Clinical Engineering: From Devices to Systems

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.

• 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

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.

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.

Professor Fabrizio Dori received his M.Sc.in 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.