Index
A
Academic Programs in Pharmacoepidemiology, 23
Active lifestyle
cerebrospinal fluid shunt and, 51, 364
defined, 51-52
developmental control over, 52-53, 303
home environments and human factors, 53
and longevity of implants, 3, 22, 51-52, 200
social dimensions, 53
Adhesion barrier, 125
Adolescents
impact of devices on, 49-50
management of devices, 143-144
psychosocial considerations, 51
Adverse event reports and reporting.
See also Postmarket surveillance
Alternative Summary Reporting program, 92, 115, 125
anonymous, 155
automated screening process, 125, 182
case reports, 86, 126, 127, 180
cerebrospinal fluid shunts, 362-364, 369-374
classification of complications, 369-374
cochlear implants, 411-414
coding system for, 168-169, 173, 177, 182, 206, 218, 236, 340-341
competitive pressures and, 155-156
confidentiality protections, 155, 171, 236
data mining techniques, 341-342, 374-375
disproportionality analyses of databases, 336-345, 374-375
by distributors and importers, 87, 88, 116-119, 121
drugs vs. devices, 90, 167-168, 340, 341-342
ECRI program, 172-173, 369-374
education and communication programs, 165, 173, 175, 176-177, 178
enforcement of requirements, 115, 120, 174
FDA programs, 38, 114-126, 164-170, 173-177, 229, 235-236
by health professional networks, 153, 155, 161-162, 163, 171, 178, 377-378
home health agencies, 126, 156, 157-158, 166, 180
home health care and, 4, 24, 112, 123, 126, 156-157, 159, 162, 178, 181-182, 230
human factors analysis, 127, 160, 169
improvement initiatives, 111, 164-170
inappropriate, 156
interactive option, 167
international vigilance reports, 111, 125, 236
investigating, 112-113, 120-126, 151, 158-160, 161-162, 163, 170-171, 172, 173, 175, 178, 180
investigational devices, 91-92
JCAHO program, 171-172
labeling devices, 138, 149, 178
liability concerns and, 132, 155, 156
limitations of programs, 8, 113, 120-121, 125-126, 152-165, 174, 235-236, 330, 338
linkages between programs and databases, 174, 225
mandatory, 9, 24, 37, 39, 40, 86, 87-92, 94, 114, 115, 116-120, 175, 177-178, 321
manufacturer response, 86, 87-92, 93, 94, 98, 100-101, 109-110, 114, 115, 116-119, 120-121, 125, 141-142, 155, 163, 171, 175, 177-178
MAUDE database, 93, 115, 151, 155, 163, 166, 206, 342, 368, 369-374, 412-413
MDR program, 87, 368, 369-370, 411
MedSun program, 8-9, 35, 76, 94, 114, 152, 155 n.3, 159, 165-167, 171, 173, 175-177, 180, 182, 236, 321, 336
MedWatch program, 35, 37, 92, 99 n.16, 164, 171, 174, 178, 181
objectives, 87, 101, 113, 163, 173, 232, 411
online option, 114-115, 167, 174, 181-182
overreporting, 156
oversight responsibility, 74-75, 112-113, 237-238
patient privacy, 91, 93-94, 104, 154, 175
patient safety programs, 154, 156, 157, 165-167, 168, 176-177, 180
private programs, 171-173
problems with, 153-157, 161-162
public availability of information, 93-94, 103, 105, 120
recommendations, 8-9, 11-13, 174-175, 176, 177, 178, 179, 180, 182
and redesign of devices, 113
in research vs. patient care, 33
resources for patients and families, 181-182
responding to problems, 58-59, 86, 124, 161-164, 174
review processes, 121-124, 152, 160, 169-170, 172, 173
root-cause analysis, 170, 172, 173
safety advisories and, 124, 153, 206-207
shared responsibility for, 173, 244, 248-249
state programs, 170-171
statutory authority, 38, 39-40, 86, 368
terminology defined, 88-89
underreporting, 8, 94, 131, 153-156, 161, 171, 174, 177, 235, 331, 338
by user facilities, 9, 39-40, 87, 88, 91, 93, 94, 114, 115, 116-119, 120, 121, 152-153, 156, 157-158, 165-167, 171, 172, 175, 180, 236, 310, 412
voluntary, 37, 39, 86, 87 n.10, 91, 92-93, 94, 114-115, 116-119, 121, 126, 151, 163, 168, 172, 178-180
Adverse events
“caused or contributed,” 89
to children, 120, 121, 151, 206
close calls or near misses, 32-33, 91, 94, 115, 127-129, 162, 165, 166
“Code Blue” events, 124
computer-based surveillance, 167-169, 182
documenting, 114-115, 122-124, 154-155, 158, 159-160, 168, 173
environmental hazards, 130-131, 150, 162
evaluation codes, 206
failure or malfunction, 33, 35, 91, 96-97, 98, 112-113, 115, 116-119, 125, 135, 147-148
high-profile events, 124-125
home care and, 101-102, 112, 126, 162, 163
identifying, 1-2, 3, 24, 112-113, 157-158, 160-161, 165, 167-170, 171, 182
illustrative vignettes, 126-148
institutional/system factors, 127-148, 153
lifestyle-related, 206
magnitude of, 152-153
manufacturing-related, 147-148, 149
remedial action, 89
risk analyses, 327-328
sentinel events, 171-172
serious injury, 89, 91, 116-119, 122, 428
sources of, 5, 33, 112, 126-151
use errors, 26, 33, 89, 122, 126, 127-130, 138-139, 144-147, 149-150
workarounds and, 154, 169, 180
Aerosol delivery devices, 67-68
Agency for Healthcare Research and Quality, 7, 8, 14, 44, 171, 218, 219, 220, 225, 227, 235, 242, 249
American Academy of Pediatrics, 66, 153, 157, 179, 181, 203
American Association of Medical Record Librarians, 37
American Association of Orthodontists, 163
American College of Cardiology, 171
American College of Radiology, 97
American Heart Association, 248
American Medical Association, 37, 189
American Society for Testing and Materials, 366
American Society of Hospital Pharmacies, 37
American Thoracic Society, 67-68, 171, 221
Aortic connector devices, 125
Apnea monitors (home), 3, 47, 70, 77, 84 n.9, 85, 101, 108, 162, 182
Approval of Class III devices, 30, 34, 76, 78 n.4, 79-80, 85, 95, 109, 110
Arrhythmia detector and alarm devices, 85
Arthroscopy, 320
Atrial septal defect occluder, 2, 57, 58, 202, 208, 209, 302, 311, 319
Availability of devices for children, 40, 41, 45
B
Baclofen infusion pump, 141-142, 203
Balloon atrial septostomy (Rashkind procedure), 20
Bartlett, Robert, 199
Bayh Dole Act, 308
Benefits of medical devices, 4, 17-18, 20, 23, 32, 422, 424
Best Pharmaceuticals for Children Act of 2002, 40, 230
Bile duct stents, 2, 68, 98, 322
Biologics Control Act, 37
Blood pressure cuffs, 98
Bone cancer, 65
Bone cements, 71
Breast implants, 92, 95, 107, 125, 193
Breathing frequency monitors, 97
Bronchoscopes, 2, 58, 132-134, 151, 164
C
Campbell, Robert, 314
Carbon dioxide sensors, 98, 99
Cardiac stents, 2, 62-63, 68, 95, 98, 193-194
Catheters, 60, 64, 77, 124, 127, 141-142, 199, 203, 314.
