本計劃之目的乃（1）利用生物監測技術，建立無菌醫療器材再處理，使能確實達到國際組織（ISO）規定之確定效果，並設計在臨床上可行之醫療院所滅菌規範。（2）將上述之實驗結果，應用於協助國內醫療院所，針對可重覆使用之醫療器材，建立醫療院所無菌醫療器材再處理滅菌之確效作業程序。研究方法：首先在實驗室之嚴格控管下，驗證並建立醫療用滅菌器微生物指示器材監測標準步驟，並採用最經典的微生物監測法為控制組，將實際設計於臨床使用之微生物指示器材監測系統作為實驗組，期取得最準確對照數據之結果，作為醫療院所滅菌確效作業程序之基礎。採訪視及問卷調查之方式，採隨機抽樣選定50家醫療院所做為代表性模組，做為期六個月之定期滅菌監控。在實際與醫療院所進行之互動過程中，累積並取得經驗，建立醫療院所無菌醫療器材再處理滅菌作業程序之規範。結果及主要發現：以臨床與實驗結合之方式設計出最適當之模式，協助國內醫療院所，針對可重複使用醫療器材(Reusable Medical Devices)之相關滅菌確效作業，建立可行之作業流程與品質管理。輔導醫療院所，建立GMP 滅菌確效作業，以確保無菌醫療器材之安全性。
The purpose of this project was (1) using the biological indicators as quality control, applied to determine whether the sterilization process is achieving the desired results of providing instruments safe for use on patients, and fulfill the criteria recommended by CDC for infection control practices. (2) To establish a standard protocol, by using the result of this study, for helping the clinical offices to reduce the incidences of sterilization failures to prevent the risk of diseases transmission in the clinical therapeutic procedure from patient. Result: In this study 50 private dental offices were randomly selected and assign to monitoring their sterilization process, every month the clinic send the processed biological indicator for culture monitoring in a period of 6 months. 436 tests were submitted to our laboratory, the proper results for the test and control indicators analyzed were performed in laboratory. Results show 5 culture positive were detected from the begin sterilization surveillance test, and a total of 3.5% sterilization failure were found in the consequently months. Which suggests that a problem exists and the sterilized instruments in that dental office may not be safe to use. Conclusion: Sterilization failure occurred in instrument loads used in patients treatment, but if the use and functioning of the sterilization is monitored routinely by a school or central hospital laboratory and record are kept to document these evaluation, the cause of sterilization failure are addressed and corrected carefully so that patient safety can be maintained.
