滅菌品質管制——化學指示劑及生物指示劑之探討

Sterilization Quality Control - General Remarks on Chemical Indicators and Biological Indicators

在國內，滅菌監測程序已執行一段長久時間，然而滅菌監測相關討論文獻及書籍卻很少。美國自1996年起，滅菌監測程序開始具備雛型。10多年來，美國政府、學術界及產業界不斷進行討論、溝通、建立共識及制定規範，其滅菌品質與滅菌管理領先國際。有鑑於此，本文首先由國際滅菌標準探討起，了解各種滅菌專業的角色定位。本文化學指示劑內容除了完整說明五級化學指示劑外，新增此次修正版第六級化學指示劑，並深入說明化學指示劑之設計原理及技術報告。生物指示劑的部分則著重於美國國家標準最新版對生物指示劑的定義，各種滅菌確效的菌種說明及簡述生物指示劑出廠時之菌種分析報告。本文以淺顯易懂的方式專章論述，期望使相關人員建立正確的基本觀念。

In Taiwan (R.O.C.), sterilization-monitoring procedures have been implemented for a long time. However, literature on sterilization monitoring is very limited. In 1996, sterilization-monitoring procedures were first launched in the United States. Since then, the U.S. government, academia, and industry sector have developed various measures for enhancing communication between the involved bodies and establishing standard practices for sterilization and monitoring of sterilization procedures. Today, United States is an international leader in the quality of sterilization and sterilization management. In view of this, this paper describes the international sterilization standards. This will provide readers a broad perspective on the importance of stringent sterilization procedures. This paper also discusses in detail 5 chemical indicators and the Class 6 chemical indicator included in the latest version of international standards for monitoring of sterilization procedures. (ANSI/AAMI ST79:2006/A2: 2009). The paper also describes in details the design principles of measured for evaluating chemical indicators and technical reports. The section on biological indicators focus on the definition of biological indicators (ANSI/AAMI ST79: 2006/A2: 2009). The article also outlines the description of processes for the validation of sterilization procedures for eliminating bacteria and highlights bio-indicators of the strain analysis of the factory. Finally, the paper also provides recommendations for monitoring sterilization processes. This article is aimed at increasing awareness and clarifying basic concepts of sterilization-monitoring processes among technicians.