Clinical Engineering Handbook > 의용공학

Table of Contents
Sect. I Clinical engineering 1
Introduction
1 Clinical engineering : evolution of a discipline 3
2 History of engineering and technology in health care 7
3 The health care environment 11
4 Enhancing patient safety : the role of clinical engineering 14
5 A model clinical engineering department 16
6 Clinical engineering in an academic medical center 18
7 Regional clinical engineering shared services and cooperatives 26
8 Nationwide clinical engineering system 28
9 Clinical engineering and biomedical maintenance in the United States military 34
10 Careers, roles, and responsibilities 36
11 Clinical engineering at the bedside 39
12 The clinical engineer as consultant 41
13 The clinical engineer as investigator and expert witness 43
14 Careers in facilities 49
Sect. II Worldwide clinical engineering practice 51
Introduction
15 World clinical engineering survey 53
16 Clinical engineering in the United Kingdom 58
17 Clinical engineering in Canada 62
18 Clinical engineering in Estonia 65
19 Clinical engineering in Germany 67
20 Clinical engineering in Brazil 69
21 Clinical engineering in Colombia 72
22 Clinical engineering in Ecuador 78
23 Clinical engineering in Mexico 80
24 Clinical engineering in Paraguay 84
25 Clinical engineering in Peru 87
26 Clinical engineering in Venezuela 89
27 Clinical engineering in Japan 91
28 Clinical engineering in Mozambique 93
29 Clinical engineering in the Middle East 97
Sect. III Health technology management 99
Introduction
30 Introduction to medical technology management practices 101
31 Good management practice for medical equipment 108
32 Health care strategic planning utilizing technology assessment 110
33 Technology evaluation 114
34 Technology procurement 118
35 Equipment control and asset management 122
36 Computerized maintenance management systems 124
37 Maintenance and repair of medical devices 130
38 A strategy to maintain essential medical equipment in developing countries 133
39 Outsourcing clinical engineering service 135
40 New strategic directions in acquiring and outsourcing high-tech services by hospitals and implications for clinical engineering organizations and ISOs 137
41 Vendor and service management 147
42 Health care technology replacement planning 153
43 Donation of medical device technologies 155
44 National health technology policy 159
45 The essential health care technology package 163
46 Impact analysis 171
Sect. IV Management 179
Introduction
47 Industrial/management engineering in healthcare 181
48 Financial management of clinical engineering services 188
49 Cost-effectiveness and productivity 199
50 Clinical engineering program indicators 202
51 Personnel management 206
52 Skills identification 212
53 Management styles and human resource development 213
54 Quality 219
Sect. V Safety 225
Introduction
55 Patient safety and the clinical engineer 227
56 Risk management 235
57 Patient safety best practices model 241
58 Hospital safety programs 243
59 Systems approach to medical device safety 246
60 Interactions between medical devices 249
61 Single use injection devices 251
62 Electromagnetic interference with medical devices : in vitro laboratory studies and electromagnetic compatibility standards 254
63 Electromagnetic interference in the hospital 263
64 Accident investigation 269
65 The great debate on electrical safety - in retrospect 281
Sect. VI Education and training 285
Introduction
66 Academic programs in North America 287
67 Clinical engineering education in Germany 294
68 Clinical engineering internship 297
69 Biomedical engineering technology program 299
70 Advanced clinical engineering workshops 301
71 Advanced health technology management workshop 305
72 Distance education 309
73 Emerging technologies : internet and interactive video conferencing 312
74 In-service education 315
75 Technical service schools 317
76 Clinical engineering and nursing 321
77 Retraining programs 328
78 Techno-bio-psycho-socio-medical approach to health care 332
Sect. VII Medical devices : design, manufacturing, evaluation, and control 337
Introduction
79 Evolution of medical device technology 339
80 Technology in health care 342
81 Medical device design and control in the hospital 346
82 Medical device research and design 350
83 Human factors : environment 353
84 Medical devices : failure models, accidents, and liability 355
85 Medical device software development 359
86 Comparative evaluations of medical devices 366
87 Evaluating investigational devices for institutional review boards 369
Sect. VIII Medical devices : utilization and service 371
Introduction
88 Intensive care 373
89 Operating room 376
90 Anesthesiology 384
91 Imaging devices 392
92 Machine vision 401
93 Perinatology 410
94 Cardiovascular techniques and technology 417
95 General hospital devices : beds, stretchers, and wheelchairs 421
96 Medical device troubleshooting 436
Sect. IX Information 449
Introduction
97 Information systems management 451
98 Physiologic monitoring and clinical information systems 456
99 Advanced diagnostics and artificial intelligence 464
100 Real-time executive dashboards and virtual instrumentation : solutions for health care systems 476
101 Telemedicine : clinical and operational issues 484
102 Picture Archiving and Communication Systems (PACS) 487
103 Wireless medical telemetry : addressing the interference issue and the new Wireless Medical Telemetry Service (WMTS) 492
104 Health Insurance Portability and Accountability Act (HIPAA) and its implications for clinical engineering 498
105 Y2K and clinical engineering 506
106 The integration and convergence of medical and information technologies 509
Sect. X Engineering the clinical environment 513
Introduction
107 Physical plant 515
108 Heating, ventilation, and air conditioning 517
109 Electrical power 520
110 Medical gas systems 522
111 Support services 525
112 Construction and renovation 527
113 Radiation safety 529
114 Sanitation 532
115 Water systems in health care facilities 546
116 Disaster planning 549
Sect. XI Medical device standards, regulations, and the law 555
Introduction
117 Primer on standards and regulations 557
118 Medical device regulatory and technology assessment agencies 559
119 Health care quality and ISO 9001:2000 565
120 Hospital facilities safety standards 568
121 JCAHO accreditation 570
122 Medical equipment management program and ANSI/AAMI EQ56 573
123 Clinical engineering standards of practice for Canada 576
124 Regulations and the law 578
125 European union medical device directives and vigilance system 582
126 United States Food & Drug Administration 586
127 Tort liability for clinical engineers and device manufacturers 590
Sect. XII Professionalism and ethics 593
Introduction
128 Professionalism 595
129 Clinical engineering advocacy 598
130 American College of Clinical Engineering 600
131 The New England Society of Clinical Engineering 610
132 New York City Metropolitan Area Clinical Engineering Directors Group 613
133 Clinical engineering certification in the United States 617
134 Clinical engineering certification in Germany 619
Sect. XIII The future 621
Introduction
135 The future of clinical engineering : the challenge of change 623
136 Virtual instrumentation - applications to health care 627
137 Clinical engineers in non-traditional roles 644
138 Clinical support : the forgotten function 646
139 Postmarket surveillance and vigilance on medical devices 647
140 Small business development : business plan development fundamentals for the entrepreneur 649
141 Engineering primary health care : the sickle cell business case 652
142 Global hospital in 2050 - a vision 655