Clinical Engineering Handbook

Clinical Engineering Handbook, 1st Edition

Clinical Engineering Handbook, 1st Edition,Ernesto Iadanza,Joseph Dyro,ISBN9780122265709


Academic Press




279 X 216

The world's first comprehensive reference for technology best practice and future prospects in clinical engineering with a fully international perspective.

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Key Features

* 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.


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.


Biomedical Engineers, Clinical Engineers, Doctors, Nurses, Physicians, Clinical Technicians, Health Care Managers.

Ernesto Iadanza

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.

Affiliations and Expertise

Ph.D., Clinical Engineering consultant and advisor, Adjunct Professor of Clinical Engineering, University of Florence, Italy

Joseph Dyro

B.S. Electrical Engineering, Massachusetts Institute of Technology M.S. and Ph.D. Biomedical Electronics Engineering, University of Pennsylvania

Affiliations and Expertise

President, Biomedical Resource Group, Setauket, NY, Editor of the Journal of Clinical Engineering

Clinical Engineering Handbook, 1st Edition


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 – in Retrospect
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
Section XIII The Future
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: Busieness Plan Development Fundamentals for the Entrepreneur
141. Engineering Primary Health Care: The Sickle Cell Business Case
142. Global Hospital in 2050 – A Vision


Quotes and reviews

13 sections, 142 chapters, 694 pages, 116 contributors! This is a comprehensive overview of the history and state of the art of clinical engineering written by an international group of generally well-known contributors to the field.

For brevity’s sake I shall give an overview of the major sections of this text. Section one covers clinical engineering history, roles, models (academic, regional, military), job descriptions, and careers. Section two gives an overview of worldwide practices in clinical engineering, with example chapters covering the practice in several countries, such as Estonia, Paraguay and Japan. Section three gives an overview of healthcare technology management topics, covering good manufacturing practices, outsourcing, maintenance and repair, etc. There are several useful forms and flowcharts to be found here. Section four reviews management styles, finances, personnel matters, skills needed, and quality assurance. Section five reviews several topics involving safety, such as risk management, best practices, accidents, and special cases involving electrical safety and electromagnetic interference. Section six reviews the education and training of clinical engineers, including reviews of practices in North America and Germany, internships, BET licensing, the use of workshops and distance education, etc. Section seven reviews the design, manufacture, evaluation and control of medical devices. It includes some useful material on human factors, liability, and Institutional Review Boards. Medical Devices, Utilization and Service is the title of section eight. This section reviews devices commonly used in different sections of the hospital (e.g. anesthesiology and perinatology) and as well discusses troubleshooting techniques. Section nine reviews information sources, transmission, and processing. Included are sections on PACS, Telemedicine, Wireless Medical Telemetry, Virtual Instruments, and the effects of the HIPA Act. Section ten reviews several topics often relegated to environmental and plant engineers, such as HVAC, Electrical Power considerations, Radiation Safety, Sanitation, Construction and Renovation, Water Systems, and Disaster Planning. Section eleven reviews Medical Device Standards, Regulations, and the Law. This is mandatory reading for all engineering involved in medicine. It covers JCAHO Accreditation, AAMI and ANSI standards, the FDA and other regulatory agencies, liability law, and ISO standards. Section twelve briefly reviews professionalism and ethics in clinical engineering practice, and gives some examples of professional organizations in New England and in Germany. Section thirteen, the final part of the text, briefly addresses some potential future trends in clinical engineering practice and some of the trends that may affect it.

To reiterate: this is an exceedingly comprehensive handbook. The field of clinical engineering (worldwide) is very well described here. While the level of each individual chapter varies considerably (from one page summaries to multiple page well-documented and illustrated chapters) this text overall will be very useful as a reference text for practitioners and students of clinical engineering. Many individual chapters will serve as teaching material for lectures in clinical and bioengineering courses.

The page count and purchase price of this text were obtained from the Academic Press web site, and may not be accurate as of the publication date. (This review was based upon page proofs.)

The editor and each author are to be congratulated for their contribution to the literature in this field.

Reviewed by:
Paul H. King, Vanderbilt University


The Clinical Engineering Handbook makes an excellent resource, particularly to someone newly entering or thinking about entering the field. It provides a good background to the wide array of tasks, programs, innovations and challenges to the clinical engineering profession...Overall, the handbook is well written and the breakdown into very specific chapters makes referencing easy. - ACCE News, Nov./Dec. 2004

"The Clinical Engineering Handbook makes an excellent resource, particularly to someone newly entering or thinking about entering the field. It provides a good background to the wide array of tasks, programs, innovations, and challenges to the clinical engineering profession." - Journal of Clinical Engineering, June 2005
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