Reliability technology, human error, and quality in health care

Reliability Technology, Human Error, and Quality in Health Care

Volumn , Issue , 2008, Pages 1-193

  Dhillon, B S ^a  

^a UNIVERSITY OF OTTAWA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84867350945     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Book

References (551)

1. Adams, J. G., Bohan, S., System Contributions to Error. Academic Emergency Medicine 7 (2000): 1189-1193.
2. Al-Abdulla, H. M., Lulu, D. J., Hypokalaemia and Pacemaker Failure. American Surgery 40 (1974): 234-236.
3. Al-Assaf, A. F., Schmele, J. A., The Textbook ofTotal Quality in Healthcare. Delray Beach, FL: St. Lucie Press, 1993.
4. Alberti, K.G.M.M., Medical Errors: A Common Problem. British Medical Journal 322 (2001): 501-502.
5. Alexander, K., Clarkson, P. J., Good Design Practice for Medical Devices and Equipment, Part II: Design for Validation. Journal ofMedical Engineering and Technology 24 (2000): 53-62.
6. Allen, D., California Home to Almost One-Fifth of U.S. Device Industry. Medical Device & Diagnostic Industry, 19 (1997): 64-67
7. Allen, R.C., FDA and the Cost of Health Care. Medical Device & Diagnostic Industry 18 (1996): 28-35
8. Altshuler, C., Aster, R., Covino, K., Gordon, S., Gajewski, M., Smith, A., Horrigan, S., Pfaff, K., Automated Donor-Recipient Identification Systems as a Means of Reducing Human Error in Blood Transfusion Transfusion 17 (1977): 586-597
9. Andrews, L. B., Stocking, C., Krizek, T., Gottlieb, L., Krizek, C., Vargish, T., Siegler, M. An Alternative Strategy for Studying Adverse Events in Medical Care Lancet 349 (1997): 309-313
10. Angelo, M D., Internet Solution Reduces Medical Errors Health Management Technology, February (2000): 20-21
11. Anon., The Quality of the NHS. Quality World 29 (2003): 14.
12. Appler, W. D., McMann, G. L., Medical Device Regulation: The Big Picture. In The Medical Device Industry: Science, Technology, and Regulation in a Competitive Environment, edited by N.F. Estrin, 35-51. New York: Marcel Dekker, 1990.
13. Arcarese, J., An FDA Perspective. Proceedings of the First Symposium on Human Factors in Medical Devices, 1989, 23-24.
14. Arearese, J. S., FDA5s Role in Medical Device User Education. The Medical Device Industry: Science, Technology, and Regulation in a Competitive Environment, edited by N.F. Estrin, 129-138. New York: Marcel Dekker, 1990.
15. Arnstein, F., Catalogue of Human Error. British Journal ofAnaesthesia 79 (1997): 645-656.
16. Association for the Advancement of Medical Instrumentation. Human Factors Engineering Guidelines and Preferred Practicesfor the Design ofMedical Devices. ANSI/AAMI HE- 48. Arlington, VA: Association for the Advancement of Medical Instrumentation, 1993.
17. Banta, H. D., The Regulation of Medical Devices. Preventive Medicine 19 (1990): 693-699.
18. Barker, K. N., McConnell, W. E., Detecting Errors in Hospitals. American Journal of Hospitals 19 (1962): 361-369.
19. Bassen, H., Silberberg, J., Houston, F., Knight, W., Computerized Medical Devices, Trends, Problems, and Safety IEEE Aerospace and Electronic Systems (AES) September (1986): 20-24
20. Batalden, P., Deming Offers Much to Healthcare Workers. Quality Progress 35 (2002): 10-12
21. Bates, D.W., Cullen, D. J., Small, S. D., Cooper, J. B., Nemeskal, A. R., Leape, L. L., The Incident Reporting System Does Not Detect Adverse Drug Events: A Problem for Quality Improvement Joint Commission Journal on Quality Improvement 21 (1995): 541-548
22. Bates, D W, Spell, N, Cullen, D J., The Costs of Adverse Drug Events in Hospitalized Patients Journal of the American Medical Association 277 (1997): 307-311
23. Bates, D.W., Using Information Technology to Reduce Rates of Medication Errors in Hospitals British Medical Journal 320 (2000): 788-791
24. Battles, J., Mercer, Q., Whiteside, M., Bradley, J., A Medical Event Reporting System for Human Errors in Transfusion Medicine In Advances in Applied Ergonomics, edited by A.F. Ozok, G. Salvendy, 809-814. West Lafayette, IN: USA Publishing, 1996.
25. Battles, J B, Kaplan, H S, Van der Schaaf, T W, Shea, C E., The Attributes of Medical Event-Reporting Systems Archives of Pathology and Laboratory Medicine 122 (1998): 231-238
26. Baylis, F., Errors in Medicine: Nurturing Truthfulness Journal of Clinical Ethics 8 (1997): 336-340
27. Beasley, L J., Reliability and Medical Device Manufacturing Proceedings of the Annual Reliability and Maintainability Symposium, 1995, 128-131
28. Beckmann, U, Baldwin, I, Hart, G K, Runciman, W B., The Australian Incident Monitoring Study in Intensive Care: AIMS-ICU. An Analysis of the First Year of Reporting. Anaesthesia and Intensive Care 24 (1996): 320-329
29. Beier, B., Liability and Responsibility for Clinical Medical Software in the Federal Republic of Germany Proceedings of the 10th Annual Symposium on Computer Applications Medical Care, 1986, 364-368
30. Beiser, E.N., Reporting Physicians5 Mistakes. Rhode Island Medical Journal 73 (1990): 333-336
31. Beith, B. H., Human Factors and the Future of Telemedicine. Medical Device & Diagnostic Industry 21 (1999): 36-40
32. Belkin, L., Human and Mechanical Failures Plague Medical Care. New York Times, March 31, 1992, B1-B6
33. Bell, B M., Error in Medicine Journal of the American Medical Association 274 (1995): 457-461
34. Bell, D D., Contrasting the Medical-Device and Aerospace-Industries Approach to Reliability Proceedings of the Annual Reliability and Maintainability Symposium, 1996, 125-127
35. Bell, R., Krivich, M. J., How to Use Patient Satisfaction Data to Improve Healthcare Qualit-y. Milwaukee, WI: ASQ Quality Press, 2000.
36. Ben-Zvi, S., Quality Assurance in Transition. Biomedical Instrumentation & Technology 23 (1989): 27-33.
37. Berglund, S., Systems Failures, Human Error and Health Care. Medical Liability Monitor (1998): 1-4.
38. Berndt, D. J., Fisher, J.W., Hevner, A. R., Healthcare Data Warehousing and Quality Assur-ance.Computer 34 (2001): 56-65.
39. Bethune, J., The Cost-Effective Bugaboo. Medical Device & Diagnostic Industry 19 (1997): 12-15
40. Beuscart, R. J., Alao, O.O., Brunetaud, J. M., Health Telematics: A Challenge for Healthcare Quality Proceedings of the 23rd Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 2001, 4105-4107
41. Beyea, S C., Tracking Medical Devices to Ensure Patient Safety AORN Journal 77 (2003): 192-194
42. Billings, C. E., Woods, D. D., Human Error in Perspective: The Patient Safety Movement. Postgraduate Medicine 109 (2001): 23-25.
43. Bindler, R., Boyne, T., Medication Calculation Ability of Registered Nurses. Image 23 (1991): 221-224
44. Blum, L.L., Equipment Design and "Human" Limitations. Anesthesiology 35 (1971): 101-102
45. Blumenthal, D., Making Medical Errors into Medical Treasures Journal of the American Medical Association 272 (1994): 1867-1869
46. Bogner, M S., Designing Medical Devices to Reduce the Likelihood of Error Biomedical Instrumentation & Technology 33 (1999): 108-113.
47. Bogner, M S., Human Error in Medicine Hillsdale, NJ: Lawrence Erlbaum Associates, 1994.
48. Bogner, M S., Helping to Reduce Human Error in Health Care Technology Biomedical Instrumentation and Technology 47 (2003): 61-64.
49. Bogner, M S., Human Error in Medicine: A Frontier for Change In Human Error in Medicine, edited by M S Bogner, 373-383 Hillsdale, NJ: Lawrence Erlbaum Associates, 1994
50. Bogner, M S., Human Factors, Human Error and Patient Safety Panel Proceedings of the Annual Human Factors Society Conference 2, 1998, 1053-1057
51. Bogner M.S., Medical Device and Human Error, Human Performance. In Automated Systems: Current Research and Trends, edited by Mouloua, M, Parasuraman, P, 64-67 Hillsdale, NJ: Lawrence Erlbaum Associates, 1994.
52. Bogner, M. S., Medical Device: A Frontier for Human Factors. CSERIAC Gateway IV (1993): 12-14
53. Bombino, A., Lessons Learned in Applying QFD at Baxter Healthcare. Proceedings of the NEPCON West '92 Conference, 1992, 877-880.
54. Boumil, M M, Elias, C E., The Law of Medical Liability in a Nutshell St Paul, MN: West Publishing, 1995
55. Bousvaros, G. A., Don, C., Hopps, J. A., An Electrical Hazard of Selective Angiocardiography. Canadian Medical Association Journal 87 (1962): 286-288
56. Bowling, P, Berglund, R., HIPAA: Where Healthcare and Software Quality Meet Proceedings of the 57th Annual Quality Congress: Expanding Horizons, 2003, 271-281.
57. Bracco, D, Favre, J B, Bissonnette, B., Human Errors in a Multidisciplinary Intensive Care Unit: A 1-Year Prospective Study. Intensive Care Medicine 27 (2001): 137-145.
58. Bradley, J B., Controlling Risk in a Complex Environment: The Design of Computer Based Systems to Minimize Human Error in Medicine Proceeding of the ASIS Annual Con-ference, October 1996, 210-213
59. Brady, W. J., Perron, A., Errors in Emergency Physician Interpretation of ST-Segment Elevation in Emergency Department Chest Pain Patients. Academic Emergency Medicine 7 (2000): 1256-1260.
60. Brasel, K. J., Layde, P. M., Hargarten, S., Evaluation of Error in Medicine: Application of a Public Health Model. Academic Emergency Medicine 7 (2000): 1298-1302.
61. Bratman, R. L., A National Database of Medical Error. Journal of Royal Society of Medicine 93 (2000): 106.
62. Brazeau, C., Disclosing the Truth About a Medical Error. American Family Physician 60 (1999): 1013-1014.
63. Brennan, T. A., The Institute of Medical Report on Medical Errors-Could It Do Harm? New England Journal of Medicine 342 (2000): 1123-1125
64. Brennan, T. A., Bates, D.W., Pappius, E., Kuperman, G. J., Sittig, D., Burstin, H., et al. Using Information Systems to Measure and Improve Quality. International Journal of Medi- cal Informatics 53 (1999): 115-124
65. Brennan, T A, Leape, L L, Laird, N M., Incidence of Adverse Events and Negligence in Hospitalised Patients: Results of the Harvard Medical Practice Study I New England Journal of Medicine 324 (1991): 370-376
66. Brennan, T A, Leape, L L, Laird, N M., Incidence of Adverse Events and Negligence in Hospitalised Patients: Results of the Harvard Medical Practice Study II New England Journal of Medicine 324 (1991): 377-384
67. Brennan, T. A., Localio, A. R., Laird, N. M., Reliability and Validity of Judgments Concerning Adverse Events and Negligence Medical Care 27 (1989): 1148-1158.
68. Brennan, T. A., Localio, R., Leape, L. L., Laird, N. M., Identification of Adverse Events Occurring During Hospitalisation Annals of Internal Medicine 112 (1990): 221-226.
