As per the notification published on 30 June 2022, the culturing and sampling study for ED-580XT (duodenoscope with a disposable component) has been finished. According to the final findings for this more recent model duodenoscope, only 1.1 percent of samples tested positive for high concern organisms and 0 percent of samples tested positive for enough low concern species to suggest reprocessing failure.

This is much better when compared to 4 to 6% high concern organism contamination seen with similar types of duodenoscopes but with an older model.  Considering the above findings, the United States Food and Drug Administration (US-FDA) has revised April 2020 Safety Communication. FDA has included fresh data favoring the switch to completely disposable duodenoscopes and duodenoscopes with disposable components as well as fresh data on finished postmarket surveillance studies (also referred to as 522 studies).

Flexible, illuminated tubes called duodenoscopes are inserted via mouth, throat, and stomach and into duodenum (upper portion of small intestine). They are utilized in endoscopic retrograde cholangiopancreatography (ERCP), a therapy that can diagnose and treat pancreaticobiliary diseases and perhaps save lives.

Medical care facilities must finish making the switch to new duodenoscope designs that encompass disposable components like disposable endcaps or to entirely disposable duodenoscopes, taking into consideration the cleaning problems and contamination data with fixed endcap duodenoscopes and the elevating availability of duodenoscope models that expedite or minimize the requirement for reprocessing.

Using removable components to ease cleaning dramatically lowers contamination. The preliminary findings from 1 duodenoscope model with a detachable component illustrated contamination rate of about 0.5%, in contrast to prior duodenoscope models, that exhibited contamination rates as high as 6%. In comparison with older fixed endcap duodenoscope models, the utilization of modern devices may diminish infection risk for patients. In United States, fixed endcap duodenoscopes are no longer sold by duodenoscope manufacturers. Any fixed endcap duodenoscopes still in usage at medical care settings ought to be changed out for more recent models.

Advice for Patients and Caregivers

• Any planned surgery should not be abandoned or postponed without consulting the advantages and dangers with a medical care practitioner.

Suggestions for Hospitals and Endoscopy Facilities, encompassing Other Health Care Providers

• If available at the facility, duodenoscopes that are totally disposable or have disposable components should be used.
• Infection risk may be reduced, but not entirely eradicated, by disposable components.
• If the facility currently employs fixed endcap duodenoscopes, it must be changed to novel types of duodenoscopes that encompass disposable components or are totally disposable. For details on the newest duodenoscope designs, the manufacturer(s) of the device must be contacted. Few manufacturers can upgrade them for free to models with disposable components via replacement programmes.
• To assemble disposable caps and distal ends, the instructions of manufacturer must be meticulously followed.
• Create inspection and maintenance schedules in accordance with the duodenoscope's manufacturer's suggestions.
• Always check that staff is strictly adhering to reprocessing guidelines.
• Establish a quality control programme that blends use of microbiological culture, sampling, and other monitoring techniques.
• Reprocessing with additional procedures like sterilization or utilization of liquid chemical sterilant processing system in accordance with device's labelling may be an option.
• Reprocessing techniques must be supervised

Innovative and revolutionary device designs that make reprocessing simpler, more efficacious, or redundant are the best way to reduce the danger of disease transmission by duodenoscopes, according to recent research. Duodenoscopes having disposable parts can minimize contamination, are easier to clean, and are less likely to spread disease after reprocessing. In comparison to reusable or fixed endcaps, the disposable designs are valuable to lessen between-patient duodenoscope infection by half or more than half.

Duodenoscopes may comprise reusable, difficult-to-clean components and sophisticated designs. If a duodenoscope is not properly reprocessed, tissue or fluid from 1 patient might still be present when it is used on another patient. Rarely, this may trigger spread of a disease from patient to patient. A pivotal factor that contributes to reprocessing challenges is device design.

The manufacturers of duodenoscopes have created transition programs for moving to fully disposable duodenoscopes and those having disposable components. Till now, FDA has given clearance to 7 duodenoscopes with disposable components that boost reprocessing or are fully disposable. The FDA is still actively collaborating with reprocessing specialists, medical device producers, and other governmental organizations to establish creative approaches to mitigate infection associated with duodenoscopes.