Table of Contents

CHAPTER 1
Introduction (Pages: 1-3)
Thomas P. Gross MD, MPH
CHAPTER 2
Medical Device Regulation in the USA (Pages: 5-19)
Thomas P. Gross MD, MPH Celia M. Witten MD, PhD Caspar Uldriks
CHAPTER 3
Medical Device Epidemiology (Pages: 21-42)
Roselie A. Bright ScD S. Lori Brown PhD, MPH
CHAPTER 5
The Medical Product Surveillance Network (MedSun) (Pages: 63-77)
Roselie A. Bright ScD Marilyn N. Flack Susan N. Gardner PhD
CHAPTER 6
The National Electronic Injury Surveillance System (NEISS) and Medical Devices (Pages: 79-85)
Brockton J. Hefflin MD, PhD, DPS Thomas P. Gross MD, MPH Thomas J. Schroeder MS
CHAPTER 7
Medical Device Nomenclature (Pages: 87-97)
Brockton J. Hefflin MD, PhD, DPS Thomas P. Gross MD, MPH Elizabeth A. Richardson MSN, MPH, RN Vivian H. Coates PhD
CHAPTER 8
Data Sources for Medical Device Epidemiology Studies and Data Mining (Pages: 99-125)
Danica Marinac-Dabic MD, PhD, MMSc Baoguang Wang MD, DrPH Brockton J. Hefflin MD, PhD, DPS Hesha J. Duggirala PhD, MPH Tripthi M. Mathew MD, MPH Cara J. Krulewitch CNM, PhD
CHAPTER 9
Ethical Requirements and Guidelines for Epidemiological Studies of Medical Devices (Pages: 127-144)
Danica Marinac-Dabic MD, PhD, MMSc Suzanne C. Fitzpatrick PhD, DABT
CHAPTER 15
Pediatric Medical Device Use (Pages: 203-218)
Judith U. Cope MD, MPH Thomas P. Gross MD, MPH
CHAPTER 16
Selected Medical Devices used to Manage Diabetes Mellitus (Pages: 219-235)
Shewit Bezabeh MD, MPH Joy H. Samuels-Reid MD, FAAP Dale R. Tavris MD, MPH
CHAPTER 17
Medical Device-Related Outbreaks (Pages: 237-257)
S. Lori Brown PhD, MPH Hesha J. Duggirala PhD, MPH Dale R. Tavris MD, MPH
CHAPTER 18
Risk of Transmission of Prions with Medical Devices (Pages: 259-271)
S. Lori Brown PhD, MPH Azadeh Shoaibi MS, MHS
CHAPTER 20
Exploring Methods for Analyzing Surveillance Reports on Electromagnetic Interference with Medical Devices (Pages: 291-318)
S. Lori Brown PhD, MPH Nilsa Loyo-Berríos PhD, MS Michèle G. Bonhomme PhD Donald M. Witters Jr. MS Nancy A. Pressly BSEng Jeffrey L. Silberberg MSEE
CHAPTER 21
Alternative and Complementary Medical Devices (Pages: 319-334)
S. Lori Brown PhD, MPH Joannie C. Shen MD, MPH, PhD
CHAPTER 22
Drug-Eluting Coronary Stents (Pages: 335-353)
Hesha J. Duggirala PhD, MPH Thomas P. Gross MD, MPH David E. Kandzari MD
CHAPTER 23
The Treatment of Abdominal Aortic Aneurysms (Pages: 355-366)
Dale R. Tavris MD, MPH Louis M. Messina MD
CHAPTER 24
Cardiovascular Devices: Aortic Valves (Pages: 367-378)
Ronald G. Kaczmarek MD, MPH Chih-Hsin K. Liu RN
CHAPTER 25
Hemostasis Devices (Pages: 379-393)
Dale R. Tavris MD, MPH Beverly Gallauresi RN Ralph G. Brindis MD, MPH, FACC
CHAPTER 26
ENT Devices: Cochlear Implants (Pages: 395-405)
James K. Kane Eric A. Mann MD
CHAPTER 28
Ophthalmic Devices and Clinical Epidemiology (Pages: 427-439)
Malvina B. Eydelman MD Gene Hilmantel OD, MS James Saviola OD Don Calogero MS
CHAPTER 29
Orthopedic Devices: Epidemiologic Considerations (Pages: 441-462)
Ronald G. Kaczmarek MD, MPH Michele G. Bonhomme PhD Stanley A. Brown PhD Judith U. Cope MD, MPH Daniel S. McGunagle
CHAPTER 30
Clinical Epidemiology of Intrapartum Fetal Monitoring Devices (Pages: 463-482)
Danica Marinac-Dabic MD, PhD, MMSc Barry S. Schifrin MD Cara J. Krulewitch CNM, PhD Roscoe M. Moore Jr. DVM, PhD, DSc