Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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Reliability Management of Mechanical Ventilator in Intensive Care Unit Using FMEA Based on ISO14971

ISO14971 기반 FMEA를 이용한 중환자실내 인공호흡기 신뢰성 관리

  • Hyun Joon, Kim (Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University) ;
  • Won Kyu, Kim (Department of Biomedical Engineering, Samsung Medical Center) ;
  • Tae Jong, Kim (Department of Biomedical Engineering, Samsung Medical Center) ;
  • Gee Young, Suh (Department of Critical Care Medicine, Samsung Medical Center)
  • 김현준 (성균관대학교 삼성융합의과학원 의료기기산업학과) ;
  • 김원규 (삼성서울병원 의공기술팀) ;
  • 김태종 (삼성서울병원 의공기술팀) ;
  • 서지영 (삼성서울병원 중환자의학과)
  • Received : 2022.12.14
  • Accepted : 2023.01.12
  • Published : 2023.02.28
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Abstract

Due to the spread of COVID-19, many patients with severe respiratory diseases have occurred worldwide, and accordingly, the use of mechanical ventilators has exploded. However, hospitals do not have systematic risk management, and the Medical Device Regulation also provides medical device risk management standards for manufacturers, but does not apply to devices in use. In this paper, we applied the Failure Mode Effects Analysis (FMEA) risk analysis technique based on the International Standard ISO 14971 (Medical Devices-Application of risk management to medical devices) for 85 mechanical ventilators of a specific model in use in hospitals. Failure modes and effects of each parts were investigated, and risk priority was derived through multiplication of each score by preparing criteria for severity, occurrence, and detection for each failure mode. As a result, it was confirmed that the microprocessor-based Patient Unit/Monitoring board in charge of monitoring scored the highest score with 36 points, and that reliability management is possible through systematic risk management according to priority.

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References

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