Document Detail


Use-related risk analysis for medical devices based on improved FMEA.
MedLine Citation:
PMID:  22317712     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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.
Authors:
Long Liu; Ma Shuai; Zhu Wang; Ping Li
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Work (Reading, Mass.)     Volume:  41     ISSN:  1875-9270     ISO Abbreviation:  Work     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2012-02-09     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9204382     Medline TA:  Work     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  5860-5     Citation Subset:  IM    
Affiliation:
College of Design & Innovation, Tongji University, Room 102, Building B, 1623 Cailun Road, Shanghai, China, 201203.
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