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[Validation of a sampling method for the channels of a flexible endoscope which is experimentally contaminated]
D Luu Duc1, J Shum Cheong Sing, H Soule
1Unité d'Hygiène Hospitalière, CHU, Grenoble, France.
Abstract:
The increase of endoscopic actions and infectious risks explains of interest in endoscopic material maintenance processing. This purpose study was to set to the point and validate a microbiological flexibles endoscopes channels (suction, biopsy, air/water) sample method. An inoculum made of faeces contents material and microorganisms suspension (Pseudomonas aeruginosa or Candida albicans), at low or high concentration, was injected into digestive endoscope's channels. For each microorganism, five trials were carried out at both of the two concentrations. After incubation, a global channels sample was performed with a recovering solution, then a counting was made. A variance analysis (ANOVA) concerning restated measures was performed for the whole results. The mean difference between the number of microorganisms injected and those recovered's is 0.114 log (IC95% [+0.088; +0.140]). It does not vary significantly according to the micro-organisms (p = 0.69) and the inoculum (p = 0.70). The coefficient of variation which is 0.525 (min: 0.010; max: 0.260) shows this method can be reproduced. This technique are allowed to be recommended to evaluate and to validate manuals and automatics endoscopes maintenance processing.
Insights
This study validates a new method for sampling flexible endoscope channels to assess cleaning effectiveness. The reproducible technique accurately quantifies microorganisms, ensuring patient safety by verifying proper endoscopic equipment reprocessing.
Area of Science:
- Microbiology
- Medical Device Reprocessing
- Infection Control
Context:
- Increasing endoscopic procedures necessitate robust methods for reprocessing flexible endoscopes to mitigate infection risks.
- Current validation methods for endoscopic equipment maintenance require precise microbiological assessment.
- Ensuring the sterility of endoscopic channels is critical for patient safety and preventing healthcare-associated infections.
Purpose:
- To develop and validate a microbiological sampling method for flexible endoscope channels (suction, biopsy, air/water).
- To assess the accuracy and reproducibility of the sampling technique using controlled inoculums of microorganisms.
- To provide a reliable method for evaluating the efficacy of manual and automated endoscope reprocessing.
Summary:
- A novel sampling technique was developed and validated for flexible endoscope channels, using controlled inoculums of Pseudomonas aeruginosa and Candida albicans.
- Microbiological analysis demonstrated a low mean difference between injected and recovered microorganisms, indicating high recovery rates.
- Statistical analysis confirmed the method's reproducibility and reliability, with a coefficient of variation of 0.525.
Impact:
- This validated sampling method can be used to rigorously evaluate and confirm the effectiveness of flexible endoscope reprocessing procedures.
- The findings support the implementation of standardized, evidence-based protocols for endoscope cleaning and disinfection.
- Improved reprocessing validation contributes to enhanced patient safety and reduced risks of endoscopic procedure-related infections.