Clinical Engineering Handbook (Biomedical Engineering)

front cover......Page 1
copyright......Page 5
table of contents......Page 6
Contributors......Page 14
Introduction......Page 18
Section I: Clinical Engineering......Page 22
1. Clinical Engineering: Evolution of a Discipline......Page 24
2. History of Engineering and Technology in Health Care......Page 28
3. The Health Care Environment......Page 32
4. Enhancing Patient Safety: The Role of Clinical Engineering......Page 35
5. A Model Clinical Engineering Department......Page 37
6. Clinical Engineering in an Academic Medical Center......Page 39
7. Regional Clinical Engineering Shared Services and Cooperatives......Page 47
8. Nationwide Clinical Engineering System......Page 49
9. Clinical Engineering and Biomedical Maintenance in the United States Military......Page 55
10. Careers, Roles, and Responsibilities......Page 57
11. Clinical Engineering at the Bedside......Page 60
12. The Clinical Engineer as Consultant......Page 62
13. The Clinical Engineer as Investigator and Expert Witness......Page 64
14. Careers in Facilities......Page 70
Section II: Worldwide Clinical Engineering Practice......Page 72
15. World Clinical Engineering Survey......Page 74
16. Clinical Engineering in the United Kingdom......Page 79
17. Clinical Engineering in Canada......Page 83
18. Clinical Engineering in Estonia......Page 86
19. Clinical Engineering in Germany......Page 88
20. Clinical Engineering in Brazil......Page 90
21. Clinical Engineering in Colombia......Page 93
22. Clinical Engineering in Ecuador......Page 99
23. Clinical Engineering in Mexico......Page 101
24. Clinical Engineering in Paraguay......Page 105
25. Clinical Engineering in Peru......Page 108
26. Clinical Engineering in Venezuela......Page 110
27. Clinical Engineering in Japan......Page 112
28. Clinical Engineering in Mozambique......Page 114
29. Clinical Engineering in the Middle East......Page 118
Section III: Health Technology Management......Page 120
30. Introduction to Medical Technology Management Practices......Page 122
31. Good Management Practice for Medical Equipment......Page 129
32. Health Care Strategic Planning Utilizing Technology Assessment......Page 131
33. Technology Evaluation......Page 135
34. Technology Procurement......Page 139
35. Equipment Control and Asset Management......Page 143
36. Computerized Maintenance Management Systems......Page 145
37. Maintenance and Repair of Medical Devices......Page 151
38. A Strategy to Maintain Essential Medical Equipment in Developing Countries......Page 154
39. Outsourcing Clinical Engineering Service......Page 156
40. New Strategic Directions in Acquiring and Outsourcing High- Tech Services by Hospitals and Implications for Clinical Engineering Organizations and ISOs......Page 158
41. Vendor and Service Management......Page 168
42. Health Care Technology Replacement Planning......Page 174
43. Donation of Medical Device Technologies......Page 176
44. National Health Technology Policy......Page 180
45. The Essential Health Care Technology Package......Page 184
46. Impact Analysis......Page 192
Section IV: Management......Page 200
47. Industrial/ Management Engineering in Health Care......Page 202
48. Financial Management of Clinical Engineering Services......Page 209
49. Cost-Effectiveness and Productivity......Page 220
50. Clinical Engineering Program Indicators......Page 223
51. Personnel Management......Page 227
52. Skills Identification......Page 233
53. Management Styles and Human Resource Development......Page 234
54. Quality......Page 240
Section V: Safety......Page 246
55. Patient Safety and the Clinical Engineer......Page 248
56. Risk Management......Page 256
57. Patient Safety Best Practices Model......Page 262
58. Hospital Safety Programs......Page 264
59. Systems Approach to Medical Device Safety......Page 267
60. Interactions Between Medical Devices......Page 270
61. Single-Use Injection Devices......Page 272
62. Electromagnetic Interference with Medical Devices: Laboratory Studies and Electromagnetic Compatibility Standards......Page 275
63. Electromagnetic Interference in the Hospital......Page 284
64. Accident Investigation......Page 290
65. The Great Debate on Electrical Safety - In Retrospect......Page 302
Section VI: Education and Training......Page 306
66. Academic Programs in North America......Page 308
67. Clinical Engineering Education in Germany......Page 315
68. Clinical Engineering Internship......Page 318
69. Biomedical Engineering Technology Program......Page 320
70. Advanced Clinical Engineering Workshops......Page 322
71. Advanced Health Technology Management Workshop......Page 326
72. Distance Education......Page 330
73. Emerging Technologies: Internet and Interactive Video Conferencing......Page 333
