運用HFMEA手法進行醫療儀器燒熔故障預防

一直以來，醫療院所火災事件層出不窮，長庚亦發生多起虛驚事件，其中與電源線、插頭及插座相關發生數最多。本院風險管理委員會遴選儀器處依醫療失效模式與效應分析針對醫療儀器燒熔故障預防進行預應式計畫，研擬符合醫院危機管理需要之減災預防與準備措施。
依往年案例及現場勘查結果進行分析，評估選定執行單位；檢視必要流程，參考醫療儀器生命週期，繪製流程圖；運用HFMEA決策樹工具，分析98項潛在原因，扣除風險較小、已具控制措施及可被偵測，計17項風險進行改善。就管理、制度及設備3構面，歸納11項真因，擬定改善方案。對策導入後危害總指數（HS），從改善前200分，至改善後降為51分。藉由品管PDCA手法持續轉動精進改善，期能發揮成效，持續降低醫療儀器燒熔故障風險，達成異常事件零發生。

Incidents of fires in hospital happened have been a recurrent issue. Chang Gung Memorial Hospital has also encountered numerous alarms. Among all these, the incidents linked to power cords, plugs, and sockets are the most common. The Risk Management Committee of hospital selected the Instrument Department to analysis meltdown hazard of medical device based on electrical faults by HFMEA technique. Aimed to develop prevention strategy that aligns with crisis management requisites.
Drawing insights from past cases and on-site investigations, determined the executing unit and devised flow charts which is refer to medical device life cycle. By using HFMEA decision tree tool, 98 potential causes were identified, and after eliminate risks of lesser significance and focusing on those lacking control measures and detectability. A total of 17 risks were pinpointed for enhancement, 11 root causes were classified in the domains of management, systems, and equipment, leading to the formulation of viable solutions.
Following the implementation of these measures, the overall Hazard Score (HS) decreased from 200 to 51. By persistently applying the PDCA (Plan-Do-Check-Act) methods approach for continuous improvement, the object is to constantly reduce the risk of electrical fault in medical devices, ultimately reaching zero of incidents.