See also Central vascular catheters
Centers for Disease Control and Prevention, 71, 93, 227
Centers for Education and Research in Therapeutics, 218-219, 226-227, 235
Centers for Medicare and Medicaid Services, 184 n.1, 220, 312-313, 321
Central vascular catheters, 60, 92, 95, 138-139, 143-146, 170
Cerebrospinal fluid shunts
adverse event reports, 342-345, 362-364, 368, 369-375, 377
classification of complications, 369-374
clinical trials, 367
cochlear implants compared, 375-376
complications, 20, 71-72, 112, 356, 357-364, 367-368, 369-374
defined, 347
disproportionality analysis of reports of complications, 342-345, 374-375, 377
identifying concerns with, 70, 170, 201, 377-378
infections, 20, 48, 359-361, 368, 377
innovations, 17, 65, 357-362, 376
and outcomes, 20
postmarketing surveillance, 201, 367-378
premarket regulation, 364-367
programmable, 367
Raimondi distal spring valve, 358-359
regulatory history, 347-378
valve-regulated, 17, 355, 356-357
Cerebrospinal fluid system
anatomy and physiology, 20, 347-350
pressure measurement, 350
Chest tubes, 54
Child Health Corporation of America, 167, 177, 217
Children.
See also Active lifestyle;
Adolescents;
Growth and developmental issues;
Infants
management of devices, 51
Children’s Amalgam Trial, 212
Children’s Health Act of 2000, 309
Children’s Hospital Boston, Pediatric Product Development Initiative, 47
Children’s Oncology Group, 222, 323-324
Circumcision clamp injury, 122, 129-130, 164, 172-173
Clark, Bennett Champ, 73
Class I devices, 30, 76, 77, 84, 109, 162, 309 n.4, 364, 422-423
Class II devices, 30, 34, 76, 77, 78, 84, 85, 95, 109, 110, 183, 238-239, 309-310 n.4, 315, 364-365, 423
Class III devices, 30, 34, 76, 77, 78 n.4, 79-80, 85, 95, 109, 110, 127, 183, 238-239, 246, 309, 310, 315, 365, 367, 423
Classification of devices, 5, 30, 34, 39, 76, 77-80, 103, 309
Clearance of Class II devices, 30, 34, 41, 76, 78, 84, 85, 95, 109, 110
Clinical trials.
See also Pediatric postmarket surveillance studies;
Postmarket surveillance studies;
Research on medical devices
age-specific, 47
appropriate circumstances for, 54, 221
biases, 6, 188, 190, 211, 331, 332-333
challenges with children, 220-222, 245-246, 303, 315-319
confidentiality issues, 106, 189, 192, 197, 210
CONSORT, 219
data monitoring committees, 92
design and protocols, 49 n.3, 106, 188, 189, 190, 192, 197, 210-219, 223, 233-234, 315-319, 332-334
drugs vs. devices, 41-42, 47, 210, 218, 309, 316
economic value assessment in, 318-319
ethical concerns, 211-212, 245-246, 333-334
experimental studies, 210-213
FDA guidance on, 25, 27, 32, 35-36, 40, 54-55, 224
generalizability of findings, 212, 234, 303, 320
historical controls, 213, 315, 334
identifying concerns through, 71, 141, 161
innovation in, 199
institutional and professional factors, 222, 322
multi-center, 209, 215, 216, 222, 309, 323-324
organizational infrastructure, 245, 315, 323-324
outcome measures and norms, 221-222, 315-316, 318-319, 320
parent factors, 222
performance standards for surgeons, 212, 317, 322
pivotal, 315-317
placebo effect, 213
population size considerations, 221, 303, 323
pragmatic or practical, 213
premarket, 3, 22, 209, 303, 320, 321, 322-323
protections for children, 2, 5, 10, 22, 40, 68, 73, 221, 240-241, 245, 317
public access to data, 6, 14, 188-189, 190, 192, 194-195, 197, 233-234
randomized controlled, 211-212, 309, 310, 314, 315, 317-318, 331, 332-334
recruitment of participants, 210, 316, 337
registry of, 187-190, 197, 213, 234, 318
reporting of, 219
single-arm, 212-213, 303, 315, 316, 318
Close calls or near misses, 32-33, 91, 94, 115, 127-129, 162, 165, 166, 426
Cochlear implants
and balance functions, 402-403
candidacy evaluation, 387-391
classification, 77
clinical trials, 319
cochlear malformations and, 394-398
and communication outcomes, 382-383, 384-385, 387, 408-410
complications, 3, 388, 391-392, 398-405, 410-415
CSF leaks, 398
defined, 383
device infection, 400
electrode placement problems, 394, 398
etiologic assessment, 389-390
facial nerve injury, 398, 399, 404
failure of device, 130-131, 303, 380, 405-408
growth and development considerations, 392-393
histopathology of, 404-405
and infections and other post-operative complications, 3, 399-405
Internet information site, 383
intra-operative complications, 398-399
labyrinthitis ossification and, 3, 388, 389, 390, 393-394
medical and otologic assessment, 387-389
and meningitis, 3, 70, 71, 100, 125, 126, 151, 161, 214, 375-376, 388-389, 393, 394, 398, 400-402
and MRI, 389, 390-391, 394-395
and otitis media, 389, 399-400
public health notification, 100
radiologic assessment, 390-391
regulation of, 410-415
revision surgery, 407
scalp flap complications, 392-393, 403-404, 408
special populations, 393-398
surgery-related complications, 392-399
surgical procedures, 392-393
and tinnitus, 402
tracking complications in children, 214, 410-415
and vertigo, 402-403
“Code Blue” events, 124
Coding system for devices, 8, 14, 168-169, 173, 177, 182, 218, 224, 225, 249, 312
Cognitive and psychosocial considerations, 49, 50-51, 52
Combination products
regulatory responsibility, 74
Compassionate use exemptions, 65, 80, 423
See also Adverse event reports and reporting
Complications.
