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9780470015957

Medical Device Epidemiology and Surveillance

by ; ;
  • ISBN13:

    9780470015957

  • ISBN10:

    0470015950

  • Edition: 1st
  • Format: Hardcover
  • Copyright: 2007-04-02
  • Publisher: WILEY

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Summary

Medical devices are crucial in medical care today and device technology advances at a dizzying pace. Medical Device Epidemiology and Surveillance is the first book to provide an overview of medical device epidemiology and surveillance as well as perspectives from regulatory agencies, the medical device industry, the health insurance industry and academia. The book is edited by experts from the US Food and Drug Administration with contributions from experienced specialists working in this field in the US and around the world. It features chapters describing broad themes in medical device epidemiology and surveillance, as well as chapters that describe specific medical devices. Medical Device Epidemiology and Surveillance is an essential reference for epidemiologists, pharmacoepidemiologists, academics, graduate students, and everybody working in the medical device industry.

Author Biography

S. Lori Brown, PhD, MPH. Epidemiologist. Epidemiology Branch. Division of Postmarket Surveillance. Center for Devices and Radiological Health. U.S. Food and Drug Administration. Rockville, MD, USA.

Roselie A. Bright, ScD. Epidemiologist. Epidemiology Branch. Division of Postmarket Surveillance. Center for Devices and Radiological Health. U.S. Food and Drug Administration. Rockville, MD, USA

Dale R. Tavris, MD, MPH. Epidemiologist. Epidemiology Branch. Division of Postmarket Surveillance. Center for Devices and Radiological Health. U.S. Food and Drug Administration. Rockville, MD, USA

Table of Contents

Foreword
Preface
Contributors
Acknowledgments
FDA Disclaimer
Introduction
Medical device regulation in the USA
Medical device epidemiology
Surveillance of adverse medical device events
The medical product surveillance network (MedSun)
The National Electronic Injury Surveillance System (NEISS) and medical devices
Medical device nomenclature
Data sources for medical device epidemiology studies and data mining
Ethical requirements and guidelines for epidemiologic studies of medical devices
An industry perspective: medical device epidemiology and surveillance
Perspective from an academic on postmarket surveillance
Perspective from a pharmacoepidemiologist
Medical device regulation and surveillance: perspective from the EU
A consumer advocate's perspective on medical device epidemiology and surveillance
Pediatric medical device use
Selected medical devices used to manage diabetes mellitus
Medical device-related outbreaks
Risk of transmission of prions with medical devices
Surveillance and epidemiology as tools for evaluating the materials used in medical devices
Exploring methods for analyzing surveillance reports on electromagnetic interference with medical devices
Alternative and complementary medical devices
Drug-eluting coronary stents
The treatment of abdominal aortic aneurysms
Cardiovascular devices: aortic valves
Hemostasis devices
ENT devices: cochlear implants
Silicone gel-filled breast implants: surveillance and epidemiology
Ophthalmic devices and clinical epidemiology
Orthopedic devices: epidemiolo
Table of Contents provided by Publisher. All Rights Reserved.

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