The FDA yesterday released updated reprocessing instructions it received from Olympus (TYO:7733) in relation to its TJF-160F and TJF-160VF duodenoscopes.
Olympus has been working on refining its reprocessing instructions since March last year, the FDA said, and only in January did the agency clear the updated reprocessing models as adequate.
The updated reprocessing instructions include a more rigorous pre-cleaning protocol, manual cleaning and high-level disinfection procedures including additional flushing, brushing and increased flushing volume, according to an FDA safety communication.
Olympus sent a letter, dated for Monday, to health care facilities and other users of the duodenoscope models with updated cleaning processes, as well as new brushes to be used for the reprocessing procedure.
In January, the FDA said it cleared a redesigned version of Olympus‘ (TYO:7733) TJF-Q180V duodenoscope, with modifications intended to reduce the risk of bacterial infections.
The company said it won new 510(k) clearance for the TJF-Q180V model, for modifications to both the design and labeling of the device.
Duodenoscopes are used for endoscopic retrograde cholangiopancreatography procedures, in which the tube-like camera instruments are inserted into the throats of patients for a variety of different treatments, such as draining fluids from pancreative and biliary ducts blocked by tumors or gallstones.
More than 500,000 such procedures are performed in the U.S. annually – but in February and March 2014, hospitals in Connecticut, Virginia, California and Washington state reported superbug outbreaks related to the devices and procedures.
The changes come after the release a new report from the U.S. Senate’s health committee, which slapped blame on medical device companies and hospitals for deadly outbreaks of so-called “superbug” infections linked to the scopes.
