滅菌起源與生物指示劑的發展

The History of Sterilization and Biological Indicator

滅菌最早期發展的目的在於保存食物，之後才漸漸因為科學家對細菌的認知，而衍生到手術的無菌概念及醫療器材的滅菌。本文介紹了滅菌的發展歷史，以及相關滅菌設備的發明，並探討生物指示劑的發展歷史以及製作、監測原理。最初發展的含孢紙片型生物指示劑，因為使用及操作不易且耗時，目前已少為人使用。生物指示劑是自含式生物指示劑，修正了之前的缺點，但因為需較長時間的培養（24-48小時），仍無法克服因醫院醫療器械庫存不足，導致醫院可能在未得知生物指示劑結果前就發放物品，而無法維護病患安全的問題。最新發展的快速判讀自含式生物指示劑，乃利用孢子上的酵素在孢子萌芽過程中的作用，對其代謝產物進行偵測，因偵測時間點在孢子萌芽生長的過程，因此可大幅縮短等候生物指示劑培養的時間，以1或3小時的結果進行物品發放與否的依據。國內疾病管制局也修訂最新滅菌監測措施指引，並於2010年5月20曰正式公告，使得用於病人相關器械與敷料的安全性也獲得更大保障。

The original objective of sterilization was food storage. After scientists discovered bacteria and understood the concepts of sterilization and aseptic surgical practices, they realized the need for sterile medical devices. In this report, we provide the history of sterilization, steam sterilizers, development and manufacture of biological indicators (BI), and monitoring principles of different generations of Bis. The spore strip type of BI is not user-friendly and is also time consuming; hence, it is no longer use in hospitals. The next generation SCBI still needs 24-48 hrs to get the result of sterilization and that still will compromise the patient safety as the inventory issue of medical devices. Another rapid readout BI could get the sterilization result in 1-3 h by detecting the activity of enzymes present in the outer spore coat, followed by monitoring the end-product of enzyme involved germination biological reaction. By this way, the rapid readout BI could shorten the incubation time to 1 or 3 h and as the evidence for load release. The Taiwan Centers for Disease Control (TW-CDC) also announced the new sterilization guideline on May 20, 2010. This guideline could help to ensure patient safety for using reprocessed medical devices and dressing.