Medical Device Epidemiology and Surveillance

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

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-Berrios, 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.