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FDA Warns Endoscope-Makers for Delaying Infection Reports

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August 17, 2015 — The FDA has issued warning letters to all three major endoscope manufacturers, including warning Olympus Corp. for waiting years to report an outbreak of bacterial infections.

In May 2012, Olympus was notified that 16 patients were infected with the bacteria Pseudomonas aeruginosa after undergoing endoscopic procedures, according to the warning letter. However, the outbreak was not reported to the FDA until May 2015.

The FDA also issued warning letters to Fujifilm and Pentax.

Pentax also failed to report that their scopes were linked to cases of antibiotic-resistant Carbapenem-resistant Enterobacteriaceae (CRE) infections within 30 days, as is required by law. Olympus scopes were linked to deadly outbreaks of CRE at hospitals in Washington and California earlier this year.

There also seems to be a problem with unapproved scopes. The Olympus duodenoscope linked to several deadly infection outbreaks had been on the market since 2010 without proper clearance.

According to the warning letters, Fujifilm’s newest endoscope does not have permission to be on the market. Pentax may also have an unapproved scope on the market, according to Bloomberg.

 

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