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FDA Recommends Use of Duodenoscopes With Innovative Designs to Enhance Safety

The agency is providing new information supporting the transition to fully disposable duodenoscopes and those with disposable components, as well as new information on completed post-market surveillance studies.

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The following is a summary of an FDA Safety Communication. To see the original post, click here.

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, the FDA states hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components, such as disposable endcaps, or 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%. Duodenoscope manufacturers no longer market fixed endcap duodenoscopes in the U.S., and fixed endcap duodenoscopes still in use at healthcare facilities should be replaced with newer duodenoscope models.

Emerging data suggests 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. Duodenoscopes that incorporate disposable components can facilitate cleaning, reduce contamination, and reduce disease transmission following reprocessing. Disposable designs may reduce between-patient duodenoscope contamination by half or more as compared to reusable or fixed endcaps.

To date, the FDA has cleared seven duodenoscopes with disposable components that facilitate reprocessing or are fully disposable:

Fully Disposable:

  • Ambu Innovation GmbH, Duodenoscope model aScope Duodeno (fully disposable duodenoscope cleared under K201098)
  • Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope (fully disposable duodenoscope cleared under K193202)

Disposable Components:

  • Fujifilm Corporation, Duodenoscope model ED-580XT (disposable endcap duodenoscope cleared under K181745)
  • Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V (disposable endcap duodenoscope cleared under K193182)
  • Pentax Medical, Duodenoscope model ED34-i10T2 (disposable elevator duodenoscope cleared under K192245 and K210710)
  • Pentax Medical, Duodenoscope model ED32-i10 (disposable elevator duodenoscope cleared under K202365)

Studies are in progress for duodenoscopes with removable components. As of August 12, 2021, the Fujifilm ED-580XT duodenoscope with a removable cap has collected 57% of the required number of samples. Interim results for this newer model of duodenoscope indicate that 0% of samples tested positive for enough low-concern organisms to indicate a reprocessing failure and only 0.5% tested positive with high-concern organisms.

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Healthcare personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.


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