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.
Emerging data summarized below 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. 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.
Duodenoscopes have complex designs that may include reusable hard-to-clean components. Failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient remaining in a duodenoscope when it is used on a subsequent patient. In rare cases, this can lead to patient-to-patient disease transmission. Device design is a key factor that contributes to reprocessing challenges.
Duodenoscope manufacturers have developed transition programs to move to fully disposable duodenoscopes and those with disposable components:
The Olympus TJF-180V duodenoscope is recalled due to deterioration of the adhesive which may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients. Olympus America is offering customers with the older generation TJF-Q180V scopes a direct, no-cost 1 for 1 replacement with the TJF-Q190V.
Pentax is withdrawing ED-3490TK and ED34-i10T.
The Fujifilm fixed endcap duodenoscope (ED-530XT) has been withdrawn.
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)
No Longer Marketed:
- Pentax Medical, Duodenoscope model ED34-i10T (disposable endcap duodenoscope cleared under K163614 and K181522)
Reprocessing Duodenoscopes: Results from the Postmarket Surveillance Studies:
In 2015, each manufacturer of reusable duodenoscopes (Fujifilm, Olympus and Pentax) currently marketing in the U.S. was ordered by the FDA to conduct postmarket surveillance studies to determine rates of contamination after clinical use and reprocessing of its fixed endcap duodenoscopes. Fixed endcap duodenoscopes have a plastic or rubber cap permanently glued to the metal edges around the distal end to prevent tissue injury from the metal edges on the scopes, but when permanently affixed, the endcaps also limit the accessibility to clean the crevices at the distal end. In 2019, the FDA also issued postmarket surveillance study orders to manufacturers of duodenoscopes with disposable endcaps to gather more information and verify that the new designs reduce the contamination rate.
The postmarket surveillance studies are intended to determine the real-world contamination rates for duodenoscopes in clinical use and serve as measures of the effectiveness of reprocessing. We previously communicated interim study results demonstrating higher than expected levels of contamination.
The final results of the postmarket surveillance studies on fixed endcap design indicate that as high as 6.6% of samples tested positive with high concern organisms after contamination. High concern organisms are defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas contamination after reprocessing. As a result, Pentax and Olympus are withdrawing their fixed endcap duodenoscopes from the market, and Fujifilm has completed withdrawal of its fixed endcap duodenoscope.
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.
