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



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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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Safe Medical Devices for Children 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

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