Clinical Engineering HandbookBy
- Joseph Dyro
As the biomedical engineering field expands throughout the world, clinical engineers play an evermore-important role as translators between the medical, engineering, and business professions. They influence procedure and policy at research facilities, universities, as well as private and government agencies including the Food and Drug Administration and the World Health Organization. The profession of clinical engineering continues to seek its place amidst the myriad of professionals that comprise the health care field. The Clinical Engineering Handbook meets a long felt need for a comprehensive book on all aspects of clinical engineering that is a suitable reference in hospitals, classrooms, workshops, and governmental and non-governmental organization. The Handbooks thirteen sections address the following areas: Clinical Engineering; Models of Clinical Engineering Practice; Technology Management; Safety Education and Training; Design, Manufacture, and Evaluation and Control of Medical Devices; Utilization and Service of Medical Devices; Information Technology; and Professionalism and Ethics. The Clinical Engineering Handbook provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world. From telemedicine and IT issues, to sanitation and disaster planning, it brings together all the important aspects of clinical engineering.
Biomedical Engineers, Clinical Engineers, Doctors, Nurses, Physicians, Clinical Technicians, Health Care Managers.
Hardbound, 696 Pages
Published: August 2004
Imprint: Academic Press
13 sections, 142 chapters, 694 pages, 116 contributors! This is a comprehensive overview of the history and state of the art of clinical engineering written by an international group of generally well-known contributors to the field. For brevitys sake I shall give an overview of the major sections of this text. Section one covers clinical engineering history, roles, models (academic, regional, military), job descriptions, and careers. Section two gives an overview of worldwide practices in clinical engineering, with example chapters covering the practice in several countries, such as Estonia, Paraguay and Japan. Section three gives an overview of healthcare technology management topics, covering good manufacturing practices, outsourcing, maintenance and repair, etc. There are several useful forms and flowcharts to be found here. Section four reviews management styles, finances, personnel matters, skills needed, and quality assurance. Section five reviews several topics involving safety, such as risk management, best practices, accidents, and special cases involving electrical safety and electromagnetic interference. Section six reviews the education and training of clinical engineers, including reviews of practices in North America and Germany, internships, BET licensing, the use of workshops and distance education, etc. Section seven reviews the design, manufacture, evaluation and control of medical devices. It includes some useful material on human factors, liability, and Institutional Review Boards. Medical Devices, Utilization and Service is the title of section eight. This section reviews devices commonly used in different sections of the hospital (e.g. anesthesiology and perinatology) and as well discusses troubleshooting techniques. Section nine reviews information sources, transmission, and processing. Included are sections on PACS, Telemedicine, Wireless Medical Telemetry, Virtual Instruments, and the effects of the HIPA Act. Section ten reviews several topics often relegated to environmental and plant engineers, such as HVAC, Electrical Power considerations, Radiation Safety, Sanitation, Construction and Renovation, Water Systems, and Disaster Planning. Section eleven reviews Medical Device Standards, Regulations, and the Law. This is mandatory reading for all engineering involved in medicine. It covers JCAHO Accreditation, AAMI and ANSI standards, the FDA and other regulatory agencies, liability law, and ISO standards. Section twelve briefly reviews professionalism and ethics in clinical engineering practice, and gives some examples of professional organizations in New England and in Germany. Section thirteen, the final part of the text, briefly addresses some potential future trends in clinical engineering practice and some of the trends that may affect it. To reiterate: this is an exceedingly comprehensive handbook. The field of clinical engineering (worldwide) is very well described here. While the level of each individual chapter varies considerably (from one page summaries to multiple page well-documented and illustrated chapters) this text overall will be very useful as a reference text for practitioners and students of clinical engineering. Many individual chapters will serve as teaching material for lectures in clinical and bioengineering courses. The page count and purchase price of this text were obtained from the Academic Press web site, and may not be accurate as of the publication date. (This review was based upon page proofs.) The editor and each author are to be congratulated for their contribution to the literature in this field. Reviewed by: Paul H. King, Vanderbilt University __________________________________________________ The Clinical Engineering Handbook makes an excellent resource, particularly to someone newly entering or thinking about entering the field. It provides a good background to the wide array of tasks, programs, innovations and challenges to the clinical engineering profession...Overall, the handbook is well written and the breakdown into very specific chapters makes referencing easy. - ACCE News, Nov./Dec. 2004 __________________________________________________ "The Clinical Engineering Handbook makes an excellent resource, particularly to someone newly entering or thinking about entering the field. It provides a good background to the wide array of tasks, programs, innovations, and challenges to the clinical engineering profession." - Journal of Clinical Engineering, June 2005
