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Problematique Et Approche Methodologique De Levaluation Clinique Des Dispositifs Medicaux En Pratique Hospitaliere
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Book Synopsis Problématique et approche méthodologique de l'évaluation clinique des dispositifs médicaux en pratique hospitalière by : Astrid Lecardonnel
Download or read book Problématique et approche méthodologique de l'évaluation clinique des dispositifs médicaux en pratique hospitalière written by Astrid Lecardonnel and published by . This book was released on 2002 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis L' évaluation clinique des dispositifs médicaux et approche de la nouvelle règlementation by : Marion Ricci
Download or read book L' évaluation clinique des dispositifs médicaux et approche de la nouvelle règlementation written by Marion Ricci and published by . This book was released on 2015 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Les dispositifs médicaux sont encadrés par une législation européenne. Leur mise sur le marché obéit à des règles strictes faisant intrvenir différents acteurs et est conditionnée à l'apposition d'un marquage "CE" sur les dispositifs. Ce marquage s'obtient après évaluation de la conformité aux exigences essentielles applicables selon une procédure choisie par le fabricant et jugée par un organisme notifié. Depuis 2007, les exigences essentielles requièrent la réalisation d'une évaluation clinique pour mettre sur le marché un dispositif médical afin de démontrer sa sécurité et ses performances pour chaque indication revendiquée dans les conditions normales d'utilisation et une surveillance clinique post-marché est imposée. L'évaluation clinique repose sur l'acquisition de données cliniques issues soit d'une évaluation critique de la littérature scientifique, soit d'investigations cliniques, soit d'une combinaison des deux approches. Ce choix constitue un véritable enjeu stratégique pour les fabricants principalement en matière de prise en charge. Malgré la volonté de la commission européenne d'encourager la conduite d'évaluations cliniques, les données cliniques sont encore insuffisantes voire absentes, des hypothèses ont été soumises pour expliquer ce constat et des lacunes dans la législation actuelle ont été soulevées. Les scandales révélés récemment ont contribué à une refonte de la règlemenation européenne des dispositifs médicaux. Un projet renforçant notamment les exigences en termes d'évaluation clinique a été proposé et adopté par la commission. Ce projet qui suscite encore des débats, est actuellement en relecture au Conseil pour une adoption prévue fin 2015.
Book Synopsis La place des données cliniques dans l'évaluation des dispositifs médicaux by : Audeline Rath-Lavialle
Download or read book La place des données cliniques dans l'évaluation des dispositifs médicaux written by Audeline Rath-Lavialle and published by . This book was released on 2015 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Évaluation clinique des dispositifs médicaux selon la voie de la littérature by : Lionel Ekedi Ngando
Download or read book Évaluation clinique des dispositifs médicaux selon la voie de la littérature written by Lionel Ekedi Ngando and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le dispositif médical (DM) se situe au carrefour de multiples technologies. Pour être commercialisés dans l'espace économique européen, les DM doivent être conformes aux exigences de sécurité et de performance définies par la réglementation européenne. L'évaluation clinique est un élément essentiel de l'évaluation de la conformité des dispositifs médicaux. L'objet de cette thèse est d'identifier les principes de l'évaluation clinique conformément au guide MEDDEV 2.7/1 rev.4, d'étudier les impacts du guide MEDDEV 2.7/1 rev.4 sur la documentation technique d'un DM déjà commercialisé, notamment en ce qui concerne le rapport d'évaluation clinique, d'étudier les impacts du règlement européen 2017/745 notamment en ce qui concerne la procédure d'évaluation clinique. Aujourd'hui, la voie majoritairement utilisée pour la conduite de l'évaluation clinique est celle de la littérature. L'évaluation clinique selon le guide MEDDEV 2.7/1 rev.4 nécessite de réelles compétences pluridisciplinaires. L'enjeu principal est l'accès au marché de produits innovants, et le maintien sur le marché de produits existants. La mise en conformité de l'évaluation clinique aux exigences du guide MEDDEV 2.7/1 rev.4 n'est qu'un premier pas vers le nouveau règlement communautaire (UE) 2017/745 applicable dès 2020. Les investigations cliniques avant mise sur le marché et après commercialisation seront d'avantage privilégiées. Ce bouleversement est nécessaire ; car il est évident que le règlement communautaire contribuera sans doute à garantir, pour le patient et l'utilisateur, un niveau de protection encore plus élevé qu'aujourd'hui.