69. Brienza, J., Medical Mistakes Study Highlights Need for System Wide Improvements. Trail February (2000): 15-17.
70. Brooke, P. S., Shaping the Medical Error Movement. Nursing Management 31 (2000): 18-19.
71. Brown, P. J. B., Warmington, V. Data Quality Probes-Exploiting and Improving the Quality of Electronic Patient Record Data and Patient Care International Journal of Medical Informatics 68 (2002): 91-98
72. Brown, R W., Errors in Medicine Journal of Quality Clinical Practice 17 (1997): 21-25
73. Bruley, M E Ergonomics and Error: Who Is Responsible Proceeding of the First Symposium on Human Factors in Medical Devices, 1989, 6-10
74. Bruner, J M R Hazards of Electrical Apparatus Anesthesiology 28 (1967): 396-425
75. Burchell, H B Electrocution Hazards in the Hospital or Laboratory Circulation (1963): 1015-1017
76. Burlington, D. B., Human Factors and the FDA5s Goal: Improved Medical Device Design. Biomedical Instrumentation & Technology 30 (1996): 107-109.
77. Busse, D K, Johnson, C W., Human Error in an Intensive Care Unit B: A Cognitive Analysis of Critical Incidents Proceedings of the 17th International Conference of the Systems Safety Society, Orlando, Florida, August 1999, 70-75.
78. Busse, D K, Wright, D J., Classification and Analysis of Incidents in Complex, Medical Envi-ronment Topics in Health Information Management 20 (2000): 56-58.
79. Caldwell, R., Alerting Staff to Medication Errors Health Management Technology August (2000): 52
80. Camishion, R C., Electrical Hazards in the Research Laboratory Journal of Surgical Research 6 (1966): 221-227
81. Caplan, R. A., Vistica, M. F., Posner, K. L., Cheney, FW., Adverse Anesthetic Outcomes Arising from Gas Delivery Equipment: A Closed Claims Analysis. Anesthesiology 87 (1997): 741-748
82. Caroselli, M, Edison, L., Quality Care: Prescriptions for Injecting Quality into Healthcare Systems Boca Raton, FL: St Lucie Press, 1997
83. Carstens, D., Hollingsworth, A.T., Barlow, J., Bean, L. A., Hott, D., Pierce, B., The Technology Gap in Patient Safety. Proceedings of the 8th World Multi-Conference on Systemics, Cybernetics and Informatics 4, 2004, 268-272.
84. Casarett, D., Helms, C., Systems Errors versus Physicians5 Errors: Finding the Balance in Medical Education. Academic Medicine 74 (1999): 19-22.
85. Casey, S., Set Phasers on Stun: And Other True Tales of Technology and Human Error. Santa Barbara, CA: Argean, 1993.
86. Cattaneo, C. R., Vecchio, A. D., Human Errors in the Calculation of Monitor Units in Clinical Radiotherapy Practice. Radiotherapy & Oncology 28 (1993): 86-88.
87. Chae, Y. M., Kim, H.S., Tark, K. C., Analysis of Healthcare Quality Indicator Using Data Mining and Decision Support System. Expert Systems with Applications 24 (2003): 167-172.
88. Chaplin, E., Customer Driven Healthcare Comprehensive Quality Function Deployment. Pro-ceedings of the 56th Annual Quality Congress, 2002, 767-781.
89. Chassin, M. R., Is Health Care Ready for Six Sigma Quality. Milbank Quarterly: Journal of Public Health and Health Care Policy 76 (1998): 59-61.
90. Chassin, M. R., Galvin, R.W., The Urgent Need to Improve Health Care Quality. Journal of the American Medical Association 280 (1998): 1000-1005.
91. Chen, Y., Agarwal, B. D., So, P. K., The Role of Numerical Stress Analysis in Failure Analysis of a Medical Device Plastics Engineering 55 (1999): 45-47
92. Chopra, V., Bovill, J.G., Koornneef, J. F., Reported Significant Observations During Anaes-thesia: A Prospective Analysis Over an 18-month Period. British Journal ofAnaesthe- sia 68 (1992): 13-17
93. Christensen, J F, Levinson, W, Dunn, P M., The Heart of Darkness: The Impact of Perceived Mistakes on Physicians Journal of General Internal Medicine 7 (1992): 424-431
94. Chung, P. H., Zhang, J., Jonson, T. R., Patel, V. L., An Extended Hierarchical Task Analysis for Error Prediction in Medical Devices Proceedings of the AMIA Annual Symposium, 2003, 165-169
95. Classen, D., Patient Safety, the Name is Quality Trustee 53 (2000): 12-15
96. Clayton, M., The Right Way to Prevent Medication Errors Registered Nurse (RN) June (1987): 30-31
97. Clifton, B.S., Hotten, W. I.T., Deaths Associated with Anaesthesia. British Journal ofAnaes- thesia 35 (1963): 250-259
98. Cohen, M R, Senders, J, Davis, N M., Failure Mode and Effects Analysis: A Novel Approach to Avoiding Dangerous Medication Errors and Accidents Hospital Pharmacy 29 (1994): 319-330
99. Cohen, T., Computerized Maintenance Management Systems: How to Match Your Depart- ment5s Needs with Commercially Available Products. Journal of Clinical Engineering November/December (1995): 457-461.
100. Cohen, T., Validating Medical Equipment Repair and Maintenance Metrics: A Progress Report. Biomedical Instrumentation & Technology January/February (1977): 23-32.
101. Cole, T., Medical Errors vs Medical Injuries: Physicians Seek to Prevent Both. Journal of the American Medical Association 284 (2000): 2175-2176
102. Coleman, I.C., Medication Errors: Picking up the Pieces. Drug Topics March 15, 1999, 83-92
103. Conlan, M. F., IOM5s Med-Error Report Spurs Changes Among Pharmacies. Drug Topics 144 (2000): 70-71
104. Cook, R I, Woods, D D., Operating at the Sharp End: The Complexity of Human Error In Human Error in Medicine, edited by M S Bogner, 255-310. Hillsdale, NJ: Lawrence Erlbaum Associates, 1994
105. Cooper, D M., Series of Errors Led to 300 Unnecessary Mastectomies British Medical Journal 320 (2000): 597
106. Cooper, J. B., Toward Prevention of Anesthetic Mishaps. International Anesthesiology Clinics 22 (1985): 167-183.
107. Cooper, J. B., Gaba, D. M., A Strategy for Preventing Anesthesia Accidents. International Anesthesiology Clinics 27 (1989): 148-152.
108. Cooper, J. B., Newbower, R.S., Kitz, R.J., An Analysis of Major Errors and Equipment Fail-ures in Anesthesia Management: Consideration for Prevention and Detection. Anesthe-siology 60 (1984): 34-42.
109. Cooper, J. B., Newbower, R.S., Long, C. D., McPeek, B., Preventable Anesthetic Mishaps: A Study of Human Factors. Anesthesiology 49 (1978): 399-406.
110. Cooper, J. B., Newbower, R. S., Ritz, R. J., An Analysis of Major Errors and Equipment Failures in Anesthesia Management: Considerations for Prevention and Detection Anes-thesiology 60 (1984): 34-42.
111. Cott, H P., Human Error in Health Care Delivery: Cases, Causes, and Correction Proceedings of the Human Factors and Ergonomics Society, 1993, 846-848
112. Cott V.H., Human Error: Their Causes and Reduction. In Human Error in Medicine, edited by M.S. Bogner, 53-65. Hillsdale, NJ: Lawrence Erlbaum Associates, 1994.
113. Craig, J., Wilson, M.E., A Survey of Anaesthetic Misadventures. Anaesthesia 36 (1981): 933-936
114. Crane, M., How Good Doctors Can Avoid Bad Errors Medical Economics, April 28, 1997, 36-43
115. Crowley, J. J., Identifying and Understanding Medical Device Use Errors. Journal of Clinical Engineering 47 (2002): 188-193
116. Cullen, D J., Risk Modification in the Post Anesthesia Care Unit International Anesthesiology Clinics 27 (1989): 184-187
117. Cuthrell, P., Managing Equipment Failures: Nursing Practice Requirements for Meeting the Challenges of the Safe Medical Devices Act. Journal ofIntravenous Nursing 19 (1996): 264-268
118. Dain, S., Normal Accidents: Human Error and Medical Equipment Design Heart Surgery Forum 5 (2002): 254-257
119. David, P P, Glyyn, C N, Laura, M., Increase in US Medication-Error Deaths Between 19831993 Lancet 351 (1998): 643-644
120. Davis, N, Cohen, M., Medication Errors: Causes and Prevention Huntingdon Valley, PA: N M Davis, 1983
121. Dawson, N V., Systematic Errors in Medical Decision Making: Judgment Limitations Journal of General Internal Medicine 2 (1987): 183-187
122. De Lemos, Z., FMEA Software Program for Managing Preventive Maintenance of Medical Equipment Proceedings of the IEEE 30th Annual Northeast Bioengineering Conference, 2004, 247-248
123. De Leval, M. R., Human Factors and Surgical Outcomes: A Cartesian Dream. Lancet 349 (1997): 723-726
124. De Leval, M R, Reason, J T., The Human Factor in Cardiac Surgery: Errors and Near Misses in a High Technology Medical Domain Annals of Thoracic Surgery 72 (2001): 300-305
125. DeAnda, A, Gaba, D M., Unplanned Incidents During Comprehensive Anesthesia Simulation Anesthesia Analgesia 71 (1990): 77-82
126. Deinstadt, D C., Dollars Plus Sense: Nine Considerations for Saving on Medical Equipment Maintenance Health Facilities Management 15 (2002): 28-33
127. Dhillon, B S., Bibliography of Literature on Medical Equipment Reliability Microelectronics and Reliability 20 (1980): 737-742
128. Dhillon, B.S., Design Reliability: Fundamentals and Applications. Boca Raton, FL: CRC Press, 1999
129. Dhillon, B. S., Human and Medical Device Reliability. In Handbook of Reliability Engineering, edited by H. Pham, 529-542. New York: Springer-Verlag Publishers, 2003.
130. Dhillon, B. S., Human Factors in Medical Devices. Proceedings of the 32nd International Conference on Computers and Industrial Engineering, 2003, 176-181.
131. Dhillon, B. S., Human Error in Medical Systems. Proceedings of the 6th ISSAT International Conference on Reliability and Quality in Design, 2000, 138-143.
132. Dhillon, B.S., Human Error in Medication. Proceedings of the 10th ISSAT International Con-ference on Reliability and Quality in Design, 2004, 325-329.
133. Dhillon, B. S., Human Reliability and Error in Medical System. River Edge, NJ: World Scientific Publishing, 2003.
134. Dhillon, B. S., Medical Device Reliability and Associated Areas. Boca Raton, FL: CRC Press, 2000
135. Dhillon, B S., Medical Device Software Failures Proceedings of the Safety and Reliability International Conference, 2001, 113-123
136. Dhillon, B S., Methods for Performing Human Reliability and Error Analysis in Health Care International Journal of Health Quality Assurance 16 (2003): 306-317.
137. Dhillon, B S., Reliability Considerations in Medical Devices Proceedings of the 43rd Congress of the European Organization for Quality Control, 1999, 400-418.
138. Dhillon, B S., Reliability Engineering Applications: Bibliography on Important Application Areas. Gloucester, Ontario: Beta Publishers, 1992, Chapter 13.
139. Dhillon, B. S., Reliability Engineering in Systems Design and Operation. New York: Van Nos-trand Reinhold, 1983, Chapter 11
140. Dhillon, B S., Reliability Technology for Manufacturers: Engineering Better Medical Devices Medical Device and Diagnostic Industry 23 (2001): 94-99.
