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題名：運用醫療失效模式與效應分析之原理於改善呼吸機維護策略之研究
作者：楊蕙瑜
作者(外文)：YANG, HUI-YU
校院名稱：中華大學
系所名稱：科技管理博士學位學程
指導教授：賀力行
學位類別：博士
出版日期：2019
主題關鍵詞：醫療失效模式與效應分析；風險優先數值；價值工程；Healthcare Failure Mode and Effect Analysis；Risk Priority Number；Value Engineering
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近年來依據衛生福利部中央健康保險署重大傷病發卡統計數量中「呼吸衰竭重大傷病」一直是繼癌症之後領卡量高居第二名，每個月發出之重大傷病卡數量穩定都在1,000多張，由此可知呼吸機的需求與日俱增。
在整個醫療照護過程中，呼吸機使用順暢與否，直接影響到病人的照護品質。人的腦部缺氧4~6分鐘即開始受損，一旦超過10分鐘，會造成腦部幾乎無法復原的損傷及死亡。為要維持患者基本的生命徵象，一定要病人吸入足夠的空氣來供應人體使用。而當病人無法自主呼吸時，就需借由外力來幫助病人維持，其中呼吸機就是最基本的維生工具之一，而且十分的重要。
此次研究對象為使用之呼吸機保養維護作業流程為分析主軸，採用醫療照護失模式與效應分析(Healthcare Failure Mode and Effects Analysis, HFMEA)一種前瞻性、預防式的風險分析工具。其最大的作用就是可以針對醫療院所的醫療作業流程做出風險管理，儘量避免異常事件的發生，同時可以提供醫管理者問題發生之優先順序，藉以改善相關的作業程序及制度。
經研究分析現行之作業中將現行保養維護流程分為四個主流程八個子流程來解析可能影響呼吸機維護保養作業之安全因素。在研究的過程中發現到了現有流程不足除尚有精進之處外，同時了解到目前的醫療院所在經營管理上由於成本的支出上逐年增加的情況下，都普遍性的延長機器的使用年限及保養方式，尤其在重大零件的維修及換購率上更是錙銖必較。但病人醫療過程中的安全及醫療院所的聲譽是不可等閒視之的。故醫療人員可藉由HFMEA的熟悉度及應用，以建立預防失效關鍵因素的對策及做為並同時提高呼吸機使用時之妥善率，將能確保更優良醫療照護品質，建立一個以病人安全為中心的醫療環境。
According to the statistics of the National Health Insurance Administration Ministry of Health and Welfare show that the issuance of Catastrophic Illness Card of severe respiratory failure has ranked in second place after cancer in recent years. The monthly issuance is more than 1,000 of Catastrophic Illness Card. It explains the demand for ventilators is increasing gradually.
In the healthcare process, whether the ventilator is appropriately used will affect the quality of patient care. Brain damage begins after only 4 to 6 minutes without oxygen, and the permanent damage or brain death can occur as soon as 10 minutes later. In order to maintain the primary vital signs, it needs to deliver enough oxygen to the patient’s body. When the patient cannot breathe spontaneously, an external support will be needed to help the patient in breathing. Therefore, the ventilator has been given a critical status as the basic lifesaving devices to sustain the vital signs.
This study analyzed the maintenance procedure of ventilator applied by a Respiratory Care Ward (RCW) in a hospital in northern Taiwan, and used a forward-looking risk assessment and risk prevention tool- Healthcare Failure Mode and Effects Analysis (HFMEA)as the methodology. The purpose of the study is to determine the medical procedure through risk management and avoid the occurrence of abnormal events. It will help hospital administrators to clarify the sequence of problem occurrence and improve the policies and procedures for medical treatments.
In this study, the current maintenance processes were divided into four major processes and eight sub-processes, to identify the factors that affect the ventilator maintenance operations and impact on patient safety. During the research, it was found that the current process is defective and needs to be improved. In addition, with the expenditures are increasing, the hospital administrators tend to extend the life of medical equipment and equipment maintenance schedule. In particular, tracking all expenses in detail when repair and replacement of critical components. Giving patient safety a high priority is key drivers of trust, and it will grow the hospital reputation. Medical staff can use HFMEA to build up the countermeasures to avoid the critical failure factors which are identified in this study. To enhance the patient safety by proper use of ventilator. To create a secure environment and concern for patient safety and health care quality.
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