基于改进FMEA的医疗器械人因可靠性评估与应用

针对失效模式与影响分析(FMEA)在医疗器械人因可靠性评估中存在的两个缺陷——风险因素的评价与权重分配问题，本文提出了一种结构化的医疗器械人因可靠性评估方法.本方法在改进的模糊集理论与有序加权几何平均(OWGA)算子基础上，引入情境参数优化了风险失误模式排序.通过将提出方法应用于实际医疗场景，验证了提出方法的有效性与可行性，并通过与传统FMEA的比较证明了本方法的优越性.所提方法解决了传统RPN数值重复问题与权重分配问题，降低了评价误差，有助于找到关键的失效模式，减少医疗不良事件的发生.

Human Factor Reliability Evaluation and Application of Medical Devices Based on Improved FMEA

In view of two significant deficiencies of failure mode and effect analysis (FMEA) in the human factors reliability evaluation for medical devices—evaluation of risk factors and weight assignment， a structured human factor reliability evaluation method for medical devices is proposed. Based on the improved fuzzy set theory and ordered weighted geometric average (OWGA) operator， context parameters are introduced to optimize the ranking of risk and error modes. By applying the proposed method to actual medical scenarios， the effectiveness and feasibility of method are verified， and the superiority of the proposed method is proved by comparison with the traditional FMEA. The proposed method solves the problem of traditional RPN value duplication and weight assignment， reduces the evaluation error， helps to find the key failure mode， and reduces the occurrence of medical adverse events.