audience; The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011. |
| Databáze: | OpenAIRE |
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