Clinical Engineering Handbook, Second Edition, covers modern clinical engineering topics, giving experienced professionals the necessary skills and knowledge for this fast-evolving field. Featuring insights from leading international experts, this book presents traditional practices, such as healthcare technology management, medical device service, and technology application. In addition, readers will find valuable information on the newest research and groundbreaking developments in clinical engineering, such as health technology assessment, disaster preparedness, decision support systems, mobile medicine, and prospects and guidelines on the future of clinical engineering.As the biomedical engineering field expands throughout the world, clinical engineers play an increasingly important role as translators between the medical, engineering and business professions. In addition, they influence procedures and policies at research facilities, universities, and in private and government agencies. This book explores their current and continuing reach and its importance.
1. Introduction - p. pgxlv 2. Section 1: Clinical engineering - p. pgxlvi 3. Introduction - p. pgxlvi 4. Chapter 1: Clinical engineering - p. 2 5. Chapter 2: Open-source medical devices: Healthcare solutions for low-, middle-, and high-resource settings - p. 6 6. Chapter 3: Clinical engineering success stories and patient outcomes based on evidence from 125 countries - p. 14 7. Chapter 4: RFID technology in health care - p. 32 8. Chapter 5: Computer-aided facilities management in health care - p. 41 9. Chapter 6: Public procurement of innovative medical technology: Femtosecond and excimer laser platform for ophthalmic surgery - p. 51 10. Section 2: Worldwide clinical engineering practice - p. 60 11. Introduction - p. 61 12. Chapter 7: Clinical engineering in the United Kingdom - p. 62 13. Chapter 8: Clinical engineering in Canada - p. 71 14. Chapter 9: Clinical Engineering in Colombia - p. 74 15. Chapter 10: Clinical engineering in Mexico - p. 81 16. Chapter 11: Clinical engineering in Paraguay - p. 86 17. Chapter 12: Clinical engineering in Peru: Looking for a healthcare technology management model - p. 93 18. Chapter 13: Clinical engineering in Venezuela - p. 100 19. Chapter 14: Clinical engineering in Japan - p. 104 20. Chapter 15: Clinical engineering in Brazil - p. 107 21. Chapter 16: Clinical engineering updates in the Middle East - p. 110 22. Chapter 17: Clinical engineering development in China - p. 113 23. Chapter 18: Clinical engineering in Argentina - p. 124 24. Chapter 19: Clinical engineering in Italy - p. 127 25. Chapter 20: Clinical engineering in India - p. 131 26. Chapter 21: Clinical engineering in Poland - p. 136 27. Chapter 22: Clinical engineering in Australia - p. 139 28. Chapter 23: Clinical engineering in Chile - p. 142 29. Chapter 24: Clinical engineering in the United States - p. 147 30. Chapter 25: Clinical engineering in Albania - p. 150 31. Chapter 26: Clinical engineering in South Africa - p. 155 32. Chapter 27: Clinical engineering in Uganda - p. 160 33. Section 3: Healthcare technology management - p. 164 34. Introduction - p. 165 35. Chapter 28: Introduction to medical technology management practices - p. 165 36. Chapter 29: Good management practices (GMP) for medical equipment/leadership - p. 177 37. Chapter 30: Healthcare strategic planning using technology assessment - p. 180 38. Chapter 31: Technology evaluation/US and global perspectives - p. 185 39. Chapter 32: Technology procurement - p. 195 40. Chapter 33: Equipment control and asset management - p. 204 41. Chapter 34: Computerized maintenance management systems - p. 207 42. Chapter 35: Maintenance and repair of medical devices - p. 218 43. Chapter 36: Outsourcing clinical engineering service - p. 221 44. Chapter 37: Medical equipment replacement planning - p. 226 45. Chapter 38: Integrated health technology package - p. 235 46. Chapter 39: Impact analysis: CE success stories - p. 242 47. Chapter 40: Medical device cybersecurity—At the convergence of CE and IT - p. 252 48. Chapter 41: CE-HTM indicators - p. 258 49. Chapter 42: HTM best practice guidelines and standards of practice around the world - p. 267 50. Chapter 43: Single-use medical devices reuse and reprocessing - p. 275 51. Chapter 44: Kaiser permanente clinical technology: Clinical systems integration (CSI) group - p. 280 52. Chapter 45: ACEW update - p. 280 53. Section 4: Management - p. 287 54. Introduction - p. 289 55. Chapter 46: Quality management systems - p. 289 56. Chapter 47: Personnel management - p. 296 57. Chapter 48: Management styles and human resource development - p. 307 58. Chapter 49: A systems management framework for medical device safety and optimal outcomes - p. 320 59. Section 5: Safety - p. 328 60. Introduction - p. 329 61. Chapter 50: Patient safety revisited - p. 329 62. Chapter 51: Risk management - p. 334 63. Chapter 52: Hospital safety programs - p. 348 64. Chapter 53: Medical device regulations and patient safety - p. 352 65. Chapter 54: Single-use injection devices - p. 356 66. Chapter 55: Electromagnetic interference in healthcare environment - p. 361 67. Chapter 56: The great 1970s debate on electrical safety—In retrospect - p. 372 68. Section 6: Professionalism, education, and ethics - p. 376 69. Introduction - p. 377 70. Chapter 57: Professionalism - p. 377 71. Chapter 58: American College of Clinical Engineering - p. 383 72. Chapter 59: Clinical engineering certification in the United States - p. 389 73. Chapter 60: Clinical engineering graduate education - p. 392 74. Chapter 61: HTM training in the USA - p. 401 75. Chapter 62: Distance education - p. 409 76. Chapter 63: In-service education - p. 415 77. Chapter 64: New York City Metropolitan Area Clinical Engineering Directors Group - p. 420 78. Section 7: Medical devices:Design, manufacturing, evaluation, and control - p. 426 79. Introduction - p. 427 80. Chapter 65: Technology in health care - p. 427 81. Chapter 66: Medical device design and control in the hospital - p. 435 82. Chapter 67: Medical device research and design - p. 444 83. Chapter 68: Comparative evaluations of medical devices - p. 450 84. Chapter 69: Evolution of prosthetic feet and design based on gait analysis data - p. 457 85. Chapter 70: Challenge in surgical robot development - p. 468 86. Chapter 71: Developing and launching a medical device: A fresh engineering point of view - p. 472 87. Section 8: Medical devices: Utilization and service - p. 475 88. Introduction - p. 477 89. Chapter 72: Anesthesia - p. 477 90. Chapter 73: Cardiovascular techniques and technology - p. 483 91. Chapter 74: Inspection of medical devices - p. 490 92. Chapter 75: Hospital beds - p. 497 93. Chapter 76: Intensive care unit - p. 502 94. Chapter 77: Imaging - p. 508 95. Chapter 78: Pediatric and neonate incubators - p. 513 96. Chapter 79: Medical devices maintenance - p. 519 97. Section 9: Management of digital healthcare, information systems, and health informatics innovations - p. 526 98. Introduction - p. 527 99. Chapter 80: The digital hospital of the 21th century, and information systems management - p. 529 100. Chapter 81: The integration and convergence of medical and information technologies - p. 542 101. Chapter 82: Telehealth, telemedicine, and telecare - p. 549 102. Chapter 83: Artificial intelligence in medical devices and clinical decision support systems - p. 555 103. Chapter 84: A practical framework for medical device interoperability conformity testing (IHE PCD and IHE DEV Domain) - p. 568 104. Chapter 85: Application of HL7® FHIR for device and health information system interoperability - p. 610 105. Chapter 86: Enterprise image management and medical informatics - p. 615 106. Chapter 87: Maintenance of complex, converged, and interoperable medical device/information systems - p. 637 107. Chapter 88: Forensics and accident/incident investigations for device/information systems - p. 643 108. Chapter 89: White paper: New opportunities for BME/CE health IT education - p. 647 109. Section 10: Engineering the clinical environment - p. 653 110. Introduction - p. 655 111. Chapter 90: Physical plant overview and fire safety - p. 656 112. Chapter 91: Heating, ventilation, and air conditioning - p. 661 113. Chapter 92: Electrical power - p. 666 114. Chapter 93: Medical gas systems - p. 669 115. Chapter 94: Construction and renovation - p. 673 116. Chapter 95: Radiation safety - p. 676 117. Chapter 96: Infection prevention & control—A clinical engineering perspective - p. 681 118. Chapter 97: Water systems in healthcare facilities - p. 693 119. Chapter 98: Disaster planning and emergency preparedness - p. 698 120. Chapter 99: Healthcare engineering in a resource-constrained environment - p. 706 121. Section 11: Medical device standards, regulations, and the law - p. 711 122. Introduction - p. 713 123. Chapter 100: Need for standards and their development - p. 714 124. Chapter 101: Regulations and laws - p. 721 125. Chapter 102: Hospital facility safety standards - p. 727 126. Chapter 