Clinical Engineering Handbook
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Table of contents
- table of contentsv
- Contributorsxiii
- Introductionxvii
- Section I: Clinical Engineering1
- 1. Clinical Engineering: Evolution of a Discipline3
- 2. History of Engineering and Technology in Health Care7
- 3. The Health Care Environment11
- 4. Enhancing Patient Safety: The Role of Clinical Engineering14
- 5. A Model Clinical Engineering Department16
- 6. Clinical Engineering in an Academic Medical Center18
- 7. Regional Clinical Engineering Shared Services and Cooperatives26
- 8. Nationwide Clinical Engineering System28
- 9. Clinical Engineering and Biomedical Maintenance in the United States Military34
- 10. Careers, Roles, and Responsibilities36
- 11. Clinical Engineering at the Bedside39
- 12. The Clinical Engineer as Consultant41
- 13. The Clinical Engineer as Investigator and Expert Witness43
- 14. Careers in Facilities49
- Section II: Worldwide Clinical Engineering Practice51
- 15. World Clinical Engineering Survey53
- 16. Clinical Engineering in the United Kingdom58
- 17. Clinical Engineering in Canada62
- 18. Clinical Engineering in Estonia65
- 19. Clinical Engineering in Germany67
- 20. Clinical Engineering in Brazil69
- 21. Clinical Engineering in Colombia72
- 22. Clinical Engineering in Ecuador78
- 23. Clinical Engineering in Mexico80
- 24. Clinical Engineering in Paraguay84
- 25. Clinical Engineering in Peru87
- 26. Clinical Engineering in Venezuela89
- 27. Clinical Engineering in Japan91
- 28. Clinical Engineering in Mozambique93
- 29. Clinical Engineering in the Middle East97
- Section III: Health Technology Management99
- 30. Introduction to Medical Technology Management Practices101
- 31. Good Management Practice for Medical Equipment108
- 32. Health Care Strategic Planning Utilizing Technology Assessment110
- 33. Technology Evaluation114
- 34. Technology Procurement118
- 35. Equipment Control and Asset Management122
- 36. Computerized Maintenance Management Systems124
- 37. Maintenance and Repair of Medical Devices130
- 38. A Strategy to Maintain Essential Medical Equipment in Developing Countries133
- 39. Outsourcing Clinical Engineering Service135
- 40. New Strategic Directions in Acquiring and Outsourcing High- Tech Services by Hospitals and Impli137
- 41. Vendor and Service Management147
- 42. Health Care Technology Replacement Planning153
- 43. Donation of Medical Device Technologies155
- 44. National Health Technology Policy159
- 45. The Essential Health Care Technology Package163
- 46. Impact Analysis171
- Section IV: Management179
- 47. Industrial/ Management Engineering in Health Care181
- 48. Financial Management of Clinical Engineering Services188
- 49. Cost-Effectiveness and Productivity199
- 50. Clinical Engineering Program Indicators202
- 51. Personnel Management206
- 52. Skills Identification212
- 53. Management Styles and Human Resource Development213
- 54. Quality219
- Section V: Safety225
- 55. Patient Safety and the Clinical Engineer227
- 56. Risk Management235
- 57. Patient Safety Best Practices Model241
- 58. Hospital Safety Programs243
- 59. Systems Approach to Medical Device Safety246
- 60. Interactions Between Medical Devices249
- 61. Single-Use Injection Devices251
- 62. Electromagnetic Interference with Medical Devices: Laboratory Studies and Electromagnetic Compat254
- 63. Electromagnetic Interference in the Hospital263
- 64. Accident Investigation269
- 65. The Great Debate on Electrical Safety - In Retrospect281
- Section VI: Education and Training285
- 66. Academic Programs in North America287
- 67. Clinical Engineering Education in Germany294
- 68. Clinical Engineering Internship297
- 69. Biomedical Engineering Technology Program299
- 70. Advanced Clinical Engineering Workshops301
- 71. Advanced Health Technology Management Workshop305
- 72. Distance Education309
- 73. Emerging Technologies: Internet and Interactive Video Conferencing312
- 74. In-Service Education315
- 75. Technical Service Schools317
- 76. Clinical Engineering and Nursing321
- 77. Retraining Programs328
- 78. Techno-Bio-Psycho- Socio- Medical Approach to Health Care332
- Section VII: Medical Devices: Design, Manufacturing, Evaluation, and Control337
- 79. Evolution of Medical Device Technology339
- 80. Technology in Health Care342
- 81. Medical Device Design and Control in the Hospital346
- 82. Medical Device Research and Design350
- 83. Human Factors: Environment353
- 84. Medical Devices: Failure Modes, Accidents, and Liability355
- 85. Medical Device Software Development359
- 86. Comparative Evaluations of Medical Devices366
- 87. Evaluating Investigational Devices for Institutional Review Boards369
- Section VIII: Medical Devices: Utilization and Service371
- 88. Intensive Care373
- 89. Operating Room376
- 90. Anesthesiology384
- 91. Imaging Devices392
- 92. Machine Vision401
- 93. Perinatology410
- 94. Cardiovascular Techniques and Technology417
- 95. General Hospital Devices: Beds, Stretchers, and Wheelchairs421
- 96. Medical Device Troubleshooting436
- Section IX: Information449
- 97. Information Systems Management451
- 98. Physiologic Monitoring and Clinical Information Systems456
- 99. Advanced Diagnostics and Artificial Intelligence464
- 100. Real-Time Executive Dashboards and Virtual Instrumentation: Solutions for Health Care Systems476
