Journal of Northeastern University(Natural Science) ›› 2021, Vol. 42 ›› Issue (9): 1360-1368.DOI: 10.12068/j.issn.1005-3026.2021.09.020

• Management Science • Previous Articles    

Human Factor Reliability Evaluation and Application of Medical Devices Based on Improved FMEA

JIN Hai-zhe1, ZHU Lin1, LI Yi1, FU Quan-wei2   

  1. 1. School of Business Administration, Northeastern University, Shenyang 110169, China; 2. Dongguan Kanghua Hospital, Dongguan 523080, China.
  • Revised:2021-01-25 Accepted:2021-01-25 Published:2021-09-16
  • Contact: JIN Hai-zhe
  • About author:-
  • Supported by:
    -

Abstract: In view of two significant deficiencies of failure mode and effect analysis (FMEA) in the human factors reliability evaluation for medical devices—evaluation of risk factors and weight assignment, a structured human factor reliability evaluation method for medical devices is proposed. Based on the improved fuzzy set theory and ordered weighted geometric average (OWGA) operator, context parameters are introduced to optimize the ranking of risk and error modes. By applying the proposed method to actual medical scenarios, the effectiveness and feasibility of method are verified, and the superiority of the proposed method is proved by comparison with the traditional FMEA. The proposed method solves the problem of traditional RPN value duplication and weight assignment, reduces the evaluation error, helps to find the key failure mode, and reduces the occurrence of medical adverse events.

Key words: medical device; failure mode and effect analysis(FMEA); human factor reliability; fuzzy set theory; OWGA operator

CLC Number: