FDA Issues Recommendation For Use Of Duodenoscopes With Disposable Components
Shortly following the recent United States Food and Drug Administration (FDA) clearance of the first duodenoscopes with disposable components, the bureau is now recommending that facilities move to the new models where available. The FDA firmly believes that a move to disposable parts, and in some cases fully disposable scopes, will help reduce infection risks. Poorly disinfected duodenoscopes have been linked to numerous cases of superbug outbreaks over the past several years.
The FDA has granted clearance to several disposable duodenoscopes and duodenoscopes with disposable components in the past several months. The manufacturers of these innovative models include Pentax Medical, Boston Scientific, Olympus and Fujifilm. As this safety communication from the FDA explains:
“Duodenoscopes play a vital role in the assessment and treatment of diseases and conditions of the pancreas and bile ducts, and are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures each year in the U.S. These devices have complex designs that 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.
The FDA takes the risk of patient infection very seriously and continues to take steps to help improve the effectiveness of duodenoscope reprocessing. Today, we are sharing the following recommendation and updates:
- We are now recommending that hospitals and endoscopy facilities transition away from fixed endcap duodenoscopes to those with newer design features that facilitate or eliminate the need for reprocessing. Please note, we recognize that a full transition away from conventional duodenoscopes to the newer, innovative models will take time.
- We continue to work with manufacturers to increase the supply of disposable cap duodenoscopes and the development of other new and innovative device designs that will further minimize or eliminate the risk of patient infection.
- We continue to address challenges with current reprocessing methods and support expanding the types of validated methods available to reprocess duodenoscopes.
Patients: Important Recommendations
- Be aware that the risk of infection from inadequate reprocessing is relatively low.
- Do not cancel or delay any planned procedure without first discussing the benefits and risks with your health care provider.
Hospitals and Endoscopy Facilities: Important Recommendations
- Consider using duodenoscopes that have disposable components, if available at your facility; this design may lower but not eliminate risks of infection.
- Ensure staff are meticulously following reprocessing instructions.
- Institute a quality control program that includes sampling and 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.
- Develop schedules for routine inspection and periodic maintenance in accordance with the duodenoscope manufacturer’s instructions.
Transition to Duodenoscopes with Innovative Designs that Can be Reprocessed More Effectively
Device design is a key factor that contributes to reprocessing challenges. The FDA believes 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. For example, 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 as compared to reusable, or fixed endcaps.
To date, the FDA has cleared five duodenoscopes with disposable components that facilitate reprocessing:
- 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-i10T (disposable endcap duodenoscope cleared under K163614 and K181522)
- Pentax Medical, Duodenoscope model ED34-i10T2 (disposable elevator duodenoscope cleared under K192245)
Because of our concerns of high contamination rates associated with conventional, fixed endcap duodenoscopes, we have asked each duodenoscope manufacturer to transition away from fixed endcap duodenoscopes to those with more modern design features that facilitate or eliminate the need for reprocessing. Hospitals and endoscopy facilities should transition to innovative duodenoscope designs that include disposable components such as disposable endcaps, or to fully disposable duodenoscopes when they become available.
We recognize that an immediate transition away from conventional duodenoscopes to the newer, innovative models will take time due to cost and market availability. We encourage health care facilities purchasing new duodenoscopes to begin developing a transition plan and work to replace their conventional duodenoscopes with newer models.
ERCP procedures performed with duodenoscopes are often life-saving and the benefits continue to outweigh the risks for appropriately selected patients. The continued availability of duodenoscopes to perform these procedures remains a critical public health need.”
Read the entire communication here: The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
While the transition from rigid end caps, to disposable end caps and elevators to now fully disposable duodenoscopes takes place, hospitals must design a standard protocol that ensures maximum disinfection of duodenoscopes after each use. Hospitals must also implement systems and processes that allow them to check that staff are following their protocols and documenting their steps for regulatory purposes, such as Joint Commission surveys. Systems such as iRIScope can display the proper workflow for reprocessing duodenoscopes and other endoscopes and document the individual steps automatically. Any breaches of protocol can be alerted in real-time to protect patients and identify which staff members need additional training on reprocessing techniques. You owe it to your staff and your patients to offer the peace of mind that duodenoscopes and all other flexible endoscopes are being properly reprocessed every single time.