麻豆传媒

In an updated safety communication, the to complete the transition from fixed endcap duodenoscopes to "innovative" designs, including fully disposable duodenoscopes and those with single-use components.

Duodenoscopes are used in more than 500,000 endoscopic retrograde cholangiopancreatography procedures each year in the U.S. Newer duodenoscope models can reduce the risk of patient infection compared with older fixed endcap models, which are no longer marketed in the U.S., but continue to be used by healthcare facilities.

In 2015, the FDA ordered manufacturers of reusable duodenoscopes to conduct postmarket surveillance studies to determine contamination rates due to features that made them difficult to clean. Final results from these studies found that up to 6.6% of samples tested positive for organisms of high concern after reprocessing.

Postmarket surveillance studies were again ordered in 2019 to determine if the new disposable endcap designs reduced contamination. Interim results for one model showed that only 0.5% tested positive for high-concern organisms.

"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 FDA noted.

"Emerging data ... suggests that the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or unnecessary," they added.

Transition programs were developed by duodenoscope manufacturers after the due to adhesive deterioration, which may increase the risk of contamination.

Pentax is also withdrawing two devices (ED-3490TK and ED34-i10T), while Fujifilm withdrew its fixed endcap duodenoscope (ED-530XT).

The FDA has currently cleared seven fully disposable duodenoscopes or models with disposable components.

The agency recommends that healthcare providers implement periodic maintenance and routine inspection schedules, per the manufacturers' instructions. In addition, reprocessing instructions should be "meticulously" followed, and a quality control program for sampling and microbiological culturing should be developed.

Furthermore, supplemental sterilization in accordance with device labeling should be considered.

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