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.%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.
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