Use-related risk analysis for medical devices based on improved FMEA

被引：10
|
作者：
Liu, Long [1 ]
Ma, Shuai [2 ]
Wang, Zhu [2 ]
Li, Ping [3 ]
机构：
[1] Tongji Univ, Coll Design & Innovat, Shanghai 201203, Peoples R China
[2] Tongji Univ, Inst Ind Engn, Shanghai 201203, Peoples R China
[3] Shanghai E Hosp, Shanghai 200120, Peoples R China
来源：
WORK-A JOURNAL OF PREVENTION ASSESSMENT & REHABILITATION | 2012年 / 41卷
关键词：
Use-related risk; medical device; FMEA;
D O I：
10.3233/WOR-2012-0976-5860
中图分类号：
R1 [预防医学、卫生学];
学科分类号：
1004 ; 120402 ;
摘要：
In order to effectively analyze and control use-related risk of medical devices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out use-related risk analysis for medical devices. As an example, the analysis process using this improved FMEA method for a certain medical device (C-arm X-ray machine) is described.
引用
收藏
页码：5860 / 5865
页数：6
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