Medical Devices
Subtitle: European Union Policymaking and the Implementation of Health and Patient Safety in France
Publisher: Taylor and Francis
Published: 2017
Place of publication: Milton
Language: eng
Number of pages: 303
ISBN-13: 9781351506298
Subjects: Medical instruments and apparatus; Safety regulations; Standards
Description: "Medical devices are the bread and butter from which health care and clinical research are derived. Such devices are used for patient care, genetic testing, clinical trials, and experimental clinical investigations. Without medical devices, there is no clinical research or patient care. Without life-adjusting devices, there are no medical procedures or surgery. Without life-saving and life-maintaining devices, there is no improvement in well-being and quality of life. Without innovative medical devices and experimentation, there can be no medical progress or patient safety. Medical devices and medical technology are used to create or support many different products and medical-surgical procedures. This volume on the regulation of medical devices in the European Union, with a focus on France, tackles a topic of interdisciplinary interest and significance for policymakers in countries around the globe. The EU regulatory regime is one of three global regional regimes, and medical products manufactured in EU countries are sold worldwide. As countries confront an aging population on a global scale, with associated increases in chronic diseases, physical handicaps, and multi-morbidity, there will inevitably be an increase in the demand for health services and, concomitantly, the use of medical devices in medical and surgical procedures. This will be the case regardless of whether services are delivered in hospitals, doctors' offices, or at home. The associated risks of a particular device will be the same whatever the country of origin for the device, or where the need occurs. Revolutionary medical advances increase diagnostic capabilities, but they increase the potential of harm and risks to patients. Medical technologies and devices are used ethically most of the time; yet they have the potential for unethical use when scientific medicine is elevated over human life and death. Assumptions that are taken for granted can be dangerous to a patient's health. That is why our understanding of appropriate and effective regulation of medical devices is significant to all people on all continents."--Provided by publisher.
Notes: The Post-2004 Era: New Wine in Old Bottles?
Table of contents: title: Cover; Half Title; Title Page; Copyright Page; Table of Contents; List of Tables and Figures; List of Websites; List of Abbreviations and Acronyms; Foreword; Acknowledgements; 1. The European Union, France, and Medical Devices in Context; An Introduction to Medical Devices; What is Known about Medical Devices?; EU Medical Device Policymaking; Why a Single Case Makes for Good Lessons; Important Questions about French Health Care; Health Crises and Institutional Change; The Domestic Coordination of EU Policy in France; 2. The Medical Device Industry in Europe and France.; title: Payers and the Industry: A Divided TableInnovation and R & D: Handicapped by Lack of an Industrial Policy; Limited Innovative Capacities; Interest Intermediation and Industry Profile; The In Vitro Diagnostic Industry; The Home Health-Care Industry; 3. EU Policymaking on Medical Devices; Medical Devices and Drugs; Public Spending and Health Protection; The Dynamics of European Integration; Targets and Forms of Interventions and Responses; A Fourth Directive on Human Engineered Products; Assistance from an Unlikely Source; Policymaking and Politics in France.; title: 4. A New Public Health Safety Policy: The Same Old Structural ProblemsAgenda Control: Who is in Charge?; The French Public Health-Care Policy Agenda in the 1990s; Sécurité Sanitaire: Crusading against Health Risks; Four Principles of Public Health; The Precautionary Principle: Moving Away from Zero-Risk; Risk Management and Vigilance Systems; Biomedical Research; 5. More Restructuring of State Governance; The Law of July 1, 1998; Two Distinctive Features: French Étatisme and Scientific Advice; State Reliance on Scientific Advice; Le Comité National de la Sécurité Sanitaire.; title: 6. Regulation in FranceEstablished Practices; Path-Dependent Processes and Structures; From Homologation to Matériovigilance, 1990-1996; Stakeholders; The Ministry of Health; National Commission of Homologation (CNH); Groups of Experts; Test Laboratories; Sites for Clinical Trials; Settling Disputes: The IGAS Report; 7. The Ministry of Health: A Weak, Low-Status Player; Roles and Responsibilities; The Active Implantable Medical Device Directive (AIMDD); The Medical Device Directive (MDD); The In Vitro Diagnostic Directive (IVDD); Bureaucratic Politics.; title: 8. Negotiating the EU Directives in Brussels, 1990-1998Negotiations; Delegations to Brussels; Why the Fuss about IVD Products?; Handling Reagents (Réactifs); French Inter-Agency Conflicts; 9. From AdM to AFSSAPS; The Institutional Legacy of the Medicinal Agency; A New Regulatory Agency; New Responsibilities and Tasks; The Organization of "First Generation" AFSSAPS; Intra-Organization Relations and Product Orientation; Inspection; Medical Devices Evaluation Directorate; Capacity-Building: Recruiting Knowledge and Manpower; Funding Levels: How Much is a Risk Policy Worth?