Preventing superbugs: FDA clears redesigned Olympus endoscope

The FDA today said it cleared a redesigned version of Olympus‘ (TYO:7733) TJF-Q180V duodenoscope, with modifications to both the device and labelling intended to reduce the risk of bacterial infections.

The redesigned endoscope from Olympus comes on the heels of 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.

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.

“We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices. The Olympus TJF-Q180V’s new design, as well as the new annual inspection program, is intended to reduce the risk of fluid leakage into the elevator channel, which in turn can reduce patient exposure to bacteria and other potential infections,” CDRH chief scientist Dr. William Maisel said in an FDA press release.

The modified scope is redesigned with a tighter elevator channel sealing mechanism to reduce the potential for leakage of patient fluids and tissues into the closed channel.

The company said it plans to perform annual inspections of each scope in use to identify wear and tear on the channel sealing mechanism or attached debris to the tip, and repair or replace potentially contaminated parts.

Olympus said it is voluntarily recalling the original model to be modified and repaired as “quickly as possible.” The company expects it will be able to correct the mechanism in 4,400 models in use by August 2016.

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