Clinical Engineering Handbook

Clinical Engineering Handbook

2nd Edition - December 4, 2019

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  • Editor: Ernesto Iadanza
  • Hardcover ISBN: 9780128134672
  • eBook ISBN: 9780128134689

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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

Product details

  • No. of pages: 958
  • Language: English
  • Copyright: © Academic Press 2019
  • Published: December 4, 2019
  • Imprint: Academic Press
  • Hardcover ISBN: 9780128134672
  • eBook ISBN: 9780128134689

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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  • JohnAdlington Fri Mar 06 2020

    Clinical Engineering Handbook

    This is an invaluable tool/resource for any Biomedical/Clinical Engineering department or anyone studying to be a Clinical Engineer.