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

Issue title: IEA 2012: 18th World congress on Ergonomics - Designing a sustainable future

Article type: Research Article

Authors: Liu, Long | Shuai, Ma | Wang, Zhu | Li, Ping

Affiliations: College of Design & Innovation, Tongji University, Room 102, Building B, 1623 Cailun Road, Shanghai, China, 201203 | Institute of Industry Engineering, Tongji University, Room 102, Building B, 1623 Cailun Road, Shanghai, China, 201203 | Shanghai East Hospital, 150 Jimo Road, Shanghai, China, 200120

Note: [] Shuai Ma. E-mail: mashuai111@gmail.com

Note: [] Ping Li. E-mail: mashuai87111@126.com

Keywords: Use-related risk, medical device, FMEA

DOI: 10.3233/WOR-2012-0976-5860

Journal: Work, vol. 41, no. Supplement 1, pp. 5860-5865, 2012

Published: 2012
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Abstract

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 userelated 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.

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