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From page 439... ... Index A cerebrospinal fluid shunts, 362-364, 369-374 Academic Programs in classes of devices, 85, 168 Pharmacoepidemiology, 23 classification of complications, 369-374 Active lifestyle cochlear implants, 411-414 cerebrospinal fluid shunt and, 51, 364 coding system for, 168-169, 173, 177, defined, 51-52 182, 206, 218, 236, 340-341 developmental control over, 52-53, 303 competitive pressures and, 155-156 home environments and human factors, confidentiality protections, 155, 171, 53 236 and longevity of implants, 3, 22, 51-52, data mining techniques, 341-342, 374 200 375 social dimensions, 53 defined, 35, 368 Adhesion barrier, 125 disproportionality analyses of Adolescents databases, 336-345, 374-375 active lifestyle, 52, 53 by distributors and importers, 87, 88, defined, 48, 49, 422 116-119, 121 impact of devices on, 49-50 drugs vs. devices, 90, 167-168, 340, management of devices, 143-144 341-342 psychosocial considerations, 51 ECRI program, 172-173, 369-374 AdvaMed, 171, 191, 192 education and communication Adverse event reports and reporting. Read the entire page →
From page 440... ... 440 SAFE MEDICAL DEVICES FOR CHILDREN FDA programs, 38, 114-126, 164-170, overreporting, 156 173-177, 229, 235-236 oversight responsibility, 74-75, 112 forms, 114-115, 154, 174, 181 113, 237-238 by health professional networks, 153, patient privacy, 91, 93-94, 104, 154, 175 155, 161-162, 163, 171, 178, 377- patient safety programs, 154, 156, 157, 378 165-167, 168, 176-177, 180 home health agencies, 126, 156, 157- private programs, 171-173 158, 166, 180 problems with, 153-157, 161-162 home health care and, 4, 24, 112, 123, public availability of information, 93 126, 156-157, 159, 162, 178, 181- 94, 103, 105, 120 182, 230 and recalls, 162, 174 human factors analysis, 127, 160, 169 recommendations, 8-9, 11-13, 174-175, improvement initiatives, 111, 164-170 176, 177, 178, 179, 180, 182 inappropriate, 156 and redesign of devices, 113 and innovation, 163, 310, 321 in research vs. patient care, 33 interactive option, 167 resources for patients and families, 181 international vigilance reports, 111, 182 125, 236 responding to problems, 58-59, 86, investigating, 112-113, 120-126, 151, 124, 161-164, 174 158-160, 161-162, 163, 170-171, review processes, 121-124, 152, 160, 172, 173, 175, 178, 180 169-170, 172, 173 investigational devices, 91-92 root-cause analysis, 170, 172, 173 JCAHO program, 171-172 safety advisories and, 124, 153, 206-207 labeling devices, 138, 149, 178 shared responsibility for, 173, 244, liability concerns and, 132, 155, 156 248-249 limitations of programs, 8, 113, 120- state programs, 170-171 121, 125-126, 152-165, 174, 235- statutory authority, 38, 39-40, 86, 368 236, 330, 338 terminology defined, 88-89 linkages between programs and trends, 115, 116-119 databases, 174, 225 underreporting, 8, 94, 131, 153-156, mandatory, 9, 24, 37, 39, 40, 86, 87- 161, 171, 174, 177, 235, 331, 338 92, 94, 114, 115, 116-120, 175, by user facilities, 9, 39-40, 87, 88, 91, 177-178, 321 93, 94, 114, 115, 116-119, 120, manufacturer response, 86, 87-92, 93, 121, 152-153, 156, 157-158, 165 94, 98, 100-101, 109-110, 114, 167, 171, 172, 175, 180, 236, 310, 115, 116-119, 120-121, 125, 141- 412 142, 155, 163, 171, 175, 177-178 voluntary, 37, 39, 86, 87 n.10, 91, 92 MAUDE database, 93, 115, 151, 155, 93, 94, 114-115, 116-119, 121, 163, 166, 206, 342, 368, 369-374, 126, 151, 163, 168, 172, 178-180 412-413 Adverse events MDR program, 87, 368, 369-370, 411 "caused or contributed," 89 MedSun program, 8-9, 35, 76, 94, 114, to children, 120, 121, 151, 206 152, 155 n.3, 159, 165-167, 171, close calls or near misses, 32-33, 91, 173, 175-177, 180, 182, 236, 321, 94, 115, 127-129, 162, 165, 166 336 "Code Blue" events, 124 MedWatch program, 35, 37, 92, 99 computer-based surveillance, 167-169, n.16, 164, 171, 174, 178, 181 182 objectives, 87, 101, 113, 163, 173, 232, deaths, 91, 94, 113, 115, 116-119, 122, 411 146-148, 162 online option, 114-115, 167, 174, 181- defined, 32-33, 422 182 design factors, 127-148, 149 Read the entire page →
