National Academies Press: OpenBook

Safe Medical Devices for Children (2006)

Chapter: Index

« Previous: Appendix H Committee Biographical Statements
Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

active lifestyle, 52, 53

defined, 48, 49, 422

impact of devices on, 49-50

management of devices, 143-144

psychosocial considerations, 51

AdvaMed, 171, 191, 192

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

classes of devices, 85, 168

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

defined, 35, 368

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

epidemiologic studies of, 71, 125, 161, 168, 194

examples, 120, 122-124

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

FDA programs, 38, 114-126, 164-170, 173-177, 229, 235-236

forms, 114-115, 154, 174, 181

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

and innovation, 163, 310, 321

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

and recalls, 162, 174

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

trends, 115, 116-119

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

deaths, 91, 94, 113, 115, 116-119, 122, 146-148, 162

defined, 32-33, 422

design factors, 127-148, 149

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

infections, 132-134, 151

institutional/system factors, 127-148, 153

labeling-related, 138, 149

lifestyle-related, 206

magnitude of, 152-153

manufacturing-related, 147-148, 149

remedial action, 89

reportable, 87 n.11, 88-90

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

Bililights, 2, 19, 58

Biologics, 29 n.3, 91

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

Cardiomyopathy, 215, 322

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

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

Central vascular catheters, 60, 92, 95, 138-139, 143-146, 170

Cerebrospinal fluid shunts

active lifestyle and, 51, 364

adult use, 2, 58, 350

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

growth issues, 201, 364

Holter valve, 17, 356, 358

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

replacement, 65, 201, 361-362

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

defined, 27, 48, 49, 422

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

blinded, 211-212, 317-318

challenges with children, 220-222, 245-246, 303, 315-319

confidentiality issues, 106, 189, 192, 197, 210

CONSORT, 219

data monitoring committees, 92

defined, 35 n.6, 423

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

Institutional Review Boards, 81, 82, 91-92, 189, 317

insurance coverage, 184 n.1, 210 n.2, 314, 321

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

patient privacy, 104, 210

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

designs, 383-384, 386

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

defined, 29-30, 423

regulatory responsibility, 74

Compassionate use exemptions, 65, 80, 423

Complaints, 89, 90, 156, 178.

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

cochlear implants, 3, 392-405

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

tracking, 214, 410-415

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

Cranial orthosis, 58, 224

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

controls, 107, 109, 424

developmental considerations, 1, 2, 23, 54, 55-68, 136-138, 141-142

environmental considerations, 131-132, 216, 224

FDA guidance on, 72, 100-101

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

Dialysis machines, 59, 123, 313, 314

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

developmental issues, 56, 57

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

Dystonia, 52, 71, 311

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

defined, 32, 424

exemptions from requirements, 40

statutory requirement, 38

Efficacy, defined, 32, 424

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

device, 220, 224-225

FDA program, 75, 106-107

proportional mortality analysis, 338

recommendations, 8, 14, 225

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

Facial nerve injury, 399, 404

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

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

benefit-harm balancing, 4, 24

budget and resources, 75-76, 163

categories of devices, 31, 38

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

design controls, 107, 109

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

evolution of, 36-41, 73

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 Pediatric Therapeutics, 10, 40, 230

