基于FMEA的C形臂X线机的使用风险分析与控制

??????? 目的 基于失效模式与效应分析（FMEA）方法分析控制C形臂X线机的使用风险。方法 成立FMEA 5人小组，运用现场观察和访谈的方法，识别C形臂X线机使用的潜在失效模式，并对其发生的严重度、发生概率及检测的难易度进行评价打分，计算失效原因的风险优先指数。结果 FMEA小组找出了必须优先解决的C臂机使用的失效模式，制定并实施了改进措施，在不增加管理成本的基础上，取得了良好的管理效果。结论 FMEA可以评估医疗设备使用过程的失效，并能排序优先解决的问题，不增加管理成本就能预防问题的发生，是有效的过程管理工具。

Risk Analysis and Control of C Arm X-ray Machine Based on the FMEA

??????? Objective Based on FMEA, analysis and control, to use risk of C arm X-ray machine. Methods A 5-member FMEA group was firstly set up. Then on spot observation and interview method was applied to identify the potential failure mode of C arm X-ray machine as well as to evaluate the severity level, occurrence probability of failure and difficulty level of detection. RPN was calculated at last. Results The FMEA group identified the failure mode of C arm machine which is prior to be improved, and then successfully revised and applied the measures. The result turned out to be satisfied without any extra management cost. Conclusion FMEA can be used to evaluate and identify process failure, so as to sort priority of problems. It is proved that FMEA can prevent potential failure without increasing management cost and that makes it efficient management tool.