From page 441... ... See also Central American Heart Association, 248 vascular catheters American Medical Association, 37, 189 Centers for Disease Control and American Society for Testing and Prevention, 71, 93, 227 Materials, 366 Centers for Education and Research in American Society of Hospital Pharmacies, Therapeutics, 218-219, 226-227, 37 235 American Thoracic Society, 67-68, 171, 221 Centers for Medicare and Medicaid Aortic connector devices, 125 Services, 184 n.1, 220, 312-313, Apnea monitors (home) Read the entire page →
From page 442... ... 442 SAFE MEDICAL DEVICES FOR CHILDREN Central vascular catheters, 60, 92, 95, 138- Class I devices, 30, 76, 77, 84, 109, 162, 139, 143-146, 170 309 n.4, 364, 422-423 Cerebrospinal fluid shunts Class II devices, 30, 34, 76, 77, 78, 84, 85, active lifestyle and, 51, 364 95, 109, 110, 183, 238-239, 309 adult use, 2, 58, 350 310 n.4, 315, 364-365, 423 adverse event reports, 342-345, 362- Class III devices, 30, 34, 76, 77, 78 n.4, 364, 368, 369-375, 377 79-80, 85, 95, 109, 110, 127, 183, classification of complications, 369-374 238-239, 246, 309, 310, 315, 365, clinical trials, 367 367, 423 cochlear implants compared, 375-376 Classification of devices, 5, 30, 34, 39, 76, complications, 20, 71-72, 112, 356, 77-80, 103, 309 357-364, 367-368, 369-374 Clearance of Class II devices, 30, 34, 41, defined, 347 76, 78, 84, 85, 95, 109, 110 disproportionality analysis of reports of Clinical trials. See also Pediatric complications, 342-345, 374-375, postmarket surveillance studies; 377 Postmarket surveillance studies; growth issues, 201, 364 Research on medical devices Holter valve, 17, 356, 358 age-specific, 47 identifying concerns with, 70, 170, 201, appropriate circumstances for, 54, 221 377-378 biases, 6, 188, 190, 211, 331, 332-333 infections, 20, 48, 359-361, 368, 377 blinded, 211-212, 317-318 innovations, 17, 65, 357-362, 376 challenges with children, 220-222, 245 and outcomes, 20 246, 303, 315-319 postmarketing surveillance, 201, 367- confidentiality issues, 106, 189, 192, 378 197, 210 premarket regulation, 364-367 CONSORT, 219 programmable, 367 data monitoring committees, 92 Raimondi distal spring valve, 358-359 defined, 35 n.6, 423 regulatory history, 347-378 design and protocols, 49 n.3, 106, 188, replacement, 65, 201, 361-362 189, 190, 192, 197, 210-219, 223, valve-regulated, 17, 355, 356-357 233-234, 315-319, 332-334 Cerebrospinal fluid system drugs vs. Read the entire page →
From page 443... ... INDEX 443 multi-center, 209, 215, 216, 222, 309, failure of device, 130-131, 303, 380, 323-324 405-408 organizational infrastructure, 245, 315, growth and development 323-324 considerations, 392-393 outcome measures and norms, 221-222, histopathology of, 404-405 315-316, 318-319, 320 and infections and other post-operative parent factors, 222 complications, 3, 399-405 patient privacy, 104, 210 Internet information site, 383 performance standards for surgeons, intra-operative complications, 398-399 212, 317, 322 labyrinthitis ossification and, 3, 388, pivotal, 315-317 389, 390, 393-394 placebo effect, 213 medical and otologic assessment, 387 population size considerations, 221, 389 303, 323 and meningitis, 3, 70, 71, 100, 125, pragmatic or practical, 213 126, 151, 161, 214, 375-376, 388 premarket, 3, 22, 209, 303, 320, 321, 389, 393, 394, 398, 400-402 322-323 and MRI, 