See also Adverse event reports and reporting;
Adverse events;
Infections
cerebrospinal fluid shunts, 20, 71-72, 112, 357-364, 369-374
classification of, 369-374
criteria for defining, 391-392
developmentally related, 21, 48, 57, 71, 134-135, 136-138, 141-142
disproportionality analysis of reports of, 342-345, 374-375
drug-related, 57
of hydrocephalus, 357-362
hypersensitivity reactions, 1, 21, 67, 166-167, 227, 330
surgery-related, 392-399
Computed tomography (CT), 2, 61, 86, 101, 224, 305, 351-352, 353, 390
Condition-of-approval studies
defined, 424
monitoring commitments, 190-192, 195, 202
pediatric, 82, 192, 202-203, 208, 209
postmarket surveillance, 34-35, 76, 78, 79, 80, 82, 85, 96, 106, 183, 190-192, 202-203, 208, 209
Confidentiality
adverse event reports, 155, 171, 236
clinical trial information, 106, 189, 192, 197, 210
of commercial information, 7, 10, 102-105, 189, 194-195, 197, 424, 429
and innovation, 10
and international cooperation, 236
statutory restrictions, 10, 102, 103, 104, 105, 106, 191, 246
of surveillance studies, 7, 102, 189
Congenital heart disease, 57
Contamination of devices, 98
Cooper, Theodore, 39
Cooper Committee, 39
Counterfeiting, 150
Craniofacial fixation devices, 66, 72, 303
Cribs, 173
Cystic fibrosis, 67, 133, 143-144
D
Data entry errors, 135-136
Data monitoring committees, 92
Deaths, 91, 94, 113, 115, 116-119, 122, 146-148, 162, 214
Deep brain stimulators, 3, 52, 56, 60, 70, 71, 77
Defibrillators, 2, 35, 58, 59, 60, 97, 101 n.17, 134-135, 173, 203, 247-248, 312, 313
Design of pediatric devices.
See also Innovation;
Use of devices with children
accessories for children, 2, 58, 59-60
adverse events related to, 127-148, 149
behavioral factors, 67-68
benefit-harm balancing, 2, 21-22
childproofing, 53
clinical trial challenges, 315-319
developmental considerations, 1, 2, 23, 54, 55-68, 136-138, 141-142
environmental considerations, 131-132, 216, 224
growth accommodation, 1, 2, 54, 55-69, 65-67, 134-138, 141-142, 200
human factors engineering, 107, 149-150, 169
identifying concerns or adaptations, 3, 4, 36, 48, 107, 232-233
lifestyle factors, 303
limits to downsizing or other adaptations, 64-65, 69-70
and malfunctions or failures, 130-131
manufacturer studies for approval of new uses, 36, 85
problem identification, 69-72, 129
redesign and preventive design, 42, 99, 100-101, 113, 129
regulatory controls, 107
same device for all patients, 1, 2, 58, 58-59
sanitation considerations, 132-134
shared responsibilities for safety, 4, 232-233, 247-248
size adjustments, 2, 19, 21, 58, 59, 61-65, 302-303
spectrum of, 56-68
unique or nearly unique to children, 1, 2, 57, 58
use errors related to, 129, 130, 149
workarounds, 68-69, 144-146, 169
Device Experience Network database, 93
Devicenet, 94
Diabetes, 53
Disproportionality analyses of databases
advantages, 337
analytic issues and strategies, 338-341
Bayesian confidence propagation neural network method, 340-341
confounding and bias, 339-340
data mining techniques, 341-342, 374-375
drugs vs. devices, 341-342
example, 342-345
overview, 336-341
use—outcome association, 336-337
Distraction osteogenesis device, 139-141
Distributors of devices
adverse event reporting, 87, 88, 116-119, 121
defined, 424
tracking devices, 97
Drug Amendments of 1962 (Kefauver-Harris), 37, 38
Drug-eluting stents, 29, 100, 161, 166-167, 330
Drug Importation Act, 37
Drug infusion pumps, 32, 43, 50, 51, 58, 69, 97, 101-102, 138-139, 141-142, 150-151, 172, 203
Drugs
accelerated approval, 185
adverse event reporting, 90, 91, 167-168, 341-342
devices compared, 4, 24, 27-28, 36, 38, 41-42, 47, 48, 49, 56, 57, 82, 90, 91, 150-151, 167-168, 229-230, 302, 316, 341-342
clinical trials, 41-42, 47, 210, 218, 309, 316
commitment monitoring, 185-187, 197, 246
complications related to, 57
confidentiality of surveillance studies, 102, 189
device-related errors, 150-151
FDA regulation compared, 4, 9, 24, 36, 38, 41-42, 48, 49, 82, 185-186, 229-230
innovation, 302
labeling, 99 n.16
patient safety initiatives, 11, 242-243
for pediatric use, 40, 185 n.3, 187
withdrawal of, 185
E
Ear thermometers, 58
ECRI, 30, 97, 172-173, 247-248, 369, 373-374, 376
Education and communication programs
adverse event reporting, 165, 173, 175, 176-177, 178
Effectiveness
exemptions from requirements, 40
statutory requirement, 38
Endoscopes and endoscopy, 320, 355-356, 357
Endovascular graft failures, 125
Endovascular Technologies, 120 n.1
Enforcement
of adverse event reporting requirements, 115, 120, 174
FDA authority, 37, 98, 99, 195, 223
Environmental hazards, 130-131, 150, 162, 216 n.4, 224, 247-248, 367
Epidemiologic research
on adverse event reports, 71, 125, 161, 168, 194
proportional mortality analysis, 338
STROBE, 219
European Standards Organization, 30
European Union, definitions of medical device, 28, 29 n.2
Extracorporeal Life Support Organization, 215-216, 321
Extracorporeal membrane oxygenation, 199-200, 215, 333-334
F
Failures or malfunctions, 33, 35, 91, 96-97, 98, 112-113, 115, 116-119, 125, 130-131, 135, 147-148, 405-408, 424, 425
Fair Packaging and Labeling Act, 37
FDA Modernization Act of 1997, 22, 38, 40, 79, 80, 82, 87, 94, 95, 96, 110, 186, 188 n.4, 218, 239, 412
FDA regulation of medical devices.