103: Healthcare quality and ISO/IEC 17020 - p. 730 127. Chapter 104: Medical equipment management program standards—ANSI/AAMI EQ56 and ANSI/AAMI EQ89 - p. 735 128. Chapter 105: Clinical engineering standards and practices - p. 741 129. Chapter 106: European Union medical device legislation, vigilance, and metrology system - p. 752 130. Chapter 107: United States food and drug administration - p. 763 131. Chapter 108: Legal metrology framework for medical devices - p. 773 132. Chapter 109: Improving the accuracy and efficiency of medical devices in the legal metrology system of Bosnia and Herzegovina - p. 779 133. Section 12: Health technology assessment - p. 786 134. Introduction - p. 787 135. Chapter 110: Introduction to economic evaluation and health technology assessment - p. 788 136. Chapter 111: Health technology assessment of medical devices - p. 794 137. Chapter 112: Early stage healthcare technology assessment - p. 798 138. Chapter 113: Multicriteria decision aiding for early health technology assessment of medical devices - p. 806 139. Chapter 114: Hospital based health technology assessment - p. 811 140. Chapter 115: Evidence generation in medicine - p. 817 141. Chapter 116: Systematic literature review and meta-analysis: The case of medical devices and medical locations - p. 820 142. Chapter 117: Human factors and system thinking for medical device - p. 828 143. Chapter 118: Health technology assessment teaching for BME - p. 831 144. Section 13: Introduction to human factors - p. 835 145. Introduction - p. 837 146. Chapter 119: Physiological and psychological aspects - p. 838 147. Chapter 120: Cognitive ergonomics - p. 846 148. Chapter 121: Bettering healthcare outcomes through environmental design - p. 851 149. Chapter 122: Clinical decision-making in complex healthcare delivery systems - p. 857 150. Chapter 123: Addressing adverse events in health care through a safety science lens - p. 864 151. Chapter 124: Medical devices - p. 870 152. Chapter 125: Human factor approaches to understand health information technology impacts on patient safety - p. 875 153. Chapter 126: Using human factors to achieve patient and family-centered care - p. 880 154. Chapter 127: Cognitive informatics in health care - p. 886 155. Index - p. 891
Clinical Engineering Handbook, Second Edition, covers modern clinical engineering topics, giving experienced professionals the necessary skills and knowledge for this fast-evolving field. Featuring insights from leading international experts, this book presents traditional practices, such as healthcare technology management, medical device service, and technology application. In addition, readers will find valuable information on the newest research and groundbreaking developments in clinical engineering, such as health technology assessment, disaster preparedness, decision support systems, mobile medicine, and prospects and guidelines on the future of clinical engineering.As the biomedical engineering field expands throughout the world, clinical engineers play an increasingly important role as translators between the medical, engineering and business professions. In addition, they influence procedures and policies at research facilities, universities, and in private and government agencies. This book explores their current and continuing reach and its importance.
1. Introduction - p. pgxlv 2. Section 1: Clinical engineering - p. pgxlvi 3. Introduction - p. pgxlvi 4. Chapter 1: Clinical engineering - p. 2 5. Chapter 2: Open-source medical devices: Healthcare solutions for low-, middle-, and high-resource settings - p. 6 6. Chapter 3: Clinical engineering success stories and patient outcomes based on evidence from 125 countries - p. 14 7. Chapter 4: RFID technology in health care - p. 32 8. Chapter 5: Computer-aided facilities management in health care - p. 41 9. Chapter 6: Public procurement of innovative medical technology: Femtosecond and excimer laser platform for ophthalmic surgery - p. 51 10. Section 2: Worldwide clinical engineering practice - p. 60 11. Introduction - p. 61 12. Chapter 7: Clinical engineering in the United Kingdom - p. 62 13. Chapter 8: Clinical engineering in Canada - p. 71 14. Chapter 9: Clinical Engineering in Colombia - p. 74 15. Chapter 10: Clinical engineering in Mexico - p. 81 16. Chapter 11: Clinical engineering in Paraguay - p. 86 17. Chapter 12: Clinical engineering in Peru: Looking for a healthcare technology management model - p. 93 18. Chapter 13: Clinical engineering in Venezuela - p. 100 19. Chapter 