Issue date: April 5, 2022
The United States 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 post-marketing surveillance studies (also called 522 studies).
Given the cleaning issues and contamination data with fixed-tip duodenoscopes and the increasing availability of duodenoscope models that facilitate or eliminate the need for reprocessing, hospitals and endoscopy facilities should complete the transition to designs innovative duodenoscopes that include disposable components such as disposable tips, or disposable duodenoscopes. Using a removable component for easy cleaning results in significantly less contamination; preliminary results from a duodenoscope model with a removable component show a contamination rate of only 0.5%, compared to older duodenoscope models that had contamination rates as high as 6%. The use of new duodenoscope models may reduce the risk of infection for patients, compared to older duodenoscope models with fixed hoods. Duodenoscope manufacturers no longer market fixed-tip duodenoscopes in the United States, and fixed-tip duodenoscopes still in use in healthcare settings should be replaced with newer models of duodenoscopes.
Recommendations for patients and carers
- Do not cancel or delay a planned procedure without first discussing the benefits and risks with your healthcare provider.
Recommendations for healthcare providers including hospitals and endoscopy facilities
- Use duodenoscopes that have disposable components or are completely disposable, if available at your facility. Disposable components can reduce, but not eliminate, the risk of infection.
- If your facility uses fixed hood duodenoscopes, upgrade to newer models of duodenoscopes with disposable or fully disposable components. We recommend that you contact the duodenoscope manufacturer(s) for information on new duodenoscope models. Some duodenoscope manufacturers offer replacement programs to upgrade fixed-tip duodenoscopes to a model with a disposable component at no cost.
- Follow manufacturer’s instructions for assembly of disposable caps and distal ends.
- Develop routine inspection and periodic maintenance schedules in accordance with the duodenoscope manufacturer’s instructions.
- Ensure staff follow reprocessing instructions meticulously.
- Review the Recommendations for patients and carers with patients wearing the devices concerned.
Description of the device
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the upper small intestine (duodenum). They are used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving procedure for diagnosing and treating problems with the pancreas and bile ducts. In the United States, duodenoscopes are used in more than 500,000 ERCP procedures each year.
Transitioning to New Models to Reduce Duodenoscope-Related Infections
Emerging data summarized below suggests that the best solution to reducing the risk of disease transmission from duodenoscopes is to design innovative devices that make reprocessing easier, more efficient, or unnecessary. Duodenoscopes that incorporate disposable components can facilitate cleaning, reduce contamination, and reduce disease transmission after reprocessing. Disposable designs can reduce duodenoscope contamination between patients by half or more compared to reusable or fixed tips.
Duodenoscopes have complex designs that may include reusable components that are difficult to clean. Failure to properly reprocess a duodenoscope may result in a patient’s tissue or fluids remaining in a duodenoscope when used on a subsequent patient. In rare cases, this can result in patient-to-patient disease transmission. Device design is a key factor contributing to reprocessing challenges.
Duodenoscope manufacturers have developed transition programs to transition to fully disposable duodenoscopes and those with disposable components:
- The Olympus TJF-180V duodenoscope is reminded due to adhesive deterioration which may present a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; Contaminated endoscope can pose a risk of infection to patients. Olympus America is offering customers of the older generation TJF-Q180V oscilloscopes a direct, free 1-to-1 replacement for the TJF-Q190V.
- Pentax is withdrawing the ED-3490TK and ED34-i10T.
- The Fujifilm fixed hood duodenoscope (ED-530XT) has been removed.
To date, the FDA has cleared seven duodenoscopes with disposable components that facilitate reprocessing or are completely disposable:
No longer marketed:
Reprocessing of duodenoscopes: results of post-marketing surveillance studies
In 2015, each manufacturer of reusable duodenoscopes (Fuji film, Olympus and Pentax) currently marketed in the United States has been ordered by the FDA to conduct post-marketing surveillance studies to determine contamination rates after clinical use and reprocessing of its fixed-hood duodenoscopes. Fixed-tip duodenoscopes have a plastic or rubber cap permanently bonded to the metal edges around the distal end to prevent tissue damage from the metal edges on endoscopes, but when permanently attached, the tips limit also accessibility to clean crevices at the distal end. In 2019, the FDA also issued postmarketing surveillance study orders to manufacturers of duodenoscopes with disposable tips to gather more information and verify that new designs reduce the rate of contamination.
Post-marketing surveillance studies aim to determine the actual contamination rates of duodenoscopes used in the clinic and serve as measures of reprocessing effectiveness. We have previously reported results from interim studies showing higher than expected levels of contamination.
Final results from post-marketing surveillance studies on fixed tip design indicate that up to 6.6% of samples tested positive for organisms of high concern after contamination. Organisms of high concern are defined as organisms that are more often associated with disease, such as E.coliand Pseudomonas contamination after reprocessing. As a result, Pentax and Olympus are retiring their fixed hood duodenoscopes from the market, and Fujifilm has completed the retirement of its fixed hood duodenoscope.
Studies are underway for duodenoscopes with removable components. Since August 12, 2021, the Fujifilm ED-580XT the duodenoscope with a removable hood collected 57% of the number of samples required. Interim results from this new duodenoscope model indicate that 0% of specimens tested positive for enough organisms of low concern to indicate reprocessing failure and only 0.5% tested positive for organisms of high concern.
|Maker||2015 Study 522 Final Results||Intermediate results of study 522 2019|
|Model||Results for organisms of high concern||Model||Results for organisms of high concern|
|Fuji film||ED-530XT||Not completed, device removed||ED-580XT||0.5%
(2/417, 57% completion)
|Not completed, device removed|
Based on 2015 studies, all three duodenoscope manufacturers identified environmental contamination as a potential cause of microbial contamination, suggesting that increased care when handling and storing reprocessed duodenoscopes is an important safety measure. Other common root causes include errors in following the reprocessing procedure and damage to the duodenoscope resulting in insufficient reprocessing.
In addition to the sampling and culture studies noted above, each duodenoscope manufacturer was instructed to conduct post-marketing surveillance studies to assess whether personnel could understand and follow the manufacturer’s reprocessing instructions for the (RIFU) in real healthcare settings. Failure to follow the RIFU may result in contamination of the duodenoscope. These studies are called human factors studies. Results from human factors studies on original RIFUs of fixed-hood duodenoscopes suggested that users often had difficulty understanding and following manufacturers’ RIFUs and, therefore, were unable to complete successful reprocessing.
The results of these human factors studies were applied when duodenoscope manufacturers developed RIFUs for their new duodenoscope designs with disposable components. Additional human factors studies have been conducted on these newer duodenoscope models, and the results confirm that the RIFU for the newer duodenoscope models is sufficient to achieve a high user success rate for user performance and knowledge of reprocessing tasks.
The FDA continues to actively work with reprocessing experts, medical device manufacturers, and other government agencies to come up with innovative ways to reduce duodenoscope-related infections. Since the last time we shared an update in 2020, we’ve taken several steps:
- Publication of completed post-marketing surveillance studies (also referred to as 522 studies) of fixed-hood duodenoscopes along with updated information on the transition to disposable duodenoscopes.
- Closed warning letters to duodenoscope manufacturers regarding their 522 studies of fixed-hood duodenoscopes.
- Additional duodenoscopes erased: K202365 and K210710.
The FDA will keep the public informed if significant new information becomes available.
Report problems with your device
If you believe you have had a problem with your device, the FDA encourages you to report the problem via the MedWatch voluntary reporting form.
Healthcare personnel employed by facilities subject to FDA user facility reporting requirements must follow the reporting procedures established by their facilities.
If you have any questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796- 7100.