Use duodenoscopes that are fully disposable or have disposable components, FDA recommends
Interim results from one duodenoscope model with a removable component showed a contamination rate of 0.5%, compared with as high as 6% among older duodenoscope models, an FDA safety communication noted.
On April 5, the FDA issued a safety communication providing new information supporting the transition to fully disposable duodenoscopes and those with disposable components.
Hospitals and endoscopy facilities should completely transition to innovative duodenoscope designs that include disposable components, such as disposable endcaps, or to fully disposable duodenoscopes, the FDA said, noting that the use of a removable component to facilitate cleaning leads to significantly less contamination. Interim results from one duodenoscope model with a removable component showed a contamination rate of 0.5%, compared with as high as 6% among older duodenoscope models, the agency noted.
“Duodenoscope manufacturers no longer market fixed endcap duodenoscopes in the US, and fixed endcap duodenoscopes still in use at healthcare facilities should be replaced with newer duodenoscope models,” the FDA said.