See also Postmarket surveillance;
Premarket regulation
Accredited Persons program, 110, 239
adequacy of, 5-10, 110, 152, 153, 163, 164, 174, 183, 185-186, 229-230, 232-238, 376-377
budget and resources, 75-76, 163
classification of devices, 5, 30, 34, 39, 76, 77-80, 103, 309, 364-365
confidentiality of information, 10, 102-106, 189
context for, 41-45
coordination of pediatric issues, 230, 232, 237-238
cross-boundary programs, 106-111
disseminating information, 237-238
drug regulation compared, 4, 24, 36, 38, 41-42, 48, 49, 82, 185-186, 229-230, 237
enforcement authority, 37, 98, 99, 195, 223
epidemiologic research program, 75, 106-107, 321
expedition of review, 25
guidance documents, 25, 27, 32, 35-36, 40, 48, 49, 54-55, 61, 74, 101, 157, 224, 230, 232
home health committee, 157, 181, 230, 236
independent oversight, 9, 237-238
and innovation, 24, 41, 45, 46, 240-241, 309-311
international harmonization activities, 30, 37, 85, 110-111
organization for, 10, 74-76, 230, 237-238
pediatric expertise in, 4, 10, 25, 40-41, 55, 173, 230
public health notifications, 5, 86, 92, 100, 103, 232
quality systems regulations, 84, 101, 107-110
recalls and corrections, 5, 26, 40, 86, 92, 98-99, 110, 164
recommendations for, 173-177
research, analysis, and methods development, 75, 106-107
responses to potential safety problems, 9, 97-102, 125, 163, 170
responsibilities, 33-34, 93, 309
safety criteria, 31
standards development, 106-107
statutory authority, 7, 22-23, 36-37, 39, 40, 41, 73, 78, 86, 107, 230, 234-235, 309, 364-365, 368
systems perspective, 44-45
Federal Food, Drug, and Cosmetic Act
510(k) applications, 78, 82, 83, 102, 104, 105, 191, 192, 365
adverse event reporting, 86
confidentiality protections, 102, 105, 106
FDA authority, 36, 37, 73, 86, 364
and quality systems regulations, 107
Section 522, 7, 14-15, 34, 85, 95, 183-184, 191, 193-195, 200, 201-202, 226
Fever reduction device, 193
Food and Drug Administration.
See also FDA entries
Bureau of Medical Devices and Diagnostic Products, 39
Center for Biologics Evaluation and Research, 74
Center for Devices and Radiological Health, 6, 10, 15, 27, 29, 39, 42, 74, 75-76, 106-107, 124, 157, 164, 173, 181, 183, 190-191, 193, 194, 195, 224, 225-226, 230, 232, 235, 236, 238, 239, 412
Center for Drug Evaluation and Research, 9, 29, 185, 186, 194, 225, 237
Drug Safety and Risk Management Advisory Committee, 237-238
extramural research program, 225-226, 235
Office of Communication, Education, and Radiation Programs, 75
Office of Device Evaluation, 74, 96
Office of In Vitro Diagnostic Device Evaluation and Safety, 74
Office of Surveillance and Biometrics, 74-75, 76, 96
Patient Safety News, 164
Pediatric Advisory Committee, 230
Freedom of Information Act, 102, 103, 104, 105, 106, 191
G
Gastronomy tubes, 136-138
General controls, 77, 78, 79, 83-84, 365, 424
Global Harmonization Task Force, 37, 111
Global Medical Device Nomenclature, 30, 173
Government Accountability Office, 152
Groopman, Jerome, 46
Growth and developmental issues
accommodations in devices, 58, 65-67, 364
active lifestyle and, 52-53, 303
cognitive and psychosocial, 49, 50-51, 52
complications related to, 21, 57, 71, 134-135, 136-138, 141-142
CSF shunts, 364
definitions, 50
in design and use of devices, 1, 2, 54, 55-69, 134-138, 141-142, 200
identifying problems with devices, 69, 70-71, 134-135
infants, 50
and innovation goals, 50
long-term studies, 3, 23, 48, 49, 61, 71-72, 127, 148-149, 193, 200, 202, 206-207, 212, 223, 226, 248-249, 303
metabolic interactions, 56
migration of implants, 50, 55, 66, 72, 202, 205, 206
overstimulation concerns for infants, 50
patient cooperation, 67
physical interactions, 56
and postmarket surveillance, 50
replacement of implants, 50, 55, 60 n.6, 61, 65, 201, 303
surgical accommodations, 62
H
Harder, Ben, 51
Harder, Nancy, 112
Health insurance coverage
clinical trials, 184 n.1, 210 n.2, 314, 321
and innovation, 312-313, 322, 324
Health Insurance Portability and Accountability Act of 1996, 91, 93-94, 154, 175, 210, 415
Health Maintenance Organization
Research Network, 218-219
Health professionals and health professional societies
adverse event reporting, 153, 155, 161-162, 163, 171, 178
educating and communicating with patients and families, 127-129, 131-132, 137, 139, 157, 178, 181, 182, 246
postmarket research, 235
recommendations, 178-180
registries, 215-217, 226-227, 321
training in device use and event reporting, 129, 150, 154, 165, 178, 180, 193, 205, 212, 247-248, 317, 322
Hearing screener for newborns, 2, 47, 58
Heart valves, 1, 2, 18, 39, 57, 58, 67, 70, 72, 95, 97, 149, 168, 302-303, 311
adverse event reporting, 126, 156, 157-158, 166, 180
Home health care
active lifestyle and, 53
and adverse event reporting, 4, 24, 112, 123, 126, 156-157, 159, 162, 178, 181-182, 230
apnea monitors, 3, 47, 70, 77, 84 n.9, 85, 101, 162
checklist for device use, 157, 181
education and assistance resources, 127-129, 131-132, 137, 139, 157, 178, 181, 182, 248
prothrombosis time test kits, 193 n.6
resources for patients and families, 181-182, 244, 248
risks of adverse events, 101-102, 112, 126, 162, 163
user errors, 126, 138-139, 248
Hospital beds, 125
Human factors analysis, 11, 127, 160, 169, 244
Human factors engineering, 107, 149-150, 169, 424
Humanitarian use devices, 29, 40, 52, 57, 59, 81-82, 83, 192, 203, 204-205, 303, 310-311, 314, 424-425
Hydraencephaly, 355
Hydrocephalus.
See also Cerebrospinal fluid shunts
in adults, 350
classification systems, 350-351
complications, 357-362
defined, 350
diagnosis, 351-352
life expectancy, 17
modern CSF shunt development, 357-362
I
Immune complex glomerulonephritis, 358
Implanted devices or implants.
