医疗器械不良事件发生原因与分析方法

中国药物警戒 ›› 2010, Vol. 7 ›› Issue (1): 7-11.

医疗器械不良事件发生原因与分析方法

蒋冬贵¹, 王刚², 努尔江·沙布开³, 李雷⁴

1湖南省药品审评认证与不良反应监测中心,湖南长沙 410013;
2国家药品不良反应监测中心,北京 100045;
3新疆维吾尔自治区药品不良反应监测中心,新疆乌鲁木齐 830002;
4吉林省食品药品评价中心,吉林长春 130062

收稿日期:2016-02-18 修回日期:2016-02-18 出版日期:2010-01-08 发布日期:2016-02-18
作者简介:蒋冬贵,男,医学博士,药品审评认证与不良反应监测。

The Cause and Analysis Method of Suspected Medical Device Adverse Events

JIANG Dong-gui¹, WANG Gang², NUERJIANG·shabukai³, LI Lei⁴

1Hunan Center for Drug Reevaluation and ADR Monitoring, Hunan Changsha 410013, China;
2National Adverse Drug Reaction Monitoring Center, Beijing 100045, China;
3Adverse Drug Reaction Monitoring Center of Xinjiang Uygur Autonomous Region, Xinjiang Urumcqi 830002, China;
4Jilin Center for Food and Drug Reevaluation, Jilin Changchun 130062, China

Received:2016-02-18 Revised:2016-02-18 Online:2010-01-08 Published:2016-02-18

摘要/Abstract

摘要： 借鉴国际上在人因和人机工程学方面的研究结果,通过对可疑医疗器械不良事件引起的损害的理论分类以及目前绝大部分引起可疑医疗器械不良事件发生原因的归纳和总结,全面比较目前普遍使用安全事件的分析方法在可疑医疗器械不良事件原因分析中的可行性,认为仿照故障树的从因到果的分析方法是一个相对可靠和普遍适用的可疑医疗器械不良事件发生原因的分析方法。

关键词: 可疑医疗器械不良事件, 损害, 发生原因, 分析方法, 故障树

Abstract: To draw on the human-computer engineering research Results, sum up and conclude the theoretic classification of damage and the current vast majority causes of suspected medical device adverse incidents, compare the current widespread using of security incidents analysis Methods in the feasibility analysis, we found the analysis modeled from the fault tree is relatively reliable and generally applicable to cause analysis of suspi-cious incident.

Key words: suspected medical device adverse event, damage, cause analysis, method, fault tree

中图分类号:

蒋冬贵, 王刚, 努尔江·沙布开, 李雷. 医疗器械不良事件发生原因与分析方法[J]. 中国药物警戒, 2010, 7(1): 7-11.

JIANG Dong-gui, WANG Gang, NUERJIANG·shabukai, LI Lei. The Cause and Analysis Method of Suspected Medical Device Adverse Events[J]. Chinese Journal of Pharmacovigilance, 2010, 7(1): 7-11.

参考文献

[1] 国家食品药品监督管理局,中华人民共和国卫生部.关于印发医疗器械不良事件监测和再评价管理办法（试行）的通知[EB/OL].2008-12-29[2009-10-26].http://www.sda.gov.cn/WS01/CL0059/34994.html.
[2] Ronald D Kaye, Robert A North, M Kathryn Peterson.UPCARE: An Analysis, Description, and Educational Tool for Medical Device Use Problems[R/OL].[2009-10-28]. http:// virtual2.pcisys.net/h/humancenteredstrategies.com/UPCARE_ paper.pdf.
[3] Center for Devices and Radiological Health .Ensuring the Safety of Marketed Medical Devices CDRH's Medical Device Postmarket Safety Program[EB/OL].2006-01-18[2009-10-28]. http://www.fda.gov/ohrms/dockets/dockets/06n0292/06n-0292-bkg0001-08-Tab-07-vol2.pdf.
[4] Card, S K, Moran, T P, and Newell, A. The Psychology of Human-Computer Interaction[M]. Lawrence Erlbaum Associates, Hi-llsdale, NJ. 1983.
[5] Center for Devices and Radiological Health. Medical Device Use-Safety:Incorporating Human Factors Engineering into Risk Management[EB/OL].2000-01-18[2009-10-28]. http://www.fdagov/downloads/MedicalDevices/DeviceRegulationandGuid-ance/GuidanceDocuments/ucm094461.pdf.
[6] 付心钊.人体便携式自动输液器的可靠性及安全性研究[D].哈尔滨: 哈尔滨工业大学,2007.
[7] Elzer, P.(Peter),Kluwe, Rainer H, et al. Human error and system design and management[G]. Springer-Verlag London Limited,Great Britain. 2000.
[8] J.Patrick, A. Gregov, P. Halliday. Analysing and training task analysis[J]. InstructionalScience, 2000,28: 51-79.
[9] Green, R. The Psychology of Human Error[J].Eur J Anaesthesiol,1999,16(3): 148-155.
[10] Barach, P. The End of the Beginning: Lessons Learned from the Patient Safety Movement[J]. J Leg Med, 2003, 24(1): 7-27.
[11] Gawron V. J, C. G. Drury, Rollin J.Fairbanks, et al. Medical Error and Human Factors Engineering: Where Are We Now? [J]. Am J Med Qual,2006, 21(1):57-67.
[12] Reason, J. Understanding Adverse Events: Human Factors[J].Qual Health Care, 1995, 4(2):80-89.
[13] Reason, J. Human Error:Models and Management[J].BMJ,2000, 320(7237): 768-770.
[14] Vincent, C. Understanding and Responding to Adverse Events[J].N Engl J Med,2003, 348(11): 1051-106.
[15] C.D.威肯斯,J.D.李,刘乙力,等著; 张侃等译.人因工程学导论[M]. 2版.上海:华东师范大学出版社与Pearson Education合作出版,2007.
[16] 郭伏,钱省三.人因工程学[M].北京:机械工业出版社,2006.
[17] GJTF. GHTF Study Group 2 Post-Market Surveillance Status Report:Global Guidance for Adverse Event Reporting for Medical Devices[R/OL]. 2007-10[2009-10-28]. http://www.ghtf.org/meetings/conferences/11thconference/plenary/05-GARCIASG2.pdf.
[18] International Organization for Standardization. ISO/14971:2007,Medical Devices Application of Risk Management to Medical Devices[S/OL].[2009-10-28]. http://www.iso.org/iso/catalogue_detail.htm?csnumber=38193.
[19] International Organization for Standardization. ISO/13485:2003,Medical Devices Quality Management Systems Requirements for Regulatory Purposes[S/OL].[2009-10-28]. http://www.iso.org/iso/catalogue_detail?csnumber=36786.
[20] 中国国家技术监督局.GB/7829-1987故障树分析程序[S].北京:中国标准出版社,1987.
[21] 杨进,俞浩荣. 基于模糊故障树的医疗器械设备可靠性分析[J]. 江苏技术师范学院学报,2007,(6):10-13.
[22] 郑仲金, 吕凤明. 船用空压机典型故障的事故树分析[J].中国修船,2008,(4):27-29.
[23] Kirwan, B. and Ainsworth, L.K.(1992).A Guide to Task Analysis[M]. Taylor & Francis Ltd, London, United Kingdom.
[24] 贾国良,葛毅. 医疗设备系统性故障的认知和处理[J]. 医疗设备信息, 2005,(8):61-62.
[25] 孟杰雄,王燕,刘志成. 医疗器械风险分析方法的介绍与应用展望[J].标准检测, 2006, （1）：49-54.