389, 390-391, 394-395 protections for children, 2, 5, 10, 22, and otitis media, 389, 399-400 40, 68, 73, 221, 240-241, 245, 317 public health notification, 100 public access to data, 6, 14, 188-189, radiologic assessment, 390-391 190, 192, 194-195, 197, 233-234 regulation of, 410-415 randomized controlled, 211-212, 309, revision surgery, 407 310, 314, 315, 317-318, 331, 332- scalp flap complications, 392-393, 403 334 404, 408 recruitment of participants, 210, 316, special populations, 393-398 337 surgery-related complications, 392-399 registry of, 187-190, 197, 213, 234, surgical procedures, 392-393 318 and tinnitus, 402 reporting of, 219 tracking complications in children, 214, single-arm, 212-213, 303, 315, 316, 410-415 318 and vertigo, 402-403 Close calls or near misses, 32-33, 91, 94, "Code Blue" events, 124 115, 127-129, 162, 165, 166, 426 Coding system for devices, 8, 14, 168-169, Cochlear implants 173, 177, 182, 218, 224, 225, 249, and balance functions, 402-403 312 candidacy evaluation, 387-391 Cognitive and psychosocial considerations, classification, 77 49, 50-51, 52 clinical trials, 319 Combination products cochlear malformations and, 394-398 defined, 29-30, 423 and communication outcomes, 382- regulatory responsibility, 74 383, 384-385, 387, 408-410 Compassionate use exemptions, 65, 80, complications, 3, 388, 391-392, 398- 423 405, 410-415 Complaints, 89, 90, 156, 178. See also CSF leaks, 398 Adverse event reports and reporting defined, 383 Complications. Read the entire page →
From page 444... ... 444 SAFE MEDICAL DEVICES FOR CHILDREN criteria for defining, 391-392 Defibrillators, 2, 35, 58, 59, 60, 97, 101 developmentally related, 21, 48, 57, 71, n.17, 134-135, 173, 203, 247-248, 134-135, 136-138, 141-142 312, 313 disproportionality analysis of reports Design of pediatric devices. See also of, 342-345, 374-375 Innovation; Use of devices with drug-related, 57 children of hydrocephalus, 357-362 accessories for children, 2, 58, 59-60 hypersensitivity reactions, 1, 21, 67, adverse events related to, 127-148, 149 166-167, 227, 330 behavioral factors, 67-68 surgery-related, 392-399 benefit-harm balancing, 2, 21-22 tracking, 214, 410-415 childproofing, 53 Computed tomography (CT) Read the entire page →
From page 445... ... INDEX 445 Disproportionality analyses of databases E advantages, 337 analytic issues and strategies, 338-341 Ear thermometers, 58 Bayesian confidence propagation neural ECRI, 30, 97, 172-173, 247-248, 369, network method, 340-341 373-374, 376 confounding and bias, 339-340 Education and communication programs data mining techniques, 341-342, 374- adverse event reporting, 165, 173, 175, 375 176-177, 178 drugs vs. devices, 341-342 Effectiveness example, 342-345 defined, 32, 424 overview, 336-341 exemptions from requirements, 40 use -- outcome association, 336-337 statutory requirement, 38 Distraction osteogenesis device, 139-141 Efficacy, defined, 32, 424 Distributors of devices Endoscopes and endoscopy, 320, 355-356, adverse event reporting, 87, 88, 116- 357 119, 121 Endovascular graft failures, 125 defined, 424 Endovascular Technologies, 120 n.1 tracking devices, 97 Enforcement Drug Amendments of 1962 (Kefauver- of adverse event reporting requirements, Harris) Read the entire page →
