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Volumn , Issue , 2016, Pages 475-505

Human Factors Risk Management for Medical Products

Author keywords

[No Author keywords available]

Indexed keywords


EID: 85043456641     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/b11219-36     Document Type: Chapter
Times cited : (2)

References (25)
  • 1
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    • Automated external defibrillator use by untrained bystanders: Can the public-use model work?
    • July/September
    • Andre, A.D., Jorgenson, D.B., Froman, J.A., Snyder, D.E., and Poole, J.E. (2004). Automated external defibrillator use by untrained bystanders: Can the public-use model work? Prehospital Emergency Care, July/September, 8(3), 284-291.
    • (2004) Prehospital Emergency Care , vol.8 , Issue.3 , pp. 284-291
    • Andre, A.D.1    Jorgenson, D.B.2    Froman, J.A.3    Snyder, D.E.4    Poole, J.E.5
  • 5
    • 84856601470 scopus 로고    scopus 로고
    • Carolla (2004). Internet site, www.carolla.com//wp-delph.htm
    • (2004) Internet site
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    • 85136386230 scopus 로고    scopus 로고
    • 21CFR820, Title 21, Prentice Hall: Upper Saddle River, NJ
    • Code of Federal Regulations (CFR) (2004). Quality System Regulations, Medical Devices. 21CFR820, Title 21, Volume 8, Prentice Hall: Upper Saddle River, NJ.
    • (2004) Quality System Regulations, Medical Devices , vol.8
  • 8
    • 0036580468 scopus 로고    scopus 로고
    • Using health care failure mode and effect analysis: The VA national center for patient safety’s prospective risk analysis system
    • DeRosier, J., Stalhandske, E., Bagian, J.P., and Nudell, T. (2002). Using health care failure mode and effect analysis: The VA national center for patient safety’s prospective risk analysis system. The Joint Commission Journal on Quality Improvement, 28, 248-267.
    • (2002) The Joint Commission Journal on Quality Improvement , vol.28 , pp. 248-267
    • DeRosier, J.1    Stalhandske, E.2    Bagian, J.P.3    Nudell, T.4
  • 14
    • 85055920156 scopus 로고    scopus 로고
    • Use-error focused risk analysis for medical devices: A case study of the Therac-25 radiation therapy system
    • Human Factors and Ergonomics Society: San Diego, CA
    • Israelski, E.W. and Muto, W.H. (2003). Use-error focused risk analysis for medical devices: A case study of the Therac-25 radiation therapy system. In Proceedings of the 47th Annual Meeting of the Human Factors and Ergonomics Society 2003, Human Factors and Ergonomics Society: San Diego, CA.
    • (2003) Proceedings of the 47th Annual Meeting of the Human Factors and Ergonomics Society 2003
    • Israelski, E.W.1    Muto, W.H.2
  • 18
    • 0000049893 scopus 로고
    • Human error and human reliability
    • G. Salvendy (Ed.), Wiley: New York
    • Miller, D.P. and Swain, A.D. (1987). Human error and human reliability. In G. Salvendy (Ed.), Handbook of Human Factors, pp. 214-250, Wiley: New York.
    • (1987) Handbook of Human Factors , pp. 214-250
    • Miller, D.P.1    Swain, A.D.2
  • 19
    • 77949322369 scopus 로고    scopus 로고
    • North Carolina Department of Environmental and Natural Resources, Office of Organizational Excellence (2002). Internet site, http://quality.enr.state.nc.us/tools/fishbone.htm
    • (2002) Internet site
  • 20
    • 0004223940 scopus 로고
    • Cambridge University Press: Cambridge, U.K
    • Reason, J. (1990). Human Error, Cambridge University Press: Cambridge, U.K.
    • (1990) Human Error
    • Reason, J.1
  • 22
    • 27844598204 scopus 로고    scopus 로고
    • The use and misuse of FMEA in risk analysis
    • Schmidt, M.W. (2004). The use and misuse of FMEA in risk analysis. Medical Device and Diagnostics Industry, 26(3), 56-61.
    • (2004) Medical Device and Diagnostics Industry , vol.26 , Issue.3 , pp. 56-61
    • Schmidt, M.W.1
  • 23
    • 84856601470 scopus 로고    scopus 로고
    • Skymark (2004). Internet site, www.skymark.com
    • (2004) Internet site


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.