141. Dhillon, B S., Reliability Technology in Health Care Systems Proceedings of the IASTED International Symposium on Computers and Advanced Technology in Medicine, Healthcare, and Bioengineering, 1990, 84-87
142. Dhillon, B S., Risk Assessment in Medical Devices Proceedings of the 6th International Conference on Probabilistic Safety Assessment and Management, 2002, 203-207.
143. Dhillon, B.S., Tools for Improving Medical Equipment Reliability and Safety. Physics in Medicine and Biology 39a (1994): 941
144. Dhillon, B. S., Rajendran, M., Human Error in Health Care Systems. International Journal of Reliability, Quality, and Safety Engineering 10 (2003): 99-117.
145. Dhillon, B S, Rajendran, M., Stochastic Analysis of Health Care Professional-Patient Interactions Subject to Human Error Proceedings of the Fifth IASTED International Conference on Modelling, Simulation, and Optimization, 2005, 145-150.
146. Dickson, C., World Medical Electronics Market: An Overview Medical Devices & Diagnostic Industry 6 (1984): 53-58
147. Domizio, G D, Davis, N M, Cohen, M R The Growing Risk of Look-Alike Trademarks Medical Marketing & Media May (1992): 24-30.
148. Donchin, Y, Biesky, M, Cotev, S, Gopher, D, Olin, M, Badihi, Y, Cohen, G., The Nature and Causes of Human Errors in a Medical Intensive Care Unit. Proceedings of the 33rd Annual Meeting of the Human Factors Society, 1989, 111-118.
149. Donchin, Y, Gopher, D, Olin, M, Badihi, Y., A Look into the Nature and Causes of Human Error in the Intensive Care Unit Critical Care Medicine 23 (1995): 294-300.
150. Donohue, J, Apostolou, S F., Shelf-Life Prediction for Radiation-Sterilized Plastic Devices Medical Device & Diagnostic Industry 12 (1996): 124-129.
151. Doyal, L., The Mortality of Medical Mistakes, Doctors-Obligations and Patients-Expectation. Practitioner 231 (1987): 615-620
152. Doyle, D J., Do It By Design: Human Factors Issues in Medical Devices Canadian Journal ofAnaesthesia 47 (2000): 1259-1260.
153. Drefs, M. J., IEC 601-1 Electrical Safety Testing. Compliance Engineering XIV (1997): 11-14.
154. Drefs, M. J., IEC 601-1 Electrical Testing, Part 2: Performing the Tests. Compliance Engineer-ing XIV (1997): 23-25.
155. Dripps, R. D., Lamont, A., Eckenhoff, J. E., The Role of Anesthesia in Surgical Mortality. Journal of the American Medical Association 178 (1991): 261-266.
156. Drury, C.G., Schiro, S.C., Czaja, S. J., Barnes, R. E., Human Reliability in Emergency Medical Response. Proceedings of the Annual Reliability and Maintainability Symposium, 1977, 38-42.
157. Dultgen, P., Meier, A., Requirements for Remote Maintenance for Medical Wearable Devices. Proceedings of the 7th Biennial Conference on Engineering Systems Design and Analysis, 2004, 367-374
158. Dunn, J D., Error in Medicine Annals of Internal Medicine 134 (2001): 342-344
159. Dutton, G. Do American Hospitals Get Away with Murders? Business and Health 18 (2000): 38-47
160. Eberhard, D. P., Qualification of High Reliability Medical Grade Batteries. Proceedings of the Annual Reliability and Maintainability Symposium, 1989, 356-362.
161. Edwards, FV., Before Design: Thoroughly Evaluate Your Concept. Medical Device & Diagnostic Industry 19 (1997): 46-50
162. Egeberg, R.O., Engineers and the Medical Crisis. Proceedings of the IEEE 57 (1969): 1807-1808
163. Eichhorn, J H., Prevention of Intraoperative Anesthesia Accidents and Related Severe Injury Through Safety Monitoring Anesthesiology 70 (1989): 572-577.
164. Eisele, G R, Watkins, J P., Survey of Workplace Violence in Department of Energy Facilities Report, U.S. Department of Energy, Office of Occupational Medicine and Medical Surveillance, Washington, DC, December 1995.
165. Eiselstem, L. E., James, B., Medical Device Failures: Can We Learn From Our Mistakes? Pro-ceedings of the Materials and Processes for Medical Devices Conference, 2004, 3-11.
166. Eisenberg, J M., Medical Error Accountability Family Practice News 30 (2000): 12.
167. Eisenberg, J M., The Best Offence Is a Good Defense Against Medical Errors: Putting the Full-Court Press on Medical Errors Agency for Healthcare Research and Quality, Duke University Clinical Research Institute, Rockville, MD: January 20, 2000.
168. Elahi, B J., Safety and Hazard Analysis for Software-Controlled Medical Devices Proceedings of the 6th Annual IEEE Symposium on Computer-Based Medical Systems, 1993, 10-15
169. Elkin, P L, Brown, S H, Carter, J., Guideline and Quality Indicators for Development, Purchase and Use of Controlled Health Vocabularies International Journal of Medical Informatics 68 (2002): 175-186
170. Elliott, L, Mojdehbakhsh, R A., Process for Developing Safe Software Proceedings of the 7th Symposium on Computer-Based Medical Systems, 1994, 241-246.
171. Epstein, R M., Morbidity and Mortality from Anesthesia Anesthesiology 49 (1978): 388-389
172. Espinosa, J. A., Nolan, TW., Reducing Errors Made by Emergency Physician in Interpreting Radiographs: Longitudinal Study British Medical Journal 320 (2000): 737-740.
173. Estrin, N F., The Medical Device Industry: Science, Technology, and Regulation in a Competitive Environment. New York: Marcel Dekker, 1990.
174. Fairhurst, G. A., Murphy, K. L., Help Wanted. Proceedings of the Annual Reliability and Maintainability Symposium, 1976, 103-106
175. Famularo, G., Salvani, P., Terranova, A., Clinical Errors in Emergency Medicine: Experience at the Emergency Department of an Italian Teaching Hospital Academic Emergency Medicine 7 (2000): 1278-1281
176. Feinstein, A R., Errors in Getting and Interpreting Evidence Perspectives in Biology and Medicine 41 (1999): 45-58
177. Feldman, S. E., Roblin, D.W., Medical Accidents in Hospitals Care: Applications of Failure Analysis to Hospitals Quality Appraisal. Journal of Quality Improvement 23 (1997): 567-580.
178. Ferman, J., Medical Errors Spur New Patient-Safety Measures. Healthcare Executive March (2000): 55-56.
179. Ferner, R. E., Medication Errors that Have Led to Manslaughter Charges. British Medical Journal 321 (2000): 1212-1216.
180. Ferner, R. E., Reporting of Critical Incidents Shows How Errors Occur. British Medical Journal 311 (1995): 1368
181. Finfer, S. R., Pacemaker Failure on Induction of Anaethesia. British Journal of Anaesthesia 66 (1991): 509-512
182. Finger, T. A., The Alpha System. Proceedings of the Annual Reliability and Maintainability Symposium, 1976, 92-96
183. Fisher, M J., Eliminating Medical Errors Is Sound Risk Management National Underwriter, October 5, 1998, 51
184. Fletcher, M., Safety-Engineered Medical Devices Become Mandatory in Saskatchewan. Canadian Nurse 101 (2005): 12-13
185. Flickinger, J C, Lunsford, L D., Potential Human Error in Setting Stereo Tactic Coordinates for Radiotherapy: Implication for Quality Assurance International Journal of Radiation Oncology, Biology, Physics 27 (1993): 397-401.
186. Food and Drug Administration. Medical Devices; Current Good Manufacturing Practice (GMP) Final Rule, Quality System Regulation. Washington, DC: Food and Drug Administration, Department of Health and Human Services, 1996
187. Food and Drug Administration Preproduction Quality Assurance Planning Recommendations for Medical Device Manufacturers, Compliance Guidance Series HHS Publication FDA 90-4236. Rockville, MD: Food and Drug Administration, September 1989.
188. Food and Drug Administration Statistical Guidance for Clinical Trials of Non-Diagnostic Medical Devices Rockville, MD: Center for Devices and Radiological Health, Food and Drug Administration, 1996
189. Fox, G. N., Minimizing Prescribing Errors in Infants and Children. American Family Physician 53 (1996): 1319-1325
190. Fried, R A., TQM in the Medical School: A Report from the Field Proceedings of the 45th Annual Quality Congress Transactions, 1991, 113-118
191. Fries, R., Human Factors and System Reliability Medical Device Technology March (1992): 42-46
192. Fries, R. C., Medical Device Quality Assurance and Regulatory Compliance. New York: Marcel Dekker, 1998
193. Fries, R C., Reliability Assurance for Medical Devices, Equipment, and Software Buffalo Grove, IL: Interpharm Press, 1991
194. Fries, R C., Reliable Design of Medical Devices New York: Marcel Dekker, 1997
195. Fries, R C., Pienkowski, P, Jorgens, J Safe, Effective and Reliable Software Design and Development for Medical Devices Medical Instrumentation 30 (1996): 75-80
196. Fries, R C., Willingmyre, G T, Simons, D, Schwartz, R T Software Regulation In The Medical Device Industry: Science, Technology, and Regulation in a Competitive Environment, edited by N F Estrin, 557-569 New York: Marcel Dekker, 1990
197. Frings, G W., Grant, L., Who Moved My Sigma. Effective Implementation of the Six Sigma Methodology to Hospitals Quality and Reliability Engineering International 21 (2005): 311-328
198. Gaba, D M., Human Error in Anesthetic Mishaps International Anesthesiology Clinics 27 (1989): 137-147
199. Gaba, D M., Human Performance Issues in Anaesthesia Patient Safety Problems in Anaesthesia 5 (1991): 329-330
200. Gaba, D. M., Howard S.K., Conference on Human Error in Anesthesia (meeting report). Anesthesiology 75 (1991): 553-554.
201. Gaba, D. M., Maxwell, M., DeAnda, A., Anesthetic Mishaps: Breaking the Chain of Accident Evolution. Anesthesiology 66 (1987): 670-676.
202. Gawande, A. A., Thomas, E. J., Zinner, M. J., The Incidence and Nature of Surgical Adverse Events in Colorado and Utah in 1992. Surgery 126 (1999): 66-75.
