Available:*
Library | Item Barcode | Call Number | Material Type | Item Category 1 | Status |
|---|---|---|---|---|---|
Searching... | 30000010157086 | R856.6 M424 2007 | Open Access Book | Book | Searching... |
On Order
Summary
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 Notes
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 |
| 1 IntroductionThomas P. Gross |
| 2 Medical device regulation in the USAThomas P. Gross and Celia M. Witten and Casper Uldriks |
| 3 Medical device epidemiologyRoselie A. Bright and S. Lori Brown |
| 4 Surveillance of adverse medical device eventsRoselie A. Bright |
| 5 The medical product surveillance network (MedSun)Roselie A. Bright and Marilyn N. Flack and Susan N. Gardner |
| 6 The National Electronic Injury Surveillance System (NEISS) and medical devicesBrockton J. Hefflin and Thomas P. Gross and Thomas J. Schroeder |
| 7 Medical device nomenclatureBrockton J. Hefflin and Thomas P. Gross and Elizabeth A. Richardson and Vivian H. Coates |
| 8 Data sources for medical device epidemiology studies and data miningDanica Marinac-Dabic and Baoguang Wang and Brockton J. Hefflin and Hesha J. Duggirala and Tripthi M. Mathew and Cara J. Krulewitch |
| 9 Ethical requirements and guidelines for epidemiologic studies of medical devicesDanica Marinac-Dabic and Suzanne C. Fitzpatrick |
| 10 An industry perspective: medical device epidemiology and surveillanceMartha A. Feldman |
| 11 Perspective from an academic on postmarket surveillanceLazar J. Greenfield |
| 12 Perspective from a pharmacoepidemiologistThomas K. Hazlet |
| 13 Medical device regulation and surveillance: perspective from the EULennart Philipson |
| 14 A consumer advocate's perspective on medical device epidemiology and surveillanceDiana Zuckerman |
| 15 Pediatric medical device useJudith U. Cope and Thomas P. Gross |
| 16 Selected medical devices used to manage diabetes mellitusShewit Bezabeh and Joy H. Samuels-Reid and Dale R. Tavris |
| 17 Medical device-related outbreaksS. Lori Brown and Hesha J. Duggirala and Dale R. Tavris |
| 18 Risk of transmission of prions with medical devicesS. Lori Brown and Azadeh Shoaibi |
| 19 Surveillance and epidemiology as tools for evaluating the materials used in medical devicesRoselie A. Bright |
| 20 Exploring methods for analyzing surveillance reports on electromagnetic interference with medical devicesS. Lori Brown and Nilsa Loyo-Berrios and Michele G. Bonhomme and Donald M. Witters and Nancy A. Pressly and Jeffrey L. Silberberg |
| 21 Alternative and complementary medical devicesS. Lori Brown and Joannie C. Shen |
| 22 Drug-eluting coronary stentsHesha J. Duggirala and David E. Kandzari and Thomas P. Gross |
| 23 The treatment of abdominal aortic aneurysmsDale R. Tavris and Louis M. Messina |
| 24 Cardiovascular devices: aortic valvesRonald G. Kaczmarek and Chih-Hsin K. Liu |
| 25 Hemostasis devicesDale R. Tavris and Beverly Gallauresi and Ralph G. Brindis |
| 26 ENT devices: cochlear implantsJames K. Kane and Eric A. Mann |
| 27 Silicone gel-filled breast implants: surveillance and epidemiologyS. Lori Brown and Joan Ferlo Todd |
| 28 Ophthalmic devices and clinical epidemiologyMalvina B. Eydelman and Gene Hilmantel and James Saviola and Don Calogero |
| 29 Orthopedic devices: epidemiolo |
