基于改进FMEA的医疗器械人因可靠性评估与应用

doi:10.12068/j.issn.1005-3026.2021.09.020

东北大学学报（自然科学版） ›› 2021, Vol. 42 ›› Issue (9): 1360-1368.DOI: 10.12068/j.issn.1005-3026.2021.09.020

• 管理科学 • 上一篇

基于改进FMEA的医疗器械人因可靠性评估与应用

金海哲¹，朱琳¹，李怡¹，傅全威²

(1. 东北大学工商管理学院，辽宁沈阳110169; 2. 东莞康华医院，广州东莞523080)

修回日期:2021-01-25 接受日期:2021-01-25 发布日期:2021-09-16
通讯作者: 金海哲
作者简介:金海哲(1983-)，男，辽宁沈阳人，东北大学副教授.
基金资助:
国家自然科学基金资助项目(71701039); 中央高校基本科研业务费专项资金资助项目(N2106007).

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

JIN Hai-zhe¹， ZHU Lin¹， LI Yi¹， FU Quan-wei²

1. School of Business Administration， Northeastern University， Shenyang 110169， China; 2. Dongguan Kanghua Hospital， Dongguan 523080， China.

Revised:2021-01-25 Accepted:2021-01-25 Published:2021-09-16
Contact: JIN Hai-zhe
About author:-
Supported by:
-

摘要/Abstract

摘要： 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.

关键词: 医疗器械;失效模式与影响分析;人因可靠性;模糊集理论;OWGA算子

Abstract: 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.

Key words: medical device; failure mode and effect analysis(FMEA); human factor reliability; fuzzy set theory; OWGA operator

中图分类号:

C939

金海哲，朱琳，李怡，傅全威. 基于改进FMEA的医疗器械人因可靠性评估与应用[J]. 东北大学学报（自然科学版）, 2021, 42(9): 1360-1368.

JIN Hai-zhe， ZHU Lin， LI Yi， FU Quan-wei. Human Factor Reliability Evaluation and Application of Medical Devices Based on Improved FMEA[J]. Journal of Northeastern University(Natural Science), 2021, 42(9): 1360-1368.

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基于改进FMEA的医疗器械人因可靠性评估与应用

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

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