| 摘要: | 以病人安全為中心的醫療照護模式，是現代醫療機構推動的重點，因此如何有效的進行風險管理來避免未來可能發生之病患安全事件，是醫療品質管理重要的議題。而醫療照護失效模式及效應分析(Healthcare Failure Mode and Effect Analysis, HFMEA) 是一種前瞻性、預應式，適合檢視高風險照護流程，可找出並矯正危險因子，防範錯誤於未然的風險管理方法。故本研究以HFMEA為工具來評估醫材滅菌確效流程之潛在失效模式與失效原因，並進行危害分析，透過決策樹模式，決定須改善之潛在失效模式與失效原因，並提出改善方案來供個案醫院醫材滅菌確效流程之參考。
研究採個案研究法，以南部某醫療體系二家醫院為研究對象，運用HFMEA方法，來評估醫材滅菌確效流程，執行步驟為：選定醫材滅菌確效流程、組成專家團隊、繪製醫材滅菌確效的流程圖、進行危害分析、擬定改善之建議方案。依據HFMEA在醫材滅菌確效流程分析共存在79 個失效模式及159個潛在失效原因。透過HFMEA小組針對滅菌確效流程失效模式及原因，進行風險指數評量分析，並以決策樹模式確認未能控制之滅菌失效潛在失效原因，再針對需改善之潛在失效模式及原因提出建議，改善之建議包含：一、清洗作業：(一)檢視並統計使用率高、送修率高或備庫量不足，常需緊急處理之醫材進行增購數量。(二)增設水溫設定裝置及水溫計設備，並執行水溫之紀錄及監控。(三)安排CJD器械處理流程教育課程，進行公告、宣導並執行測試。二、配盤作業：(一)依規範重新檢視、測量並重整設計滅菌包大小及重量之組成。(二)於會議時執行包裝時鬆緊度分享，使人員認知及做法一致。(三)針對包裝適當之鬆緊度進行稽核。三、滅菌監控作業：(一)醫工組對儀器進行增加定期保養及重點檢視之頻率。(二)由醫工組及供應中心制定各滅菌程式及參數標準規範。(三)依制定之標準規範，針對供應中心人員辦理在職教育訓練。(四)依規範進行滅菌過程查核監控、判讀及紀錄之稽核。四、儲存作業：(一)由感染管制室、工務室及供應中心將供應中心工作區域動線重新規畫；以硬體設計屏障落實動線不交叉之感染管制原則。(二)增設儲存區之氣壓計，並執行氣壓紀錄監控。五、配送作業：(一)檢視並統計使用率高、送修率高或備庫量不足，常需緊急處理之醫材進行增購數量；以避免掉落地面的無菌物品仍撿起做配送。六、使用作業：(一)使用者進行包外化學性指示帶之存留檢視。(二)導入無菌醫材包盤條碼資訊管理作業系統。(三)使用單位進行包內化學性指示帶雙重檢視。
增進病人安全需要醫療相關團隊的共同努力，而HFMEA是一種預應式風險管理，透過預防失效的結構性系統分析方法，在危害尚未造成前，針對流程改善而避免之，因此可有效提高醫療品質及確保病人安全。
Whereas the medical establishments are paying more and more attention to the medical care mode of patient-oriented, it becomes an important subject in management of medical quality to avoid the occurrence of patient’s safety accident by risk management, while the Healthcare Failure Mode and Effect Analysis (HFMEA) is a risk management method for predictive and preventive to search and correct any risky element in the procedures of highly risky care. In this study, HFMEA was used to assess the mode of potential failure and its causes in validation of sterilization for medical materials, with hazard analysis and decision tree to determine the mode of potential failure and its causes for improvement and propose corrective action for reference in sterilization procedures of medical materials in case hospital. This study took two hospitals in southern Taiwan as subject to assess the validation procedures of sterilization for medical materials by HFMEA with procedures as: selection of validation procedures, establishment of expert team, preparation of flow chart, hazard analysis, and preparation of suggestive actions. The analyses on validation procedure of sterilization resulted in 79 failure modes and 159 potential causes. With quantitative analysis on the risk index of failure modes and their causes by HFMEA group to verify the causes of sterilization failure with HFMEA group, and suggestions were presented for the possible failure modes and their causes as: 1. cleaning operation: (1) add medical materials which have been frequently required for urgent sterilization and have been frequently used, serviced and in low inventory; (2) add water temperature regulating apparatus and thermometer, and implement water temperature recording and monitoring; (3) arrange training on CJD treatment procedures, publish and instruct the procedures, and implement testing. 2. switches panel operations: (1) review, measure and redesign the size and weight of sterilization package; (2) communicate the tension degree in packaging to enable uniform knowledge among the operators; (3) monitor the tension adequacy of packaging. 3. sterilization operation: (1) increase periodic maintenance and major review; (2) prepare sterilization procedures and norms; (3) provide training for staffs of provision center; (4) monitor, study and monitor the records. 4 storage operation: (1) redesign the movement lines in the working areas of provision center to prevent cross infection; (2) add barometer in storage area. 5. distribution operation: (1) add devices which have been frequently required for urgent sterilization and have been frequently used, serviced and in low inventory; prevent the sterilized stuff fallen on the ground being distributed. 6. Use operation: (1) review the residual of reducible tape for external packaging; (2) introduce the information management system for bar code of sterilized materials packaging; (3) double review the reducible tape for external packaging.
It needs teamwork to improve patient safety in medical establishment, and HFMEA is a predictive way of risk management with structural system analysis method to improve procedures for preventing risk before its occurrence to improve medical quality and protect patient safety. |
