The Food and Drug Administration (FDA) has cleared Olympus' modified design and labeling of its TJF-Q180V duodenoscope that was linked to a superbug outbreak. The new design is intended to help reduce the risk of bacterial infections, the FDA said in an announcement. Meanwhile, the manufacturer will voluntarily recall its original model currently being used in healthcare facilities and make the needed repair as quickly as possible.
While awaiting repair, healthcare organizations can continue to use the Olympus TJF-Q180V, but must meticulously follow the manufacturer's reprocessing instructions, the FDA said.
Both manufacturers and the FDA were criticized in a recent federal report for failing to act quickly and notify hospitals and the public about the scopes' risk of spreading antibiotic-resistant bacteria. Announcement