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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. • A risk assessment model is developed to improve the safe use of medical devices. • Swiss cheese model and SHEL model are integrated to identify the human failures. • A FMEA method based on rough set theory and grey relational analysis is proposed. • The method is applied in clinical use of respirator to verify its effectiveness. [ABSTRACT FROM AUTHOR]

The paper aims to identify and evaluate the factors influencing the human performance of Air Traffic Control (ATC) in Thailand. The objective of the study has been operationalized utilizing the extended SHEL model of ergonomics. Fuzzy Graded Mean Integration method has been employed to establish the importance and Fuzzy Additive Ratio Assessment method was utilized to measure actual performance of the factors on the response received from all ten air traffic control centers of Thailand. The finding of study facilitates the insights for improvement of various dimensions and constructs for an effective human performance management for ATC in Thailand. The study fulfills the theoretical gap by employing the Fuzzy Multi Criteria Decision Making (MCDM) method of identifying and measuring human performance in ATC. • Evaluates the human performance factors for ATC utilizing Fuzzy MCDM method. • Renders insights for effective human performance management for ATC in Thailand. • Suggests improvement for constructs hardware, software, environment & organization. • Contributes by including prominent dimensions to the extended SHEL model. [ABSTRACT FROM AUTHOR]