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
相关论文
共 50 条
  • [21] An improved FMEA analysis method based on QFD and TOPSIS theory
    Ying-Kui Gu
    Zi-xin Cheng
    Guang-qi Qiu
    International Journal on Interactive Design and Manufacturing (IJIDeM), 2019, 13 : 617 - 626
  • [22] Individual Differences in the Associations Between Risk Factors for Alcohol Use Disorder and Alcohol Use-Related Outcomes
    Haeny, Angela M.
    Gueorguieva, Ralitza
    Jackson, Asti
    Morean, Meghan E.
    Krishnan-Sarin, Suchitra
    DeMartini, Kelly S.
    Pearlson, Godfrey D.
    Anticevic, Alan
    Krystal, John H.
    O'Malley, Stephanie S.
    PSYCHOLOGY OF ADDICTIVE BEHAVIORS, 2021, 35 (05) : 501 - 513
  • [23] An Analysis of Drug Use-Related Curriculum Documents for Paramedic Students in British Columbia
    Bolster, Jennifer L.
    Batt, Alan M.
    CUREUS JOURNAL OF MEDICAL SCIENCE, 2023, 15 (11)
  • [24] Drugscapes and the role of place and space in injection drug use-related HIV risk environments
    Tempalski, Barbara
    McQuie, Hilary
    INTERNATIONAL JOURNAL OF DRUG POLICY, 2009, 20 (01) : 4 - 13
  • [25] Approach to the detection of the use of medical devices based on the analysis of video streams
    Rockstroh, M.
    Wittig, M.
    Franke, S.
    Neumuth, T.
    BIOMEDICAL ENGINEERING-BIOMEDIZINISCHE TECHNIK, 2014, 59 : S399 - S399
  • [26] Usability first. Model-based approach for the use-oriented risk analysis of medical devices
    Janss, A.
    Radermacher, K.
    BUNDESGESUNDHEITSBLATT-GESUNDHEITSFORSCHUNG-GESUNDHEITSSCHUTZ, 2014, 57 (12) : 1384 - 1392
  • [27] Spatial-temporal Pattern Analysis of Land Use-related Carbon Emissions in Chongqing Based on County Space
    Yuan X.
    Ni J.
    Xie D.
    Yingyong Jichu yu Gongcheng Kexue Xuebao/Journal of Basic Science and Engineering, 2021, 29 (01): : 25 - 38
  • [28] The Use of Linguistic Variables and the FMEA Analysis in Risk Assessment in Inland Navigation
    Skupien, E.
    Tubis, A.
    TRANSNAV-INTERNATIONAL JOURNAL ON MARINE NAVIGATION AND SAFETY OF SEA TRANSPORTATION, 2018, 12 (01) : 143 - 148
  • [29] Assessment of Risk in a Production System with the Use of the FMEA Analysis and Linguistic Variables
    Burduk, Anna
    HYBRID ARTIFICIAL INTELLIGENT SYSTEMS, PT II, 2012, 7209 : 250 - 258
  • [30] A cybersecurity risk analysis methodology for medical devices
    Jagannathan, Srinivasan
    Sorini, Adam
    2015 IEEE SYMPOSIUM ON PRODUCT COMPLIANCE ENGINEERING (ISPCE 2015), 2015,
12345