Human factors risk assessment: An integrated method for improving safety in clinical use of medical devices

被引：34
|
作者：
Song, Wenyan [1 ,2 ]
Li, Jing [1 ]
Li, Hao [3 ]
Ming, Xinguo [4 ]
机构：
[1] Beihang Univ, Sch Econ & Management, 37 Xueyuan Rd, Beijing 100191, Peoples R China
[2] Beihang Univ, Minist Educ, Key Lab Complex Syst Anal Management & Decis, Beijing 100191, Peoples R China
[3] Zhengzhou Univ Light Ind, Zhengzhou 450002, Henan, Peoples R China
[4] Shanghai Jiao Tong Univ, Sch Mech Engn, Shanghai 200240, Peoples R China
来源：
APPLIED SOFT COMPUTING | 2020年 / 86卷
基金：
中国国家自然科学基金;
关键词：
Medical device; Risk assessment; swiss cheese'' model; SHEL model; Failure mode and effects analysis (FMEA); CARE FAILURE MODE; EXTENDED MULTIMOORA; REASONING APPROACH; HUMAN ERROR; FMEA; PRIORITIZATION; FRAMEWORK;
D O I：
10.1016/j.asoc.2019.105918
中图分类号：
TP18 [人工智能理论];
学科分类号：
081104 ; 0812 ; 0835 ; 1405 ;
摘要：
Medical devices play a critical role in care and treatment. The human-related failures can significantly affect the safety of patients in clinical use of medical devices. This study develops a comprehensive risk assessment model for identification and evaluation of failures which may occur in the clinical use of medical devices. First, the "Swiss cheese'' model and SHEL model (the acronym of software, hardware, environment, and liveware) are integrated to comprehensively identify the potential human errors. Then, a new failure mode and effects analysis (FMEA) approach improved by rough set theory and grey relational analysis is developed to assess the risk of the identified failures. The proposed method integrates the strengths of the "Swiss cheese'' and SHEL model in identifying human failures from both the vertical and horizontal perspectives of the system, and the advantages of the improved FMEA approach in flexibly manipulating vague information in risk evaluation without much priori information. Finally, the proposed method is applied in clinical use of respirator to verify its efficiency and effectiveness. (C) 2019 Elsevier B.V. All rights reserved.
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页数：14
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