Date Issued: April 5, 2022
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.
- Do not cancel or delay any planned procedure without first discussing the benefits and risks with your health care provider.
Recommendations for Health Care Providers, including Hospitals and Endoscopy Facilities
- Use duodenoscopes that have disposable components or are fully disposable, if available at your facility. Disposable components may lower, but not eliminate, risks of infection.
- If your facility uses fixed endcap duodenoscopes, transition to newer models of duodenoscopes that have disposable components or are fully disposable. We recommend you contact duodenoscope manufacturer(s) for information about the newer duodenoscope designs. Some duodenoscope manufacturers are offering replacement programs to upgrade fixed endcap duodenoscopes to a model with a disposable component at no-cost.
- Follow the manufacturer’s instructions for the assembly of the disposable caps and distal ends.
- Develop schedules for routine inspection and periodic maintenance in accordance with the duodenoscope manufacturer's instructions.
- Ensure staff are meticulously following reprocessing instructions.
- Institute a quality control program that includes sampling, microbiological culturing, and other monitoring methods.
- Consider reprocessing with supplemental measures such as sterilization or use of a liquid chemical sterilant processing system consistent with the device's labeling.
- Monitor your reprocessing procedures. Examples of monitoring are sampling and culturing using the Duodenoscope Surveillance Sampling & Culturing: Reducing the Risks of Infection developed by the FDA-Centers for Disease Control and Prevention-American Society of Microbiology Working Group on Duodenoscope Culturing.
- Review the Recommendations for Patients and Caregivers with patients who have the affected devices.
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). They are used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving procedure to diagnose and treat problems in the pancreas and bile ducts. In the United States, duodenoscopes are used in more than 500,000 ERCP procedures each year.
Transition to New Models to Decrease Infections Related to Duodenoscopes
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:
- 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)
- 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:
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.
|Manufacturer||Final Results of 2015 522 Study||Interim Results of 2019 522 Study|
|Model||High Concern Organism Results||Model||High Concern Organism Results|
|Fujifilm||ED-530XT||Not completed, device withdrawn||ED-580XT||0.5%
(2/417, 57% study completion)
|Not completed, device withdrawn|
From the 2015 studies, all three duodenoscope manufacturers identified environmental contamination as a potential root cause of microbial contamination, suggesting increased care during handling and storage of 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 culturing studies noted above, each duodenoscope manufacturer was ordered to conduct postmarket surveillance studies to evaluate whether staff could understand and follow the manufacturer's reprocessing instructions for use (RIFU) in real-world healthcare settings. Failure to adhere to the RIFU may result in duodenoscope contamination. These studies are called human factors studies. The results of human factors studies on original RIFU of fixed endcap duodenoscopes suggested that users frequently had difficulty understanding and following manufacturers' RIFU and, as a result, were not able to successfully complete reprocessing.
The findings of those human factors studies were applied when duodenoscope manufacturers developed RIFU for their newer model duodenoscopes with disposable components. Additional human factors studies were conducted on those newer model duodenoscopes, and the results support that the RIFU for newer model duodenoscopes are 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 advance innovative ways to decrease infection related to duodenoscopes. Since we last shared an update in 2020, we have taken several actions:
- Posted the completed postmarket surveillance studies (also known as 522 studies) on the fixed endcap duodenoscopes as well as updated information on the transition to disposable duodenoscopes.
- Closed out Warning Letters to duodenoscope manufacturers regarding their 522 studies on the fixed endcap duodenoscopes.
- Cleared additional duodenoscopes: K202365 and K210710.
The FDA will keep the public informed if significant new information becomes available.
Reporting Problems with Your Device
If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.