An FDA advisory panel last week declared that duodenoscopes, linked to sometimes lethal antibacterial-resistant outbreaks across the U.S., are unsafe as designed.
The panel urged the FDA to act on this information, but didn’t ask for a halt to further use of the devices.
“We have heard enough data to say these devices are not safe using current conditions. Everyone in this room is a potential patient, and no one would accept anything other than a device free of pathogens,” panel member Dr. Irving Nachamkin of the University of Pennsylvania told the LA Times.
The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs using the devices are performed in the U.S. annually.
“We need to take steps to assure [patients] – and health providers that perform the procedures – that this procedure can be done as safely and effectively as possible,” acting FDA commissioner Dr. Stephen Ostroff said.
Olympus (TYO:7733), the largest manufacturer of duodenoscopes, issued an urgent advisory in March for new cleaning procedures for the devices, which have been linked to multiple outbreaks, infections and deaths across the U.S. Fujifilm Holdings (TSE:4901) and Hoya Corp.‘s (TYO:7741) Pentax subsidiary also make commonly used duodenoscopes.