The FDA has cleared for marketing the first duodenoscope with a sterile, disposable elevator component, which will reduce the number of device parts that need to be cleaned and disinfected in between uses, the agency announced on Nov. 15.
While the FDA has previously cleared duodenoscopes with removable endcap components, the Pentax Medical Video ED34-i10T2 model duodenoscope is the first device with a disposable elevator component, a part that has been traditionally difficult to clean and reprocess. It is intended to be used with endoscopic devices, and its risks include the potential for injuries, including burns, electric shock, perforation, infection, and bleeding.
The FDA has previously issued communications to health care facilities about following appropriate steps for safely reprocessing duodenoscopes between uses. In August, the agency published a safety communication recommending that duodenoscope manufacturers and health care facilities transition to duodenoscopes with disposable components, which can simplify or eliminate the need for reprocessing certain components and may reduce between-patient duodenoscope contamination.