74. In-Service Education......Page 336
75. Technical Service Schools......Page 338
76. Clinical Engineering and Nursing......Page 342
77. Retraining Programs......Page 349
78. Techno-Bio-Psycho- Socio- Medical Approach to Health Care......Page 353
Section VII: Medical Devices: Design, Manufacturing, Evaluation, and Control......Page 358
79. Evolution of Medical Device Technology......Page 360
80. Technology in Health Care......Page 363
81. Medical Device Design and Control in the Hospital......Page 367
82. Medical Device Research and Design......Page 371
83. Human Factors: Environment......Page 374
84. Medical Devices: Failure Modes, Accidents, and Liability......Page 376
85. Medical Device Software Development......Page 380
86. Comparative Evaluations of Medical Devices......Page 387
87. Evaluating Investigational Devices for Institutional Review Boards......Page 390
Section VIII: Medical Devices: Utilization and Service......Page 392
88. Intensive Care......Page 394
89. Operating Room......Page 397
90. Anesthesiology......Page 405
91. Imaging Devices......Page 413
92. Machine Vision......Page 422
93. Perinatology......Page 431
94. Cardiovascular Techniques and Technology......Page 438
95. General Hospital Devices: Beds, Stretchers, and Wheelchairs......Page 442
96. Medical Device Troubleshooting......Page 457
Section IX: Information......Page 470
97. Information Systems Management......Page 472
98. Physiologic Monitoring and Clinical Information Systems......Page 477
99. Advanced Diagnostics and Artificial Intelligence......Page 485
100. Real-Time Executive Dashboards and Virtual Instrumentation: Solutions for Health Care Systems......Page 497
101. Telemedicine: Clinical and Operational Issues......Page 505
102. Picture Archiving and Communication Systems ( PACS)......Page 508
103. Wireless Medical Telemetry: Addressing the Interference Issue and the New Wireless Medical Telemetry Service ( WMTS)......Page 513
104. Health Insurance Portability and Accountability Act ( HIPAA) and Its Implications for Clinical Engineering......Page 519
105. Y2K and Clinical Engineering......Page 527
106. The Integration and Convergence of Medical and Information Technologies......Page 530
Section X: Engineering the Clinical Environment......Page 534
107. Physical Plant......Page 536
108. Heating, Ventilation, and Air Conditioning......Page 538
109. Electrical Power......Page 541
110. Medical Gas Systems......Page 543
111. Support Services......Page 546
112. Construction and Renovation......Page 548
113. Radiation Safety......Page 550
114. Sanitation......Page 553
115. Water Systems in Health Care Facilities......Page 567
116. Disaster Planning......Page 570
Section XI: Medical Device Standards, Regulations, and the Law......Page 576
117. Primer on Standards and Regulations......Page 578
118. Medical Device Regulatory and Technology Assessment Agencies......Page 580
119. Health Care Quality and ISO 9001: 2000......Page 586
120. Hospital Facilities Safety Standards......Page 589
121. JCAHO Accreditation......Page 591
122. Medical Equipment Management Program and ANSI/ AAMI EQ56......Page 594
123. Clinical Engineering Standards of Practice for Canada......Page 597
124. Regulations and the Law......Page 599
125. European Union Medical Device Directives and Vigilance System......Page 603
126. United States Food & Drug Administration......Page 607
127. Tort Liability for Clinical Engineers and Device Manufacturers......Page 611
Section XII: Professionalism and Ethics......Page 614
128. Professionalism......Page 616
129. Clinical Engineering Advocacy......Page 619
130. American College of Clinical Engineering......Page 621
131. The New England Society of Clinical Engineering......Page 631
132. New York City Metropolitan Area Clinical Engineering Directors Group......Page 634
133. Clinical Engineering Certification in the United States......Page 638
134. Clinical Engineering Certification in Germany......Page 640
Section XIII: The Future......Page 642
135. The Future of Clinical Engineering: The Challenge of Change......Page 644
136. Virtual Instrumentation- Applications to Health Care......Page 648
137. Clinical Engineers in Non- Traditional Roles......Page 665
138. Clinical Support: The Forgotten Function......Page 667
139. Postmarket Surveillance and Vigilance on Medical Devices......Page 668
140. Small Business Development: Business Plan Development Fundamentals for the Entrepreneur......Page 670
141. Engineering Primary Health Care: The Sickle Cell Business Case......Page 673
142. Global Hospital in 2050- A Vision......Page 676
Appendix 10-A: Sample Request for Proposal ( rfp)......Page 682
Appendix 10-B Position Description......Page 684
index......Page 686