From page 446... ... applications, 78, 82, 83, 102, 106, 189 104, 105, 191, 192, 365 context for, 41-45 adverse event reporting, 86 coordination of pediatric issues, 230, confidentiality protections, 102, 105, 232, 237-238 106 cross-boundary programs, 106-111 FDA authority, 36, 37, 73, 86, 364 design controls, 107, 109 and quality systems regulations, 107 disseminating information, 237-238 Section 522, 7, 14-15, 34, 85, 95, 183 drug regulation compared, 4, 24, 36, 184, 191, 193-195, 200, 201-202, 38, 41-42, 48, 49, 82, 185-186, 226 229-230, 237 Fever reduction device, 193 enforcement authority, 37, 98, 99, 195, Food and Drug Administration. See also 223 FDA entries epidemiologic research program, 75, Bureau of Medical Devices and 106-107, 321 Diagnostic Products, 39 evolution of, 36-41, 73 Center for Biologics Evaluation and expedition of review, 25 Research, 74 guidance documents, 25, 27, 32, 35-36, Center for Devices and Radiological 40, 48, 49, 54-55, 61, 74, 101, 157, Health, 6, 10, 15, 27, 29, 39, 42, 224, 230, 232 74, 75-76, 106-107, 124, 157, 164, home health committee, 157, 181, 230, 173, 181, 183, 190-191, 193, 194, 236 195, 224, 225-226, 230, 232, 235, independent oversight, 9, 237-238 236, 238, 239, 412 and innovation, 24, 41, 45, 46, 240- Center for Drug Evaluation and 241, 309-311 Research, 9, 29, 185, 186, 194, 225, international harmonization activities, 237 30, 37, 85, 110-111 Drug Safety and Risk Management organization for, 10, 74-76, 230, 237- Advisory Committee, 237-238 238 extramural research program, 225-226, pediatric expertise in, 4, 10, 25, 40-41, 235 55, 173, 230 Office of Communication, Education, public health notifications, 5, 86, 92, and Radiation Programs, 75 100, 103, 232 Office of Device Evaluation, 74, 96 quality systems regulations, 84, 101, Office of In Vitro Diagnostic Device 107-110 Evaluation and Safety, 74 recalls and corrections, 5, 26, 40, 86, Office of Pediatric Therapeutics, 10, 40, 92, 98-99, 110, 164 230 recommendations for, 173-177 Office of Science and Engineering Laboratories, 74, 97 Read the entire page →
From page 447... ... INDEX 447 Office of Surveillance and Biometrics, H 74-75, 76, 96 Patient Safety News, 164 Harder, Ben, 51 Pediatric Advisory Committee, 230 Harder, Nancy, 112 Fraudulent devices, 36, 38 Harm, defined, 31, 32, 424 Freedom of Information Act, 102, 103, Hazard, defined, 31-32, 424 104, 105, 106, 191 Health insurance coverage clinical trials, 184 n.1, 210 n.2, 314, 321 G and innovation, 312-313, 322, 324 Health Insurance Portability and Gastronomy tubes, 136-138 Accountability Act of 1996, 91, 93General controls, 77, 78, 79, 83-84, 365, 94, 154, 175, 210, 415 424 Health Maintenance Organization Global Harmonization Task Force, 37, 111 databases, 217, 218, 225 Global Medical Device Nomenclature, 30, Research Network, 218-219 173 Health professionals and health Glucose meters, 101, 311 professional societies Government Accountability Office, 152 adverse event reporting, 153, 155, 161Groopman, Jerome, 46 162, 163, 171, 178 Growth and developmental issues educating and communicating with accommodations in devices, 58, 65-67, patients and families, 127-129, 131 364 132, 137, 139, 157, 178, 181, 182, active lifestyle and, 52-53, 303 246 cognitive and psychosocial, 49, 50-51, 52 postmarket research, 235 complications related to, 21, 57, 71, recommendations, 178-180 134-135, 136-138, 141-142 registries, 215-217, 226-227, 321 CSF shunts, 364 training in device use and event definitions, 50 reporting, 129, 150, 154, 165, 178, in design and use of devices, 1, 2, 54, 180, 193, 205, 212, 247-248, 317, 55-69, 134-138, 141-142, 200 322 drugs vs. devices, 56, 57 Hearing screener for newborns, 2, 47, 58 FDA guidance on, 49, 54-55 Heart valves, 1, 2, 18, 39, 57, 58, 67, 70, identifying problems with devices, 69, 72, 95, 97, 149, 168, 302-303, 311 70-71, 134-135 Holter, John, 17, 356 infants, 50 Home health agencies, 24, 88 and innovation goals, 50 adverse event reporting, 126, 156, 157 long-term studies, 3, 23, 48, 49, 61, 71- 158, 166, 180 72, 127, 148-149, 193, 200, 202, Home health care 206-207, 212, 223, 226, 248-249, active lifestyle and, 53 303 and adverse event reporting, 4, 24, 112, metabolic interactions, 56 123, 126, 156-157, 159, 162, 178, migration of implants, 50, 55, 66, 72, 181-182, 230 202, 205, 206 apnea monitors, 3, 47, 70, 77, 84 n.9, overstimulation concerns for infants, 50 85, 101, 162 patient cooperation, 67 checklist for device use, 157, 181 physical interactions, 56 education and assistance resources, and postmarket surveillance, 50 127-129, 131-132, 137, 139, 157, replacement of implants, 50, 55, 60 n.6, 178, 181, 182, 248 61, 65, 201, 303 FDA home committee, 157, 181, 230, surgical accommodations, 62 236 Read the entire page →