- 101. Telemedicine: Clinical and Operational Issues484
- 102. Picture Archiving and Communication Systems ( PACS)487
- 103. Wireless Medical Telemetry: Addressing the Interference Issue and the New Wireless Medical Tele492
- 104. Health Insurance Portability and Accountability Act ( HIPAA) and Its Implications for Clinical498
- 105. Y2K and Clinical Engineering506
- 106. The Integration and Convergence of Medical and Information Technologies509
- Section X: Engineering the Clinical Environment513
- 107. Physical Plant515
- 108. Heating, Ventilation, and Air Conditioning517
- 109. Electrical Power520
- 110. Medical Gas Systems522
- 111. Support Services525
- 112. Construction and Renovation527
- 113. Radiation Safety529
- 114. Sanitation532
- 115. Water Systems in Health Care Facilities546
- 116. Disaster Planning549
- Section XI: Medical Device Standards, Regulations, and the Law555
- 117. Primer on Standards and Regulations557
- 118. Medical Device Regulatory and Technology Assessment Agencies559
- 119. Health Care Quality and ISO 9001: 2000565
- 120. Hospital Facilities Safety Standards568
- 121. JCAHO Accreditation570
- 122. Medical Equipment Management Program and ANSI/ AAMI EQ56573
- 123. Clinical Engineering Standards of Practice for Canada576
- 124. Regulations and the Law578
- 125. European Union Medical Device Directives and Vigilance System582
- 126. United States Food & Drug Administration586
- 127. Tort Liability for Clinical Engineers and Device Manufacturers590
- Section XII: Professionalism and Ethics593
- 128. Professionalism595
- 129. Clinical Engineering Advocacy598
- 130. American College of Clinical Engineering600
- 131. The New England Society of Clinical Engineering610
- 132. New York City Metropolitan Area Clinical Engineering Directors Group613
- 133. Clinical Engineering Certification in the United States617
- 134. Clinical Engineering Certification in Germany619
- Section XIII: The Future621
- 135. The Future of Clinical Engineering: The Challenge of Change623
- 136. Virtual Instrumentation- Applications to Health Care627
- 137. Clinical Engineers in Non- Traditional Roles644
- 138. Clinical Support: The Forgotten Function646
- 139. Postmarket Surveillance and Vigilance on Medical Devices647
- 140. Small Business Development: Business Plan Development Fundamentals for the Entrepreneur649
- 141. Engineering Primary Health Care: The Sickle Cell Business Case652
- 142. Global Hospital in 2050- A Vision655
- Appendix 10-A: Sample Request for Proposal ( rfp)661
- Appendix 10-B Position Description663
- Index665
As the biomedical engineering field expands throughout the world, clinical engineers play an evermore-important role as translators between the medical, engineering, and business professions. They influence procedure and policy at research facilities, universities, as well as private and government agencies including the Food and Drug Administration and the World Health Organization. The profession of clinical engineering continues to seek its place amidst the myriad of professionals that comprise the health care field.
The Clinical Engineering Handbook meets a long felt need for a comprehensive book on all aspects of clinical engineering that is a suitable reference in hospitals, classrooms, workshops, and governmental and non-governmental organization. The Handbook’s thirteen sections address the following areas: Clinical Engineering; Models of Clinical Engineering Practice; Technology Management; Safety Education and Training; Design, Manufacture, and Evaluation and Control of Medical Devices; Utilization and Service of Medical Devices; Information Technology; and Professionalism and Ethics. The Clinical Engineering Handbook provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world. From telemedicine and IT issues, to sanitation and disaster planning, it brings together all the important aspects of clinical engineering.
* Clinical Engineers are the safety and quality faciltators in all medical facilities.
* The most definitive, comprehensive, and up-to-date book available on the subject of clinical engineering.
* Over 170 contributions by leaders in the field of clinical engineering.
The Clinical Engineering Handbook meets a long felt need for a comprehensive book on all aspects of clinical engineering that is a suitable reference in hospitals, classrooms, workshops, and governmental and non-governmental organization. The Handbook’s thirteen sections address the following areas: Clinical Engineering; Models of Clinical Engineering Practice; Technology Management; Safety Education and Training; Design, Manufacture, and Evaluation and Control of Medical Devices; Utilization and Service of Medical Devices; Information Technology; and Professionalism and Ethics. The Clinical Engineering Handbook provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world. From telemedicine and IT issues, to sanitation and disaster planning, it brings together all the important aspects of clinical engineering.
* Clinical Engineers are the safety and quality faciltators in all medical facilities.
* The most definitive, comprehensive, and up-to-date book available on the subject of clinical engineering.
* Over 170 contributions by leaders in the field of clinical engineering.