Clinical Engineering Handbook, Second Edition, covers modern clinical engineering topics, giving experienced professionals the necessary skills and knowledge for this fast-evolving field. Featuring insights from leading international experts, this book presents traditional practices, such as healthcare technology management, medical device service, and technology application. In addition, readers will find valuable information on the newest research and groundbreaking developments in clinical engineering, such as health technology assessment, disaster preparedness, decision support systems, mobile medicine, and prospects and guidelines on the future of clinical engineering.
As the biomedical engineering field expands throughout the world, clinical engineers play an increasingly important role as translators between the medical, engineering and business professions. In addition, they influence procedures and policies at research facilities, universities, and in private and government agencies. This book explores their current and continuing reach and its importance.
- Presents a definitive, comprehensive, and up-to-date book on clinical engineering
- Written by worldwide experts with ties to IFMBE, IUPESM, Global CE Advisory Board, IEEE, ACCE, and more
- Includes coverage of new topics, such as Health Technology Assessment (HTA), Decision Support Systems (DSS), Mobile Apps, IFMBE/Clinical Engineering Division projects, Success Stories in Clinical Engineering, and Human Factors Engineering
Section I Clinical Engineering I 1. Clinical Engineering: Evolution of a Discipline 2. History of Engineering and Technology in Health Care 3. The Health Care Environment 4. Enhancing Patient Safety: The Role of Clinical Engineering 5. A Model Clinical Engineering Department 6. Clinical Engineering in an Academic Medical Center 7. Regional Clinical Engineering Shared Services and Cooperatives 8. Nationwide Clinical Engineering System 9. Clinical Engineering and Biomedical Maintenance in the United States Military 10. Careers, Roles and Responsibilities 11. Clinical Engineering at the Bedside 12. The Clinical Engineer as Consultant 13. The Clinical Engineer as Investigator and Expert 14. Careers in Facilities
Section II Worldwide Clinical Engineering Practice 15. World Clinical Engineering Survey 16. Clinical Engineering in the United Kingdom 17. Clinical Engineering in Canada 18. Clinical Engineering in Estonia 19. Clinical Engineering in Germany 20. Clinical Engineering in Brazil 21. Clinical Engineering in Columbia 22. Clinical Engineering in Ecuador 23. Clinical Engineering in Mexico 24. Clinical Engineering in Paraguay 25. Clinical Engineering in Peru 26. Clinical Engineering in Venezuela 27. Clinical Engineering in Japan 28. Clinical Engineering in Mozambique 29. Clinical Engineering in the Middle East
Section III Health Technology Management 30. Introduction to Medical Technology Management 31. Good Management Practice for Medical Equipment 32. Health Care Strategic Planning Utilizing Technology Assessment 33. Technology Evaluation 34. Technology Procurement 35. Equipment Control and Asset Management 36. Computerized Maintenance Management Systems 37. Maintenance and Repair of Medical Devices 38. A Strategy to Maintain Essential Medical Equipment in Developing Countries 39. Outsourcing Clinical Engineering Service 40. New Strategic Directions in Acquiring and Outsourcing High-Tech Services by Hospitals and Implications for Clinical Engineering Organizations and ISOs. 41. Vendor and Service Management 42. Health Care Technology Replacement Planning 43. Donation of Medical Device Technologies 44. National Health Technology Policy 45. The Essential Health Care Technology Package 46. Impact Analysis
Section IV Management 47. Industrial/Management Engineering in Healthcare 48. Financial Management of Clinical Engineering Services 49. Cost-Effectiveness and Productivity 50. Clinical Engineering Program Indicators 51. Personnel Management 52. Skills Identification 53. Management Styles and Human Resource Development 54. Quality Section V Safety 55. Patient Safety and the Clinical Engineer 56. Risk Management 57. Patient Safety Best Practices Model 58. Hospital Safety Programs 59. Systems Approach to Medical Device Safety 60. Interactions Between Medical Devices 61. Single Use Injection Devices 62. Electromagnetic Interference with Medical Devices: In Vitro Laboratory Studies and Electromagnetic Compatibility Standards 63. Electromagnetic Interference in the Hospital 64. Accident Investigation 65. The Great Debate on Electrical Safety
