The FDA announced today that it has cleared the updated design and labeling for Pentax ED-3490TK duodenoscopes and that the scopes will be recalled so the manufacturer can make design changes meant to reduce leakage of patient fluids — thus limiting the spread of infection — and update product operations manuals.
In 2015, the FDA issued a safety warning against Pentax and two other duodenoscope companies. The warning stated that a design flaw prevented the scopes, which are designed to be used on multiple patients, from being cleaned properly, creating an infection risk. Duodenoscopes are flexible, lighted tubes that threaded through the mouth, throat and stomach into the top of the small intestine (duodenum).
A subsequent Senate investigation revealed that dirty scopes were the direct cause of 25 infection outbreaks, sickening dozens of patients and leading to the death to at least 21 people . The FDA bore some of the blame for deciding to not alert the public to the threat  until after its 17-month investigation into the matter.
After the manufacturers revised their reprocessing instructions , the FDA in 2016 deemed the duodenoscopes safe for healthcare facilities to use again.
The FDA stated in today’s news release that since then it has been working with the manufacturers to “modify and validate their reprocessing instructions to further enhance the safety margin of their devices,” and “show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.”
Specifically, the FDA asked that Pentax reduce the potential for leakage of patient fluids into ED-3490TK’s closed elevator channel and under the distal cap.
Now that Pentax has done this, the FDA recommends that facilities acknowledge their Urgent Medical Device Correction and Removal notification disclaimer icon and identify affected products, return the field correction response form, and indicate if they do not have any affected duodenoscopes or operations manuals, and remove and dispose of older operations manuals once the new ones are received.
For more information on today’s news, check out the FDA’s official release here .