Medical Device Epidemiology and Surveillance

Medical Device Epidemiology and Surveillance

Editor(s): S. Lori Brown, Roselie A. Bright, Dale R. Tavris

Published Online: 27 APR 2007

Print ISBN: 9780470015957

Online ISBN: 9780470060872

DOI: 10.1002/9780470060872

About this Book

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.

Table of contents

    1. You have free access to this content
    2. Chapter 2

      Medical Device Regulation in the USA (pages 5–19)

      Thomas P. Gross, Celia M. Witten and Caspar Uldriks

    3. Chapter 7

      Medical Device Nomenclature (pages 87–97)

      Brockton J. Hefflin, Thomas P. Gross, Elizabeth A. Richardson and Vivian H. Coates

    4. Chapter 8

      Data Sources for Medical Device Epidemiology Studies and Data Mining (pages 99–125)

      Danica Marinac-Dabic, Baoguang Wang, Brockton J. Hefflin, Hesha J. Duggirala, Tripthi M. Mathew and Cara J. Krulewitch

    5. Chapter 17

      Medical Device-Related Outbreaks (pages 237–257)

      S. Lori Brown, Hesha J. Duggirala and Dale R. Tavris

    6. Chapter 20

      Exploring Methods for Analyzing Surveillance Reports on Electromagnetic Interference with Medical Devices (pages 291–318)

      S. Lori Brown, Nilsa Loyo-Berríos, Michèle G. Bonhomme, Donald M. Witters, Nancy A. Pressly and Jeffrey L. Silberberg

    7. Chapter 22

      Drug-Eluting Coronary Stents (pages 335–353)

      Hesha J. Duggirala, Thomas P. Gross and David E. Kandzari

    8. Chapter 25

      Hemostasis Devices (pages 379–393)

      Dale R. Tavris, Beverly Gallauresi and Ralph G. Brindis

    9. Chapter 28

      Ophthalmic Devices and Clinical Epidemiology (pages 427–439)

      Malvina B. Eydelman, Gene Hilmantel, James Saviola and Don Calogero

    10. Chapter 29

      Orthopedic Devices: Epidemiologic Considerations (pages 441–462)

      Ronald G. Kaczmarek, Michele G. Bonhomme, Stanley A. Brown, Judith U. Cope and Daniel S. McGunagle

    11. Chapter 30

      Clinical Epidemiology of Intrapartum Fetal Monitoring Devices (pages 463–482)

      Danica Marinac-Dabic, Barry S. Schifrin, Cara J. Krulewitch and Roscoe M. Moore

    12. You have free access to this content