ISO14971 기반 FMEA를 이용한 중환자실내 인공호흡기 신뢰성 관리
Reliability Management of Mechanical Ventilator in Intensive Care Unit Using FMEA Based on ISO14971
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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 man- agement, and the Medical Device Regulation also provides medical device risk management standards for manu- facturers, 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 man- agement 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 micro- processor-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.
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 man- agement, and the Medical Device Regulation also provides medical device risk management standards for manu- facturers, 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 man- agement 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 micro- processor-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.
참고문헌 (15)
- Kumar M, "A Low-cost Ambu-bag Based Ventilator for Covid-19Pandemic", 2021 IEEE Biomedical Circuits and Systems Conference (BioCAS), Biomedical Circuits and Systems Conference (BioCAS) 2021 IEEE, pp.1~5 (2021)
- Ciotti M, "The COVID-19 pandemic", Critical Reviews in Clinical Laboratory Sciences, 57(6), pp.365~388 (2020)
- Hiremath A, "Integrated Clinical and CT Based Artificial Intelligence Nomogram for Predicting Severity and Need for Ventilator Support in COVID-19 Patients : A Multi-Site Study", IEEE Journal of Biomedical and Health Informatics, 25(11), pp.4110~4118 (2021)
- Gajdos O, "Failure mode and effects analysis application on a home mechanical ventilation", 2019 7th E-Health and Bioengineering Conference (2019)
- Motta D, "Collaborative and Structured Network for Maintenance of Mechanical Ventilators during the SARS-CoV-2 Pandemic", Healthcare, 9(6), pp.754~ (2021)
- Sampath T, "Medical Device Guidelines and Regulations Handbook", pp.31~56 (2022)
- "ISO 14971:2019: Medical devices, Application of risk managementto medical devices", 1~7 (2019)
- Hegde V, "Case study — Risk management for medical devices (based on ISO 14971)", 2011 Proceedings. Annual Reliability and Maintainability Symposium, Reliability and Maintainability Symposium (RAMS), 2011 Proceedings – Annual, pp.1~6 (2011)
- Duwe B, "Failure mode and effects analysis application to critical care medicine", Critical Care Clinics, 21(1), pp.21~30 (2005)
- Rusu I, "Failure mode and effects analysis of linac-based liver stereotactic body radiotherapy", Medical Physics, 47(3), pp.937~947 (2020)
- Rosen M, "Failure mode and effects analysis of the universal anaesthesia machine in two tertiary care hospitals in Sierra Leone", British journal of anaesthesia, 113(3), pp.410~415 (2014)
- 서기홍, "병원내 의료기기 교체의 우선순위 결정을 위한 단순평가법 개발", 의공학회지, 41(6), pp.256~263 (2020), 대한의용생체공학회
- Seo GH, "How to calculate the life cycle of high-risk medical devices for patient safety", Frontiers in Public Health, 10 (2022)
- Frazão D, "The impact of human error on medical procedures", International Journal of Risk & Safety in Medicine, 33(3), pp.287~298 (2022)
- Sameera V, "Human errors and their prevention in healthcare", Journal of Anaesthesiology Clinical Pharmacology, 37(3), pp.328~335 (2021)