Research & Development Department, Advanced Sterilization Products, Irvine, CA, USA.
Research & Development Department, Advanced Sterilization Products, Irvine, CA, USA.
J Hosp Infect. 2021 Apr;110:133-138. doi: 10.1016/j.jhin.2021.01.021. Epub 2021 Feb 5.
At present, the most frequent method for processing flexible gastrointestinal (GI) endoscopes is cleaning followed by high-level disinfection as terminal sterilization is often not practicable. Post-processing monitoring studies consistently show high levels of positive cultures remaining on endoscopes, which can lead to patient infection and even fatality. The processing deficiency is attributed to the complex design of endoscopes, incomplete cleaning, formation of biofilms and lack of margin of safety with high-level disinfection.
To demonstrate that flexible GI endoscopes can be practicably terminally sterilized.
An endoscope sterilization cycle was developed in a vaporized hydrogen peroxide sterilization system. The cycle was used to study the sterilization of flexible GI endoscopes which included colonoscopes and duodenoscope and material compatibility for both original flexible GI endoscopes and those experimentally modified endoscopes using compatible materials.
Testing demonstrated that the vaporized hydrogen peroxide can sterilize flexible GI endoscopes (colonoscopes, duodenoscope) with a sterility assurance level of 10. Additionally, no recoverable survivors were detected when devices were artificially soiled with hard water and serum. Material compatibility test results demonstrated that replacing molybdenum disulphide lubricant with a graphite-based inert lubricant can make them compatible with vaporized hydrogen peroxide sterilizers.
Flexible GI endoscopes can be practicably terminally sterilized using vaporized hydrogen peroxide sterilization technologies if their materials are revised to become compatible.
目前，处理软性胃肠道（GI）内窥镜最常见的方法是清洗后进行高水平消毒，因为终端灭菌通常不可行。事后处理监测研究一致表明，内窥镜上仍存在高水平的阳性培养物，这可能导致患者感染甚至死亡。处理不足归因于内窥镜的复杂设计、清洗不彻底、生物膜的形成以及高水平消毒缺乏安全裕度。
证明软性 GI 内窥镜可以实际进行终端灭菌。
在汽化过氧化氢灭菌系统中开发了一种内窥镜灭菌循环。该循环用于研究软性 GI 内窥镜（结肠镜和十二指肠镜）的灭菌，以及原始软性 GI 内窥镜和使用兼容材料进行实验性修改的内窥镜的材料兼容性。
测试表明，汽化过氧化氢可以对软性 GI 内窥镜（结肠镜、十二指肠镜）进行灭菌，其无菌保证水平为 10。此外，当设备用硬水和血清人工污染时，未检测到可回收的幸存者。材料兼容性测试结果表明，用基于石墨的惰性润滑剂替代二硫化钼润滑剂可以使它们与汽化过氧化氢灭菌器兼容。
如果软性胃肠道内窥镜的材料经过修改使其与汽化过氧化氢灭菌技术兼容，则可以实际进行终端灭菌。