203. Gebhart, F., Hospitals-VHA and VA Alike-Launch Programs to Cut Errors. Drug Topics 20 (2000): 53
204. Gechman, R., Tiny Flaws in Medical Design Can Kill. Hospital Topics 46 (1968): 23-24.
205. Gehlot, V., Sloane, E. B., Ensuring Patient Safety in Wireless Medical Device Networks. Com-puter 39 (2006): 54-60.
206. Gerlin, A., Medical Mistakes. The Inquirer, September 12, 1999, 65-64.
207. Ghahramani, B., An Internet Based Total Quality Management System. Proceedings of the 34th Annual Meeting of the Decision Sciences Institute, 2003, 345-349
208. Gingerich, D., Medical Product Liability. New York: F&S Press, 1981.
209. Ginsburg, G., Human Factors Engineering: A Tool for Medical Evaluation in Hospital Pro-curement Decision-Making Journal of Biomedical Informatics 38 (2005): 213-219
210. Giuntini, R E., Developing Safe, Reliable, Medical Devices Medical Device & Diagnostic Industry 35 (2000): 10-15
211. Glick, T H, Workman, T P, Gaufrerg, S V., Human Error in Medicine Academic Emergency Medicine 7 (2000): 1272-1277
212. Goodman, G R., Medical Device Error Critical Care Nursing Clinics of North America 14 (2002): 407-416
213. Gopher, D., Olin, M., Badihi, Y., The Nature and Causes of Human Errors in a Medical Intensive Care Unit. Proceedings of the Human Factors Society 33rd Annual Meeting, 1989, 956-960
214. Gosbee, J., The Discovery Phase of Medical Device Design: A Blend of Intuition, Creativity and Science Medical Device & Diagnostic Industry 19 (1997): 79-85
215. Gosbee, J, Ritchie, E M., Human Computer Interaction and Medical Software Development Interactions 4 (1997): 13-18
216. Grabarz, D. F., Cole, M. F., Developing a Recall Program. In The Medical Device Industry: Science, Technology, and Regulation in a Competitive Environment, edited by N F Estrin, 335-351 New York: Marcel Dekker, 1990
217. Graham, R., Why Are We Not Teaching Health Care Professionals About Human Error? Hospital Pharmacist 13 (2006): 371-372
218. Grant, L J., Product Liability Aspects of Bioengineering Journal of Biomedical Engineering 12 (1990): 262-266.
219. Grant, L. J., Regulations and Safety in Medical Equipment Design. Anaethesia 53 (1998): 1-3
220. Grasha, A F., Into the Abyss: Seven Principles for Identifying the Causes of and Preventing Human Error in Complex Systems American Journal of Health-System Pharmacy 57 (2000): 554-564
221. Gravenstein, J S., How Does Human Error Affect Safety in Anesthesia? Surgical Oncology Clinics of North America 9 (2000): 81-95
222. Green, R., The Psychology of Human Error European Journal of Anaesthesiology 16 (1999): 148-55
223. Gruppen, L D, Wolf, F M, Billi, J E., Information Gathering and Integration as Sources of Error in Diagnostic Decision Making Medical Decision Making 11 (1991): 233-239
224. Gunn, I P., Patient Safety and Human Error: The Big Picture CRNA: The Clinical Forum for Nurse Anesthetists 11 (2000): 41-48
225. Gurwitz, J. H., Sanchez-Cross, M.T., Eckler, M. A., Matulis, J., The Epidemiology of Adverse and Unexpected Events in the Long-Term Care Setting. Journal of the American Geriatric Society 42 (1994): 33-38.
226. Guyton, B., Human Factors and Medical Devices: A Clinical Engineering Perspective. Journal of Clinical Engineering 27 (2002): 116-122.
227. Hales, R. F., Quality Function Deployment in Concurrent Product/Process Development. Pro-ceedings of the 6th Annual IEEE Symposium on Computer-Based Medical Systems, 1993, 28-33
228. Hallam, K., An Erosion of Trust: Survey Finds Consumers Fear Medical Errors and Want Better Protection From Such Mistakes Modern Healthcare 30 (2000): 30-31
229. Handler, J. A., Gillam, M., Sanders, A. B. Defining, Identifying, and Measuring Medical Error in Emergency Medicine. Academic Emergency Medicine 7 (2000): 1183-1188.
230. Hart G K, Baidwin, I, Ford, J, Gutteridge, G., A Adverse Incidents in Intensive Care Survey Anaesthesia and Intensive Care 21 (1993): 65-68.
231. Haslam, K R, Bruner, J M R., The Epidemiology of Failure in Cardiac Monitoring Systems Medical Instrumentation 7 (1973): 293-296
232. Hatlie, M. J., Scapegoating Won5t Reduce Medical Errors. Medical Economics 77 (2000): 92-100
233. Haugh, R., Medical/Surgical Equipment: All Eyes on Safety. Hospitals and Health Networks 75 (2001): 30-33
234. Hearnshaw, H., Human Error in Medicine Ergonomics 39 (1996): 899-900
235. Hector, J, Tom, P Missed Diagnosis of Acute Cardiac Ischemia in the Emergency Department New England Journal of Medicine 342 (2000): 1163-1170
236. Helmreich, R. L., Schaefer, H. G. Team Performance in the Operating Room. In Human Error in Medicine, edited by M.S. Bogner, 225-254. Hillsdale, NJ: Lawrence Erlbaum Associates, 1994.
237. Heydrick, L., Jones, K. A., Applying Reliability Engineering During Product Development. Medical Device & Diagnostic Industry 18 (1996): 80-84.
238. Hobgood, C D, John, O, Swart, L., Emergency Medicine Resident Errors: Identification and Educational Utilization Academic Emergency Medicine 7 (2000): 1317-1320.
239. Hogl, O, Muller, M, Stoyan, H., On Supporting Medical Quality with Intelligent Data Min-ing Proceedings of the 34th IEEE Annual Hawaii International Conference on System Sciences, 2001, 141-145
240. Hollnagel, E., Cognitive Reliability and Error Analysis. Amsterdam: Elsevier, 1998
241. Hooten, W F A Brief History of FDA Good Manufacturing Practices Medical Device & Diagnostic Industry 18 (1996): 96
242. Hopps, J A., Electrical Hazards in Hospital Instrumentation Proceedings of the Annual Sym-posium on Reliability, 1969, 303-307
243. Horan, S., Is Human Error the Cause of Accident and Disaster? Occupational Health 45 (1993): 169-172
244. Hough, G W., Preproduction Quality Assurance for Healthcare Manufacturers Buffalo Grove, IL: Interpharm Press, 1997
245. Hughes, C. M., Honig, P., Phillips, J., Woodcook, J., Richard E. Anderson, R. E., et al., How Many Deaths Are Due to Medical Errors? Journal of the American Medical Associa-tion 284 (2000): 2187-2189
246. Hupert, N, Lawthers, A G, Brennan, T A, Peterson, L M., Processing the Tort Deterrent Signal: A Qualitative Study Social Science Medicine 43 (1996): 1-11.
247. Hutt, P B A., History of Government Regulation of Adulteration and Misbranding of Medical Devices In The Medical Device Industry: Science, Technology, and Regulation in a Competitive Environment, edited by N.F. Estrin, 17-33. New York: Marcel Dekker, 1990.
248. Hyman, W. A., Errors in the Use of Medical Equipment. In Human Error in Medicine, edited by M S Bogner, 327-347 Hillsdale, NJ: Lawrence Erlbaum Associates, 1994
249. Ibojie, J., Urbaniak, S. J., Comparing Near Misses with Actual Mistransfusion Events: A More Accurate Reflection of Transfusion Errors. British Journal ofHaematology 108 (2000): 458-460.
250. International Electrotechnical Commission. Safety of Medical Electrical Equipment, Part 1: General Requirements. IEC 601-1. Geneva, Switzerland: International Electrotechnical Commission, 1977.
251. International Organization for Standardization. Medical Devices-Risk Management-Part I: Application of Risk Analysis to Medical Devices. ISO/DIS 14971. Geneva, Switzerland: International Organization for Standardization (ISO), 1996
252. Iseli, K.S., Burger, S. Diagnostic Errors in Three Medical Eras: A Necropsy Study. Lancet 355 (2000): 2027-2031.
253. Israelski, E.W., Muto, W. H., Human Factors Risk Management as a Way to Improve Medical Device Safety; A Case Study of the Therac 25 Radiation Therapy System. Joint Com-mission Journal of Quality and Safety 30 (2004): 689-695.
254. Ivy, M. E., Cohn, K., Human Error in Hospitals and Industrial Accidents. Journal of the American College of Surgeons 192 (2001): 421.
255. Iz, P. H., Warren, J., Sokol, L., Data Mining for Healthcare Quality, Efficiency, and Practice Support Proceedings of the IEEE 34th Annual Hawaii International Conference on System Sciences, 2001, 147-152
256. Jackson, T., How the Media Report Medical Errors British Medical Journal 322 (2001): 562-564
257. Jacky, J., Risks in Medical Electronics Communications of the ACM 33 (1990): 138.
258. James, B. C., Hammond, E. H. The Challenge of Variation in Medical Practice. Archives of Pathology and Laboratory Medicine 124 (2000): 1001-1004
259. Jameson, F. L. Exposing Medical Mistakes. New York Times, February 24, 2000, A4.
260. Johns, R. J. What is Blunting the Impact of Engineering on Hospitals? Proceedings ofthe IEEE 57 (1969): 1823-1827
261. Johnson, J P Reliability of ECG Instrumentation in a Hospital Proceedings of the Annual Symposium on Reliability, 1969, 314-318
262. Johnson, W. G., Brennan, T. A., Newhouse, J. P., Leape, L. L., Lawthers, A. G., Hiath, H. H., Weiler, P C The Economic Consequences of Medical Injuries Journal of the American Medical Association 267 (1992): 2487-2492.
263. Joice, P., Hanna, G. B., Cuschieri, A. Errors Enacted During Endoscopic Surgery-A Human Reliability Analysis Applied Ergonomics 29 (1998): 409-415.
264. Jones, J, Hunter D Qualitative Research: Consensus methods for medical and health services research British Medical Journal 311 (1995): 376-380.
265. Jorgens, J Computer Hardware and Software as Medical Devices Medical Device & Diagnostic Industry 5 (1983): 62-67
266. Joyce, E Malfunction 54: Unraveling Deadly Medical Mystery of Computerized Accelerator Gone Awry American Medical News, October 3, 1986, 1-8.
267. Kagey, K S Reliability in Hospital Instrumentation Proceedings of the Annual Reliability and Maintainability Symposium, 1973, 85-88
268. Kandel, G L, Ostrander, L E Preparation of the Medical Equipment Designer: Academic Opportunities and Constraints Proceedings of the First Symposium on Human Factors in Medical Devices, 1989, 11-13
269. Karp, D. Your Medication Orders Can Become Malpractice Traps. Medical Economics, Feb-ruary 1, 1988, 79-91.
270. Kaye, R Human Factors in Medical Device Use Safety: How to Meet the New Challenges Proceedings of the Human Factors and Ergonomics Society Meeting, 2002, 550-552.
271. Keenan, R L, Boyan, P Cardiac Arrest Due to Anesthesia Journal of the American Medical Association 253 (1985): 2373-2377
272. Keller, A. Z., Kamath, A. R. R., Peacock, S.T. A Proposed Methodology for Assessment of Reliability, Maintainability and Availability of Medical Equipment. Reliability Engi-neering 9 (1984): 153-174.
273. Keller, J., Top Ten Safety Issues with Medical Devices. OR Manager 19 (2003): 24-25.
274. Keller, J. P., Human Factors Issues in Surgical Devices. Proceeding of the First Symposium on Human Factors in Medical Devices, 1989, 34-36.
275. Kelley, J. B., Medical Diagnostic Device Reliability Improvement and Prediction Tools: Lessons Learned. Proceedings of the Annual Reliability and Maintainability Symposium, 1999, 29-31
276. Keselman, A., Tang, X., Patel, V. L., Johnson, T. R., Zhang, J., Institutional Decision-Making for Medical Purchasing: Evaluating Patient Safety. Medinfo 11 (2004): 1357-1361.
277. Khorramshahgol, R., Al-Barmil, J., Stallings, R.W., TQM in Hospitals and the Role of Infor-mation Systems in Providing Quality Services. Proceedings of the IEEE Annual Inter-national Engineering Management Conference, 1995, 196-199.
278. Kieffer, R. G., Validation and the human element. PDA Journal of Pharmaceutical Science and Technology 52 (1998): 52-54.
279. Kim, J. S., Determining Sample Size for Testing Equivalence. Medical Device & Diagnostic Industry 19 (1997): 114-117.
280. Kim, J. S., Larsen, M., Improving Quality with Integrated Statistical Tools. Medical Device & Diagnostic Industry 18 (1996): 78-82.