Section VI Education and Training 66. Academic Programs in North America 67. Clinical Engineering Education in Germany 68. Clinical Engineering Internship 69. Biomedical Engineering Technology Program 70. Advanced Clinical Engineering Workshops 71. Advanced Health Technology Management Workshop 72. Distance Education 73. Emerging Technologies: Internet and Interactive Video Conferencing 74. In-Service Education 75. Technical Service Schools 76. Clinical Engineering and Nursing 77. Retraining Programs 78. Techno-Bio-Psycho-Socio-Medical Approach to Health Care Section VII Medical Devices: Design, Manufacturing, Evaluation, and Control 79. Evolution of Medical Device Technology 80. Technology in Health Care 81. Medical Device Design and Control in the Hospital 82. Medical Device Research and Design 83. Human Factors: Environment 84. Medical Devices: Failure Modes, Accidents, and Liability 85. Medical Device Software Development 86. Comparative Evaluations of Medical Devices 87. Evaluating Investigational Devices for Institutional Review Boards
Section VIII Medical Devices: Utilization and Service 88. Intensive Care 89. Operating Room 90. Anaesthesiology 91. Imaging Devices 92. Machine Vision 93. Perinatology 94. Cardiovascular Techniques and Technology 95. General Hospital Devices: Beds, Stretchers, and Wheelchairs 96. Medical Device Troubleshooting
Section IX Information 97. Information Systems Management 98. Physiologic Monitoring and Clinical Information Systems 99. Advanced Diagnostics and Artificial Intelligence 100. Real-Time Executive Dashboards and Virtual Instrumentation: Solutions for Health Care Systems 101. Telemedicine: Clinical and Operational Issues 102. Picture Archiving and Communication Systems (PACS) 103. Wireless Medical Telemetry: Addressing the Interference Issue and the New Wireless Medical Telemetry Service 104. Health Insurance Portability and Accountability Act and its Implications for Clinical Engineering 105. YSK and Clinical Engineering 106. The Integration and Convergence of Medical and Information Technologies
Section X Engineering the Clinical Environment 107. Physical Plant 108. Heating, Ventilation, and Air Conditioning 109. Electrical Power 110. Medical Gas Systems 111. Support Services 112. Construction and Renovation 113. Radiation Safety 114. Sanitation 115. Water Systems in Health Care Facilities 116. Disaster Planning
Section XI Medical Device Standards, Regulations, and the Law 117. Primer on Standards and Regulations 118. Medical Device Regulatory and Technology Assessment Agencies 119. Health Care Quality and IS 9001:2000 120. Hospital Facilities Safety Standards 121. JCAHO Accreditation 122. Medical Equipment Management Program and ANSI/AAMI EQ56 123. Clinical Engineering Standards of Practice for Canada 124. Regulations and the Law 125. European Union Medical Device Directives and Vigilance System 126. United States Food & Drug Administration 127. Tort Liability for Clinical Engineers and Device Manufacturers
Section XII Professionalism and Ethics 128. Professionalism 129. Clinical Engineering Advocacy 130. American College of Clinical Engineering 131. The New England Society of Clinical Engineering 132. New York City Metropolitan Area Clinical Engineering Directors Group 133. Clinical Engineering Certification in the United States 134. Clinical Engineering Certification in Germany 135. The Future of Clinical Engineering: The Challenge of Change 136. Virtual Instrumentation
Applications to Health Care 137. Clinical Engineers in Non-Traditional Roles 138. Clinical Support: The Forgotten Function 139. Postmarket Surveillance and Vigilance on Medical Devices 140. Small Business Development: Business Plan Development Fundamentals for the Entrepreneur 141. Engineering Primary Health Care: The Sickle Cell Business Case 142. Global Hospital in 2050
Chairman of the Clinical Engineering Division Board at the IFMBE and Chairman of the Education and Training Committee at the IUPESM. Clinical Engineering consultant and advisor, Adjunct Professor in Clinical Engineering at the University of Florence (Italy), and member of IFMBE, EMBS, IEEE. Dr. Ernesto Iadanza received both his MSc degree (Electronics Engineering - biomedical curriculum) and his PhD degree (Telematics) at the University of Florence (Italy). He is the founder and coordinator of the Biomedical Committee - Association of Professional Engineers, Florence. He was awarded with the IBM Faculty Award in 2013.