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.