281. Kimberly, J. R., Minvielle, E., The Quality Imperative: Measurement and Management of Quality in Healthcare London: Imperial College Press, 2000
282. King, R., Six Sigma and Its Application in Healthcare. Proceedings of the 57th Annual Quality Congress: Expanding Horizons, 2003, 39-47.
283. Kirk, R., Healthcare Quality & Productivity: Practical Management Tool. Rockville, MD: Aspen Publishers, 1988.
284. Kirwan, B., Human Error Identification Techniques for Risk Assessment of High Risk System, Part 1: Review and Evaluation of Techniques Applied Ergonomics 29 (1998): 157-178
285. Kirwan, B., Human Error Identification Techniques for Risk Assessment of High Risk System, Part 2: Towards a Framework Approach Applied Ergonomics 29 (1998): 299-318
286. Klatzky, R. L., Geiwitz, J., Fischer, S., Using Statistics in Clinical Practice: A Gap Between Training and Application In Human Error in Medicine, edited by M S Bogner, 123140. Hillsdale, NJ: Lawrence Erlbaum Associates, 1994.
287. Klemola, U M., The Psychology of Human Error Revisited European Journal of Anaesthesiology 17 (2000): 401
288. Knaus, W. A., Draper, E. A., Wagner, D. P., An Evaluation of Outcome from Intensive Care in Major Medical Centres. Annals of Internal Medicine 104 (1986): 410-418.
289. Knepell, P L., Integrating Risk Management with Design Control Medical Device & Diagnostic Industry 20 (1998): 83-89
290. Knight, J. C., Issues of Software Reliability in Medical Systems. Proceedings of the 3rd Annual IEEE Symposium on Computer-Based Medical Systems, 1990, 124-129
291. Knuckey, L. M., EPSM 2005 Workshop IEC 6060-1: Medical Electrical Equipment-Part I: General Requirements for Basic Safety and Essential Performance Australian Physical and Engineering Sciences in Medicine 29 (2006): 117-118
292. Kohn, L. T., Corrigan, J. M., Donaldson, M. S., To Err Is Human: Building a Safer Health System Washington, DC: Institute of Medicine, National Academy of Medicine, National Academies Press, 1999
293. Kortstra, J.R.A., Designing for the User. Medical Device Technology January/February (1995): 22-28
294. Krueger, G P., Fatigue, Performance, and Medical Error In Human Error in Medicine, edited by M S Bogner, 311-326 Hillsdale, NJ: Lawrence Erlbaum Associates, 1994
295. Kruk, S. M., Do Diligence: A Look at The 10 Most Common Errors in Medical Equipment Maintenance Invoices. Health Facilities Management 18 (2005): 34-36.
296. Kumar, V., Barcellos, W. A., Mehta, M. P., An Analysis of Critical Events in a Teaching Department for Quality Assurance: A Survey of Mishaps During Anesthesia. Anesthesia 43 (1988): 879-883.
297. Kuwahara, S.S., Quality Systems and GMP Regulations for Device Manufacturers. Buffalo Grove, IL: Interpharm Press, 1998.
298. Kyriacou, D. N., Coben, J. N., Errors in Emergency Medicine: Research Strategies. Academic Emergency Medicine 7 (2000): 1201-1203.
299. Labovitz, G. H., Total-quality Health Care Revolution. Quality Progress 24 (1991): 45-47.
300. Lane, R., Applying Hierarchical Task Analysis to Medication Administration Errors. Applied Ergonomics 37 (2006): 669-679
301. Larimer, M L, Bergquist, T M., A Comparison of Three Quality Improvement Systems for Health Care Proceedings of the 34th Annual Meeting of the Decision Sciences Institute, 2003, 1843-1848
302. Le Cocq, A. D., Application of Human Factors Engineering in Medical Product Design. Journal of Clinical Engineering 12 (1987): 271-277
303. Le Duff, F., Daniel, S., Kamendje, B., Monitoring Incident Report in the Healthcare Process to Improve Quality in Hospitals International Journal of Medical Informatics 74 (2005): 111-117
304. Leape, L L., Error in Medicine Journal of the American Medical Association 272 (1994): 1851-1857
305. Leape, L L., The Preventability of Medical Injury In Human Error in Medicine, edited by M S Bogner, 13-27 Hillsdale, NJ: Lawrence Erlbaum Associates, 1994
306. Leape, L. L., Cullen, D. J., Laird, N., Petersen, L. A., Teich, J. M., Burdick, E., et al., Effect of Computerized Physician Order Entry and a Team Intervention on Prevention of Serious Medication Errors Journal of the American Medical Association 280 (1998): 1311-1316
307. Leape L.L., Gullen, D. J., Clapps, M. D., Pharmacist Participation on Physician Rounds and Adverse Drug Events in the Intensive Care Unit. Journal of the American Medical Association 282 (1999): 267-270
308. Leape, L. L., Swankin, D.S., Yessian, M. R., A Conversation on Medical Injury. Public Health Reports 114 (1999): 302-317.
309. Leape, L L, Woods, D D, Hatlie, M J, Kizre, K W., Promoting Patient Safety by Preventing Medical Error Journal of the American Medical Association 280 (1998): 1444-1448
310. Ledley, R S., Practical Problems in the Use of Computers in Medical Diagnosis Proceedings of the IEEE 57 (1969): 1941.
311. Leffingwell, D. A., Norman, B., Software Quality in Medical Devices: A Top-Down Approach. Proceedings of the 6th Annual IEEE Symposium on Computer-Based Medical Systems, 1993, 307-311
312. Levkoff, B., Increasing Safety in Medical Device Software. Medical Device & Diagnostic Industry 18 (1996): 92-97
313. Lin, L, Isla, R, Doniz, K, Harkness, H, Vicente, K J, Doyle, D J., Applying Human Factors to the Design of Medical Equipment: Patient Controlled Analgesia Journal of Clinical Monitoring and Computing 14 (1998): 253-263
314. Lin, L, Vicente, K J, Doyle, D J., Patient Safety, Potential Adverse Drug Events, and Medical Device Design: A Human Factors Approach Journal of Biomedical Informatics 34 (2001): 274-284
315. Linberg, K R., Defining the Role of Software Quality Assurance in a Medical Device Company Proceedings of the 6th Annual IEEE Symposium on Computer-Based Medical Systems, 1993, 278-283
316. Ling, M.T. K, Sandford, C., Sadik, A., Blom, H., Ding, S.Y., Woo, L., How Processing Conditions Can Cause Degradation and Failure in Medical Devices. Plastics Engineering 57 (2001): 50-55.
317. Link, D. M., Current Regulatory Aspects of Medical Devices. Proceedings of the Annual Reli-ability and Maintainability Symposium, 1972, 249-250.
318. Lo, M., Formulating Equipment Maintenance Strategy in Hospital Authority (HA). IEE 3rd Seminar on Appropriate Medical Technology for Developing Countries. IEE Colloquium (Digest) No. V4-10408, 2004, 61-64.
319. Lori, A. B., Carol, S., An Alternative Strategy for Studying Adverse Events in Medical Care. Lancet 349 (1997): 309-313.
320. Ludbrook, G. L., Webb, R. K., Fox, M. A., Singletons, R. J., Problems Before Induction of Anaesthesia: An Analysis of 2000 Incidents Report. Anaesthesia and Intensive Care 21 (1993): 593-595
321. Lunn, J., Devlin, H., Lessons From the Confidential Inquiry into Preoperative Deaths in Three NHS Regions Lancet 2 (1987): 1384-1386
322. Maddox, M. E., Designing Medical Devices to Minimize Human Error. Medical Device & Diagnostic Industry 19 (1997): 160-180.
323. Marconi, M., Sirchia, G., Increasing Transfusion Safety by Reducing Human Error. Current Opinion in Hematology 7 (2000): 382-386.
324. Marsden, P., Hollnagel, E., Human Interaction With Technology: The Accidental User. Acta Psychologica 91 (1996): 345-358.
325. Marshall, D., Health Care Quality: It Is Not "Job One"! Proceedings of the 56th ASQ Annual Quality Congress, 2002, 83-91.
326. Marszalek-Gaucher, E., Total Quality in Healthcare: From Theory to Practice San Francisco: Jossey-Bass Publishers, 1993.
327. Maschino, S., Duffell, W., Can Inspection Time be Reduced?: Developing a HACCP Plan. Medical Device & Diagnostic Industry 20, 10 (1998): 64- 68.
328. Mayor, S., English NHS to Set Up New Reporting System for Errors British Medical Journal 320 (2000): 1689
329. Mazur, G., Quality Function Development for a Medical Device Proceedings of the 6th Annual IEEE Symposium on Computer-Based Medical Systems, 1993, 22-27
330. McCadden, P., Medical Errors Proceedings of a Conference on Enhancing Patient Safety and Reducing Errors in Health Care, National Patient Safety Foundation, Rancho Mirage, CA, 1999, 68-69
331. McClure, M. L., Human Error-A Professional Dilemma. Journal of Professional Nursing 7 (1991): 207
332. McConnel, E A., Pointed Strategies for Needle Stick Prevention Nursing Management 30 (1999): 57-60
333. McCray, S., Medical Errors in the US Medical System, Institute of Medicine Washington, DC: Institute of Medicine, National Academy of Medicine, National Academies Press, 1999
334. McCune, C G., Development of an Automated Pacemaker Testing System Proceedings of the 27th Midwest Symposium on Circuits and Systems, 1984, 9-12
335. McDaniel, J G., Improving System Quality Through Software Evaluation Computers in Biology and Medicine 32 (2002): 127-140
336. McLinn, J A., Reliability Development and Improvement of a Medical Instrument Proceedings of the Annual Reliability and Maintainability Symposium, 1996, 236-242
337. McManus, B., A Move to Electronic Patient Records in the Community: A Qualitative Case Study of a Clinical Data Collection System Problems Caused by Inattention to Users and Human Error Topics in Health Information Management 20 (2000): 23-37
338. McManus, J., Hong Kong Issues Guidelines to Prevent Further Medical Blunders British Medical Journal 315 (1997): 967-972
339. Mead, D., Human Factors Evaluation of Medical Devices. Proceedings of the First Symposium on Human Factors in Medical Devices, 1989, 17-18.
340. Meadows, S., Human Factors Issues with Home Care Devices. Proceedings of the First Sym-posium on Human Factors in Medical Devices, 1989, 37-38.
341. Meguro, T., Minimizing Human Error Based on Clinical Engineering and Safety Management of Medical Equipment. IRYO Japanese Journal of National Medical Services 59 (2005): 34-35.
342. Mehra, R. H., Eagle, K. A., Missed Diagnosis of Acute Coronary Syndromes in the Emergency Room-Continuing Challenges. New England Journal ofMedicine 342 (2000): 1207-1209
343. Merry, M. D., Healthcare5s Need for Revolutionary Change. Quality Progress 36 (2003): 31-35
344. Meyer, J. L., Some Instrument Induced Errors in the Electrocardiogram. Journal of the Ameri-can Medical Association 201 (1967): 351-358
345. Micco, L., A Motivation for the Biomedical Instrument Manufacturer Proceedings of the Annual Reliability and Maintainability Symposium, 1972, 242-244.
346. Miller, M. J., Bridgeman, E. A., Role of AAMI in the Voluntary Standards Process. In The Medical Device Industry: Science, Technology, and Regulation in a Competitive Envi-ronment, edited by N.F. Estrin, 163-175. New York: Marcel Dekker, 1990.