See also Complications;
individual devices
“active,” 29 n.2
and active lifestyle, 3, 22, 51-52, 200, 303
capsular contracture, 125
failures or malfunctions, 33, 35, 91, 96-97, 98, 112-113, 115, 116-119, 125, 130-131, 135, 147-148, 159, 214-215, 356-357, 405-408
list, 295-301
longevity of, 3, 22, 51-52, 200, 206, 303
migration of, 50, 55, 66, 72, 202, 205, 206, 358, 361, 362
MRI magnetization, 97
permanent, 426
replacement, 50, 55, 60 n.6, 61, 65, 201, 303
resorbable, 66-67
retrieval of failed or malfunctioning devices, 159, 214-215, 361-362
skin thickness and, 64-65
tracking, 28-29, 39-40, 42-43, 97, 410-415, 424
Incubators, 2, 47, 57, 58, 77, 147-149, 173
Infants
adverse events, 122, 123, 356-357
brain plasticity, 48-49
complications of implants, 48, 71
device placement, 60
devices for, 2, 18, 20, 47, 57, 65, 98, 123, 356-357
developmental considerations, 50, 57, 64-65, 69
overstimulation, 50
oxygen therapy, 148-149
Infections, 61
cerebrospinal fluid shunts, 20, 48, 359-361
cochlear implants and, 3, 70, 71, 100, 125, 126, 399-405
Innovation.
See also Design of pediatric devices;
Manufacturers
adoption of new technology and continuation of, 319-320
adverse event reporting and, 163, 310, 321
cerebrospinal fluid shunts, 17, 65, 357-362
in clinical trial design, 199, 240-241
defined, 68
drug industry compared, 302
economic value assessment, 318-319, 324
FDA regulation and, 24, 41, 45, 46, 240-241, 309-311, 321
federal support for R&D, 308-309
growth-accommodating devices, 50, 66, 68
incentives for, 322-324
industry and markets, 21, 46, 240, 304-306, 313, 322, 323
miniaturization of components and, 59, 64
players in, 304-308
policy environment, 10, 240-241, 308-313, 321, 324
postmarket evaluation and, 232, 235, 310, 320-322, 323, 324
premarket evaluation, 207, 310, 314-319, 320, 321, 322-323, 324;
see also Clinical trials
product development cycle, 42-44
prototype development, 313-314, 315
public-private partnerships, 324
reimbursement issues, 312-313, 322, 324
research burdens, 207-208
and shared responsibility for safety, 232-233, 243-244
universities and academic health centers, 47, 306-308, 313-314, 315
workarounds and, 67, 69, 144-146
Inspection of facilities and devices, 5, 36, 109, 129, 238-239
Institute for Safe Medical Practices, 171
Institutional Review Boards (IRBs), 81, 82, 91-92, 96, 189, 317, 425
Insulin Amendment, 37
International Classification of Diseases, 168 n.5
International Committee of Medical Journal Editors, 189
International Conference on Harmonization, 111
International Electrotechnical Commission, 97
International harmonization activities, 30, 37, 85, 108-109, 110-111
International Organization for Standardization, 108-109, 110, 365-366
International Society for Pharmacoepidemiology, 23, 220
International Society for Pharmacovigilance, 23
International vigilance reports, 111, 125
Internet, adverse event reporting online, 114-115, 167, 174, 181-182
Intracardiac echocardiography, 63-64
Intraocular lens replacement, 62
Intravenous catheters and needles, 58, 68-69
Investigating adverse events, 112-113, 120-126, 151, 158-160, 161-162, 163, 170-171, 172, 173, 175, 178, 180, 194
Investigational devices, 80-81, 91-92, 102-103, 104, 106, 109, 425
J
Joint Commission of Accreditation of Healthcare Organizations, 32 n.5, 44, 171-172, 248
L
Labels and labeling of devices
adverse events and, 87 n.11, 138, 149, 178
drugs, 99 n.16
guidance to manufacturers, 246
indications for use, 45, 56, 68, 83, 125, 178, 209, 224, 241
links to databases for monitoring studies, 197
special controls, 84
Labyrinthitis ossification, 3, 393-394
Lap band adjustable gastric band, 125
Laparoscopic surgery, 319, 320
Liability issues, 132, 155, 156
Limb prostheses, 65-66
Long Q-T Syndrome, 134-135
Lung function evaluation devices, 67
M
Magnetic resonance imaging, 97, 305, 314, 351, 352, 354, 367, 389, 390-391
Mandatory Medical Device Reporting (MDR) program, 87, 368, 369-370
Manufacturer and User Facility Device Experience (MAUDE) database, 93, 115, 151, 155, 163, 166, 342, 412-413
Manufacturers
adverse event reporting, 86, 87-92, 93, 94, 109-110, 114, 115, 155-156, 177-178, 310, 411-412
Alternative Summary Reporting program, 92, 246
annual reports, 192-193
competitive pressures, 155-156
complaint handling, 90, 156, 178
confidentiality protections, 7, 10, 102-105, 189, 194-195, 197, 424
corrective and preventive actions, 99, 109-110, 178-179, 424
disclosure of notifications, 100
educational support information from, 141-142, 178, 246
enforcement actions against, 115, 120, 195
inspections, 5, 109, 110, 115, 120, 126, 178, 247
investigating adverse events, 120-121, 159, 175, 177, 178, 194
labeling products, 178
postmarket surveillance, 35, 37, 86, 106, 125, 246
quality assurance, 5, 109, 110, 115, 120, 126, 178
recommendations for, 177-178
redesign and preventive design, 100-101
response to adverse events, 86, 87-92, 93, 94, 98, 100-101, 109-110, 114, 115, 116-119, 120-121, 125, 141-142, 155, 163, 171, 175, 177-178
studies for approval of new uses, 36, 85
surveillance plans, 102-103
tracking devices, 97, 110, 161, 310, 424
withdrawal of products, 125
Mechanical ventilators, 1, 17-18, 19, 20, 26, 50, 58-59, 64-65, 97, 101, 112, 173, 222
Medicaid programs, 312
Medical Device Amendments
of 1976, 22, 37, 39, 73, 79, 87, 309, 368
of 1992, 87
Medical Device Engineering Network (M-DEN), 167
Medical Device Laboratory Product Problem Reporting Program, 87 n.10
Medical Device Safety Network, See MedSun
Medical Device User Fee and Modernization Act of 2002, 2-3, 22-23, 25, 38, 40, 54, 55, 82, 110, 190, 192, 230, 239
Medical devices.
