The FDA has released updated information on automated endoscope reprocessors identifying which manufacturers have completed Automated Endoscope Reprocessors (AER) validation testing with adequate results. AERs are important devices widely used in the health care setting to reprocess endoscopes, such as duodenoscopes, and endoscope accessories, to decontaminate them between uses. According to the FDA, in the United States, there are five companies that manufacture AERs labeled to reprocess duodenoscopes currently in use in health care facilities.
This table lists the manufacturers and AER models that have completed the updated high level disinfection or liquid chemical sterilization validation testing with duodenoscopes.
FDA also released guidance on Tuesday detailing which medical devices present a clear potential for serious harm and should have premarket submissions from manufacturers that include human factors data to help evaluate safety and effectiveness. Included on the list are duodenoscopes with elevator channels and gastroenterology-urology endoscopic ultrasound systems with elevator channels.
The ACG News Team