347. Moeller, J., O, Reilly, J.B., Elser, J., Quality Management in German Health Care-The EFQM Excellence Model. International Journal of Health Care Quality Assurance 13 (2000): 254-258
348. Moliver, M., Computerization Helps Reduce Human Error in Patient Dosing Contemporary Long Term Care 10 (1987): 56-58
349. Montanez, J., Medical Device Quality Assurance Manual Buffalo Grove, IL: Interpharm Press, 1996.
350. Moraes, L, Garcia, R., Contribution for the Functionality and the Safety in Magnetic Resonance: An Approach for the Imaging Quality Proceedings of the 25th Annual International Con-ference of the IEEE Engineering in Medicine and Biology Society, 2003, 3613-3616
351. Moray, D., Error Reduction as a Systems Problem In Human Error in Medicine, edited by M.S. Bogner, 67-92. Hillsdale, NJ: Lawrence Erlbaum Associates, 1994.
352. Mosenkis, R., Critical Alarms Proceedings of the First Symposium on Human Factors in Medical Devices, 1989, 25-27
353. Muldur, S., Computer-Aided Planned Maintenance System for Medical Equipment Journal of Medical Systems 27 (2003): 393-398
354. Murray, K., Canada5s Medical Device Industry Faces Cost Pressures, Regulatory Reform. Medical Device & Diagnostic Industry 19 (1997): 30-39
355. Nakata, Y., Fujiwara, M. O., Goto, T., Risk Attitudes of Anesthesiologists and Surgeons in Clinical Decision Making with Expected Years of Life Journal of Clinical Anesthesia 12 (2000): 146-150.
356. Narumi, J., Analysis of Human Error in Nursing Care, Accident Analysis and Prevention 31 (1999): 625-629
357. National Bureau of Standards. Reliability Technology for Cardiac Pacemakers. NBS/FDA Workshop, June 1974. NBS Publication No. 400-28. Washington, DC: National Bureau of Standards, Department of Commerce, 1974
358. Naylor, D., Reporting Medical Mistakes and Misconduct Canadian Medical Association Journal 160 (1999): 1323-1324.
359. Neumann, P G., Some Computer-Related Disasters and Other Egregious Horrors Proceedings of the 7th Annual Conference of the IEEE/Engineering in Medicine and Biology Society, 1985, 1238-1239
360. Nevland, J G., Electrical Shock and Reliability Considerations in Clinical Instruments Proceedings of the Annual Symposium on Reliability, 1969, 308-313
361. Newhall, C., The Institute of Medicine Report on Medical Errors. New England Journal of Medicine 343 (2000): 105-109.
362. Nichols, T.R., Dummer, S., Assessing Pass/Fail Testing When There Are No Failures to Assess. Medical Device & Diagnostic Industry 19 (1997): 97-100.
363. No author. Tracking Medical Errors, From Humans to Machines. New York Times, March 31, 1992, 81.
364. Nobel, J. J., Medical Device Accident Reporting: Does It Improve Patient Safety? Studies in Health Technology and Informatics 28 (1996): 29-35.
365. Nobel, J. J., Medical Device Failures and Adverse Effects. Pediatric Emergency Care 7 (1991): 120-123
366. Nolan, T W., System Changes to Improve Patient Safety British Medical Journal 320 (2000): 771-773
367. Nordenberg, T., Make No Mistakes: Medical Errors Can Be Deadly Serious. FDA Consumer September-October (2000): 104-106.
368. Norman, J. C., Goodman, L., Acquaintance with and Maintenance of Biomedical Instrumen-tation Journal of the Association of Advanced Medical Instrumentation September (1966): 8-9
369. Northrup, S. J., Reprocessing Single-Use Devices: An Undue Risk. Medical Device & Diag-nostic Industry 21 (1999): 38-41
370. Northup, S J., Safety Evaluation of Medical Devices: U S Food and Drug Administration and International Standards Organization Guidelines. International Journal of Toxicology 18 (1999): 275-283
371. Norton, G. S., Romlein, J., Lyche, D. K., PACS 2000-Quality Control using the Task Allocation Chart. Proceedings of the SPIE Medical Imaging Conference, 2000, 384-389.
372. O5Leary, D. S., Accreditation5s Role in Reducing Medical Errors. British Medical Journal 320 (2000): 727-728
373. O'Reilly, M.V., Murnaghan, D. P., Williams, M. B., Transvenous Pacemaker Failure Induced by Hyperkalemia Journal of the American Medical Association 228 (1974): 336-337
374. O'Rourke, K., The Human Factors in Medical Error. New England Journal of Medicine 304 (1981): 634-641
375. O'Shea, A., Factors Contributing to Medication Errors: A Literature Review. Journal of Clinical Nursing 8 (1999): 496-504
376. Offredy, M, Scott, J, Moore, R., Improving Safety and Learning: Case Study of an Incident Involving Medical Equipment Quality in Primary Care 12 (2004): 19-27
377. Okeyo, T. M., Adelhardt, M., Health Professionals Handbook on Quality Management in Healthcare in Kenya Centre for Quality in Healthcare, Nairobi, Kenya, 2003
378. Okuyama, Y., Sakamoto, K., Study of Failure Analysis for Safety Security During Medical Care. Transactions of the Institute of Electronics, Information, and Communication Engineers J88A (2005): 511-518
379. Oliver, S., The Healthy Standard Quality World 29 (2003): 16-20
380. Olivier, D. P., Engineering Process Improvement Through Error Analysis. Medical Device & Diagnostic Industry 21 (1999): 130-136
381. Ovretveit, J., System Negligence Is at the Root of Medical Error International Journal of Health Care Quality Assurance 13 (2000): 103-105
382. Owei, V., Healthcare Quality and Productivity: Framework for an Information Technology Impact Architecture Proceedings of the Annual Meeting of the Decision Sciences Institute, 1998, 46-48
383. Ozog, H., Risk Management in Medical Device Design. Medical Device & Diagnostic Industry 19 (1997): 112-115
384. Palmer, P., Mason, L., Dunn, M., A Case Study in Healthcare Quality Management: A Practical Methodology for Auditing Total Patient X-ray Dose During a Diagnostic Procedure.Proceedings of the 7th Biennial Conference on Engineering Systems Design and Analysis, 2004, 469-474.
385. Passey, R. D., Foresight Begins with FMEA. Delivering Accurate Risk Assessments. Medical Device Technology 10 (1999): 88-92.
386. Pelnik, T. M., Suddarth, G. J., Implementing Training Programs for Software Quality Assur-ance Engineers. Medical Device & Diagnostic Industry 20 (1998): 75-85.
387. Perper, J. A., Life-Threatening and Fatal Therapeutic Misadvantages. In Human Error in Medicine, edited by M.S. Bogner, 27-52. Hillsdale, NJ: Lawrence Erlbaum Associates, 1994
388. Persson, J., Ekberg, K., Linden, M., Work Organization, Work Environment and the Use of Medical Equipment: A Survey Study of the Impact on Quality and Safety. Medical & Biological Engineering & Computing 31 (1993): 20-24.
389. Peters, M., Implementation of Rules Based Computerized Bedside Prescribing and Adminis-tration: Intervention Study. British Medical Journal 320 (2000): 750-753.
390. Peterson, M G E., The Probability of Failure Depends on Who is Asking Proceedings of the 8th IEEE Symposium on Computer Based-Medical Systems, 1995, 51-56
391. Phillips, D. P., Christenfeld, N., Glynn, L. M., Increase in US Medication-Error Deaths Between 1983-1993 Lancet 1351 (1998): 1024-1029
392. Pickett, R. M., Triggs, T. J., Human Factors in Health Care. Lexington, MA: Lexington Books, 1975
393. Plamer, B., Managing Software Risk. Medical Device & Diagnostic Industry 19 (1997): 36-40
394. Posner, K. L., Freund, P. R., Trends in Quality of Anesthesia Care Associated with Changing Staffing Patterns. Productivity and Concurrency of Case Supervision in a Teaching Hospital Anesthesiology 91 (1999): 839-847
395. Preboth, M., Medication Errors in Pediatric Patients American Family Physician 63 (2001): 678
396. Pretzer, M., Congress Backs Away from Mandatory Reporting of Medical Errors Medical Economics 77 (2000): 25-26
397. Purday, J P., Monitoring During Paediatric Cardiac Anaesthesia Canadian Journal of Anaesthesia 41 (1994): 818-844
398. Purday, J. P., Towey, R. M., Apparent Pacemaker Failure Caused by Activation of Ventricular Threshold Test by a Magnetic Instrument Mat During General Anaesthesia British Journal of Anaesthesia 69 (1992): 645-646
399. Ransom, S B, Joshi M, Nash, D., The Healthcare Quality Book: Vision, Strategy, and Tools Chicago, IL: Health Administration Press, 2005
400. Rao, S N., Errors in the Treatment of Tuberculosis in Baltimore Journal of the American Medical Association 283 (2000): 2502
401. Rappaport, M., Human Factors Applications in Medicine Human Factors 12 (1970): 25-35
402. Rascona, D., Gubler, K. D., Kobus, D. A., Amundson, D., Moses, J. D., A Computerized Medical Incident Reporting System for Errors in the Intensive Care Unit: Initial Evaluation of Interrater Agreement Military Medicine 166 (2001): 350-353
403. Rasmussen, J., Human Error and the Problem of Causality in Analysis of Accidents Philosophical Transactions of the Royal Society of London-Series B: Biological Sciences 327 (1990): 449-460
404. Rastogi, A. K., High-Quality Care at Low Cost. Medical Device & Diagnostic Industry 19 (1997): 28-32
405. Rau, G, Tripsel, S., Ergonomic Design Aspects in Interaction Between Man and Technical Systems in Medicine Medical Progress Through Technology 9 (1982): 153-159
406. Ray, P., Weerakkody, G., Quality of Service Management in Healthcare Organizations: A Case Study. Proceedings of the IEEE Symposium on Computer-Based Medical Systems, 1999, 80-85.
407. Redig, G., Swanson, M., Total Quality Management for Software Development. Proceedings of the 6th Annual IEEE Symposium on Computer-Based Medical Systems, 1993, 301-306.
408. Reed, L., Blegen, M. A., Goode, C.S., Adverse Patient Occurrences as a Measure of Nursing Care Quality. Journal of Nursing Administration 28 (1998): 62-69.
409. Reeter, A. K., The Role of Training in Human Factors. Proceedings of the First Symposium on Human Factors in Medical Devices, 1989, 30-31.
410. Reid, R. D., Christensen, M. M., Quality Healthcare-A Path Forward. Proceedings of the ASQJs 55th Annual Quality Congress, 2001, 57-63.
411. Rendell-Baker, L., Some Gas Machine Hazards and Their Elimination. Anesthesia Analgesia 88 (1977): 26-33.
412. Reupke, W. A., Srinivasan, R., Rigterink, P.V., Card, D. N., The Need for a Rigorous Development and Testing Methodology for Medical Software Proceedings of the Symposium on the Engineering of Computer-Based Medical Systems, 1988, 15-20
413. Revere, L., Black, K., Huq, A., Integrating Six Sigma and CQI for Improving Patient Care. TQM Magazine 16 (2004): 105-113.
414. Ribiere, V., La Salle, A. J., Khorramshahgol, R., Hospital Information Systems Quality: A Customer Satisfaction Assessment Tool Proceedings of the 32nd Annual Hawaii Inter-national Conference on System Sciences, 1999, 140.