From page 448... ... 448 SAFE MEDICAL DEVICES FOR CHILDREN prothrombosis time test kits, 193 n.6 MRI magnetization, 97 recommendations, 13, 181-182 permanent, 426 resources for patients and families, 181- placement, 60-61, 64-65, 71 182, 244, 248 replacement, 50, 55, 60 n.6, 61, 65, risks of adverse events, 101-102, 112, 201, 303 126, 162, 163 resorbable, 66-67 safety initiatives, 244, 248 retrieval of failed or malfunctioning user errors, 126, 138-139, 248 devices, 159, 214-215, 361-362 Hospital beds, 125 skin thickness and, 64-65 Human factors analysis, 11, 127, 160, 169, tracking, 28-29, 39-40, 42-43, 97, 410 244 415, 424 Human factors engineering, 107, 149-150, Importers, 88, 89, 425 169, 424 Incubators, 2, 47, 57, 58, 77, 147-149, Humanitarian use devices, 29, 40, 52, 57, 173 59, 81-82, 83, 192, 203, 204-205, Infants 303, 310-311, 314, 424-425 adverse events, 122, 123, 356-357 Hydraencephaly, 355 brain plasticity, 48-49 Hydrocephalus. See also Cerebrospinal complications of implants, 48, 71 fluid shunts defined, 48-49, 425 in adults, 350 device placement, 60 classification systems, 350-351 devices for, 2, 18, 20, 47, 57, 65, 98, complications, 357-362 123, 356-357 defined, 350 developmental considerations, 50, 57, diagnosis, 351-352 64-65, 69 life expectancy, 17 lifestyle factors, 52, 53 modern CSF shunt development, 357- overstimulation, 50 362 oxygen therapy, 148-149 physiology, 20, 350 premature, 48, 64-65, 69 prognosis, 20, 352 recall of devices, 98, 164 treatment, 352, 355-356 skin damage, 64-65, 123 Infections, 61 cerebrospinal fluid shunts, 20, 48, 359 I 361 cochlear implants and, 3, 70, 71, 100, Immune complex glomerulonephritis, 358 125, 126, 399-405 Implanted devices or implants. Read the entire page →
From page 449... ... INDEX 449 economic value assessment, 318-319, International Organization for 324 Standardization, 108-109, 110, 365 FDA regulation and, 24, 41, 45, 46, 366 240-241, 309-311, 321 International Society for federal support for R&D, 308-309 Pharmacoepidemiology, 23, 220 growth-accommodating devices, 50, 66, International Society for 68 Pharmacovigilance, 23 incentives for, 322-324 International vigilance reports, 111, 125 industry and markets, 21, 46, 240, 304- Internet, adverse event reporting online, 306, 313, 322, 323 114-115, 167, 174, 181-182 miniaturization of components and, 59, Intracardiac echocardiography, 63-64 64 Intraocular lens replacement, 62 patent protection, 306, 308 Intrauterine devices, 39, 314 players in, 304-308 Intravenous catheters and needles, 58, 68 policy environment, 10, 240-241, 308- 69 313, 321, 324 Investigating adverse events, 112-113, 120 postmarket evaluation and, 232, 235, 126, 151, 158-160, 161-162, 163, 310, 320-322, 323, 324 170-171, 172, 173, 175, 178, 180, premarket evaluation, 207, 310, 314- 194 319, 320, 321, 322-323, 324; see Investigational devices, 80-81, 91-92, 102 also Clinical trials 103, 104, 106, 109, 425 product development cycle, 42-44 prototype development, 313-314, 315 public-private partnerships, 324 J reimbursement issues, 312-313, 322, Joint Commission of Accreditation of 324 research burdens, 207-208 Healthcare Organizations, 32 n.5, and shared responsibility