Clinical Engineering Handbook

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.

• Section 1 Clinical Engineering Section 1 Overview1. Clinical Engineering:2. Open Source Medical Devices: Healthcare Solutions for Low- and High- Resource Settings3. Success Stories in Clinical Engineering4. RFID technology in healthcare5. Computer Aided Facilities Management6. Public Procurement Of Innovative Medical Technology: Femtosecond And Excimer Laser Platform For Ophthalmic SurgerySection 2 Worldwide Clinical Engineering Practice Section 2 Overview7. Clinical Engineering in the United Kingdom8. Clinical Engineering in Canada9. Clinical Engineering in Colombia10. Clinical Engineering in Mexico11. Clinical Engineering in Paraguay12. Clinical Engineering in Peru13. Clinical Engineering in Venezuela14. Clinical Engineering in Japan15. Clinical Engineering in Brazil16. Clinical Engineering in the Middle East17. Clinical Engineering in China18. Clinical Engineering in Argentina19. Clinical Engineering in Italy20. Clinical Engineering in India21. Clinical Engineering in Poland22. Clinical Engineering in Australia23. Clinical Engineering in Chile24. Clinical Engineering in USA25. Clinical Engineering in Albania26. Clinical Engineering in South Africa27. Clinical Engineering in UgandaSection 3 Health Technology Management Section 3 Overview28. Introduction to Medical Technology Management Practices29. Good Management Practice for Medical Equipment / Leadership30. Health Care Strategic Planning Utilizing Technology Assessment31. Technology Evaluation / US and Global perspectives32. Technology Procurement / Strategic Acquisition Planning/Replacement 33. Equipment Control and Asset Management34. Computerized Maintenance Management Systems35. Maintenance and Repair of Medical Devices (Healthcare Technology)36. Outsourcing Clinical Engineering Service37. Health Care Technology Replacement Planning38. The integrated Health Care Technology Package         39. Impact Analysis40. CE-IT, cybersecurity, CE-IT HTM41. 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 Reprocessing44. Clinical Systems Integration Support 45. A framework for medical device safety                             46. ACCE ACEW UpdateSection 4 ManagementSection 4 Overview47. Quality Management Systems    48. Personnel Management/Skills Identification49. Management Styles and Human Resource Development50. A Systems Management Framework for Medical Device Safety and Optimal OutcomesSection 5 SafetySection 5 Overview51. Patient Safety Revisited52. Risk Management53. Hospital Safety Programs54. Medical Device Regulations and Patient Safety55. Single Use Injection Devices56. Electromagnetic Interference in the Hospital57. The Great Debate on Electrical Safety - In RetrospectSection 6 Professionalism, Education and EthicsSection 6 Overview58. Professionalism59. American College of Clinical Engineering60. Clinical Engineering Certification in the United States61. Clinical Engineering Internship62. HTM Training in the USA63. Distance Education64. In-Service Education65. New York City Metropolitan Area Clinical Engineering Directors GroupSection 7 Medical Devices: Design, Manufacturing, Evaluation, and Control Section 7 Overview66. Technology in Health Care67. 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 development72. Developing and launching a medical device:  a fresh engineering point of viewSection 8  Medical Devices: Utilization and Service Section 8 Overview73. Anaesthesia machines74. Cardiovascular techniques and technology75. Device Inspection76. Hospital bed77. ICU78. Imaging79. Incubator80. MaintenanceSection 9 Information Technology and Mobile AppsSection 9: Overview81. The Digital Hospital of the 20th Century, and Information Systems Management82. The Integration and Convergence of Medical and Information Technologies83. Telehealth, Telemedicine, and Telecare84. Artificial Intelligence In Medical Devices And Clinical Decision Support Systems85. A Practical Framework for  Medical Device Interoperability Conformity Testing (IHE PCD)86. Application of HL7® FHIR for Device and Health Information System (HIS) Interoperability87. Enterprise Image Management and Medical Informatics88. Maintenance of Complex, Converged, and Interoperable Medical Device / Information Systems89. Forensics and Accident/Incident Investigations for Interoperable Medical Device and Information Systems90. New Opportunities for BME/CE Health IT EducationSection 10 Engineering the Clinical Environment Section 10 Overview91. Physical Plant and Fire Safety92. Heating, Ventilation, and Air Conditioning93. Electrical Power94. Medical Gas Systems95. Construction and Renovation96. Radiation Safety97. Infection Prevention and Control – A Clinical Engineering Perspective98. Water Systems in Health Care Facilities99. Disaster Planning and Emergency Preparedness100. Healthcare Engineering in a Resource Constrained EnvironmentSection 11 Medical Device Standards, Regulations, and the Law Section 11 Overview101. Standards and Regulations102. Regulations and the Law103. Hospital Facilities Safety Standards104. Healthcare Quality and ISO IEC 17020105. Medical Equipment Management Program Standards - ANSI/AAMI EQ56 and ANSI/AAMI EQ89106. Clinical Engineering Standards and Practice107. European Union Medical Device Directives and Vigilance System108. United States Food & Drug Administration109. Legal Metrology Framework for Medical Devices110. Increasing of Accuracy and Efficency of Medical Devices In Legal Metrology System of Bosnia and HerzegovinaSection 12 Health Technology AssessmentSection 12 Overview111. Introduction to Health Economics and HTA112. HTA of Medical Devices: criticisms and peculiarities113. eHTA 114. MCDA in eHTA115. Hospital Based HTA116. Generation of Evidence in biomedical engineering117. 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 value119. Health Technology Assessment teaching for BMESection 13 Introduction to Human FactorsSection 13 Overview120. Physiological and Psychological Aspects121. Cognitive Ergonomics122. Environmental Research and Design123. Clinical Decision Making124. Safety Science125. Medical Devices126. Health IT127. Patient Facing Technology128. Cognitive Informatics