Standardizing manual cleaning of endoscopes: assessing the effectiveness of the AquaTYPHOON device

Endoscopic procedures carry a risk of infection, often due to inadequate cleaning of internal channels. Manual cleaning is essential but prone to human error. Automated systems are emerging to standardize this step, yet no specific performance standard exists for these 'pre-cleaning' devices, making their evaluation challenging.

To propose a standardized evaluation approach for automated endoscope cleaning devices based on existing ISO benchmarks, and to assess the cleaning efficacy of the AquaTYPHOON device, a chemical-free and brushless system on the market.

The AquaTYPHOON was tested using protocols from ISO 15883-4:2018 and ISO 15883-5:2021. Cleaning efficacy was evaluated on: (i) surrogate devices with Pseudomonas aeruginosa biofilm; (ii) complex surrogate devices soiled with blood; and (iii) endoscopes contaminated with Austrian test soil. Residual protein and total organic carbon (TOC) levels were measured post-cleaning and compared with action levels (6.4 μg/cm² for protein, 12 μg/cm² for TOC).

Across all test conditions, the AquaTYPHOON achieved protein and TOC levels below the action levels, except for one surrogate position. The device showed significant reduction of soil levels, meeting the efficacy requirements for endoscope cleaning before disinfection.

This study supports the feasibility of using ISO-based methods to evaluate automated pre-cleaning devices, and confirms the effectiveness of the AquaTYPHOON. Establishing clear performance criteria for such systems is essential to improve patient safety, reduce human error, and standardize endoscope reprocessing practices in clinical settings.