Office of Science and Engineering Laboratories, 74, 97

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

Office of Surveillance and Biometrics, 74-75, 76, 96

Patient Safety News, 164

Pediatric Advisory Committee, 230

Fraudulent devices, 36, 38

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

Glucose meters, 101, 311

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

drugs vs. devices, 56, 57

FDA guidance on, 49, 54-55

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

Harm, defined, 31, 32, 424

Hazard, defined, 31-32, 424

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

databases, 217, 218, 225

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

Holter, John, 17, 356

Home health agencies, 24, 88

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

FDA home committee, 157, 181, 230, 236

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

prothrombosis time test kits, 193 n.6

recommendations, 13, 181-182

resources for patients and families, 181-182, 244, 248

risks of adverse events, 101-102, 112, 126, 162, 163

safety initiatives, 244, 248

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

physiology, 20, 350

prognosis, 20, 352

treatment, 352, 355-356

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

defined, 28-29, 425

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

monitoring, 50, 135, 137

MRI magnetization, 97

permanent, 426

placement, 60-61, 64-65, 71

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

Importers, 88, 89, 425

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

defined, 48-49, 425

device placement, 60

devices for, 2, 18, 20, 47, 57, 65, 98, 123, 356-357

developmental considerations, 50, 57, 64-65, 69

lifestyle factors, 52, 53

overstimulation, 50

oxygen therapy, 148-149

premature, 48, 64-65, 69

recall of devices, 98, 164

skin damage, 64-65, 123

Infections, 61

cerebrospinal fluid shunts, 20, 48, 359-361

cochlear implants and, 3, 70, 71, 100, 125, 126, 399-405

device, 132-134, 151, 400

reporting, 132-134, 151

Informed consent, 38, 317

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

dynamics of, 21, 46, 66, 199, 240, 305-306, 313-322

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

patent protection, 306, 308

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

unmet needs, 302-303, 322

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

Insulin pumps, 29, 51, 53, 77

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

Intrauterine devices, 39, 314

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

changes, 90, 103, 106

content, 36, 56

defined, 246, 425

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

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

corrections, 99, 110

corrective and preventive actions, 99, 109-110, 178-179, 424

defined, 88, 425

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

recalls by, 98, 110, 215

recommendations for, 177-178

redesign and preventive design, 100-101

registries, 215, 322

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

defined, 27-28, 426

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

“significant risk,” 80, 428

Medical Devices Technical Corrections Act, 38, 41, 230

Medicare

coverage, 44, 86, 184, 210 n.2

enrollee databases, 217, 225

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

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

Misbranded devices, 195, 426

Monitoring postmarket study commitments

action toward, 186-187

condition-of-approval studies, 190-192, 195, 202

for devices, 190-195

for drugs, 185-187, 197, 246

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

Nebulizers, 68, 123, 149, 221

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

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

demand for, 47, 305-306

developmental considerations, 55-69

examples, 1, 17-18, 20, 76, 77

incentives for developing, 47

identifying concerns with, 70, 170, 201

labeling, 56, 73-74

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

pharmaceuticals, 23, 40

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

required, 7, 201-207

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

Phototherapy devices, 2, 19

Plastic tubing, 216 n.4

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

computer-based, 167-169, 182

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

tools, 5, 35, 86;

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

defined, 34-35, 427

designs and information resources, 95, 331-336

disproportionality analyses of spontaneous adverse event reporting databases, 336-345

of drugs, 3, 102, 185-187, 195

epidemiologic, 75, 107, 249

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

purpose, 5, 95-96, 101

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

voluntary, 184, 191, 215

Premarket approval applications (PMAs), 82

“agreement” meetings, 79, 244

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

summary, 219, 246

supplemental, 79, 105, 202-203

task-specific approach, 208-209

user fees, 192, 238

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

Premarket evaluation, 3, 22

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

user fees, 40, 190, 238

Premarket notifications (510(k)), 78, 82, 83, 102, 104, 105, 191, 192, 365, 366-367, 427

Premarket regulation.

See also Premarket approval applications

activities, 5, 33-34

basics of, 4, 74 n.2, 76-85

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

exemptions, 65, 77, 80

expedited review, 80, 82

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

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

defined, 35, 215, 427-428

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

time line, 36, 37-38

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

importance of, 24, 227, 249

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

defined, 31, 428

management, 428

probability analysis of adverse events, 327-331

Root-cause analysis, 11, 170, 172, 173

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

Scoliosis, 21, 71

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

defined, 34, 422, 429

Syringe, aspirated cap, 127-129

Systematic Technical Assessment of Medical Products (STAMP), 169-170, 365, 367, 376

T

Tampering and sabotage, 150

Tampons, 107, 125

Telemedicine, 151

Temporomandibular joint prostheses, 95, 97

Testicular prostheses, 2, 58, 61, 311

Thoracic insufficiency syndrome, 314

Tinnitus, 402

Tissue engineering, 67

Titanium nails, 49, 66

Toxic shock syndrome, 107, 125

Tracheostomy tubes, 51, 52, 58-59, 63, 64, 69, 126, 221

Trade Secrets Act, 102, 103

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

checklist, 157, 181

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

in home environment, 101-102, 112, 126, 138-139, 162, 163

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
×

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

defined, 88, 429

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

Vacuum extractor, 122, 153

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 products, 125, 425

of approval, 429

Women’s Health Initiative, 335

Workarounds, 67, 68-69, 144-146, 154, 169, 180

World Health Organization, 168 n.5, 229, 340-341

Suggested Citation:"Index." Institute of Medicine. 2006. Safe Medical Devices for Children. Washington, DC: The National Academies Press. doi: 10.17226/11313.
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Safe Medical Devices for Children Get This Book
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Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines:

  • The Food and Drug Administration's monitoring and use of adverse event reports
  • The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing
  • The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance

Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.

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