Medical Device Epidemiology and Surveillance (Google eBook)

Front Cover
S. Lori Brown, Roselie A. Bright, Dale R. Tavris
John Wiley & Sons, Mar 13, 2007 - Medical - 528 pages
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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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Contents

Acknowledgments
xxv
1 Introduction
1
2 Medical device regulation in the USA
5
3 Medical device epidemiology
21
4 Surveillance of adverse medical device events
43
5 The Medical Product Surveillance Network MedSun
63
6 The National Electronic Injury Surveillance System NEISS and medical devices
79
7 Medical device nomenclature
87
17 Medical devicerelated outbreaks
237
18 Risk of transmission of prions with medical devices
259
19 Surveillance and epidemiology as tools for evaluating the materials used in medical devices
273
20 Exploring methods for analyzing surveillance reports on electromagnetic interference with medical devices
291
21 Alternative and complementary medical devices
319
22 Drugeluting coronary stents
335
23 The treatment of abdominal aortic aneurysms
355
24 Cardiovascular devices aortic valves
367

8 Data sources for medical device epidemiology studies and data mining
99
9 Ethical requirements and guidelines for epidemiological studiesof medical devices
127
10 An industry perspective medical device epidemiology and surveillance
145
11 Perspective from an academic on postmarket surveillance
159
12 Perspective from a pharmacoepidemiologist
171
13 Medical device regulation and surveillance perspective from the EU
177
14 A consumer advocates perspective on medical device epidemiology and surveillance
187
15 Pediatric Medical Device Use
203
16 Selected medical devices used to manage diabetes mellitus
219
25 Hemostasis Devices
376
26 ENT devices cochlear implants
395
27 Silicone gelfilled breast implants surveillance and epidemiology
407
28 Ophthalmic devices and clinical epidemiology
427
29 Orthopedic devices epidemiologic considerations
441
30 Clinical epidemiology of intrapartum fetal monitoring devices
463
31 The postmarket surveillance of medical devices meeting the challenge
483
Index
487
Copyright

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About the author (2007)

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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