Chia Jen-Shu, Chang Ching, Yang Chen-Hsuan, Yang Ching-Hui, Chiang Yung-Tai, Wu Cheng-En
Program of Technology Management.
Department of Business Administration, College of Management.
Ann Med Surg (Lond). 2023 Jul 7;85(8):3916-3924. doi: 10.1097/MS9.0000000000001064. eCollection 2023 Aug.
This study explored the application of healthcare failure mode and effect analysis (HFMEA) to identify and evaluate risk-associated factors in the intensive care unit (ICU) through a clinical-based expert knowledge (decision) for the physiological monitor operational maintenance process.
A mixed qualitative and quantitative proactive approach to explore the HFMEA process by analyzing 20 units of physiological monitors in the ICU. An HFMEA expert team of six people was formed to perform a risk-based analysis and evaluate the potential hazard index, mitigating the hazard scores and risks.
From the main processes and possible failure reasons, one high-risk hazard index greater than or equal to 8 of the standard score was found. This standard score indicates the signed manufacturer's contract for maintenance was the hazard index failure mode on the parts not regularly replaced according to the contract. This systematic hazard index failure mode shows the highest hazard scores in the possible failure reason category, established as a standard maintenance procedure. In addition, the HFMEA expert analysis of the 20 units of physiological monitors within 6 months of the original and remanufactured part maintenance results in operational availability from 90.9% for self-repair to 99.2% for contract manufacturer repair.
This study concludes a systematic reference in malpractices caused by maintenance negligence. The HFMEA expert team agrees that hazard failure scores greater than or equal to 8 are vital assessments and evaluations for decision-making, especially in maintaining healthcare intensive unit care physiological monitors.
本研究通过基于临床的专家知识（决策），探讨了医疗失效模式与效应分析（HFMEA）在重症监护病房（ICU）生理监测仪操作维护过程中识别和评估风险相关因素的应用。
采用定性与定量相结合的前瞻性方法，通过分析ICU中的20台生理监测仪来探索HFMEA过程。组建了一个由六人组成的HFMEA专家团队，进行基于风险的分析并评估潜在危害指数、减轻危害得分和风险。
从主要流程和可能的故障原因来看，发现了一个标准得分大于或等于8的高风险危害指数。该标准得分表明，制造商签订的维护合同中，未按合同定期更换部件的危害指数是失效模式。这种系统性的危害指数失效模式在可能的故障原因类别中显示出最高的危害得分，被确立为标准维护程序。此外，HFMEA专家对20台生理监测仪在原厂和再制造部件维护6个月内的分析结果显示，操作可用性从自行维修的90.9%提高到合同制造商维修的99.2%。
本研究得出了关于维护疏忽导致的不当行为的系统性参考。HFMEA专家团队一致认为，大于或等于8的危害失效得分是决策的重要评估指标，尤其是在维护重症监护病房的生理监测仪时。
