Hobson D W, Seal L A
Pharmaceutical Sciences, Research and Development, Healthpoint, Ltd, San Antonio, TX 78215, USA.
Am J Infect Control. 2000 Oct;28(5):370-5. doi: 10.1067/mic.2000.109182.
Test data are presented for a novel chemical germicide formulation capable of sterilizing reusable medical devices in 30 minutes at 20 degrees C in an open tray. The tests conducted with this rapid-acting sterilizing solution (RSS) included sporicidal, mycobactericidal, and virucidal studies performed in accordance with Association of Official Analytical Chemist International or Environmental Protection Agency published guidelines, by using RSS stressed for as long as 7 days. Sporicidal assays were performed at 20 degrees C with a 30-minute exposure time by using both Clostridium sporogenes and Bacillus subtilis spores dried on porcelain penicylinders or suture loops (n = 60 carriers per treatment). For comparison, identical carriers were exposed to a commercial glutaraldehyde-based sterilizing solution stressed to a maximum-use time of 14 days and exposed per manufacturer's requirements (10 hours at 25 degrees C). The RSS sterilized 100% of the carriers of both spore types. The glutaraldehyde solution demonstrated 100% sterilization of C sporogenes -treated carriers but had difficulty sterilizing B subtilis spore-laden carriers (ie, no sterilization of suture loops and only 57% sterilization of porcelain penicylinders). Similarly, Mycobacteria bovis and selected fungal and viral agents were exposed to stressed solution for 5 minutes or less at 20 degrees C. In each case, the resulting log decrease in viable microorganisms significantly supported a claim for rapid high-level disinfection. Based on these data, RSS demonstrates high-level disinfection in 5 minutes and sterilization in 30 minutes at 20 degrees C.
本文给出了一种新型化学杀菌剂配方的测试数据,该配方能够在20摄氏度的开放托盘中30分钟内对可重复使用的医疗器械进行灭菌。使用这种快速作用灭菌溶液(RSS)进行的测试包括根据国际官方分析化学家协会或美国环境保护局发布的指南进行的杀孢子、杀分枝杆菌和杀病毒研究,所使用的RSS经过长达7天的强化处理。杀孢子试验在20摄氏度下进行,暴露时间为30分钟,使用干燥在瓷制青霉素瓶或缝合线上的生孢梭菌和枯草芽孢杆菌孢子(每次处理n = 60个载体)。作为比较,将相同的载体暴露于一种基于戊二醛的商业灭菌溶液中,该溶液的最大使用时间为14天,并按照制造商的要求进行暴露(25摄氏度下10小时)。RSS对两种孢子类型的载体灭菌率均为100%。戊二醛溶液对经生孢梭菌处理的载体灭菌率为100%,但对载有枯草芽孢杆菌孢子的载体灭菌困难(即对缝合线无灭菌效果,对瓷制青霉素瓶的灭菌率仅为57%)。同样,将牛分枝杆菌以及选定的真菌和病毒制剂在20摄氏度下暴露于强化溶液中5分钟或更短时间。在每种情况下,活微生物数量的对数下降显著支持了快速高效消毒的说法。基于这些数据,RSS在20摄氏度下5分钟内可实现高效消毒,30分钟内可实现灭菌。