March 23, 2017
A superbug outbreak at a foreign health facility has been linked to Olympus-made duodenoscopes that were recently redesigned to prevent such infections, according to the Los Angeles Times.
In the U.S., Olympus issued a voluntary recall of TJF-Q180V duodenoscopes in January 2016, asking hospitals to return the devices so the manufacturer could replace the scope’s forceps elevator mechanism with a new design that would be easier to clean. The recall came after contaminated scopes were linked to multiple outbreaks around the world.
Here are seven things to know about the most recent outbreak.
1. The most recent outbreak, which appears to have occurred in December 2016, was reported to the U.S. Food and Drug Administration by a foreign health professional. The facility’s location was undisclosed. The FDA report said the device had undergone modification in October 2016.
2. The newly reported outbreak involves five patients infected with Klebsiella pneumoniae, a gram-negative bacterium resistant to last-resort antibiotics. One of the patients has died, but the report cited the patient’s pre-existing condition as responsible for the death.
3. Lawrence Muscarella, PhD, an independent medical safety expert based in Montgomeryville, Pa., discovered the outbreak report in an FDA database. Dr. Muscarella said the outbreak calls into question the safety of the newly modified scopes, according to the LA Times.
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4. On Wednesday, Deborah Katz, a spokeswoman for the FDA, told the LA Times the federal agency is “aware of these reports and continues to investigate adverse events associated with duodenoscopes as appropriate.”
5. Olympus told the LA Times it had informed the FDA of the event. “In the interest of patient safety, it is premature to reach a conclusion regarding the cause,” said Mark Miller, an Olympus spokesman.
6. In January 2016, a U.S. Senate investigation estimated the number of infections caused by duodenoscopes between 2012 and 2015 to be roughly 250 and linked 25 outbreaks to scopes made by Olympus and two other companies. In April 2016, the FDA said it believes the hard-to-clean scopes caused closer to 350 infections between 2010 and 2015.
7. Currently, there are approximately 4,400 modified Olympus duodenoscopes being used in American hospitals, according to the LA Times.