Clinical Institute of Hospital Hygiene, Vienna General Hospital, Medical University of Vienna, Waehringer Guertel 18-20, Vienna, Austria.
Am J Infect Control. 2010 Dec;38(10):806-10. doi: 10.1016/j.ajic.2010.05.023. Epub 2010 Sep 24.
Sterrad sterilizers have been developed for the sterilization of thermolabile materials. The aim of the present study was to challenge the efficacy of this low-temperature hydrogen peroxide-based sterilization system with different carrier materials and wrappings under experimental "clean" and "dirty" conditions.
We tested the sporocidal effect of the Sterrad 100NX sterilizer (Advanced Sterilization Products, Irvine, CA) on the carrier materials titanium, polyethylene, and polyurethane with single versus 3 wrappings of inoculated carriers. To simulate insufficient cleaning or crystalline residues, carriers were charged with spore inocula containing organic and inorganic burdens.
Our qualitative results show that irrespective of the number of wrappings in the "clean" condition, sterilization by the Sterrad 100NX was equally effective on all 3 carrier materials, reaching a log-10 reduction rate of ≥ 6 under standard half-cycle conditions. Any additional organic or inorganic challenge significantly impaired the sterilization outcome.
Results of our current study emphasize the utmost importance of thorough and reliable cleaning of medical devices before being exposed to a subsequent hydrogen peroxide sterilization process. Any institution using this sterilization technology should have a well-established and validated cleaning process and enforce a rigorous quality assurance program for all steps of the presterilization processing of medical devices.
Sterrad 灭菌器是为灭菌热敏材料而开发的。本研究的目的是在实验“清洁”和“污染”条件下，用不同的载体材料和包装材料对这种基于低温过氧化氢的灭菌系统的有效性进行挑战。
我们测试了 Sterrad 100NX 灭菌器（Advanced Sterilization Products，Irvine，CA）对钛、聚乙烯和聚氨酯载体材料的杀菌效果，分别用 1 层和 3 层包裹接种载体进行实验。为了模拟清洗不彻底或结晶残留的情况，载体上接种了含有有机和无机污染物的孢子。
我们的定性结果表明，无论在“清洁”条件下包裹的数量如何，Sterrad 100NX 对所有 3 种载体材料的灭菌效果都是一样的，在标准半循环条件下，达到了≥6 的对数减少率。任何额外的有机或无机挑战都会显著影响灭菌效果。
本研究结果强调了在进行后续过氧化氢灭菌处理之前，彻底可靠地清洗医疗器械的重要性。任何使用这种灭菌技术的机构都应该有一个完善和经过验证的清洗流程，并对医疗器械的预灭菌处理的所有步骤执行严格的质量保证计划。
