DOI QR코드

DOI QR Code

사용적합성 평가를 적용한 국산 범용인공호흡기의 위험요인 분석

Analysis of Hazard Factors for Domestic General Purpose Ventilator using Usability Assessment

  • 권경민 (연세대학교 의과대학 의료기기산업학과) ;
  • 김승희 (연세대학교 의과대학 의료기기산업학과) ;
  • 김유림 (연세대학교 의과대학 의료기기산업학과) ;
  • 장원석 (연세대학교 의과대학 의료기기산업학과)
  • Gyeongmin Kwon (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Seung hee Kim (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • You Rim Kim (Department of Medical Device Engineering and Management, Yonsei University College of Medicine) ;
  • Won Seuk Jang (Department of Medical Device Engineering and Management, Yonsei University College of Medicine)
  • 투고 : 2023.12.10
  • 심사 : 2024.01.22
  • 발행 : 2024.02.28

초록

The purpose of this study is to conduct a summative evaluation of the usability of a general-purpose ventilator to determine whether it can be used for its intended purpose in the intended environment by the intended user and to find possible errors in use. The importance of ventilators has increased due to the accelerated aging of the population and the impact of the pandemic. In addition, patients who require ventilators are often in critical condition, so even a small error in use can be fatal. Therefore, it is important to ensure that the ventilator has sufficient stability and can be used satisfactorily without inconvenience to the user. In this study, we conducted a usability test with 17 respiratory nurses with more than 3 years of experience using the ventilator. We analyzed the task success rate, satisfaction, and opinions of the intended users while going through a total of 17 scenarios. Satisfaction was captured through an ASQ questionnaire and subjective opinions were captured through a detailed opinion questionnaire. The results showed a high level of satisfaction with an average score of 6.3 for the use scenarios. Evaluators expressed satisfaction with the overall visibility and versatility of the features, but noted that improvements were needed for calibration tasks with low task success rates. As the calibration method is different from other equipment, it was suggested that specific explanations of the calibration method and the picture that appears when calibrating are needed, and that if relevant training is provided, the equipment can be used without problems. If the usability evaluation is not limited to securing efficiency and satisfaction from the intended users, but also continuously receives feedback from users to prepare for use in emergency environments such as pandemic situations, it will be very helpful to seize opportunities such as emergency authorization in future situations, and ultimately contribute to patient safety by reducing use errors.

키워드

과제정보

본 연구는 정부(범부처)의 재원으로 범부처전주기의료기기연구개발사업단의 지원을 받아 수행된 연구임(과제고유번호 : RS-2020-KD000263).

참고문헌

  1. Rubinson L, Shah C, Rubenfeld G. Surge Mechanical Ventilation for the COVID-19 Surge and Future Pandemics-Time to Reframe the Strategy. JAMA. 2022;5(8).
  2. Jeon SE, Kim HK, Lee DW, Kim HJ, Park JE. User experience of MV2000-MT (SU:M2)® as a Mechanical Ventilator: A Comparative Clinical Study on Usability, Safety, and Medical Staff Satisfaction. J Biomed Eng Res. 2019;40:260-267.
  3. Choi EJ. A study on how to promote the use of domestically produced medical devices. The Graduate School, Yonsei University. 2022;50-60.
  4. Fairbanks, R. J. and S. Caplan. Poor interface design and lack of usability testing facilitate medical error. Jt Comm J Qual Saf. 2004;30(10):579-584.
  5. Olga Vl, Kim HK, Park JH. Usability and user experience of medical devices: An overview of the current state, analysis methodologies, and future challenges. International Journal of Industrial Ergonomics. Volume 76. 2020.
  6. Kim YR, Son JM. Usability Study on Patient Monitoring Systems: An Evaluation of a User Interface Based on User Experience and Preference. MEDICAL SCIENCE MONITOR. 2023.
  7. MFDS. Regulation on Medical Device Groups and Class by Group, Ministry of Food and Drug Safety Public Notification No. 2023-41;2023
  8. FDA. List of Highest Priority Devices for Human Factors Review Draft Guidance for Industry and Food and Drug Administration Staff;2016.
  9. FDA. Content of Human Factors Information in Medical Device Marketing Submissions Draft Guidance for Industry and Food and Drug Administration Staff;2022.
  10. https://www.medicaltimes.com/Main/News/NewsView.html?ID=1148761. Acceessed on 05 Dec 2023.
  11. Onder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA. 2020;323(18):1775-1776.
  12. Moon JH. COVID-19 Crisis in Italian Socioeconomic Context, Global Social Security Review, 2021;16:83-92
  13. Jiang M, Liu S, Feng Q, Gao J, Zhang Q. Usability Study of the User-Interface of Intensive Care Ventilators Based on User Test and Eye-Tracking Signals. Med Sci Monit. 2018; 6617-6629.
  14. Blanch, P. B. An evaluation of ventilator reliability: a multivariate, failure time analysis of 5 common ventilator brands. Respir Care. 2001;46(8):789-797.
  15. Andrea Remuzzi, Giuseppe Remuzzi. COVID-19 and Italy: what next?. Lancet. 2020;1225-1228.
  16. Pham JC, Williams TL, Sparnon EM, et al. Ventilator-related adverse events: a taxonomy and findings from 3 incident reporting systems. Respir Care. 2016;621-631.