- ContributorsIntroductionSection I Clinical Engineering I1. Clinical Engineering: Evolution of a Discipline2. History of Engineering and Technology in Health Care3. The Health Care Environment4. Enhancing Patient Safety: The Role of Clinical Engineering5. A Model Clinical Engineering Department6. Clinical Engineering in an Academic Medical Center7. Regional Clinical Engineering Shared Services and Cooperatives8. Nationwide Clinical Engineering System9. Clinical Engineering and Biomedical Maintenance in the United States Military10. Careers, Roles and Responsibilities11. Clinical Engineering at the Bedside12. The Clinical Engineer as Consultant13. The Clinical Engineer as Investigator and Expert14. Careers in FacilitiesSection II Worldwide Clinical Engineering Practice15. World Clinical Engineering Survey16. Clinical Engineering in the United Kingdom17. Clinical Engineering in Canada18. Clinical Engineering in Estonia19. Clinical Engineering in Germany20. Clinical Engineering in Brazil21. Clinical Engineering in Columbia22. Clinical Engineering in Ecuador23. Clinical Engineering in Mexico24. Clinical Engineering in Paraguay25. Clinical Engineering in Peru26. Clinical Engineering in Venezuela27. Clinical Engineering in Japan28. Clinical Engineering in Mozambique29. Clinical Engineering in the Middle EastSection III Health Technology Management30. Introduction to Medical Technology Management31. Good Management Practice for Medical Equipment32. Health Care Strategic Planning Utilizing Technology Assessment33. Technology Evaluation34. Technology Procurement35. Equipment Control and Asset Management36. Computerized Maintenance Management Systems37. Maintenance and Repair of Medical Devices38. A Strategy to Maintain Essential Medical Equipment in Developing Countries39. Outsourcing Clinical Engineering Service40. New Strategic Directions in Acquiring and Outsourcing High-Tech Services by Hospitals and Implications for Clinical Engineering Organizations and ISOs.41. Vendor and Service Management42. Health Care Technology Replacement Planning43. Donation of Medical Device Technologies44. National Health Technology Policy45. The Essential Health Care Technology Package46. Impact AnalysisSection IV Management 47. Industrial/Management Engineering in Healthcare48. Financial Management of Clinical Engineering Services49. Cost-Effectiveness and Productivity50. Clinical Engineering Program Indicators51. Personnel Management52. Skills Identification53. Management Styles and Human Resource Development54. QualitySection V Safety55. Patient Safety and the Clinical Engineer56. Risk Management57. Patient Safety Best Practices Model58. Hospital Safety Programs59. Systems Approach to Medical Device Safety60. Interactions Between Medical Devices61. Single Use Injection Devices62. Electromagnetic Interference with Medical Devices: In Vitro Laboratory Studies and Electromagnetic Compatibility Standards63. Electromagnetic Interference in the Hospital64. Accident Investigation65. The Great Debate on Electrical Safety in RetrospectSection VI Education and Training66. Academic Programs in North America67. Clinical Engineering Education in Germany68. Clinical Engineering Internship69. Biomedical Engineering Technology Program70. Advanced Clinical Engineering Workshops71. Advanced Health Technology Management Workshop72. Distance Education73. Emerging Technologies: Internet and Interactive Video Conferencing74. In-Service Education75. Technical Service Schools76. Clinical Engineering and Nursing77. Retraining Programs78. Techno-Bio-Psycho-Socio-Medical Approach to Health CareSection VII Medical Devices: Design, Manufacturing, Evaluation, and Control79. Evolution of Medical Device Technology80. Technology in Health Care81. Medical Device Design and Control in the Hospital 82. Medical Device Research and Design83. Human Factors: Environment84. Medical Devices: Failure Modes, Accidents, and Liability85. Medical Device Software Development86. Comparative Evaluations of Medical Devices87. Evaluating Investigational Devices for Institutional Review BoardsSection VIII Medical Devices: Utilization and Service88. Intensive Care89. Operating Room90. Anaesthesiology91. Imaging Devices92. Machine Vision93. Perinatology94. Cardiovascular Techniques and Technology95. General Hospital Devices: Beds, Stretchers, and Wheelchairs96. Medical Device TroubleshootingSection IX Information97. Information Systems Management98. Physiologic Monitoring and Clinical Information Systems99. Advanced Diagnostics and Artificial Intelligence100. Real-Time Executive Dashboards and Virtual Instrumentation: Solutions for Health Care Systems101. Telemedicine: Clinical and Operational Issues102. Picture Archiving and Communication Systems (PACS)103. Wireless Medical Telemetry: Addressing the Interference Issue and the New Wireless Medical Telemetry Service104. Health Insurance Portability and Accountability Act and its Implications for Clinical Engineering105. YSK and Clinical Engineering106. The Integration and Convergence of Medical and Information TechnologiesSection X Engineering the Clinical Environment107. Physical Plant108. Heating, Ventilation, and Air Conditioning109. Electrical Power110. Medical Gas Systems111. Support Services112. Construction and Renovation113. Radiation Safety114. Sanitation115. Water Systems in Health Care Facilities116. Disaster PlanningSection XI Medical Device Standards, Regulations, and the Law117. Primer on Standards and Regulations118. Medical Device Regulatory and Technology Assessment Agencies119. Health Care Quality and IS 9001:2000120. Hospital Facilities Safety Standards121. JCAHO Accreditation122. Medical Equipment Management Program and ANSI/AAMI EQ56123. Clinical Engineering Standards of Practice for Canada124. Regulations and the Law125. European Union Medical Device Directives and Vigilance System126. United States Food & Drug Administration127. Tort Liability for Clinical Engineers and Device ManufacturersSection XII Professionalism and Ethics128. Professionalism129. Clinical Engineering Advocacy130. American College of Clinical Engineering131. The New England Society of Clinical Engineering132. New York City Metropolitan Area Clinical Engineering Directors Group133. Clinical Engineering Certification in the United States134. Clinical Engineering Certification in GermanySection XIII The Future135. The Future of Clinical Engineering: The Challenge of Change136. Virtual Instrumentation Applications to Health Care137. Clinical Engineers in Non-Traditional Roles138. Clinical Support: The Forgotten Function139. Postmarket Surveillance and Vigilance on Medical Devices140. Small Business Development: Busieness Plan Development Fundamentals for the Entrepreneur141. Engineering Primary Health Care: The Sickle Cell Business Case142. Global Hospital in 2050 A VisionAppendicesIndex