for safety, 44, 171-172, 248 232-233, 243-244 universities and academic health L centers, 47, 306-308, 313-314, 315 unmet needs, 302-303, 322 Labels and labeling of devices workarounds and, 67, 69, 144-146 adverse events and, 87 n.11, 138, 149, Inspection of facilities and devices, 5, 36, 178 109, 129, 238-239 changes, 90, 103, 106 Institute for Safe Medical Practices, 171 content, 36, 56 Institutional Review Boards (IRBs) , 81, 82, defined, 246, 425 91-92, 96, 189, 317, 425 drugs, 99 n.16 Insulin Amendment, 37 guidance to manufacturers, 246 Insulin pumps, 29, 51, 53, 77 indications for use, 45, 56, 68, 83, 125, International Classification of Diseases, 178, 209, 224, 241 168 n.5 links to databases for monitoring International Committee of Medical studies, 197 Journal Editors, 189 special controls, 84 International Conference on Labyrinthitis ossification, 3, 393-394 Harmonization, 111 Lap band adjustable gastric band, 125 International Electrotechnical Commission, Laparoscopic surgery, 319, 320 97 Liability issues, 132, 155, 156 International harmonization activities, 30, Limb prostheses, 65-66 37, 85, 108-109, 110-111 Long Q-T Syndrome, 134-135 Lung function evaluation devices, 67 Read the entire page →
From page 450... ... database, 93, of 1992, 87 115, 151, 155, 163, 166, 342, 412- Medical Device Engineering Network 413 (M-DEN) , 167 Manufacturers Medical Device Laboratory Product Problem adverse event reporting, 86, 87-92, 93, Reporting Program, 87 n.10 94, 109-110, 114, 115, 155-156, Medical Device Safety Network, See MedSun 177-178, 310, 411-412 Medical Device User Fee and Alternative Summary Reporting Modernization Act of 2002, 2-3, 22 program, 92, 246 23, 25, 38, 40, 54, 55, 82, 110, annual reports, 192-193 190, 192, 230, 239 competitive pressures, 155-156 Medical devices. Read the entire page →
From page 451... ... INDEX 451 MedWatch program, 35, 37, 92, 99 n.16, National Institute of Standards and 164, 171, 174, 178, 181 Technology, 227 Meningitis, 3, 70, 71, 100, 125, 126, 151, National Institutes of Health, 7, 36, 44, 49 161, 214, 400-402 n.3, 86, 126, 188 n.4, 212, 220, 222, Misbranded devices, 195, 426 227, 235, 244, 249, 307, 308, 321 Monitoring postmarket study commitments National Science Foundation, 227 action toward, 186-187 Near misses. See Close calls or near misses condition-of-approval studies, 190-192, Nebulizers, 68, 123, 149, 221 195, 202 Neonatal ECMO Registry, 321 for devices, 190-195 Neonatal intensive care units, 151, 222. Read the entire page →
From page 452... ... devices, 226, 234, 303, 310, 365 safety advisories and, 201, 206-207 active lifestyles considerations, 51-52, Section 522, 7, 14-15, 200, 201-202, 200, 202, 206, 207, 223, 234 226, 234-235 adequacy, 3, 7-8, 14-15, 22, 23, 51-52, sharing responsibility for, 231, 246 199-228, 232, 234-235 voluntary, 7, 60, 203, 207, 212, 235 adverse event reports and, 201, 206- Pediatric Research Equity Act of 2003, 185 207, 214, 217 n.3, 187, 194 age-specific, 47 Pediatric Research Initiative, 309 availability of data, 7, 196, 200, 201- Pediatrics, defined, 27 202, 207, 219, 233-234, 246 Pharmaceutical Research and benefits, 201 Manufacturers Association, 189 cerebrospinal fluid shunts, 201, 367- Pharmacoepidemiology, 219 369 Phototherapy devices, 2, 19 Plastic tubing, 216 n.4 Read the entire page →
From page 453... ... , reports and reporting 82 tracking of medical devices, 28-29, 39- "agreement" meetings, 79, 244 40, 86, 96-97, 110, 167-169, 310, confidentiality protections, 10, 102, 410-415 103-104, 105, 106 Postmarket surveillance studies. See also content, 109 Clinical trials; Monitoring delays in approval, 40, 42, 229, 238 postmarket study commitments; 239, 310 n.5 Pediatric postmarket surveillance design controls, 109 studies; Research on medical devices "determination" meetings, 79, 244 bias sources, 330-331 inspections, 110, 238-239, 247 characteristics of interest, 327-331 summary, 219, 246 condition-of-approval studies, 34-35, supplemental, 79, 105, 202-203 76, 78, 79, 80, 82, 85, 96, 106, task-specific approach, 208-209 183, 190-192 user fees, 192, 238 Read the entire page →
