April 22, 2015 — Olympus Corp. warned hospitals in Europe about the risk of transmitting “superbug” infections on contaminated duodenoscopes in January 2013, but failed to warn hospitals in the United States.
The Los Angeles Times reports that Olympus sent two letters to hospitals in Europe warning them about potential risks associated with hard-to-clean scopes.
The first letter recommended using a specific cleaning brush for the TJF-Q180V duodenoscope, the same scope linked to deadly outbreaks of antibiotic-resistant infections at hospitals in Los Angeles, Seattle, and other cities.
The second letter was sent in August 2014 after reports of contamination on scopes that were disinfected.
However, Olympus did not issue similar warnings in the United States until earlier this year, just days after hospital officials reported that 179 patients at UCLA’s Ronald Reagan Medical Center were exposed to a “superbug” on the TJF-Q180V scope, including seven who were infected and two who died.
In March 2015, Olympus updated the cleaning protocol for the scope and recommended using the same cleaning brush that was recommended in Europe nearly two years earlier.
The FDA apparently knew about the letters issued in Europe but did not alert hospitals in the United States until issuing a Safety Communication in February 2015. The FDA also admitted that the TJF-Q180V scope has been on the market since 2010 without proper clearance. Olympus has twice failed to submit data proving that the scope can be cleaned to the FDA’s standards.