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KMID : 1137820230440010019
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의공학회지
2023 Volume.44 No. 1 p.19 ~ p.24
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Reliability Management of Mechanical Ventilator in Intensive Care Unit Using FMEA Based on ISO14971
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Yang Ye-Seul
Kim Won-Kyu
Kim Tae-Jong
Suh Gee-Young
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Abstract
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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.
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KEYWORD
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Mechanical ventilator, ISO14971, FMEA, Medical device, Risk management, Reliability management
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