Medical devices : European Union policymaking and the implementation of health and patient safety in France
Author(s)
Bibliographic Information
Medical devices : European Union policymaking and the implementation of health and patient safety in France
Transaction Publishers, c2008
Available at 1 libraries
  Aomori
  Iwate
  Miyagi
  Akita
  Yamagata
  Fukushima
  Ibaraki
  Tochigi
  Gunma
  Saitama
  Chiba
  Tokyo
  Kanagawa
  Niigata
  Toyama
  Ishikawa
  Fukui
  Yamanashi
  Nagano
  Gifu
  Shizuoka
  Aichi
  Mie
  Shiga
  Kyoto
  Osaka
  Hyogo
  Nara
  Wakayama
  Tottori
  Shimane
  Okayama
  Hiroshima
  Yamaguchi
  Tokushima
  Kagawa
  Ehime
  Kochi
  Fukuoka
  Saga
  Nagasaki
  Kumamoto
  Oita
  Miyazaki
  Kagoshima
  Okinawa
  Korea
  China
  Thailand
  United Kingdom
  Germany
  Switzerland
  France
  Belgium
  Netherlands
  Sweden
  Norway
  United States of America
Note
Includes bibliographical references (p. 243-260) and index
"Government documents": p. 261-265
Description and Table of Contents
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.
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, 2. The Medical Device Industry in Europe and France, 3. EU Policymaking on Medical Devices, 4. A New Public Health Safety Policy: The Same Old Structural Problems, 5. More Restructuring of State Governance, 6. Regulation in France, 7. The Ministry of Health: A Weak, Low- Status Player, 8. Negotiating the EU Directives in Brussels, 1990-1998, 9. From AdM to AFSSAPS, 10. Implementing the IVD Regulatory Regime, 11. Medical Device Vigilance, 12. Local Operations: Regulations in the Hospital, 13. Conclusion and Lessons Learned, References, Government Documents, Index
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