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Clinical Engineering Handbook - 2nd Edition - ISBN: 9780128134672, 9780128134689

Clinical Engineering Handbook

2nd Edition

Editor: Ernesto Iadanza
Hardcover ISBN: 9780128134672
eBook ISBN: 9780128134689
Imprint: Academic Press
Published Date: 4th December 2019
Page Count: 958
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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.

Key Features

  • Presents a definitive, comprehensive, and up-to-date resource 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, Success Stories in Clinical Engineering, and Human Factors Engineering


Researchers, professionals, and students of clinical engineering and biomedical engineering; health technology managers, healthcare managers, and healthcare organizations.

Table of Contents

Section 1 Clinical Engineering
Section 1 Overview
1. Clinical Engineering:
2. Open Source Medical Devices: Healthcare Solutions for Low- and High- Resource Settings
3. Success Stories in Clinical Engineering
4. RFID technology in healthcare
5. Computer Aided Facilities Management
6. Public Procurement Of Innovative Medical Technology: Femtosecond And Excimer Laser Platform For Ophthalmic Surgery

Section 2 Worldwide Clinical Engineering Practice
Section 2 Overview
7. Clinical Engineering in the United Kingdom
8. Clinical Engineering in Canada
9. Clinical Engineering in Colombia
10. Clinical Engineering in Mexico
11. Clinical Engineering in Paraguay
12. Clinical Engineering in Peru
13. Clinical Engineering in Venezuela
14. Clinical Engineering in Japan
15. Clinical Engineering in Brazil
16. Clinical Engineering in the Middle East
17. Clinical Engineering in China
18. Clinical Engineering in Argentina
19. Clinical Engineering in Italy
20. Clinical Engineering in India
21. Clinical Engineering in Poland
22. Clinical Engineering in Australia
23. Clinical Engineering in Chile
24. Clinical Engineering in USA
25. Clinical Engineering in Albania
26. Clinical Engineering in South Africa
27. Clinical Engineering in Uganda

Section 3 Health Technology Management
Section 3 Overview
28. Introduction to Medical Technology Management Practices
29. Good Management Practice for Medical Equipment / Leadership
30. Health Care Strategic Planning Utilizing Technology Assessment
31. Technology Evaluation / US and Global perspectives
32. Technology Procurement / Strategic Acquisition Planning/Replacement
33. Equipment Control and Asset Management
34. Computerized Maintenance Management Systems
35. Maintenance and Repair of Medical Devices (Healthcare Technology)
36. Outsourcing Clinical Engineering Service
37. Health Care Technology Replacement Planning
38. The integrated Health Care Technology Package
39. Impact Analysis
40. CE-IT, cybersecurity, CE-IT HTM
41. Metrics, Indicators, Analytics
42. Standards of Practice (HTM Best Practice Guidelines and Standards of Practice Around the World)
43. Single-Use Medical Devices Reuse and Reprocessing
44. Clinical Systems Integration Support
45. A framework for medical device safety
46. ACCE ACEW Update

Section 4 Management
Section 4 Overview
47. Quality Management Systems
48. Personnel Management/Skills Identification
49. Management Styles and Human Resource Development
50. A Systems Management Framework for Medical Device Safety and Optimal Outcomes

Section 5 Safety
Section 5 Overview
51. Patient Safety Revisited
52. Risk Management
53. Hospital Safety Programs
54. Medical Device Regulations and Patient Safety
55. Single Use Injection Devices
56. Electromagnetic Interference in the Hospital
57. The Great Debate on Electrical Safety - In Retrospect

Section 6 Professionalism, Education and Ethics
Section 6 Overview
58. Professionalism
59. American College of Clinical Engineering
60. Clinical Engineering Certification in the United States
61. Clinical Engineering Internship
62. HTM Training in the USA
63. Distance Education
64. In-Service Education
65. New York City Metropolitan Area Clinical Engineering Directors Group

Section 7 Medical Devices: Design, Manufacturing, Evaluation, and Control
Section 7 Overview
66. Technology in Health Care
67. Medical Device Design and Control in the Hospital
68. Medical Device Research and Design
69. Comparative Evaluations of Medical Devices
70. Evolution of prosthetic feet and design based on Gait analysis data
71. Challenge in surgical robot development
72. Developing and launching a medical device: a fresh engineering point of view

Section 8 Medical Devices: Utilization and Service
Section 8 Overview
73. Anaesthesia machines
74. Cardiovascular techniques and technology
75. Device Inspection
76. Hospital bed
77. ICU
78. Imaging
79. Incubator
80. Maintenance

Section 9 Information Technology and Mobile Apps
Section 9: Overview
81. The Digital Hospital of the 20th Century, and Information Systems Management
82. The Integration and Convergence of Medical and Information Technologies
83. Telehealth, Telemedicine, and Telecare
84. Artificial Intelligence In Medical Devices And Clinical Decision Support Systems
85. A Practical Framework for Medical Device Interoperability Conformity Testing (IHE PCD)
86. Application of HL7® FHIR for Device and Health Information System (HIS) Interoperability
87. Enterprise Image Management and Medical Informatics
88. Maintenance of Complex, Converged, and Interoperable Medical Device / Information Systems
89. Forensics and Accident/Incident Investigations for Interoperable Medical Device and Information Systems
90. New Opportunities for BME/CE Health IT Education

Section 10 Engineering the Clinical Environment
Section 10 Overview
91. Physical Plant and Fire Safety
92. Heating, Ventilation, and Air Conditioning
93. Electrical Power
94. Medical Gas Systems
95. Construction and Renovation
96. Radiation Safety
97. Infection Prevention and Control – A Clinical Engineering Perspective
98. Water Systems in Health Care Facilities
99. Disaster Planning and Emergency Preparedness
100. Healthcare Engineering in a Resource Constrained Environment

Section 11 Medical Device Standards, Regulations, and the Law
Section 11 Overview
101. Standards and Regulations
102. Regulations and the Law
103. Hospital Facilities Safety Standards
104. Healthcare Quality and ISO IEC 17020
105. Medical Equipment Management Program Standards - ANSI/AAMI EQ56 and ANSI/AAMI EQ89
106. Clinical Engineering Standards and Practice
107. European Union Medical Device Directives and Vigilance System
108. United States Food & Drug Administration
109. Legal Metrology Framework for Medical Devices
110. Increasing of Accuracy and Efficency of Medical Devices In Legal Metrology System of Bosnia and Herzegovina

Section 12 Health Technology Assessment
Section 12 Overview
111. Introduction to Health Economics and HTA
112. HTA of Medical Devices: criticisms and peculiarities
113. eHTA
114. MCDA in eHTA
115. Hospital Based HTA
116. Generation of Evidence in biomedical engineering
117. Systematic literature review and Meta-analysis: the case of medical devices and medical locations
118. human factors and system thinking for medical device: evidence to design, evaluate and generate value
119. Health Technology Assessment teaching for BME

Section 13 Introduction to Human Factors
Section 13 Overview
120. Physiological and Psychological Aspects
121. Cognitive Ergonomics
122. Environmental Research and Design
123. Clinical Decision Making
124. Safety Science
125. Medical Devices
126. Health IT
127. Patient Facing Technology
128. Cognitive Informatics


No. of pages:
© Academic Press 2019
4th December 2019
Academic Press
Hardcover ISBN:
eBook ISBN:

About the Editor

Ernesto Iadanza

Ernesto Iadanza

Ernesto Iadanza, BME, CE, M. Sc., Ph.D., Adjunct Professor in Clinical Engineering and Research Fellow at the Department of Information Engineering, University of Florence. He is currently a member of the IFMBE Administrative Council, chairman of the International Federation for Medical and Biological Engineering/Health Technology Assessment Division Board (IFMBE/HTAD), Immediate Past Chairman of the Clinical Engineering Division Board (IFMBE/CED. He is also IEEE (and IEEE-EMBS) Senior Member and received the IBM Faculty Award in 2013 and the IFMBE/CED Teamwork Award in 2019. Associate Editor of “Health & Technology” and of “Future Internet”, Section editor of the International Journal of Clinical Engineering and Healthcare Technology Assessment (CEHTA), Member of the Editorial Board of China Medical Devices Journal and of the Journal of Healthcare Engineering. Guest editor for the journal Health and Technology (Special issue: “Global issues in Clinical Engineering”). Co-chair, member of the scientific committee, track chair and session chairman of many national and international scientific conferences in Biomedical Engineering, Clinical Engineering and HTA. Dr. Iadanza is the organiser of postgraduate master courses in Clinical Engineering, Healthcare Engineering and HTA at the University of Florence since 2007. Supervisor in 190+ graduation theses. Author of 145+ publications on international books, scientific journals, volumes and conference proceedings.

Affiliations and Expertise

Adjunct Professor in Clinical Engineering and Research Fellow at the Department of Information Engineering, University of Florence, Italy

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