Use Duodenoscopes with Innovative Designs to Enhance Safety

The U.S. Food and Drug Administration (FDA) is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components as well as new information on completed postmarket surveillance studies (also known as 522 studies).

Given the cleaning concerns and contamination data with fixed endcap duodenoscopes and the increasing availability of duodenoscope models that facilitate or eliminate the need for reprocessing, hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components such as disposable endcaps, or to fully disposable duodenoscopes. The use of a removable component to facilitate cleaning leads to significantly less contamination; interim results from one duodenoscope model with a removable component show a contamination rate of just 0.5%, as compared to older duodenoscope models which had contamination rates as high as 6%. Use of the newer models of duodenoscopes can reduce the risk of infection for patients, compared to the older fixed endcap duodenoscope models. 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.

Read more at here.