Book Synopsis Aspects of Medical Care Administration by : Avedis Donabedian
Download or read book Aspects of Medical Care Administration written by Avedis Donabedian and published by . This book was released on 1973 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Health System Performance Comparison: an Agenda for Policy, Information and Research by : Irene Papanicolas
Download or read book Health System Performance Comparison: an Agenda for Policy, Information and Research written by Irene Papanicolas and published by McGraw-Hill Education (UK). This book was released on 2013-06-16 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: International comparison of health system performance has become increasingly popular, made possible by the rapidly expanding availability of health data. It has become one of the most important levers for prompting health system reform. Yet, as the demand for transparency and accountability in healthcare increases, so too does the need to compare data from different health systems both accurately and meaningfully. This timely and authoritative book offers an important summary of the current developments in health system performance comparison. It summarises the current state of efforts to compare systems, and identifies and explores the practical and conceptual challenges that occur. It discusses data and methodological challenges, as well as broader issues such as the interface between evidence and practice. The book draws out the priorities for future work on performance comparison, in the development of data sources and measurement instruments, analytic methodology, and assessment of evidence on performance. It concludes by presenting the key lessons and future priorities, and in doing so offers a rich source of material for policy-makers, their analytic advisors, international agencies, academics and students of health systems.
Book Synopsis Healthier Societies by : Jody Heymann
Download or read book Healthier Societies written by Jody Heymann and published by Oxford University Press, USA. This book was released on 2006 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Publisher description
Book Synopsis Pain in Infants, Children, and Adolescents by : Neil L. Schechter
Download or read book Pain in Infants, Children, and Adolescents written by Neil L. Schechter and published by Lippincott Williams & Wilkins. This book was released on 2003 with total page 924 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Second Edition is a significant revision of the leading text and clinical reference on pediatric pain. Written by an international group of experts from all relevant disciplines, this new edition is a vital reference for all pain practitioners, and for nurses, psychologists, PTs, anesthesiologists, and pediatricians dealing with acute and chronic pediatric pain. This edition includes new and expanded information on NSAIDs, opioids, and regional anesthesia. New chapters cover sedation, pain in the ICU, multidisciplinary pain services, palliative care, and the long-term consequences of pain. User-friendly new features include many more illustrations of techniques.
Book Synopsis Innovate Bristol by : Sven Boermeester
Download or read book Innovate Bristol written by Sven Boermeester and published by . This book was released on 2019-12 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovate Bristol highlights and celebrates those companies and individuals that are actively working at building a better tomorrow for all. Innovation Ecosystems thrive through the involvement and support of companies and individuals from all industries, which is why the Innovate series not only focuses on the innovators but also those people whom the Innovation Ecosystem, would not be able to thrive without.
Book Synopsis Adjuvant Therapy for Breast Cancer by : Monica Castiglione
Download or read book Adjuvant Therapy for Breast Cancer written by Monica Castiglione and published by Springer Science & Business Media. This book was released on 2009-07-11 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adjuvant treatment is administered prior to or as follow up to surgical procedures for breast cancer. Proven success in using medical therapies allowing for breast conserving procedures or reducing risk of occurrence. Although there has been much progress towards a cure, including the introduction of new targeted therapies, metastasizing cancer remains highly incurable.
Book Synopsis Comprehensive Cervical Cancer Control by : World Health Organization
Download or read book Comprehensive Cervical Cancer Control written by World Health Organization and published by World Health Organization. This book was released on 2006 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most women who die from cervical cancer, particularly in developing countries, are in the prime of their life. They may be raising children, caring for their family, and contributing to the social and economic life of their town or village. Their death is both a personal tragedy, and a sad and unnecessary loss to their family and their community. Unnecessary, because there is compelling evidence, as this Guide makes clear, that cervical cancer is one of the most preventable and treatable forms of cancer, as long as it is detected early and managed effectively. Unfortunately, the majority of women in developing countries still do not have access to cervical cancer prevention programmes. The consequence is that, often, cervical cancer is not detected until it is too late to be cured. An urgent effort is required if this situation is to be corrected. This Guide is intended to help those responsible for providing services aimed at reducing the burden posed by cervical cancer for women, communities and health systems. It focuses on the knowledge and skills needed by health care providers, at different levels of care.
Book Synopsis The Abuse of Casuistry by : Albert R. Jonsen
Download or read book The Abuse of Casuistry written by Albert R. Jonsen and published by Univ of California Press. This book was released on 1988 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this engaging study, the authors put casuistry into its historical context, tracing the origin of moral reasoning in antiquity, its peak during the sixteenth and early seventeenth century, and its subsequent fall into disrepute from the mid-seventeenth century.
Book Synopsis Biosocialities, Genetics and the Social Sciences by : Sahra Gibbon
Download or read book Biosocialities, Genetics and the Social Sciences written by Sahra Gibbon and published by Routledge. This book was released on 2007-07-20 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biosocialities, Genetics and the Social Sciences explores the social, cultural and economic transformations that result from innovations in genomic knowledge and technology. This pioneering collection uses Paul Rabinow’s concept of biosociality to chart the shifts in social relations and ideas about nature, biology and identity brought about by developments in biomedicine. Based on new empirical research, it contains chapters on genomic research into embryonic stem cell therapy, breast cancer, autism, Parkinson’s and IVF treatment, as well as on the expectations and education surrounding genomic research. It covers four main themes: novel modes of identity and identification, such as genetic citizenship the role of institutions, ranging from disease advocacy organizations and voluntary organizations to the state the production of biological knowledge, novel life-forms, and technologies the generation of wealth and commercial interests in biology. Including an afterword by Paul Rabinow and case studies on the UK, US, Canada, Germany, India and Israel, this book is key reading for students and researchers of the new genetics and the social sciences – particularly medical sociologists, medical anthropologists and those involved with science and technology studies.
