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Clinical Engineering - 1st Edition - ISBN: 9780128037676, 9780128038246

Clinical Engineering

1st Edition

From Devices to Systems

Paperback ISBN: 9780128037676
eBook ISBN: 9780128038246
Imprint: Academic Press
Published Date: 23rd December 2015
Page Count: 244
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Clinical Systems Engineering: New Challenges for Future Healthcare covers the critical issues relating to the risk management and design of new technologies in the healthcare sector. It is a comprehensive summary of the advances in clinical engineering over the past 40 years, presenting guidance on compliance and safety for hospitals and engineering teams.

This contributed book contains chapters from international experts, who provide their solutions, experiences, and the successful methodologies they have applied to solve common problems in the area of healthcare technology. Topics include compliance with the European Directive on Medical Devices 93/42/EEC, European Norms EN 60601-1-6, EN 62366, and the American Standards ANSI/AAMI HE75: 2009.

Content coverage includes decision support systems, clinical complex systems, and human factor engineering. Examples are fully supported with case studies, and global perspective is maintained throughout. This book is ideal for clinical engineers, biomedical engineers, hospital administrators and medical technology manufacturers.

Key Features

  • Presents clinical systems engineering in a way that will help users answer many questions relating to clinical systems engineering and its relationship to future healthcare needs
  • Explains how to assess new healthcare technologies and what are the most critical issues in their management
  • Provides information on how to carry out risk analysis for new technological systems or medical software
  • Contains tactics on how to improve the quality and usability of medical devices


Biomedical Engineers, Clinical Engineers, Electronic Engineers, Hospital Administrators, Students in medical engineering, Medical Technology Manufacturers, Consultants, Regulators

Table of Contents

  • List of Contributors
  • Acknowledgments
  • Introduction
  • 1. The Evolution of Clinical Engineering: History and the Role of Technology in Health Care
    • Abstract
    • Explaining What Is a Clinical Engineer
    • Requirements to Be a Clinical Engineer
    • Educational System for CEs
    • How Clinical Engineering Shall Evolve
    • Conclusion
    • References
  • 2. Clinical Engineering in Growing Markets: The China Case Study
    • Abstract
    • Introduction
    • Overview of Clinical Engineering and Healthcare Technology Management Market
    • The Evolution of Clinical Engineering in China
    • Professional Development of Chinese Clinical Engineers
    • References
  • 3. Clinical Engineering in Developing Countries
    • Abstract
    • Introduction
    • Funding
    • Geography
    • Healthcare Policies
    • Traditional Medicine
    • Distinction Between BME and MP
    • Maintenance Difficulties
    • Diversity of Manufacturers
    • Donated Equipment
    • Training
    • Conclusion
    • References
  • 4. Clinical Engineering for Consolidated Markets: European Case Study
    • Abstract
    • Introduction
    • Clinical Engineering Work
    • Clinical Engineering Processes
    • Research, Development, and Education
    • Conclusions
    • References
  • 5. Hospital Technology Management
    • Abstract
    • Introduction
    • Medical Technology Life Cycle
    • Hospital Technology Management and Clinical Engineering
    • Computerized Maintenance Management Systems
    • Future Perspectives
    • References
  • 6. Management of Complex Clinical System
    • Abstract
    • Introduction
    • Foundational Principles and Concepts
    • Managing the Evolution to Today’s Complex Clinical Systems
    • The Rapidly Evolving Complex 21st-Century Clinical System
    • Unintended Consequences: Understanding and Managing Emergent Behaviors in Systems of Systems
    • Management Approaches for 21st-Century Complex Clinical Systems
    • Conclusion
    • References
    • Web References
  • 7. Decision Support Systems in Healthcare
    • Abstract
    • Introduction
    • A Clinical Decision Support System for Congestive Heart Failure Management
    • The Heart M&M System
    • The Machine Learning Core
    • A DSS for Hospital Administration and Facilities Management
    • SVG Rendering Engine
    • EUREKA
    • References
  • 8. Early Stage Healthcare Technology Assessment
    • Abstract
    • Healthcare Technology
    • Health Technology Assessment: Standard De Facto
    • Standard Method Limitations and Weaknesses
    • Early Stage HTA (eHTA)
    • Conclusion
    • References
  • 9. Integrated Risk and Quality Management in Hospital Systems
    • Abstract
    • Introduction
    • Methods
    • Case Study
    • References
  • 10. Management of New Technologies: Software and Integrated Systems
    • Abstract
    • Introduction
    • Methods
    • Discussion
    • Conclusions
    • References
  • 11. Clinical Engineering and Disaster Preparedness
    • Abstract
    • Introduction
    • Overview of Disaster Types Its Management and Terminology
    • What Are the Disaster Stages?
    • How to Prepare?
    • Levels of Responsibility
    • Concluding Advice
    • References
    • Other Resources
  • 12. Human Factors Engineering in Healthcare
    • Abstract
    • Human Factor Engineering for Medical Devices
    • A Usability Engineering Process following IEC 62366-1:2015
    • Abbreviations
    • References
  • 13. Clinical Engineering Education and Careers: Overview at the University of Connecticut
    • Abstract
    • Introduction
    • Curriculum
    • Clinical Engineering Internship
    • Employment
    • Employment Market
    • Conclusion
    • References
  • 14. Certification of Clinical Engineers
    • Abstract
    • Introduction
    • Certification in the United States
    • References
  • Index


No. of pages:
© Academic Press 2016
23rd December 2015
Academic Press
Paperback ISBN:
eBook ISBN:

About the Authors

Roberto Miniati

Dr Roberto Miniati received his M.Sc. in Biomedical Engineering in 2007 at the School of Engineering, University of Florence (Italy), and Ph.D. in 2012 within the international program on Risk Mitigation at the University of Florence (Italy) and TU Braunschweig (Germany). He has published over 100 scientific papers in refereed journals, international conference proceedings and book chapters.

His main research fields include Healthcare Engineering, Health Technology Assessment (HTA) and Risk Management, Usability Engineering, Hospital Lean Manufacturing and Disaster Risk Reduction with focus in Health Emergency Planning and Vulnerability Assessment Methods.

Affiliations and Expertise

Ph.D., Clinical engineering consultant and advisor, Post-doctoral research fellow, Florence, Italy



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


Professor Fabrizio Dori received his Electronics Engineering (biomedical curriculum) at the University of Florence (Italy) in 2001. His main professional activity is in the field of Clinical Engineering and Occupational Safety, as Health Technology Assessment Referring Coordinator, Regional Health Technology Department Tuscany (Italy), and as head of Protection and Prevention of Occupational Risks Office at "Le Scotte" Hospital, Siena (Italy).

His main research fields include Safety in Health Care, Clinical Engineering and Health Technology Assessment, safety management and technology application in healthcare structures.

Affiliations and Expertise

Adjunct Professor of Clinical Engineering, member of the managing committee for the post-degree Master in Clinical Engineering, University of Florence, Italy

Ratings and Reviews