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Medical Device Epidemiology and Surveillance

S. Lori Brown (Editor), Roselie A. Bright (Co-Editor), Dale R. Tavris (Co-Editor)
ISBN: 978-0-470-06086-5
528 pages
March 2007
Medical Device Epidemiology and Surveillance (0470060867) cover image
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.

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Foreword.

Preface.

Contributors.

Acknowledgments.

FDA Disclaimer.

1 Introduction (Thomas P. Gross).

2 Medical device regulation in the USA (Thomas P. Gross, Celia M. Witten, and Casper Uldriks).

3 Medical device epidemiology (Roselie A. Bright and S. Lori Brown).

4 Surveillance of adverse medical device events (Roselie A. Bright).

5 The medical product surveillance network (MedSun) (Roselie A. Bright, Marilyn N. Flack, and Susan N. Gardner).

6 The National Electronic Injury Surveillance System (NEISS) and medical devices (Brockton J. Hefflin, Thomas P. Gross, and Thomas J. Schroeder).

7 Medical device nomenclature (Brockton J. Hefflin, Thomas P. Gross, Elizabeth A. Richardson and Vivian H. Coates).

8 Data sources for medical device epidemiology studies and data mining (Danica Marinac-Dabic, Baoguang Wang, Brockton J. Hefflin, Hesha J. Duggirala, Tripthi M. Mathew, and Cara J. Krulewitch).

9 Ethical requirements and guidelines for epidemiologic studies of medical devices (Danica Marinac-Dabic and Suzanne C. Fitzpatrick).

10 An industry perspective: medical device epidemiology and surveillance (Martha A. Feldman).

11 Perspective from an academic on postmarket surveillance (Lazar J. Greenfield).

12 Perspective from a pharmacoepidemiologist (Thomas K. Hazlet).

13 Medical device regulation and surveillance: perspective from the EU (Lennart Philipson).

14 A consumer advocate’s perspective on medical device epidemiology and surveillance (Diana Zuckerman).

15 Pediatric medical device use (Judith U. Cope and Thomas P. Gross).

16 Selected medical devices used to manage diabetes mellitus (Shewit Bezabeh, Joy H. Samuels-Reid, and Dale R. Tavris).

17 Medical device-related outbreaks (S. Lori Brown, Hesha J. Duggirala, and Dale R. Tavris).

18 Risk of transmission of prions with medical devices (S. Lori Brown and Azadeh Shoaibi).

19 Surveillance and epidemiology as tools for evaluating the materials used in medical devices (Roselie A. Bright).

20 Exploring methods for analyzing surveillance reports on electromagnetic interference with medical devices (S. Lori Brown, Nilsa Loyo-Berríos, Michele G. Bonhomme, Donald M. Witters, Nancy A. Pressly, and Jeffrey L. Silberberg).

21 Alternative and complementary medical devices (S. Lori Brown and Joannie C. Shen).

22 Drug-eluting coronary stents (Hesha J. Duggirala, David E. Kandzari, and Thomas P. Gross).

23 The treatment of abdominal aortic aneurysms (Dale R. Tavris and Louis M. Messina).

24 Cardiovascular devices: aortic valves (Ronald G. Kaczmarek and Chih-Hsin K. Liu).

25 Hemostasis devices (Dale R. Tavris, Beverly Gallauresi, and Ralph G. Brindis).

26 ENT devices: cochlear implants (James K. Kane and Eric A. Mann).

27 Silicone gel-filled breast implants: surveillance and epidemiology (S. Lori Brown and Joan Ferlo Todd).

28 Ophthalmic devices and clinical epidemiology (Malvina B. Eydelman, Gene Hilmantel, James Saviola, and Don Calogero).

29 Orthopedic devices: epidemiologic considerations (Ronald G. Kaczmarek, Michele G. Bonhomme, Stanley A. Brown, Judith U. Cope, and Daniel S. McGunagle).

30 Clinical epidemiology of intrapartum fetal monitoring devices (Danica Marinac-Dabic, Barry S. Schifrin, Cara J. Krulewitch, and Roscoe M. Moore).

31 The postmarket surveillance of medical devices: meeting the challenge (Susan N. Gardner and Daniel Schultz).

Index.

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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

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"The first book to provide an overview of medical device epidemiology and surveillance … a very good exposition of how epidemiology can be used." (BMA Medical Book Competition - Programme and Award Winners, September 2008)

"This book is unique, providing a comprehensive view of device surveillance and monitoring." (Doody's, March 2008)

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