Clinical Engineering Handbook Book

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