See also Combination products;
Implanted devices or implants;
Innovation;
Pediatric devices;
individual devices
drugs compared, 4, 24, 27-28, 36, 38, 41-42, 47, 48, 49, 56, 57, 82, 90, 91, 150-151, 167-168, 229-230, 302, 316, 341-342
failure or malfunction, 33, 35, 91, 96-97, 98, 112-113, 115, 116-119, 125, 130-131, 135, 147-148, 405-408, 424
industry characteristics, 21, 41-42, 46, 240, 304-306, 313, 322, 323
maintenance and repair, 129
nomenclature/coding system, 8, 14, 30-31, 168-169, 173, 177, 182, 218, 224, 225, 249, 288-301, 312
non-implant, 288-294
“non-significant risk,” 81, 426
product development cycle, 42-44
shared responsibilities for safety, 4, 24, 232-233, 243-249
Medical Devices Technical Corrections Act, 38, 41, 230
Medicare
coverage, 44, 86, 184, 210 n.2
MedSun (Medical Device Safety Network) program, 8-9, 35, 76, 94, 114, 152, 155 n.3, 159, 165-167, 171, 173, 175-177, 180, 182, 236, 321, 336
MedWatch program, 35, 37, 92, 99 n.16, 164, 171, 174, 178, 181
Meningitis, 3, 70, 71, 100, 125, 126, 151, 161, 214, 400-402
Monitoring postmarket study commitments
action toward, 186-187
condition-of-approval studies, 190-192, 195, 202
for devices, 190-195
FDA shortfalls in, 3, 6, 183, 185-186, 229-230, 233
humanitarian device exemptions, 193
links to alerts and labeling changes, 197
pediatric use of devices, 192, 193, 197-198
public availability of information on, 6, 186, 190-191, 192, 193, 194, 197-198, 233, 237-238
recommendations, 6, 13-14, 195-198
registry of clinical trials, 187-190, 197
responsibility for, 6, 75, 96, 183
Section 522 postmarket surveillance studies, 191, 193-195
status reports, 9-10, 186-187, 190, 191, 194, 197, 233
tracking system, 192, 193, 195-197
N
Nasal dressing, 122
National Association of Children’s Hospitals and Related Institutions, 157, 167, 177, 181
National Cancer Institute, 61, 222
National Center for Patient Safety, 170
National Childhood Vaccine Injury Act of 1986, 93 n.15
National Consumers League, 171
National Electronic Injury Surveillance System (NEISS), 152-153, 225
National Heart Lung and Blood Institute, 39, 215, 308-309
National Institute for Biomedical Imaging and Bioengineering, 308
National Institute for Child Health and Human Development, 222
National Institute of Dental and Craniofacial Research, 212
National Institute of Standards and Technology, 227
National Institutes of Health, 7, 36, 44, 49 n.3, 86, 126, 188 n.4, 212, 220, 222, 227, 235, 244, 249, 307, 308, 321
National Science Foundation, 227
Near misses. See Close calls or near misses
Neonatal ECMO Registry, 321
Neonatal intensive care units, 151, 222.
See also Incubators;
Infants
Neurological devices, 54-55, 77, 224, 311, 334
New England Research Institute, 215
New York Patient Occurrence and Tracking System, 170-171
New York State Cardiac Advisory Committee, 321
North American Industrial Classification System, 30 n.4
O
Office of Inspector General, 185, 186
Office of Pediatric Therapeutics, 40
Oral swabs, 26
Organisation for Economic Co-operation and Development, 308
Orphan technologies, 59 n.5
Orthodontic headgear injury, 131-132, 163, 178
Orthopedic devices, 3, 70, 224
growth accommodating, 65-66, 66, 139-141
Otitis media, 399-400
Outcomes
adverse, 32
improvements in, 20
measures and norms, 221-222, 315-316, 318-319, 320
P
Pacemakers, 1, 2, 3, 19, 21, 26, 35, 39, 52-53, 61, 62-63, 65, 70, 77, 95, 97, 113, 313
Patent ductus arteriosus, 47
Patient consent
for retrieval of implants, 159
for tracking, 97
Patient privacy, 91, 93-94, 104, 105, 154, 175, 210
Patient safety
communication of information affecting, 9
drugs v. devices, 11, 31, 242-243
FDA initiatives, 9, 97-102, 125, 163, 170
innovation and, 232-233, 243-244
programs, 10, 154, 156, 157, 165-167, 168, 170, 176-177, 180
shared responsibility for, 10-11, 232-233, 241-243
Pediatric devices.
See also Design of pediatric devices;
Implanted devices or implants;
Use of devices with children
barriers to development of, 230, 231
cleaning, disinfecting, and inspecting, 133
developmental considerations, 55-69
examples, 1, 17-18, 20, 76, 77
incentives for developing, 47
identifying concerns with, 70, 170, 201
lists, 288-301
longevity, 206
waiver of fees for, 83
Pediatric Health Information System, 217
Pediatric Heart Transplant Study, 216-217
Pediatric population, defined, 27, 426
Pediatric postmarket surveillance studies.
See also Clinical trials
510(k) devices, 226, 234, 303, 310, 365
active lifestyles considerations, 51-52, 200, 202, 206, 207, 223, 234
adequacy, 3, 7-8, 14-15, 22, 23, 51-52, 199-228, 232, 234-235
adverse event reports and, 201, 206-207, 214, 217
age-specific, 47
availability of data, 7, 196, 200, 201-202, 207, 219, 233-234, 246
benefits, 201
cerebrospinal fluid shunts, 201, 367-369
condition-of-approval studies, 82, 192, 202-203, 208, 209
data mining techniques, 374-375
designs and information resources, 210-219, 225-226, 233-234
dimensions and complexity of research, 207-220
epidemiologic, 201, 220, 224-225, 249
follow-up studies, 202, 203, 209, 210, 216, 223
growth and developmental aspects, 7, 23, 49, 50, 200, 202, 203, 204-205, 206, 207, 212, 222-223, 234
and innovation, 232, 235, 310, 320-322, 323, 324
length of, 3, 23, 48, 49, 61, 71-72, 127, 148-149, 193, 200, 202, 206-207, 212, 223, 226, 232, 248-249, 303
patient databases as resources, 7-8, 217-219, 224, 225, 236
premarket clinical studies as resources, 204-205
protections for children, 2, 5, 10, 22, 40, 49, 68, 73
public access to information from, 6, 14, 190-191, 196, 197-198, 232, 233-234, 246
recommendations, 7-8, 14-15, 195-197, 222-228
registry-based, 6, 199, 204, 208, 214, 215-217, 225, 226, 303, 312
reporting of information from, 219
safety advisories and, 201, 206-207
Section 522, 7, 14-15, 200, 201-202, 226, 234-235
sharing responsibility for, 231, 246
voluntary, 7, 60, 203, 207, 212, 235
Pediatric Research Equity Act of 2003, 185 n.3, 187, 194
Pediatric Research Initiative, 309
Pediatrics, defined, 27
Pharmaceutical Research and Manufacturers Association, 189
Pharmacoepidemiology, 219
Plastic tubing, 216 n.4
Postmarket surveillance.
