Microbiology Services Division, Health Protection Agency-Porton Down, Salisbury, UK.
J Hosp Infect. 2013 May;84(1):59-65. doi: 10.1016/j.jhin.2012.12.015. Epub 2013 Apr 4.
Heightened awareness of the importance of cleaning has led to an emphasis on automated systems for the decontamination of re-usable medical devices. The authors have previously described an enzymatic indicator system, based on thermostable adenylate kinases (tAK), for quantitative monitoring of automated cleaning processes within hospital sterile services departments (SSDs).
To evaluate tAK indicators for routine process monitoring across a range of SSDs with different cleaning chemistries and different automated washer disinfectors (AWDs).
tAK indicator devices and alternative industry test indicators were included in five independent cleaning cycles in each of eight different AWDs. Residual tAK post wash was determined by a coupled luciferase assay using a modified hygiene monitoring system.
In all cases, with the exception of a single test, the alternative indicators showed that cleaning had been adequate. They were not able to discriminate between the performance of different processes. In contrast, the tAK indicators were able to resolve differences in the performance of processes across the different SSDs. Where the tAK indicators identified cleaning to the limits of detection of the assay, this demonstrated a log10 enzyme removal factor of >5.69.
The results suggest that tAK indicators are suitable for providing improved process control for automated cleaning processes, being able to distinguish between wash performance in different hospital settings and between individual process runs. This technology is believed to be a useful addition to routine AWD performance qualification when used as a daily or weekly test.
人们越来越意识到清洁的重要性，这促使人们更加重视可重复使用医疗器械的自动化去污系统。作者之前曾描述过一种基于热稳定腺嘌呤激酶（tAK）的酶促指示剂系统，用于定量监测医院无菌服务部门（SSD）内的自动化清洗过程。
评估 tAK 指示剂在具有不同清洗化学物质和不同自动化清洗消毒器（AWD）的一系列 SSD 中进行常规过程监测的效果。
将 tAK 指示剂装置和替代行业测试指示剂包含在 8 个不同 AWD 中的每个 AWD 的 5 个独立清洗循环中。清洗后的残余 tAK 通过改良卫生监测系统使用偶联荧光素酶测定法来确定。
除了一个单独的测试外，所有情况下，除了一个单独的测试外，替代指示剂都表明清洗是充分的。它们无法区分不同过程的性能。相比之下，tAK 指示剂能够分辨不同 SSD 之间的过程性能差异。在 tAK 指示剂检测到清洗达到检测限的情况下，这表明酶去除率的对数为>5.69。
结果表明，tAK 指示剂适用于为自动化清洗过程提供改进的过程控制，能够区分不同医院环境中的清洗性能以及单个过程运行之间的差异。当用作日常或每周测试时，这项技术被认为是对常规 AWD 性能验证的有用补充。
