Endoscope Cleaning Verification Testing

Question:

What is endoscope cleaning verification testing?

Answer:

Cleaning verification is performed after manual cleaning and before an endoscope undergoes high-level disinfection (HLD) or sterilization. Its purpose is to detect residual organic soils that are not identifiable through visual inspection. Depending on the test, it may be checking for adenosine triphosphate (ATP), protein, carbohydrate, and/or hemoglobin. The goal of cleaning verification testing is to inform reprocessing technicians whether additional manual cleaning should be performed to further reduce soil levels on the endoscope. This is especially important given reported challenges in performing, and variability in time spent, manual cleaning [1 - 3].

Recognizing these challenges, some guidelines and standards now recommend or require the implementation of cleaning verification tests as part of quality control in reprocessing.[4] Residual soil can compromise the effectiveness of HLD and sterilization by forming a barrier that blocks disinfectants, vapor, or steam from contacting the device surface. Additionally, soil can promote biofilm formation, which may lead to persistent contamination [5 - 7].

By incorporating cleaning verification, end-users gain a measure of cleaning effectiveness. This data point can help determine whether manual cleaning is being performed thoroughly, supported by proper training and tools. However, not all cleaning verification tests are created equal. Facilities should carefully evaluate available products and consult relevant scientific literature when selecting a test. Key considerations include ease of use, compatibility with the facility’s workflow, and the benchmark or threshold values associated with the analyte. Always refer to the manufacturer's IFU for proper test execution and interpretation of results.

Sources and further readings

  1. Sivek AD, Davis J, Tremoulet P, et al. Healthcare worker feedback on duodenoscope reprocessing workflow and ergonomics. Am J Infect Control. 2022;50(9):1038-1048. doi:10.1016/j.ajic.2022.01.012.

  2. van der Ploeg K, Vos MC, Erler NS, et al. Impact of duodenoscope reprocessing factors on duodenoscope contamination: a retrospective observational study. J Hosp Infect. 2024;154:88-94. doi:10.1016/j.jhin.2024.09.018.

  3. Ofstead CL, Hopkins KM, Buro BL, Eiland JE, Wetzler HP. Challenges in achieving effective high-level disinfection in endoscope reprocessing. Am J Infect Control. 2020;48(3):309-315. doi:10.1016/j.ajic.2019.09.013.

  4. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities. AAMI; 2021. https://www.aami.org/st91.

  5. Johani K, Hu H, Santos L, et al. Determination of bacterial species present in biofilm contaminating the channels of clinical endoscopes. Infect Dis Health. 2018;23(4):189-196. doi:10.1016/j.idh.2018.06.003.

  6. Primo MGB, Tipple AFV, Costa DM, et al. Biofilm accumulation in new flexible gastroscope channels in clinical use. Infect Control Hosp Epidemiol. 2022;43(2):174-180. doi:10.1017/ice.2021.99.

  7. Ren-Pei W, Hui-Jun X, Ke Q, Dong W, Xing N, Zhao-Shen L. Correlation between the growth of bacterial biofilm in flexible endoscopes and endoscope reprocessing methods. Am J Infect Control. 2014;42(11):1203-1206. doi:10.1016/j.ajic.2014.07.029.