Medical Device Epidemiology and Surveillance (eBook, PDF)

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

• Format: PDF

Produktbeschreibung

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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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 528
• Erscheinungstermin: 13. März 2007
• Englisch
• ISBN-13: 9780470060865
• Artikelnr.: 37290178

Autorenporträt

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

Inhaltsangabe

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.

Rezensionen

"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)