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 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