Application of rapid read-out cleaning indicators for improved process control in hospital sterile services departments

Background: 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). Aim: To evaluate tAK indicators for routine process monitoring across a range of SSDs with different cleaning chemistries and different automated washer disinfectors (AWDs). Methods: 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. Findings: 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. Conclusion: 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.