Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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Hazard Analysis for Usability Evaluation of Central Monitoring System through Text Network Analysis

텍스트 네트워크 분석을 통한 환자중앙감시시스템의 사용적합성 평가를 위한 위해요인 분석

  • Ji-Yong Chung (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Wonseuk Jang (Department of Medical Device Engineering and Management, Yonsei University College of Medicine)
  • 정지용 (연세대학교 대학원 의료기기산업학과 ) ;
  • 장원석 (연세대학교 대학원 의료기기산업학과 )
  • Received : 2024.08.05
  • Accepted : 2024.08.19
  • Published : 2024.08.31
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Abstract

In this study, text network analysis was performed using PMS(Post-Marketing Surveillance) data collected from the FDA's MAUDE(Manufacturer and User Facility Device Experience) database to evaluate the usability of the central monitoring system. Based on the data reported from January 1, 2021 to June 30, 2023, keywords related to the central monitoring system were extracted and visualized with a text network. By analyzing the eigenvector centrality of text network, we identified hazards and types of hazardous situations related to usability of the central monitoring system. Eigenvector centrality was chosen because it is relatively more accurate than other centralities. In addition, we derived an appropriate use scenario to evaluate the usability of the central monitoring system. The research results provide more realistic and valuable insights through data derived based on actual adverse event cases, and are expected to contribute to improving safety and reliability by identifying user requirements for improved usability and reducing use errors in the future.

Keywords

Acknowledgement

본 연구는 정부(과학기술정보통신부, 산업통상자원부, 보건복지부, 식품의약품안전처)의 재원으로 범부처전주기의료기기연구개발사업단의 지원을 받아 수행된 연구임(과제고유번호 : 1711174540, RS-2020-KD000030).

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