Evaluation of a rapid quality control method for endoscope cleaning

Area of Science:

• Medical Device Reprocessing
• Infection Control
• Biomedical Engineering

Background:

• Endoscope reprocessing faces persistent contamination challenges, with over 21% of scopes exceeding limits in 2021.
• Effective cleaning and pre-treatment are crucial for endoscope safety.
• Current standards like ISO 15883-5 and AAMI guidelines inform cleaning efficacy evaluation.

Purpose of the Study:

• To evaluate the EndoCheck protein detection kit for assessing endoscope channel cleanliness.
• To compare the kit's performance against standard flush sampling methods.

Main Methods:

• The study involved two phases: performance testing (limit of detection, extraction efficiency, sensitivity) and real-use testing.
• Real-use testing compared the EndoCheck kit with a standard flush sampling method for endoscope cleanliness verification.

Main Results:

• The EndoCheck kit demonstrated high sensitivity, detecting low levels of protein contamination (≥5 μg BSA).
• Under real-use conditions, the kit identified 51% of endoscopes as non-compliant, significantly higher than the 14% detected by the flush method.
• Discrepancies were notable in bronchoscopes, suggesting variations in residual soil composition.

Conclusions:

• The EndoCheck kit is a sensitive and user-friendly tool for detecting residual protein in endoscope biopsy channels.
• Its stringent detection capabilities provide reliable negative confirmation of cleanliness.
• Positive results from the kit serve as crucial early indicators for further investigation and improved patient safety.