Clinical Institute of Hospital Hygiene, Vienna General Hospital, Medical University of Vienna, Austria.
Am J Infect Control. 2011 Nov;39(9):770-4. doi: 10.1016/j.ajic.2011.01.010. Epub 2011 Jun 25.
According to manufacturers information, the STERRAD 100NX sterilizer-a low temperature H(2)O(2) gas plasma sterilizer-can adequately process single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a maximum length of 500 mm using standard cycle sterilizing conditions. The aim of this study was to qualify the performance of this H(2)O(2) gas plasma sterilizer under different experimental settings representing worst case conditions.
Inoculated carriers were placed at the midpoint position of specified lumens and then submitted to flex scope sterilizing conditions. To simulate insufficient cleaning or crystalline residues, we added organic and inorganic challenges to our inoculated carriers.
For experiments done with unchallenged carriers, quantitative analysis reached a log(10) reduction rate of ≥5.71, whereas qualitative results showed no growth in 24 out of 30 biologic indicators tested using flex scope half cycle conditions. Any additional kind of challenge significantly impaired the sterilization outcome.
The findings of our current study emphasize the importance of a thorough validated cleaning of medical devices as well as timing for cleaning and decontamination before being exposed to the H(2)O(2) sterilization process and, furthermore, the need for strict adherence to manufacturer's recommendations.
根据制造商的信息，STERRAD 100NX 灭菌器-一种低温 H（2）O（2）气体等离子体灭菌器-可以使用标准循环灭菌条件，充分处理内径为 0.7 毫米或更大且最长为 500 毫米的单通道不锈钢管腔。本研究的目的是在代表最坏情况的不同实验设置下，对这种 H（2）O（2）气体等离子体灭菌器的性能进行鉴定。
将接种载体放置在指定管腔的中点位置，然后提交给柔性内镜灭菌条件。为了模拟清洁不充分或晶体残留物，我们向接种载体中添加了有机和无机挑战物。
对于未受挑战载体进行的实验，定量分析达到了≥5.71 的对数减少率，而定性结果显示，在使用柔性内镜半周期条件测试的 30 个生物指标中，有 24 个没有生长。任何额外的挑战都会显著影响灭菌效果。
本研究的结果强调了彻底验证医疗器械清洗的重要性，以及在暴露于 H（2）O（2）灭菌过程之前进行清洗和消毒的时间安排，并且需要严格遵守制造商的建议。