415. Richard, C, Woods, C., Operating at the Sharp Ends: The Complexity of Human Error In Human Error in Medicine, edited by M S Bogner, 255-310 Hillsdale, NJ: Lawrence Erlbaum Associates, 1994
416. Richard, J., Identifying Ways to Reduce Surgical Errors. Journal of the American Medical Association 275 (1996): 35
417. Richards, C. F., Cannon, C. P., Reducing Medication Errors: Potential Benefits of Bolus Throm-bolytic Agents Academic Emergency Medicine 7 (2000): 1285-1289
418. Richards, P, Kennedy, I M, Woolf, L., Managing Medical Mishaps British Medical Journal 313 (1996): 243-244
419. Ridgway, M., Analyzing Planned Maintenance (PM) Inspection Data by Failure Mode and Effect Analysis Methodology Biomedical Instrumentation and Technology 37 (2003): 167-169
420. Riley, W. J., Densford, J.W., Processes, Techniques, and Tools: The "How" of a Successful Design Control System Medical Device & Diagnostic Industry 19 (1997): 75-80
421. Ritchie, J., Doctors Make Mistakes that Are Less Obvious than Lawyers5 Mistakes. British Medical Journal 310 (1995): 1671-1672.
422. Robert, DW., Robert, B. H., Preventable Deaths: Who, How Often, and Why? Annals of Inter- nal Medicine 109 (1998): 582-589
423. Rocha, L S, Bassani, J W M., Cost Management of Medical Equipment Maintenance Proceedings of the IEEE Annual International Conference on Engineering in Medicine and Biology, 2004, 3508-3511
424. Rogers, A. S., Isreal, E., Smith, C.R., A Physician5s Knowledge, Attitudes, and Behaviour Related to Reporting Adverse Drug Events Archives of Internal Medicine 148 (1988): 1596-1600
425. Rollins, G., Study First to Analyze Multiple Surveillance Methods for Medical Device Errors Report on Medical Guidelines and Outcomes Research 15 (2004): 9-12
426. Rooks, J., Zedick, J. L., The Baldrige Criteria: Managing for Quality in Healthcare. Proceedings of the 56th Annual Quality Congress, 2002, 549-550
427. Rooney, J J., Seven Steps to Improve Safety for Medical Devices, Quality Progress 34 (2001): 33-41
428. Rose, H.B., A Small Instrument Manufacturer, s Experience with Medical Instrument Reliability. Proceedings of the Annual Reliability and Maintainability Symposium, 1972, 251-254.
429. Rosenthal, M. M., Lloyd, S. B., eds. Medical Mishaps: Pieces ofthe Puzzle. London: Open University Press 1999
430. Rosenthal, M. M., Lloyd, S. B., eds. Medical Mishaps: Pieces ofthe Puzzle. London: Open University Press, 1999.
431. Rubin, S. B., Zoloth, L., Margin of Error: The Ethics of Mistakes in the Practice of Medicine. New England Journal o;f Medicine 344 (2001): 374-376.
432. Rudov, M. H., Professional Standards Review in Health Systems. In Human Factors in Health Care, edited by R.M. Pickett, T. J. Triggs, 7-47. Lexington, MA: Lexington Books, 1977.
433. Runciman, W. B., Helps, S. C., Sexton, E. J., Malpass, A. A Classification for Incidents and Accidents in the Health-Care System. Journal of Quality and Clinical Practice 18/3 (1998): 199-212.
434. Runciman, W. B., Webb, R. K., Lee, R., System Failure: An Analysis of 2000 Incidents Reports. Anaesthesia and Intensive Care 21 (1993): 684-695.
435. Russell, C., Human Error: Avoidable Mistakes Kill 100, 000 a Year, Washington Post, February 18, 1992, WH7
436. Sahni, A., Seven Basic Tools that Can Improve Quality, Medical Device & Diagnostic Industry 20 (1998): 89-96
437. Santel, C, Trautmann, C, Liu, W., The Integration of a Formal Safety Analysis into the Software Engineering Process: An Example from the Pacemaker Industry Proceedings of the Symposium on the Engineering of Computer Based-Medical Systems, 1988, 152-154 Sayre, K, Kenner, J, Jones, P L Safety Models: An Analytical Tool for Risk Analysis of Medical Device Systems. Proceedings of the IEEE Symposium on Computer-Based Medical Systems, 2001, 445-454
438. Scheffler, A. L., Zipperer, L., Patient Safety. Proceeding of the Symposium on Enhancing Patient Safety and Reducing Errors in Health Care, Rancho Mirage, CA, November 1998, 115-120.
439. Schneider, P, Hines, M L., A Classification of Medical Device Software Proceedings of the Symposium on Applied Computing, 1990, 20-27.
440. Schreiber, P., Human Factors Issues with Anesthesia Devices Proceedings of the First Symposium on Human Factors in Medical Devices, 1989, 32-36.
441. Schwartz, A. P., A Call for Real Added Value. Medical Industry Executive February/March (1994): 5-9
442. Schwartz, R J, Weiss, K M, Buchanan, A V., Error Control in Medical Data MD Computing 2 (1985): 19-25
443. Scott, D., Preventing Medical Mistakes RN Magazine 63 (2000): 60-64
444. Senders, J W Medical Devices, Medical Errors, and Medical Accidents In Human Error in Medicine, edited by M S Bogner, 159-177 Hillsdale, NJ: Lawrence Erlbaum Associates, 1994.
445. Serig, D. I., Radiopharmaceutical Misadministrations: What5s Wrong. In Human Error in Medicine, edited by M S Bogner, 179-195 Hillsdale, NJ: Lawrence Erlbaum Associates, 1994.
446. Sexton, J B, Thomas, E J, Helmreich, R L., Error, Stress, and Teamwork in Medicine and Aviation: Cross Sectional Surveys British Medical Journal 320 (2000): 745-749.
447. Shanghnessy, A F, Nickel, R O., Prescription-Writing Patterns and Errors in a Family Medicine Residency Program Journal of Family Practice 29 (1989): 290-296.
448. Shaw, R., Safety-Critical Software and Current Standards Initiatives Computer Methods and Programs in Biomedicine 44 (1994): 5-22
449. Shea, C. E., Battles, J. B., A System of Analyzing Medical Errors to Improve GME Curricula and Programs, Academic Medicine 76 (2001): 125-133.
450. Shelton, N., To Err Is Human Skeptical Inquirer 20 (1996): 21-22
451. Shepherd, M A., Systems Approach to Medical Device Safety Monograph, Association for the Advancement of Medical Instrumentation, Arlington, Virginia, 1983
452. Shepherd, M., Brown, R., Utilizing a Systems Approach to Categorize Device-Related Failures and Define User and Operator Errors. Bio-medical Instrumentation and Technology November/December (1992): 461-475.
453. Shepherd, M., Painter, F. R., Dyro, J. F., Baretich, M. F., Identification of Human Errors During Device-Related Accident Investigations. IEEE Engineering in Medicine and Biology 23 (2004): 66-72.
454. Shephard, M. D., Shepherd's System for Medical Device Incident Investigation. Brea, CA: Quest Publishing Company, 1992.
455. Sheridan, T. B., Thompson J.M., People Versus Computers in Medicine. In Human Error in Medicine, edited by M.S. Bogner, 141-159. Hillsdale, NJ: Lawrence Erlbaum Associ-ates, 1994.
456. Shinn, J. A., Root Cause Analysis: A Method of Addressing Errors and Patient Risk. Progress in Cardiovascular Nursing 15 (2000): 25-25
457. Short, T. G., Regan, A., Oh, T. E., Critical Incident Reporting in an Anaesthetic Department Assurance Programme Anaesthesia 47 (1992): 3-7.
458. Simonaitis, D. F., Anderson, R.T., Kaye, M. P., Reliability Evaluation of a Heart Assist System Proceedings of the Annual Reliability and Maintainability Symposium, 1972, 233-241
459. Smirnov, I. P., Shneps, M. A., Medical System Engineering. Proceedings of the IEEE 57 11 (1969): 1869-1879.
460. Smith, C. E., Peel, D., Safety Aspects of the Use of Microprocessors in Medical Equipment. Measurement and Control 21 (1988): 275-276.
461. Smith, J., Study into Medical Errors Planned for the UK British Medical Journal 319 (1999): 1091-1092
462. Smith, L.S., Documenting Known or Suspected Medical Failure. Nursing 34 (2004): 28-29.
463. Sommer, T J Telemedicine: A Useful and Necessary Tool to Improving Quality of Healthcare in the European Union Computer Methods and Programs in Biomedicine 48 (1995): 73-77
464. Souhrada, L., Human Error Limits MRIJs Quality Potential. Hospitals 63 (1989): 38.
465. Souhrada, L., Man Meets Machine: Buying Right Can Reduce Human Error Materials Management in Health Care 4 (1995): 20-22.
466. Spath, P L., Medical Errors: Root Cause Analysis OR Manager 14 (1998): 40-41.
467. Spencer, F.C., Human Error in Hospitals and Industrial Accidents: Current Concepts. Journal of the American College of Surgeons 191 (2000): 410-418.
468. Spice, C., Misdiagnosis of Ventricular Tachycardia Lancet 354 (1999): 2165-2169.
469. Spicer, J., How to Measure Patient Satisfaction Quality Progress 35 (2002): 97-98.
470. Staender, S., Davies, J., Helmreich, B., Sexton, B., Kaufmann, M., The Anaesthesia Critical Incident Reporting System: An Experience Based Database. International Journal of Medical Informatics 47 (1997): 87-90
471. Stahlhut, R.W., To Err Is Human: Human Error in Medicine Is Common, Inevitable and Man-ageable Medical Device & Diagnostic Industry 19 (1997): 13-14.
472. Stahlhut, R.W., Gosbee, J.W., Gardner-Bonneau, D. J., A Human-Centered Approach to Medi-cal Informatics for Medical Students, Residents, and Practicing Clinicians Academic Medicine 72 (1997): 881-887
473. Stanley, P E., Monitors that Save Lives Can Also Kill Modern Hospital 108 (1967): 119-121
474. Stanton, N A, Stevenage, S V Learning to Predict Human Error: Issues of Acceptability, Reliability and Validity Ergonomics 41 (1998): 1737-1756.
475. Stein, P E., Reliability and Performance Criteria for Electromedical Apparatus Proceedings of the Annual Reliability and Maintainability Symposium, 1973, 89.
476. Steindel, B., Quality Control in the Practice of Medicine Proceedings of the 11th Annual West Coast Reliability Symposium, 1970, 197-202
477. Steward, S., Making Device Software Truly Trustworthy. Medical Device & Diagnostic Industry 20 (1998):86-89.
478. Stoecklein, M., ASQJs Role in Healthcare. Quality Progress 36 (2003): 90-91.
479. Swartz, E.M., Product Liability, Manufacturer Responsibility for Defective or Negligently Designed Medical and Surgical Instruments. De Paul Law Review 18 (1969): 348-407.
480. Tarcinale, M., A Patient Classification: Cutting the Margin of Human Error. Nursing Man-agement 17 (1986): 49-51.
481. Taxis, K., Barber, N., Ethnographic Study of Incidence and Severity of Intravenous Drug Errors. British Medical Journal 326 (2003): 684-687.
482. Taylor, E. F., Reliability, Risk and Reason in Medical Equipment. Proceedings of the 5th Annual Meeting of the Association for the Advancement of Medical Instrumentation, March 23, 1970, 1-5
483. Taylor, E F., The Effect of Medical Test Instrument Reliability on Patient Risks Proceedings of the Annual Symposium on Reliability, 1969, 328-330
484. Taylor, E F., The Impact of FDA Regulations on Medical Devices Proceedings of the Annual Reliability and Maintainability Symposium, 1980, 8-10
485. Taylor, E F., The Reliability Engineer in the Health Care System Proceedings of the Reliability and Maintainability Symposium, 1972, 245-248
486. Taylor, G., What Is Minimal Monitoring, Essential Non-invasive Monitoring. In Anaesthesia, edited by Gravenstein, J.S., Newbower, R. S., Ream, A. K., Smith, N.T., Barden, J., 263-267. New York: Grune & Stratton Publishers, 1980.
