Clinical Engineering Handbook - 1st Edition - ISBN: 9780122265709, 9780080476575

Clinical Engineering Handbook

1st Edition

Authors: Joseph Dyro Ernesto Iadanza
eBook ISBN: 9780080476575
Hardcover ISBN: 9780122265709
Imprint: Academic Press
Published Date: 27th August 2004
Page Count: 696
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Table of Contents

Contributors Introduction

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

Appendices Index


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.

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


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


No. of pages:
© Academic Press 2004
Academic Press
eBook ISBN:
Hardcover ISBN:


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

Ratings and Reviews

About the Authors

Joseph Dyro Author

Affiliations and Expertise

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

Ernesto Iadanza Author

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

Clinical Engineering Consultant and Advisor, Adjunct Professor of Clinical Engineering, University of Florence, Italy