Medical Device Epidemiology and Surveillance

Medical Device Epidemiology and Surveillance......Page 4
Contents......Page 8
Foreword......Page 16
Preface......Page 20
Contributors......Page 22
Acknowledgments......Page 28
1 Introduction......Page 30
Introduction......Page 34
Premarket review......Page 35
Marketing applications......Page 37
Postmarket oversight......Page 39
Conclusion......Page 47
Introduction......Page 50
Features of medical devices that are relevant to epidemiology study design......Page 55
Study designs for medical device epidemiology......Page 64
Summary and recommendations......Page 66
Introduction......Page 72
Rationale for surveillance......Page 73
Surveillance based on adverse event reports......Page 76
Surveillance based on registries......Page 81
Active surveillance......Page 82
Necessary conditions for effective surveillance......Page 83
Ideal AMDE surveillance program......Page 84
Summary......Page 87
Historical motivation......Page 92
Initial considerations for the design of DeviceNet......Page 93
MedSun basic design......Page 98
Current status......Page 100
Is MedSun successful in promoting the safe use of medical devices?......Page 103
Epidemiologic considerations......Page 104
Summary......Page 105
Description and history of NEISS......Page 108
Potential uses and limitations of NEISS......Page 109
Utilization of NEISS to produce national medical device-associated adverse event estimates......Page 110
Potential for long-term utilization of NEISS for medical device surveillance......Page 112
Technical elements......Page 116
Current terminologies......Page 120
Applications of nomenclature......Page 122
Future developments......Page 124
Introduction......Page 128
Data sources......Page 129
Surveillance databases......Page 130
Registries......Page 134
Automated large administrative databases......Page 141
National surveys......Page 144
Data mining......Page 148
Future use databases for medical device epidemiology......Page 149
Introduction......Page 156
US government human subjects protection regulations......Page 157
HHS human subjects protection regulatory requirements......Page 159
FDA human subjects protection regulations......Page 160
Other professional ethical guidelines......Page 162
Ethical requirements for medical devices epidemiologic studies......Page 165
Future ethical requirements for epidemiologic studies......Page 171
Introduction......Page 174
The product’s life cycle: premarket (preclinical and clinical) and postmarket (PM) studies......Page 177
Postmarket studies......Page 182
Summary......Page 185
Introduction......Page 188
Adverse event reporting......Page 189
Postmarket condition of approval studies and Section 522 studies......Page 192
Industry use of information from adverse event reports......Page 194
Academic opportunities......Page 196
Summary......Page 197
Review of literature......Page 200
Contrasts with pharmacopeidemiology......Page 202
Conclusions......Page 204
Introduction......Page 206
Medical devices: the European directives and definitions......Page 207
New approach......Page 208
Classification of medical devices in Europe......Page 211
Market surveillance......Page 212
The vigilance system......Page 213
14 A consumer advocate’s perspective on medical device epidemiology and surveillance......Page 216
Examples of widely publicized problems with selected medical devices......Page 218
Consumer concerns......Page 222
Regulatory mechanism recommendations......Page 226
Consumer group accomplishments: mixed results......Page 228
Introduction......Page 232
Medical device use in children......Page 233
Special device risks and safety concerns for children......Page 240
Regulatory framework......Page 241
The future for pediatric medical device surveillance and epidemiology......Page 243
Introduction......Page 248
Insulin delivery devices......Page 250
Continuous glucose monitoring devices......Page 254
Future medical devices for the management of diabetes......Page 257
Introduction......Page 266
Endoscopes: bronchoscopes and gastrointestinal (GI) endoscopes......Page 268
Hemodialysis-related outbreaks......Page 273
Neonatal and pediatric intensive care units......Page 276
Miscellaneous device-related outbreaks......Page 279
Summary......Page 280
18 Risk of transmission of prions with medical devices......Page 288
Iatrogenic transmission of prion disease via neurological or surgical instruments......Page 289
Surgical instruments used to transplant tissues known to have transmitted prion disease (corneal transplant)......Page 290
Surgical instruments in contact with lower risk peripheral tissues......Page 291
Decontaminating surgical instruments to reduce risk of TSE transmission......Page 292
FDA measures to minimize risk of transmission of BSE by medical products......Page 296
Summary......Page 297
General considerations that affect the design of epidemiologic studies of materials used in medical devices......Page 302
Example: natural rubber and latex allergy......Page 308
Summary......Page 315
20 Exploring methods for analyzing surveillance reports on electromagnetic interference with medical devices......Page 320
The MAUDE database......Page 321
Adverse event reports to FDA (December 1984–October 1995):EMI with cardiovascular devices......Page 322
Adverse events reported to FDA (January 1994–March 2005):a recent epidemiological analysis......Page 326
Discussion......Page 340
Introduction......Page 348
Acupuncture needles......Page 351
Ear candles......Page 355
Magnets......Page 357
Adverse events associated with alternative or complementary devices......Page 360
History and evolution of coronary stents: clinical perspective......Page 364
Novel drug-eluting stent programs......Page 369
Comparative trials of drug-eluting stents......Page 371
Application of drug-eluting stents in complex coronary lesion subsets......Page 374
Drug-eluting stents: regulatory perspective......Page 375
Natural history and indications for treatment......Page 384
FDA experience with the postmarket assessment of an endovascular graft......Page 387
Advances in stent-graft design and performance......Page 390
Conclusion......Page 392
Introduction......Page 396
Operative mortality......Page 399
The FDA guidance for replacement valves and the objective performance criteria (OPC)......Page 401
The need for epidemiological studies......Page 402
25 Hemostasis Devices......Page 405
The ideal vascular hemostasis device......Page 409
Origin of FDA concern with the postmarket performance of hemostasis devices......Page 411
FDA study to evaluate the risk associated with hemostasis device use......Page 416
Follow-up FDA study to assess the safety of hemostasis devices......Page 418
Conclusion......Page 419
Cochlear implant description......Page 424
Epidemiological investigations involving meningitis associated with cochlear implants......Page 425
Conclusions......Page 434
Breast implant types......Page 436
A brief regulatory history of breast implants......Page 438
FDA surveillance studies on breast implants......Page 440
Summary......Page 450
Epidemiological contributions to IOL evaluation......Page 456
Epidemiology of contact lens ulcers and public policy......Page 459
Conclusion......Page 466
Selected orthopedic materials......Page 470
Artificial hips......Page 473
Intervertebral disc replacement......Page 481
Data sources and selected methodological issues to consider in epidemiologic studies of orthopedic medical devices......Page 485
Summary......Page 487
Introduction......Page 492
Electronic fetal monitoring......Page 493
Scalp and umbilical cord blood gases analyses......Page 499
Fetal pulse oximetry......Page 500
Fetal ECG waveform monitoring......Page 502
Challenges of intrapartum fetal monitoring modalities......Page 505
Conclusion......Page 507
31 The postmarket surveillance of medical devices: meeting the challenge......Page 512
Index......Page 516