487. Tecca, M. B., Weitzner, W. M., Measuring Performance in Home Health from Internal and External Vantage Points. Proceedings of the 9th Annual Quest for Quality and Produc-tivity in Health Services, 1997, 27-38.
488. Thibeault, A., Documenting a Failure Investigation. Medical Device & Diagnostic Industry 19 (1997): 14-15.
489. Thibeault, A., Handling Reports of Product Use in Incidents Causing Injury or Death. Medical Device & Diagnostic Industry 20 (1998): 91-96.
490. Thierry, G, Dhainaut, J F, Joseph, T, Journois, D., Iatrogenic Complications in Adult Intensive Care Units: A Prospective Two-Center Study Critical Care Medicine 21 (1993): 40-52
491. Thomas, E J, Sherwood, G D, Adams-McNeill, J., Identifying and Addressing Medical Errors in Pain Mismanagement Joint Commission Journal on Quality Improvement 27 (2001): 191-199
492. Thomas, E. J., Studdert, D. M., Runciman, W. B., Webb, R. K., Sexton, E. J., Wilson, R. M., et al., A Comparison of Iatrogenic Injury Studies in Australia and the USA I: Context, Methods, Casemix, Population, Patient and Hospital Characteristics International Journal for Quality in Health Care 12 (2000): 371-378
493. Thompson, C N W., Model of Human Performance Reliability in Health Care System Proceedings of the Annual Reliability and Maintainability Symposium, 1974, 335-339
494. Thompson, P W., Safer Design of Anaesthesia Equipment British Journal of Anaesthesiology 59 (1987): 913-921
495. Thompson, R.C., Fault Therapy Machines Cause Radiation Overdoses. FDA Consumer 21 (1987): 37-38
496. Truby, C., Quality and Productivity: Then and Now. Medical Device & Diagnostic Industry 21 (1999): 104-108
497. Turk, A R, Poulakos, E M., Practical Approaches for Healthcare: Indoor Air Quality Management, Energy Engineering Journal of the Association of Energy Engineering 93 (1996): 12-79
498. Turley, J. P., Johnson, T. R., Smith, D. P., Zhang, J., Brixey, J.J., Operating Manual-Based Usability Evaluation of Medical Devices: An Effective Patient Safety Screening Method. Joint Commission Journal on Quality and Patient Safety 32 (2006): 214-220.
499. Van Cott, H., Human Errors: Their Causes and Reduction. In Human Error in Medicine, edited by M.S. Bogner, 53-91. Hillsdale, NJ: Lawrence Erlbaum Associates, 1994.
500. Van Grunsven, P. R., Criminal Prosecution of Health Care Providers for Clinical Mistakes and Fatal Errors: Is Bad Medicine a Crime? Journal of Health and Hospital Law 29 (1996): 107.
501. Varricchio, F., Another Type of Medication Error. Southern Medical Journal 93 (2000): 834.
502. Vincent, C., Neale, G., Woloshynowych, M., Adverse Events in British Hospitals: Preliminary Retrospective Record Review. British Medical Journal 322 (2001): 517-519.
503. Vincent, C., Taylor, S., Chapman J.E., How to Investigate and Analyze Clinical Incidents: Clinical Risk Unit and Association of Litigation and Risk Management Protocol British Medical Journal 320 (2000): 777-778
504. Vroman, G, Cohen, I, Volkman, N., Misinterpreting Cognitive Decline in the Elderly: Blaming the Patient In Human Error in Medicine, edited by M S Bogner, 93-122 Hillsdale, NJ: Lawrence Erlbaum Associates, 1994
505. Wadsworth, H. M., Standards for Tools and Techniques. Transactions ofthe ASQC Annual Conference (1994): 882-887
506. Walfish, S., Using Statistical Analysis in Device Testing. Medical Device & Diagnostic Industry 19 (1997): 36-42
507. Wallace, D. R., Kuhn, R. D., Lessons from 342 Medical Device Failures. In Information Technology Laboratory Gaithersburg, MD: National Institute of Standards and Tech-nology, 2000, 25-31
508. Walters, D., Jones, P., Value and Value Chains in Healthcare: A Quality Management Perspective.TQM Magazine 13 (2001): 319-333.
509. Wang, B, Eliason, R W, Vanderzee, S C., Global Failure Rate: A Promising Medical Equipment Management Outcome Benchmark Journal of Clinical Engineering 31 (2006): 145-151
510. Ward, J R, Clarkson, P J., An Analysis of Medical Device-Related Errors: Prevalence and Possible Solutions Journal of Medical Engineering and Technology 28 (2004): 2-21
511. Waynant, R W., Quantitative Risk Analysis of Medical Devices: An Endoscopic Imaging Example Proceedings of the International Society for Optical Engineering Conference, 1995, 237-245
512. Wear, J O., Maintenance of Medical Equipment in the Veterans Administration Proceedings of the Third Annual Meeting of the Association for the Advancement of Medical Instrumentation, July 1968, 10-14
513. Wear, J O., Technology and the Future of Medical Equipment Maintenance Health Estate 53 (1999): 12-19
514. Wears, R. L., Janiak, B., Moorhead, J. C., Kellermann, A. L., Yeh, C.S., Rice, M. M., et al., Human Error in Medicine: Promise and Pitfalls, Part 1 Annals of Emergency Medicine 36 (2000): 58-60
515. Wears, R L, Janiak, B, Moorhead, J C, Kellermann, A L, Yeh, C S, Rice, M M, et al., Human Error in Medicine: Promise and Pitfalls, Part 2 Annals of Emergency Medicine 36 (2000): 142-144
516. Wears, R L, Leape L L., Human Error in Emergency Medicine Annals of Emergency Medicine 34 (1999): 370-372
517. Webb, R K, Russell, W J, Klepper, I., Equipment Failure: An Analysis of 2000 Incidents Report Anaesthesia and Intensive Care 21 (1993): 673-677
518. Webster, S A., Technology Helps Reduce Mistakes on Medications Detroit News, February 6, 2000, A2
519. Weese, D. L., Buffaloe, V. A., Conducting Process Validations with Confidence. Medical Dev/ce&D/agnost/c/ndustry20 (1998):107-112.
520. Weide, P., Improving Medical Device Safety with Automated Software Testing. Medical Device & Diagnostic Industry 16 (1994): 66-79.
521. Weilgart, S. N., Ship, A. N., Aronson, M. D., Confidential Clinican-Reported Surveillance of Adverse Events Among Medical Inpatients. Journal ofGeneral Internal Medicine 15 (2000): 470-477.
522. Weinberg, D. I., Artley, J. A., Whalen, R. E., McIntosh, M.T., Electrical Shock Hazards in Cardiac Catheterization. Circulation Research 11 (1962): 1004-1011.
523. Weingart, S. N., Wilkson, R.S., Gibberd, R.W., Epidemiology of Medical Error. British Medi-cal Journal 320 (2000): 774-776.
524. Weinger, M. B., Anesthesia Equipment and Human Error. Journal ofClinical Monitoring & Computing 15 (1999): 319-323.
525. Weinger, M.B., Englund, C. E., Ergonomic and Human Factors Affecting Anesthetic Vigilance and Monitoring Performance in the Operating Room Environment. Anesthesiology 73 (1990): 995-1021
526. Welch, D L., Human Error and Human Factors Engineering in Health Care Biomedical Instrumentation & Technology 31 (1997): 627-631.
527. Welch, D L., Human Factors Analysis and Design Support in Medical Device Development Biomedical Instrumentation & Technology 32 (1998): 77-82.
528. Welch, D. L., Human Factors in the Health Care Facility. Biomedical Instrumentation &Tech- nology 32 (1998): 311-316.
529. Whalen, R E, Starmer, C F, McIntosh, H D., Electrical Hazards Associated with Cardiac Pacemaking. Transactions of the New York Academy of Sciences 111 (1964): 922-931.
530. Widman, L E, Tong, D A., EINTHOVEN and Tolerance for Human Error: Design Issues in Decision Support System for Cardiac Arrhythmia Interpretation. Proceedings of the AMIA Annual Fall Symposium, 1986, 224-228
531. Wiklund, M E., Human Error Signals Opportunity for Design Improvement Medical Device & Diagnostic Industry 14 (1992): 57-61.
532. Wiklund, M E., Medical Device and Equipment Design Buffalo Grove, IL: Interpharm Press, 1995
533. Wiklund, M. E., Making Medical Device Interfaces More User Friendly. Medical Device & Diagnostic Industry 20 (1998): 177-183
534. Wiklund, M E, Weinger, M B, Pantiskas, C, Carstensen, P., Incorporating Human Factors into the Design of Medical Devices Journal of the American Medical Association 280 (1998): 1484.
535. Wilkins, R. D., Holley, L. K., Risk Management in Medical Equipment Management. Proceed-ings of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 1998, 3343-3345
536. Williamson, J A, Webb, R K, Sellen, A., Human Failure: An Analysis of 2000 Incidents Reports Anaesthsia and Intensive Care 21 (1993): 678-683
537. Willis, G., Failure modes and effects analysis in clinical engineering Journal of Clinical Engineering 17 (1992): 59-63
538. Wilson, C J., ME: A Survey of Anesthetic Misadventures Anaesthesia 36 (1981): 933-936
539. Winger, J, Bray, T, Halter, P., Lower Health Costs from High Reliability Proceedings of the Annual Reliability and Maintainability Symposium, 1979, 203-210
540. Winterberg, L., Quality Improvement in Healthcare. Proceedings of the ASQ5s 55th Annual Quality Congress, 2001, 352-353.
541. Wood, B. J., Software Risk Management for Medical Devices. Medical Device & Diagnostic Industry 21 (1999): 139-145
542. Wood, B J, Ermes, J W., Applying Hazard Analysis to Medical Devices, Part II Medical Device & Diagnostic Industry 15 (1993): 58-64.
543. Wright, D., Critical Incident Reporting in an Intensive Care Unit: 10 Years5 Experience, Intensive Therapy Unit. Report, Western General Hospital, Edinburgh, Scotland, 1999.
544. Wu, A.W., Handling Hospital Errors: Is Disclosure the Best Defence? Annals of Internal Med-icine 131 (1999): 970-972.
545. Wu, A.W., Medical Error: The Second Victim. British Medical Journal 320 (2000): 726-727.
546. Wu, A.W., Folkman, S., Mc Phee, S. J., How House Officers Cope with Their Mistakes. West-ern Journal ofMedicine 159 (1993): 565-569.
547. Yi, G., Johnson, T. R., Patel, Y. L., Research on Basic Element for Medical Equipment Main-tenance Satisfaction Under Requirement Theory. Journal of Services Operations and Informatics 1 (2002): 165-173.
548. Zane, M., Patient Care Appraisal. Proceedings of the Annual Reliability and Maintainability Symposium, 1976, 84-91.
549. Zhang, J., Xing-San, Q., Wei, D., Using Usability Heuristics to Evaluate Patient Safety of Medical Devices Journal of Biomedical Informatics 36 (2003): 23-30
550. Zimmerman, J. E., Knaus, W. A., Wagner, D. P., Draper, E. A., Lawrence, D.E., The Range of Intensive Care Services Today Journal of the American Medical Association 246 (1981): 2711-2716
551. Zimmerman, J E, Shortell, S M, Rousseau, D M, Duffy, J, Gillies, R R., Improving Intensive Care: Observations Based on Organizational Case Studies in Nine Intensive Care Units: A Prospective Multicenter Study Critical Care Medicine 21 (1983): 1443-1451