European Norms (EN)

The bacterium Clostridioides difficile is the most frequent pathogen of nosocomial diarrhoeal diseases worldwide and is also increasingly found in the outpatient sector. According to studies, 20 to 30 cases of community-acquired infections occur per 100,000 inhabitants every year. The pathogen appears in the form of vegetative cells and in considerably resistant spore form. When selecting C. difficile-effective procedures for reprocessing flexible endoscopes, various aspects must be taken into account.
The vegetative Clostridioides difficile cells survive gastric acid only at pH values > 4. Therefore, patients with atrophic gastritis or patients taking proton pump inhibitors or H2 antagonists are considered to be more at risk, because in these cases C. difficile cells could enter the intestine.
The spore form of C. difficile, on the other hand, is very resistant: it remains infectious on inanimate surfaces for up to 5 months, survives gastric acid even at a pH value of 1 and germinates in the small intestine within 1 hour. The C. difficile spore can therefore pass the stomach easily even at a low pH value and germinate in the small intestine in a fairly short time and thus be converted into a form capable of reproduction.
Against this background, a differentiated picture emerges for the risk of infection through endoscopes:
The spores of C. difficile have an enormous environmental resistance and can therefore only be inactivated using disinfection procedures with sporicidal efficacy.
Important for cleaning:
In the case of C. difficile, the already fundamental pre-cleaning of endoscopes is even more important. Mechanical removal of debris during pre-cleaning contributes to spore removal, especially in the narrow canals.
Important during disinfection:
In order to ensure the greatest possible safety, users should only use programmes for which procedural reports are available in accordance with the recommendations of EN ISO 15883-4:2008 (Washer-disinfectors - Part 4: Requirements and test for washer-disinfectors employing chemical disinfection for thermolabile endoscopes) or the guideline for the validation of automated washer-disinfectors for the reprocessing of thermolabile endoscopes from 2011.