From page 454... ... 454 SAFE MEDICAL DEVICES FOR CHILDREN Premarket evaluation, 3, 22 Privacy Act, 102. See also Patient privacy clearance without testing, 59-60 Prothrombosis time test kits, 193 n.6 clinical studies, 3, 22, 209, 303, 310, Psychosocial factors 319, 320, 322-323 active lifestyle, 53 FDA guidance on, 25, 27, 32, 54-55, adolescents, 51 243-244 Public access to information identification of concerns, 70, 71 adverse event reports, 93-94, 103, 105, in vitro testing, 208-209, 314 120 and innovation, 207, 310, 314-319, clinical trial data, 188-189, 190, 192, 320, 321, 322-323, 324 194-195, 197 inspections, 110, 238-239, 247 communication strategy, 9 Institutional Review Boards, 81, 82, 91- pediatric postmarket surveillance 92 studies, 6, 14, 190-191, 196, 197 regulatory responsibility, 74 198, 232, 233-234, 246 uncertainties in, 319, 322-323 status of study commitments by user fees, 40, 190, 238 manufacturers, 6, 186, 190-191, Premarket notifications (510(k) Read the entire page →
From page 455... ... See also REMATCH trial, 316 Humanitarian use devices Research on medical devices. See also Recalls and corrections, 5, 26, 36, 40, 86, Clinical trials; Innovation; Pediatric 90, 92, 98-99, 110, 111, 133, 153, postmarket surveillance studies; 162, 164, 172, 174, 215, 376, 424, Postmarket surveillance studies 427 adverse event reporting in, 33 Recommendations autopsy studies, 214 adverse event reporting, 8-9, 11-13, bias sources, 6, 188, 190, 211, 330 174-175, 176, 177, 178, 179, 180, case cohort studies, 330 182 case control studies, 214, 330, 335-336, coding system for devices, 8, 14, 177, 337 182, 225 case reports, 86, 126, 127, 180 epidemiological research, 8, 14, 225 challenges with children, 220-222 FDA programs, 10, 15, 173-177, 232 clinical evaluation, 22, 244-246, 332-334 health professionals and professional collaborative, 7, 15, 225-226, 227, 235, organizations, 178-180 309 home care resources, 13, 181-182 conference to set agenda for, 7, 227 manufacturers, 177-178 228, 235 monitoring postmarket study criteria for, 227-228 commitments, 6, 13-14, 195-198 dimensions and complexity, 207-220 patient safety initiatives, 9, 13, 15, 180, FDA extramural program, 225-226, 242 235 pediatric postmarket surveillance study importance of, 24, 227, 249 improvements, 7-8, 14-15, 195-197, observational studies, 211, 213-215, 222-228 217, 321 public access to information, 6, 14, prospective comparative studies, 212 197-198 213, 218, 312, 314, 334-335 recommendations, 181-182 registry-based, 35, 179, 180, 213, 215, Registries 225, 226, 321-322, 330, 335-336 of clinical trials, 187-190, 197 on retrieved devices, 214-215 defined, 35, 215, 427-428 retrospective, 214, 216, 334-335 diagnosis-based, 213, 215, 226, 336 retrospective studies, 335, 337 funding for, 321-322 risk analyses, 327-331 health professional organizations as shared responsibilities for, 225-226, sponsors, 215-217, 226-227, 321 227, 244-246, 249 intervention-based, 215-216 Reuse of devices, 97 manufacturer, 215 Risk postmarket studies based on, 35, 179, biased estimated, 331 180, 213, 215, 225, 226, 321-322, classification of devices based on, 5, 39, 330, 335-336 76 registry of registries, 225 defined, 31, 428 warranty lists, 214 management, 428 probability analysis of adverse events, 327-331 Root-cause analysis, 11, 170, 172, 173 Read the entire page →
