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Suggested Citation:"Index." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Page 183
Suggested Citation:"Index." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Page 184
Suggested Citation:"Index." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Page 185
Suggested Citation:"Index." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Page 186

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Index A Aaronson, William, 1~17 Acceptance of new technology, 3-4, 7, 9 Acquired immune deficiency syndrome (AIDS), 6 ALZA Corporation, 142-144 Angioplasty, 10, 56, 116, 131-132 Appropriate care payments review, 130 Appropriate Technology International, 30 Artificial organs, 57 Auto analyzer, 13-16 B Bioengineering Research Panel, 51-52, 6~61 Biomaterials, 54 Biomechanics, 53-54 Biomedical engineering artificial organs, 57 biomaterials, 54 biomechanics, 53-54 biosensors, 5~55 federal funding, 57-60 183 innovation proposal, 152 metabolic imaging, 55-56 minimally invasive procedures, 56 neural protheses, 53 systems physiology and modeling, 52-53 Biosensors, 54-55 Blood supply testing, 6 Blue Shield of California, 116 C Cardiac pacemakers, 10, 24-29, 98, 104-105 Centralization of skills and facilities, 115-116, 134 Chardack, William C., 24, 2~28 Chemical analysis, see Auto analyzer Clinical management, 135 Company size, role in innovation, 42-47 Comprehensive accident compensation plans, 83 Computed tomographic (CT) scanning, 7, 132-133, 153, 159

184 Coronary artery disease, 9-10 Cost containment practices, 109-112 centralization of skills and facilities, 115-116, 134 interim coverage policies, 115-118 and managed care providers, 108, 110, 129-130 rationing health care resources, 111-112, 13~135 D Diagnosis-related groups (DRGs), 94-95, 97-100, 10~108, 111, 117-119, 130-132 Diagnostic procedures, 7-8 Dialysis, 9, 57-58 Diffusion of technology, 116, 133, 159, 171-172 Disabled persons, independent living movement, 29-30 E Endoscopy, 7 F Federal funding, 111, 155-159 for biomedical engineering, 57-60 see also specific agency names Fiber-optic endoscopy, 7 Financing strategies auto analyzer, 14 pneumatic extradural intracranial pressure monitor, 19 wheelchair project for Nicaragua, 30 Food and Drug Administration (FDA), 4~45, 74-76, 79-82, 84-86, 89-90, 114, 140, 14~148, 169 For-profit health care enterprises, 109 Funding, see Federal funding; Private investment decisions INDEX G Gage, Andrew, 24, 26 Government role in financing care, 156-157 in public safety, 157 in reconciling conflicting interests, 15~163 in research, 155-156 see also specific agency names Greatbatch, Wilson, 24-29 H Health care costs, 3-4, 10-11, 170-171; see also Cost containment practices; Hospital finances; Medicare; Prospective Payment Assessment Commission (ProPAC); Prospective payment system (PPS) Health Care Financing Administration, 9~99, 107- 108, 118-119, 132, 161-162 Health Industry Manufacturers Association, 148-149 Health maintenance organizations, see Managed care providers Heart transplants, 112, 116 Hospital finances, 10~103, 130-136 Hospital market share decisions, 134 Hospitals and technology development, 127-136 I ICP monitor, see Pneumatic extradural intracranial pressure monitor Imaging technology, see Computed tomographic (CT) scanning; Magnetic resonance imaging Independent living movement for the disabled, 29-30

INDEX Informed consent, 141-143 Innovation factors, 152 company size, effect of, 42-47 market considerations, 66-68 stages of innovation, 35-38, 145-150, 165-167 technical considerations, 63-66 user versus manufacturer innovations, 38-41 see also Food and Drug Administration (FDA) Institute of Medicine, 121, 162, 171-173 Interim coverage policies, 115-118 International Classification of Diseases, 117 Intracranial pressure monitor, see Pneumatic extradural intracranial pressure monitor Intrauterine devices (IUDs), 142-143 Intravenous therapy, 133 L Labeling products, 140 Lithotriptor, 9, 132 M Magnetic resonance imaging, 7, 55-56, 99, 110-111, 116, 159 Mammography, 6-7 Managed care providers, 108, 110, 129-130 Marketing strategies, 6~68 auto analyzer, 14-15 cardiac pacemaker, 27-28 pneumatic extradural intracranial pressure monitor, 19 retinoscope, 24 Medical Device Amendments of 1976, 65, 73-75 Medicare, 93-94, 111-112, 116-117; see also Prospective payment system (PPS) 185 Metabolic imaging, see Magnetic resonance imaging Minimally invasive procedures, 56 Mortality data, 161 N National Academy of Engineering, 171-173 National Center for Health Care Technology, 116 National Institutes of Health, 58-60, 155-156 National Science Foundation, 58-60 Neural prostheses, 53 Nicaragua wheelchair project, 29-34 o Outdated technology, identification of, 119-12() p Pacemakers, see Cardiac pacemakers Penile prostheses, 99-100 Plasmapheresis, 16-17 Pneumatic extradural intracranial pressure monitor, 17-19 Preferred provider organizations, see Managed care providers President's Science Advisory Committee, 127-128 Preventive medicine, 9-10 Private investment decisions, 62-70, 167-168 market considerations, 66-68 technical considerations, 63-66 Product liability and regulation compensation board, proposal for, 86-89 comprehensive accident compensation plans, 83 data deficiencies, 151-152 inconsistencies between, 79-81

186 informed consent, 141-143 and insurance premiums, 78 labeling, 140 limits of, 7~79, 170 Medical Device Amendments of 1976, 65, 73-75 prosecutions, proposed federal role, 89-90 punitive damage awards, 78 reform framework, 81-90 strict liability interpretation, 77-78 and tort law, 75-79, 170 see also Food and Drug Administration (FDA) Prospective Payment Assessment Commission (ProPAC), 94-103, 108, 1 16-1 19 Prospective payment system (PPS), 94-103, 106-108, 117-118, 130, 150~151, 159-160 Public participation in payment coverage decisions, 119 R Rationing health care resources, 1 1 1-1 12, 134-135 Regionalization of skills, see Centralization of skills and facilities Regulations, see Food and Drug Administration (FDA); Product liability and regulation Rehabilitation procedures, 11-12 Renal disease, 9, 57-58 Research and development INDEX financing decisions, 62-70, 155-156 Retinoscope, 19-24 Risk/benefit analysis and responsibilities, 139-144, 152-154, 169 S Screening procedures, ~7 Self-insurance by large employers, 109 Siting decisions, 4 Skeggs, Leonard, 13-14 Specialized medicine, 128-129 Stethoscope, 4, 7 Systems physiology and modeling, 52-53 T Technicon Corporation, 13-16 Technology assessment for policy decisions, 113-115 Therapy procedures, ~11 Thomas, Lewis, 8-10, 127-128, 136 Tort law, see Product liability and regulation U United Kingdom yellow-card program, 140 Utilization review mechanisms, 109-1 10 W Wheelchairs, 29~34

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In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.

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