RésuméLa table ronde a choisi d'orienter sa discussion sur les essais qui, par leur importance, sont susceptibles de modifier les pratiques médicales et les comportements. Ces essais peuvent être pré-ou post-AMM (autorisation de mise sur le marché). Pour que les résultats d'un essai aboutissent à un changement de pratique, ils doivent être crédibles et répondre aux critères fondamentaux de la méthodologie. Il convient néanmoins de compléter cette évaluation binaire par l'utilisation d'une grille d'évaluation adaptée à chaque catégorie d'utilisateurs, qu'il s'agisse de l'Agence, des prescripteurs ou des patients parfois informés directement par la presse. Les membres de la table ronde proposent la grille de Giens 2003. Il s'agit d'une grille d'évaluation semi-quantitative interprétative faite de messages simples liés à la pratique. Ces étapes d'évaluation sont le prélude nécessaire à la diffusion des résultats aux différentes personnes concernées (personnel de santé, patients, associations de patients, médias et grand public), à leur information en termes compréhensibles mais exacts. La mise en pratique des résultats avec changement de comportement et/ou l'émission de recommandations sont les étapes ultérieures, pour lesquelles un certain délai est inévitable. L'élaboration de programmes de mise en pratique, facilités par une analyse précise des freins au changement, devrait dans l'avenir améliorer et accélérer l'application de résultats importants pour l'optimisation de la prise en charge des patients.
-Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII th Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.Abbreviations: see end of article.
Analysis of reinforced concrete frame with steel braces has been done to compare the behavior of the open frame structure with reinforced concrete structure with steel braces. Three models of 2D open frame structure with 3, 4 and 5 floors were made and analyzed in SAP2000 v17 with intermediate detailing according to Indonesian Codes for Seismic Load (SNI 1726: 2002). 3-span frame structure with a span length of 6 m and level height of 3,5 m were designed according to SNI 1726: 2002, and then re-analyzed with special detailing according to New Indonesian Codes for Seismic Load (SNI 1726: 2012). After that, it was added with braces as seismic retrofitting. Two types of braces (X and concentric inverted V) were used in this study and analyzed with conventional analysis and stage construction analysis according to their stages of implementation. From the analysis results, several structure components that analyzed according to SNI 1726:2012 provitions were experience over-stressed. After retrofitted with steel braces, those components fulfill strength provition according to SNI 2847:2013 about structural concrete regulations for buildings. In addition to that, displacements that occurs on braced frame are smaller than displacements of the open frame structure with ratio of 0.08, 0.12, and 0.18 for X-brace frames with 3,4, and 5 storey and 0.07, 0.11, and 0.16 for inverted-V brace. With staged construction analysis, displacements of X-braced frame structure increased by 14.38%, 13.62%, and 9.98% from the conventional analysis results for structure with 3, 4,and 5 storey. For structure with inverted-V brace, displacements increased by 15.83%, 14.29%, and 10.09%.
Analysis of reinforced concrete frame with steel braces has been done to compare the behavior of the open frame structure with reinforced concrete structure with steel braces. Three models of 2D open frame structure with 3, 4 and 5 floors were made and analyzed in SAP2000 v17 with intermediate detailing according to Indonesian Codes for Seismic Load (SNI 1726: 2002). 3-span frame structure with a span length of 6 m and level height of 3,5 m were designed according to SNI 1726: 2002, and then re-analyzed with special detailing according to New Indonesian Codes for Seismic Load (SNI 1726: 2012). After that, it was added with braces as seismic retrofitting. Two types of braces (X and concentric inverted V) were used in this study and analyzed with conventional analysis and stage construction analysis according to their stages of implementation. From the analysis results, several structure components that analyzed according to SNI 1726:2012 provitions were experience over-stressed. After retrofitted with steel braces, those components fulfill strength provition according to SNI 2847:2013 about structural concrete regulations for buildings. In addition to that, displacements that occurs on braced frame are smaller than displacements of the open frame structure with ratio of 0.08, 0.12, and 0.18 for X-brace frames with 3,4, and 5 storey and 0.07, 0.11, and 0.16 for inverted-V brace. With staged construction analysis, displacements of X-braced frame structure increased by 14.38%, 13.62%, and 9.98% from the conventional analysis results for structure with 3, 4,and 5 storey. For structure with inverted-V brace, displacements increased by 15.83%, 14.29%, and 10.09%.
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