From page 456... ... 456 SAFE MEDICAL DEVICES FOR CHILDREN S Temporomandibular joint prostheses, 95, 97 Safe Medical Devices Act, 37, 39-40, 85, Testicular prostheses, 2, 58, 61, 311 87, 95, 96, 107, 310, 411 Thoracic insufficiency syndrome, 314 Safeguards Tinnitus, 402 commitments for postmarket studies as, Tissue engineering, 67 196-197, 244 Titanium nails, 49, 66 defined, 31 Toxic shock syndrome, 107, 125 postmarket surveillance as, 223 Tracheostomy tubes, 51, 52, 58-59, 63, 64, Safety 69, 126, 221 alerts, see Patient safety; Public health Trade Secrets Act, 102, 103 advisories and notifications Transmyocardial revascularization, 107 criteria, 31 Twiddler's syndrome, 65 defined, 31 device, 243-249 long-term, 248-249 U in manufacturing and supply, 246-247 patient, 241-243 Universal Medical Device Nomenclature shared responsibility for, 4, 24, 43, System, 30 173, 237-238, 241-249 Universities and academic health centers, tips for preventing medical errors, 242- 47, 306-308, 313-314, 315 243 University of Alabama at Birmingham, 216 in use of devices, 69, 247-248 University of Michigan, 215 Scoliosis, 21, 71 U.S. Department of Agriculture, 37 Section 522, 7-8, 14-15, 35, 95, 96, 183- U.S. Read the entire page →
From page 457... ... INDEX 457 identifying concerns with, 70, 113, 232- V 233 risk analyses, 328-329 Vaccine Adverse Event Reporting System, shared responsibility for safety, 247- 93, 114, 179 248 Vacuum extractor, 122, 153 spectrum of, 56-68 Vascular grafts, 193 n.6 training of health professionals, 129, Ventricular assist devices, 29-30, 59, 64, 150, 154, 165, 178, 180, 193, 205, 77, 82, 97, 192, 203, 213-214, 306, 212, 317, 322 308-309, 311, 313, 314, 316, 321, unlabeled or off-label, 45, 68, 125, 209, 322 224, 241, 429 Ventriculitis, 359 workarounds, 68-69, 144-146, 150 Ventriculoperitoneal shunt, 214 User facilities Verapamil, 48 adverse event reporting, 9, 39-40, 87, Vertical Expandable Prosthetic Titanium 88, 89, 91, 93, 94, 114, 115, 116- Rib, 2, 43, 70-71, 204-205, 311, 119, 120, 121, 152-153, 156, 157- 314 158, 165-167, 171, 172, 175, 180 Vesicoureteral reflux, 202, 311 defined, 88, 429 inspection and maintenance of devices, 150 W investigating adverse events, 171, 236 Withdrawal MedSun recruits, 165-166 of products, 125, 425 quality management and patient safety of approval, 429 programs, 9, 13, 154, 156, 157, Women's Health Initiative, 335 165-167, 168, 176-177, 180, 321 Workarounds, 67, 68-69, 144-146, 154, registry support, 322 169, 180 sources of adverse events, 149-150, 151 World Health Organization, 168 n.5, 229, 340-341 Read the entire page →

From page 439...

... Index A cerebrospinal fluid shunts, 362-364, 369-374 Academic Programs in classes of devices, 85, 168 Pharmacoepidemiology, 23 classification of complications, 369-374 Active lifestyle cochlear implants, 411-414 cerebrospinal fluid shunt and, 51, 364 coding system for, 168-169, 173, 177, defined, 51-52 182, 206, 218, 236, 340-341 developmental control over, 52-53, 303 competitive pressures and, 155-156 home environments and human factors, confidentiality protections, 155, 171, 53 236 and longevity of implants, 3, 22, 51-52, data mining techniques, 341-342, 374 200 375 social dimensions, 53 defined, 35, 368 Adhesion barrier, 125 disproportionality analyses of Adolescents databases, 336-345, 374-375 active lifestyle, 52, 53 by distributors and importers, 87, 88, defined, 48, 49, 422 116-119, 121 impact of devices on, 49-50 drugs vs. devices, 90, 167-168, 340, management of devices, 143-144 341-342 psychosocial considerations, 51 ECRI program, 172-173, 369-374 AdvaMed, 171, 191, 192 education and communication Adverse event reports and reporting.

Index Pages 439-458

Index
Pages 439-458