14: Clinical engineering in Japan - p. 104 20. Chapter 15: Clinical engineering in Brazil - p. 107 21. Chapter 16: Clinical engineering updates in the Middle East - p. 110 22. Chapter 17: Clinical engineering development in China - p. 113 23. Chapter 18: Clinical engineering in Argentina - p. 124 24. Chapter 19: Clinical engineering in Italy - p. 127 25. Chapter 20: Clinical engineering in India - p. 131 26. Chapter 21: Clinical engineering in Poland - p. 136 27. Chapter 22: Clinical engineering in Australia - p. 139 28. Chapter 23: Clinical engineering in Chile - p. 142 29. Chapter 24: Clinical engineering in the United States - p. 147 30. Chapter 25: Clinical engineering in Albania - p. 150 31. Chapter 26: Clinical engineering in South Africa - p. 155 32. Chapter 27: Clinical engineering in Uganda - p. 160 33. Section 3: Healthcare technology management - p. 164 34. Introduction - p. 165 35. Chapter 28: Introduction to medical technology management practices - p. 165 36. Chapter 29: Good management practices (GMP) for medical equipment/leadership - p. 177 37. Chapter 30: Healthcare strategic planning using technology assessment - p. 180 38. Chapter 31: Technology evaluation/US and global perspectives - p. 185 39. Chapter 32: Technology procurement - p. 195 40. Chapter 33: Equipment control and asset management - p. 204 41. Chapter 34: Computerized maintenance management systems - p. 207 42. Chapter 35: Maintenance and repair of medical devices - p. 218 43. Chapter 36: Outsourcing clinical engineering service - p. 221 44. Chapter 37: Medical equipment replacement planning - p. 226 45. Chapter 38: Integrated health technology package - p. 235 46. Chapter 39: Impact analysis: CE success stories - p. 242 47. Chapter 40: Medical device cybersecurity—At the convergence of CE and IT - p. 252 48. Chapter 41: CE-HTM indicators - p. 258 49. Chapter 42: HTM best practice guidelines and standards of practice around the world - p. 267 50. Chapter 43: Single-use medical devices reuse and reprocessing - p. 275 51. Chapter 44: Kaiser permanente clinical technology: Clinical systems integration (CSI) group - p. 280 52. Chapter 45: ACEW update - p. 280 53. Section 4: Management - p. 287 54. Introduction - p. 289 55. Chapter 46: Quality management systems - p. 289 56. Chapter 47: Personnel management - p. 296 57. Chapter 48: Management styles and human resource development - p. 307 58. Chapter 49: A systems management framework for medical device safety and optimal outcomes - p. 320 59. Section 5: Safety - p. 328 60. Introduction - p. 329 61. Chapter 50: Patient safety revisited - p. 329 62. Chapter 51: Risk management - p. 334 63. Chapter 52: Hospital safety programs - p. 348 64. Chapter 53: Medical device regulations and patient safety - p. 352 65. Chapter 54: Single-use injection devices - p. 356 66. Chapter 55: Electromagnetic interference in healthcare environment - p. 361 67. Chapter 56: The great 1970s debate on electrical safety—In retrospect - p. 372 68. Section 6: Professionalism, education, and ethics - p. 376 69. Introduction - p. 377 70. Chapter 57: Professionalism - p. 377 71. Chapter 58: American College of Clinical Engineering - p. 383 72. Chapter 59: Clinical engineering certification in the United States - p. 389 73. Chapter 60: Clinical engineering graduate education - p. 392 74. Chapter 61: HTM training in the USA - p. 401 75. Chapter 62: Distance education - p. 409 76. Chapter 63: In-service education - p. 415 77. Chapter 64: New York City Metropolitan Area Clinical Engineering Directors Group - p. 420 78. Section 7: Medical devices:Design, manufacturing, evaluation, and control - p. 426 79. Introduction - p. 427 80. Chapter 65: Technology in health care - p. 427 81. Chapter 66: Medical device design and control in the hospital - p. 435 82. Chapter 67: Medical device research and design - p. 444 83. Chapter 68: Comparative evaluations of medical devices - p. 450 84. Chapter 69: Evolution of prosthetic feet and design based on gait analysis data - p. 457 85. Chapter 70: Challenge in surgical robot development - p. 468 86. Chapter 71: Developing and launching a medical device: A fresh engineering point of view - p. 472 87. Section 8: Medical devices: Utilization and service - p. 475 88. Introduction - p. 477 89. Chapter 72: Anesthesia - p. 477 90. Chapter 73: Cardiovascular techniques and technology - p. 483 91. Chapter 74: Inspection of medical devices - p. 490 92. Chapter 75: Hospital beds - p. 497 93. Chapter 76: Intensive care unit - p. 502 94. Chapter 77: Imaging - p. 508 95. Chapter 78: Pediatric and neonate incubators - p. 513 96. Chapter 79: Medical devices maintenance - p. 519 97. Section 9: Management of digital healthcare, information systems, and health informatics innovations - p. 526 98. Introduction - p. 527 99. Chapter 80: The digital hospital of the 21th century, and information systems management - p. 529 100. Chapter 81: The integration and convergence of medical and information technologies - p. 542 101. Chapter 82: Telehealth, telemedicine, and telecare - p. 549 102. Chapter 83: Artificial intelligence in medical devices and clinical decision support systems - p. 555 103. Chapter 84: A practical framework for medical device interoperability conformity testing (IHE PCD and IHE DEV Domain) - p. 568 104. Chapter 85: Application of HL7® FHIR for device and health information system interoperability - p. 610 105. Chapter 86: Enterprise image management and medical informatics - p. 615 106. Chapter 87: Maintenance of complex, converged, and interoperable medical device/information systems - p. 637 107. Chapter 88: Forensics and accident/incident investigations for device/information systems - p. 643 108. Chapter 89: White paper: New opportunities for BME/CE health IT education - p. 647 109. Section 10: Engineering the clinical environment - p. 653 110. Introduction - p. 655 111. Chapter 90: Physical plant overview and fire safety - p. 656 112. Chapter 91: Heating, ventilation, and air conditioning - p. 661 113. Chapter 92: Electrical power - p. 666 114. Chapter 93: Medical gas systems - p. 669 115. Chapter 94: Construction and renovation - p. 673 116. Chapter 95: Radiation safety - p. 676 117. Chapter 96: Infection prevention & control—A clinical engineering perspective - p. 681 118. Chapter 97: Water systems in healthcare facilities - p. 693 119. Chapter 98: Disaster planning and emergency preparedness - p. 698 120. Chapter 99: Healthcare engineering in a resource-constrained environment - p. 706 121. Section 11: Medical device standards, regulations, and the law - p. 711 122. Introduction - p. 713 123. Chapter 100: Need for standards and their development - p. 714 124. Chapter 101: Regulations and laws - p. 721 125. Chapter 102: Hospital facility safety standards - p. 727 126. Chapter 103: Healthcare quality and ISO/IEC 17020 - p. 730 127. Chapter 104: Medical equipment management program standards—ANSI/AAMI EQ56 and ANSI/AAMI EQ89 - p. 735 128. Chapter 105: Clinical engineering standards and practices - p. 741 129. Chapter 106: European Union medical device legislation, vigilance, and metrology system - p. 752 130. Chapter 107: United States food and drug administration - p. 763 131. Chapter 108: Legal metrology framework for medical devices - p. 773 132. Chapter 109: Improving the accuracy and efficiency of medical devices in the legal metrology system of Bosnia and Herzegovina - p. 779 133. Section 12: Health technology assessment - p. 786 134. Introduction - p. 787 135. Chapter 110: Introduction to economic evaluation and health technology assessment - p. 788 136. Chapter 111: Health technology assessment of medical devices - p. 794 137. Chapter 112: Early stage healthcare technology assessment - p. 798 138. Chapter 113: Multicriteria decision aiding for early health technology assessment of medical devices - p. 806 139. Chapter 114: Hospital based health technology assessment - p. 811 140. Chapter 115: Evidence generation in medicine - p. 817 141. Chapter 116: Systematic literature review and meta-analysis: The case of medical devices and medical locations - p. 820 142. Chapter 117: Human factors and system thinking for medical device - p. 828 143. Chapter 118: Health technology assessment teaching for BME - p. 831 144. Section 13: Introduction to human factors - p. 835 145. Introduction - p. 837 146. Chapter 119: Physiological and psychological aspects - p. 838 147. Chapter 120: Cognitive ergonomics - p. 846 148. Chapter 121: Bettering healthcare outcomes through environmental design - p. 851 149. Chapter 122: Clinical decision-making in complex healthcare delivery systems - p. 857 150. Chapter 123: Addressing adverse events in health care through a safety science lens - p. 864 151. Chapter 124: Medical devices - p. 870 152. Chapter 125: Human factor approaches to understand health information technology impacts on patient safety - p. 875 153. Chapter 126: Using human factors to achieve patient and family-centered care - p. 880 154. Chapter 127: Cognitive informatics in health care - p. 886 155. Index - p. 891
