医疗设备使用风险评估中的FMECA新方法

工业工程 ›› 2012, Vol. 15 ›› Issue (2): 109-114.

医疗设备使用风险评估中的FMECA新方法

同济大学 1.机械工程学院；2.设计与创意学院，上海 201804

出版日期:2012-04-30 发布日期:2012-05-17
作者简介:王竹（1986-），女，河北省人，硕士研究生，主要研究方向为人因工程和安全管理.
基金资助:
同济大学医学院“同济-国药”医院管理研究基金资助项目（TJGY0807）

A New FMECA Method for Risk Analysis of Medical Device Employment

1.Institute of Mechanical Engineering, Tongji University，Shanghai 201804, China；2.College of Design & Innovation, Tongjing University, Shanghai 201804, China

Online:2012-04-30 Published:2012-05-17

摘要/Abstract

摘要： 基于FMECA的风险分析方法可以帮助医疗机构更加有效地评估、控制医疗设备的使用风险。根据医疗设备的使用特点，利用模糊数学与灰色关联理论对方法进行改进,可更为客观地得出各风险模式的模糊评价结果和优先控制顺序。新方法以C臂机的风险分析为实例,说明其改进和应用过程。新方法扩展了FMECA的应用领域，为医疗设备的科学管理提供了依据。

关键词: 医疗设备, 风险分析, 失效模式影响及危害性分析(FMECA)

Abstract: For effective control of risk, risk analysis of medical device employment is addressed by using failure mode effects and criticality analysis (FMECA) in this paper. After the properties of medical device employment is analyzed, based on fuzzy mathematics and grey relational theory, an improved FMECA method for the problem is presented. Compared with the existing FMECA methods, the proposed method has the advantage of having the ability to deal with uncertainty. As an example, the proposed method is used to analyze the operation of a C arm X ray machine. Result shows that it can obtain the risk priority of the failure modes and select its most safe operation policy.

Key words: medical device, risk analysis, failure mode effects and criticality analysis(FMECA)

王竹1，刘胧2，马帅1. 医疗设备使用风险评估中的FMECA新方法[J]. 工业工程, 2012, 15(2): 109-114.

Wang Zhu1, Liu Long2, Ma Shuai1. A New FMECA Method for Risk Analysis of Medical Device Employment[J]. Industrial Engineering Journal , 2012, 15(2): 109-114.

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