Book Synopsis Global Burden of Disease and Risk Factors by : Alan D. Lopez
Download or read book Global Burden of Disease and Risk Factors written by Alan D. Lopez and published by World Bank Publications. This book was released on 2006-04-02 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: Strategic health planning, the cornerstone of initiatives designed to achieve health improvement goals around the world, requires an understanding of the comparative burden of diseases and injuries, their corresponding risk factors and the likely effects of invervention options. The Global Burden of Disease framework, originally published in 1990, has been widely adopted as the preferred method for health accounting and has become the standard to guide the setting of health research priorities. This publication sets out an updated assessment of the situation, with an analysis of trends observed since 1990 and a chapter on the sensitivity of GBD estimates to various sources of uncertainty in methods and data.
Book Synopsis The Patient Will See You Now by : Eric Topol
Download or read book The Patient Will See You Now written by Eric Topol and published by Basic Books. This book was released on 2016-10-25 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: The essential guide by one of America's leading doctors to how digital technology enables all of us to take charge of our health A trip to the doctor is almost a guarantee of misery. You'll make an appointment months in advance. You'll probably wait for several hours until you hear "the doctor will see you now"-but only for fifteen minutes! Then you'll wait even longer for lab tests, the results of which you'll likely never see, unless they indicate further (and more invasive) tests, most of which will probably prove unnecessary (much like physicals themselves). And your bill will be astronomical. In The Patient Will See You Now, Eric Topol, one of the nation's top physicians, shows why medicine does not have to be that way. Instead, you could use your smartphone to get rapid test results from one drop of blood, monitor your vital signs both day and night, and use an artificially intelligent algorithm to receive a diagnosis without having to see a doctor, all at a small fraction of the cost imposed by our modern healthcare system. The change is powered by what Topol calls medicine's "Gutenberg moment." Much as the printing press took learning out of the hands of a priestly class, the mobile internet is doing the same for medicine, giving us unprecedented control over our healthcare. With smartphones in hand, we are no longer beholden to an impersonal and paternalistic system in which "doctor knows best." Medicine has been digitized, Topol argues; now it will be democratized. Computers will replace physicians for many diagnostic tasks, citizen science will give rise to citizen medicine, and enormous data sets will give us new means to attack conditions that have long been incurable. Massive, open, online medicine, where diagnostics are done by Facebook-like comparisons of medical profiles, will enable real-time, real-world research on massive populations. There's no doubt the path forward will be complicated: the medical establishment will resist these changes, and digitized medicine inevitably raises serious issues surrounding privacy. Nevertheless, the result-better, cheaper, and more human health care-will be worth it. Provocative and engrossing, The Patient Will See You Now is essential reading for anyone who thinks they deserve better health care. That is, for all of us.
Book Synopsis Handbook for Integrating Risk Analysis in the Economic Analysis of Projects by : Asian Development Bank
Download or read book Handbook for Integrating Risk Analysis in the Economic Analysis of Projects written by Asian Development Bank and published by . This book was released on 2002 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aiming to support the development of a framework for the analysis of risk in project design and economic analysis, this handbook outlines technical approaches to modeling risk. Also summarized is the nature and practice of sensitivity analysis in dealing with uncertain outcomes as well as the principles to consider in typical risk analysis situations sector by sector. Case studies are included to demonstrate the application of quantitative risk analysis using actual Asian Development Bank projects to help improve project design and quality. Handbook users will learn to identify factors that are the key determinants of project outcomes, determine the likelihood of an individual project's returns being unacceptable, and design measures to mitigate the risks arising from the identified key factors.
Book Synopsis Crisis Management in Anesthesiology E-Book by : David M. Gaba
Download or read book Crisis Management in Anesthesiology E-Book written by David M. Gaba and published by Elsevier Health Sciences. This book was released on 2014-09-02 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fully updated Crisis Management in Anesthesiology continues to provide updated insights on the latest theories, principles, and practices in anesthesiology. From anesthesiologists and nurse anesthetists to emergency physicians and residents, this medical reference book will effectively prepare you to handle any critical incident during anesthesia. Identify and respond to a broad range of life-threatening situations with the updated Catalog of Critical Incidents, which outlines what may happen during surgery and details the steps necessary to respond to and resolve the crisis. React quickly to a range of potential threats with an added emphasis on simulation of managing critical incidents. Useful review for all anesthesia professionals of the core knowledge of diagnosis and management of many critical events. Explore new topics in the ever-expanding anesthesia practice environment with a detailed chapter on debriefing. Expert Consult eBook version included with purchase.
