With the issue of inadequate and/or difficult endoscope cleaning attracting scrutiny from regulators worldwide, the TGA is urging Australian health professionals to be alert to the issue and potential changes to some devices’ Instructions for Use.
The issue has been particularly acute in the USA, where there have been many reports of duodenoscopes cross-contaminating patients with carbapenem-resistant enterobacteriaceae (CRE), a type of intestinal bacteria.
Duodenoscopes are a type of endoscope and their complex design makes them particularly challenging to clean and sterilise (reprocess) following procedures.
Transmission of CRE often results in colonisation that is asymptomatic for many months before causing clinical infection. Clinical infections due to CRE have a 40-50% mortality rate.