Use-related risk analysis for medical devices based on improved FMEA.
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 user-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.
College of Design & Innovation, Tongji University, 1623 Cailun Road, Shanghai, China.
Long
L
Liu
Ma
M
Shuai
Zhu
Z
Wang
Ping
P
Li
D019544:Equipment Failure Analysis; D004864:Equipment and Supplies; D006801:Humans; D012308:Risk Management