Medical Device Epidemiology and Surveillance

by Brown, S. Lori; Bright, Roselie A.; Tavris, Dale R.

• ISBN13: 9780470015957
• ISBN10: 0470015950
• Edition: 1st
• Format: Hardcover
• Copyright: 2007-04-02
• Publisher: WILEY

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

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