See also Adverse event reports and reporting;
FDA regulation of medical devices;
Pediatric postmarket surveillance studies;
Postmarket surveillance studies
by accrediting groups, 35
active, 35, 114, 166-167, 175, 329, 422
basics of, 85-97
budget, funding, and resources, 76, 186, 238-240
compliance with, 190
defined, 34, 74 n.2, 85, 95, 422, 426-427
departure of device from market and, 42
FDA responsibilities, 34, 74-75
follow-up information, 197, 232
by health care providers, 35
international initiatives, 111
limitations of, 72, 76, 94, 113, 376-377
mandatory, 37, 95, 193 n.6, 234-235
by manufacturers, 35, 37, 86, 106
objectives, 5, 34, 95-96, 232, 368-369
passive, 35, 94, 114, 152, 165, 173-174, 329-330, 426
pediatric context, 46-72
by private organizations, 35
regulatory framework, 73-111
resources to support, 238-240
Section 522 activities, 34, 85
sentinal system, 94
shared responsibilities for safety, 35, 232-233, 248-249
by state governments, 35
systems perspective, 45
see also Adverse event reports and reporting
tracking of medical devices, 28-29, 39-40, 86, 96-97, 110, 167-169, 310, 410-415
Postmarket surveillance studies.
See also Clinical trials;
Monitoring postmarket study commitments;
Pediatric postmarket surveillance studies;
Research on medical devices
bias sources, 330-331
characteristics of interest, 327-331
condition-of-approval studies, 34-35, 76, 78, 79, 80, 82, 85, 96, 106, 183, 190-192
confidential information, 10, 103, 106, 189, 203, 210
criteria for, 96
designs and information resources, 95, 331-336
disproportionality analyses of spontaneous adverse event reporting databases, 336-345
of drugs, 3, 102, 185-187, 195
fees for evaluating, 82-83
for humanitarian device exemption, 183
identifying concerns or adaptations, 3, 70, 71, 86, 232-233
and IRBs, 96
knowledge-building activities, 86
for labeling for use changes, 184
numerator and denominator data, 160, 165, 329-330
probabilities of outcome events, 327-328
questions and methods, 327-345
registry-based, 35, 187-190, 215, 321, 336
release from requirements, 195, 196, 197
required, 7, 22, 40, 78, 85, 95-96, 193-195
Section 522, 7-8, 14-15, 35, 95, 96, 183-184, 191
statutory authority, 7, 183-184, 234-235
use—outcome associations, 328-329
Premarket approval applications (PMAs), 82
confidentiality protections, 10, 102, 103-104, 105, 106
content, 109
delays in approval, 40, 42, 229, 238-239, 310 n.5
design controls, 109
“determination” meetings, 79, 244
inspections, 110, 238-239, 247
supplemental, 79, 105, 202-203
task-specific approach, 208-209
clearance without testing, 59-60
clinical studies, 3, 22, 209, 303, 310, 319, 320, 322-323
FDA guidance on, 25, 27, 32, 54-55, 243-244
identification of concerns, 70, 71
in vitro testing, 208-209, 314
and innovation, 207, 310, 314-319, 320, 321, 322-323, 324
inspections, 110, 238-239, 247
Institutional Review Boards, 81, 82, 91-92
regulatory responsibility, 74
uncertainties in, 319, 322-323
Premarket notifications (510(k)), 78, 82, 83, 102, 104, 105, 191, 192, 365, 366-367, 427
Premarket regulation.
See also Premarket approval applications
cerebrospinal fluid shunts, 364-367
Class I devices, 30, 76, 77, 84
Class II devices, 30, 76, 77, 78, 84, 85
Class III devices, 30, 34, 76, 77, 78 n.4, 79-80, 85
clearance or approval requirements, 5, 76-83, 110, 239
general controls, 77, 78, 79, 83-84, 365, 424
guidance documents, 78, 84 n.9, 85, 108
humanitarian device exemption, 29, 40, 52, 57, 59, 81-82, 83, 310-311
investigational device exemptions, 80-81, 102-103
least burdensome approach, 82
mandatory performance standards, 84-85, 103, 110-111
off-label or unlabeled use of devices, 83
product development protocol, 79-80, 103
special controls, 5, 78, 79, 84-85, 108, 365, 428-429
“substantially equivalent” devices, 78, 82, 309, 365-367, 376, 429
supplemental applications, 79, 105
user fees, 82-83
Privacy Act, 102.
See also Patient privacy
Prothrombosis time test kits, 193 n.6
Psychosocial factors
active lifestyle, 53
adolescents, 51
Public access to information
adverse event reports, 93-94, 103, 105, 120
clinical trial data, 188-189, 190, 192, 194-195, 197
communication strategy, 9
pediatric postmarket surveillance studies, 6, 14, 190-191, 196, 197-198, 232, 233-234, 246
status of study commitments by manufacturers, 6, 186, 190-191, 192, 193, 194, 197-198, 233, 237-238
Public health advisories and notifications, 5, 9, 86, 92, 100, 103, 106, 124, 129, 153, 161, 162, 163, 164, 172, 174, 192, 194, 206-207, 232, 248, 427
Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 186
Public Health Service Act, 37
Pulmonary artery rupture, 107
Pulmonary valved conduit, 57
Pulse oximeters, 2, 20, 58, 59, 71
Pure Food and Drugs Act, 36, 37
Q
Quality Interagency Coordination (QulC) Task Force, 170
Quality systems regulations, 84, 108-109
complaint review and evaluation, 90, 156, 178
corrective and preventive actions, 101, 109-110
defined, 427
design controls, 109
good manufacturing practices, 107-108, 322
inspections, 5, 110, 109, 115, 120, 126, 178, 247
international standardization, 108-109
statutory authority, 107
R
Radiation
acne treatment, 320
dose errors, 135-136
Radiolabeled drug markers, 68
Rare disease or condition, 81, 427.
