Human cause reliability evaluation and application of medical devices based on the improved FMEA method——Take the color ultrasound instrument as an example
Pan Yu
Shanghai Institute of Technology
DOI: https://doi.org/10.59429/bam.v6i4.8389
Keywords: Improve the FMEA method; Medical equipment; Orderly weighted geometric average; Fuzzy set theory; SHELL model
Abstract
To improve the safety and reliability of medical devices in use, This paper combines the human factor reliability evaluation method based on SHELL model and an improved FMEA method based on fuzzy set and ordered weighted geometric average operator (OWGA), The improved method in this paper is compared to the traditional method, Solve the problem of relying on expert experience and consistent risk factor weights in traditional methods, And introduced the scenario parameter α that can represent the attitude in the risk ranking, Built a human cause reliability assessment model with FMEA as the core, Taking the color Doppler ultrasound instrument in a hospital as an example, To ify the validity and reliability of the method in this paper, Provide targeted risk control measures for hospitals or device companies, Raise the risk awareness, Convenient for doctors and patients while reducing the occurrence of adverse events.
References
[1] Shi Dongmei & Ma Xiaoyan Analysis of related factors of causing adverse medical events 3,269+272,doi:10.16281/j.cnki.jocml.2016.02.053 (2016).
[2] Cooper, S.E., Brown, W.S.& Wreathall, J.A Human Reliability-Centered Approach to the Development of Job Aids for Reviewers of Medical Devices That Use Radiological Byproduct Materials.probabilitstic Safety Assessment and Manage-men (2006).
[3] Based on fuzzy set and COPRAS 31,69-78 (2017).
[4] Liu Oo, Wang Zhu & Li Ping Comparcomparative improvement of medical equipment and application of industrial engineering and management 16,133-138,doi:10.19495/j.cnki.1007-5429.2011.06.026 (2011).
[5] FMEA method of door-peak fuzzy set theory and grey correlation theory, 109-112 + 117 (2008).