See also Humanitarian use devices
Recalls and corrections, 5, 26, 36, 40, 86, 90, 92, 98-99, 110, 111, 133, 153, 162, 164, 172, 174, 215, 376, 424, 427
Recommendations
adverse event reporting, 8-9, 11-13, 174-175, 176, 177, 178, 179, 180, 182
coding system for devices, 8, 14, 177, 182, 225
epidemiological research, 8, 14, 225
FDA programs, 10, 15, 173-177, 232
health professionals and professional organizations, 178-180
home care resources, 13, 181-182
manufacturers, 177-178
monitoring postmarket study commitments, 6, 13-14, 195-198
patient safety initiatives, 9, 13, 15, 180, 242
pediatric postmarket surveillance study improvements, 7-8, 14-15, 195-197, 222-228
public access to information, 6, 14, 197-198
recommendations, 181-182
Registries
of clinical trials, 187-190, 197
diagnosis-based, 213, 215, 226, 336
funding for, 321-322
health professional organizations as sponsors, 215-217, 226-227, 321
intervention-based, 215-216
manufacturer, 215
postmarket studies based on, 35, 179, 180, 213, 215, 225, 226, 321-322, 330, 335-336
registry of registries, 225
warranty lists, 214
Regulation of medical devices.
See also FDA regulation of medical devices;
Postmarket surveillance
international initiatives, 110-111
terminology, 27-36
REMATCH trial, 316
Research on medical devices.
See also Clinical trials;
Innovation;
Pediatric postmarket surveillance studies;
Postmarket surveillance studies
adverse event reporting in, 33
autopsy studies, 214
bias sources, 6, 188, 190, 211, 330
case cohort studies, 330
case control studies, 214, 330, 335-336, 337
case reports, 86, 126, 127, 180
challenges with children, 220-222
clinical evaluation, 22, 244-246, 332-334
collaborative, 7, 15, 225-226, 227, 235, 309
conference to set agenda for, 7, 227-228, 235
criteria for, 227-228
dimensions and complexity, 207-220
FDA extramural program, 225-226, 235
observational studies, 211, 213-215, 217, 321
prospective comparative studies, 212-213, 218, 312, 314, 334-335
registry-based, 35, 179, 180, 213, 215, 225, 226, 321-322, 330, 335-336
on retrieved devices, 214-215
retrospective, 214, 216, 334-335
retrospective studies, 335, 337
risk analyses, 327-331
shared responsibilities for, 225-226, 227, 244-246, 249
Reuse of devices, 97
Risk
biased estimated, 331
classification of devices based on, 5, 39, 76
management, 428
probability analysis of adverse events, 327-331
S
Safe Medical Devices Act, 37, 39-40, 85, 87, 95, 96, 107, 310, 411
Safeguards
commitments for postmarket studies as, 196-197, 244
defined, 31
postmarket surveillance as, 223
Safety
alerts, see Patient safety;
Public health advisories and notifications
criteria, 31
defined, 31
device, 243-249
long-term, 248-249
in manufacturing and supply, 246-247
patient, 241-243
shared responsibility for, 4, 24, 43, 173, 237-238, 241-249
tips for preventing medical errors, 242-243
in use of devices, 69, 247-248
Section 522, 7-8, 14-15, 35, 95, 96, 183-184, 191
Securities and Exchange Commission, 105
Sentinal events, 32 n.5, 171-172.
See also Adverse events
Skin thickness and implants, 64-65
Special controls, 5, 78, 79, 84-85, 108, 365, 428-429
Statz-Hill, Melisande, 126
Sudden infant death syndrome, 3, 339-340
Surveillance.
See also Postmarket surveillance
bias sources, 330-331
characteristics of interest, 327-331
data collection strategies, 329-330
Syringe, aspirated cap, 127-129
Systematic Technical Assessment of Medical Products (STAMP), 169-170, 365, 367, 376
T
Tampering and sabotage, 150
Telemedicine, 151
Temporomandibular joint prostheses, 95, 97
Testicular prostheses, 2, 58, 61, 311
Thoracic insufficiency syndrome, 314
Tinnitus, 402
Tissue engineering, 67
Toxic shock syndrome, 107, 125
Tracheostomy tubes, 51, 52, 58-59, 63, 64, 69, 126, 221
Transmyocardial revascularization, 107
Twiddler’s syndrome, 65
U
Universal Medical Device Nomenclature System, 30
Universities and academic health centers, 47, 306-308, 313-314, 315
University of Alabama at Birmingham, 216
University of Michigan, 215
U.S. Department of Agriculture, 37
U.S. Department of Commerce, 30 n.4
U.S. Department of Defense, 227
U.S. Department of Health and Human Services, 9, 49 n.3, 100, 185, 186, 221, 237
U.S. Department of Health, Education, and Welfare, 39
U.S. Department of Veterans Affairs, 86, 170, 227
U.S. Postal Service, 36
Use of devices with children.
See also Design of pediatric devices
accommodations for developmental differences, 58
adaptations in programming, placement, or operation, 36, 48, 52-53, 54, 60-62, 64-65, 71
behavioral factors, 67-68, 143-144
communication with parents and education and training, 127-129, 131-132, 137, 139, 150
data availability on, 47, 59 n.5, 113
errors in, 26, 33, 89, 122, 126, 127-130, 138-139, 143-144, 146-147, 149-150
identifying concerns with, 70, 113, 232-233
risk analyses, 328-329
shared responsibility for safety, 247-248
spectrum of, 56-68
training of health professionals, 129, 150, 154, 165, 178, 180, 193, 205, 212, 317, 322
unlabeled or off-label, 45, 68, 125, 209, 224, 241, 429
workarounds, 68-69, 144-146, 150
User facilities
adverse event reporting, 9, 39-40, 87, 88, 89, 91, 93, 94, 114, 115, 116-119, 120, 121, 152-153, 156, 157-158, 165-167, 171, 172, 175, 180
inspection and maintenance of devices, 150
investigating adverse events, 171, 236
MedSun recruits, 165-166
quality management and patient safety programs, 9, 13, 154, 156, 157, 165-167, 168, 176-177, 180, 321
registry support, 322
sources of adverse events, 149-150, 151
V
Vaccine Adverse Event Reporting System, 93, 114, 179
Vascular grafts, 193 n.6
Ventricular assist devices, 29-30, 59, 64, 77, 82, 97, 192, 203, 213-214, 306, 308-309, 311, 313, 314, 316, 321, 322
Ventriculitis, 359
Ventriculoperitoneal shunt, 214
Verapamil, 48
Vertical Expandable Prosthetic Titanium Rib, 2, 43, 70-71, 204-205, 311, 314
Vesicoureteral reflux, 202, 311
W
Withdrawal
of approval, 429
Women’s Health Initiative, 335