The U.S. Justice Department is investigating the manufacturer of the medical scopes linked to a spate of hospital superbug outbreaks, according to the Los Angeles Times.
Olympus Corp. said the DOJ subpoenaed it in March, according to the article, and attorneys representing Seattle's Virginia Mason Medical Center said the hospital also received a subpoena seeking several years' worth of communication and information relating to the company's duodenoscopes.
The devices' design makes them susceptible to bacteria collecting at the tip, and Food and Drug Administration officials told Reuters in March that the cleaning process Olympus recommends may not adequately sterilize them. This adds to several lawsuits and federal inquiries involving Olympus, which did not disclose the infection risks its scopes posed until after the L.A. Times reported that Olympus scopes may have exposed up to 179 UCLA patients tocarbapenem-resistant Enterobacteriaceae (CRE) bacteria. In contrast, Olympus issued a safety alert to its European customers in January 2013.
"Who knew what and when did they know it about these risks?" said Lawrence Muscarella, a hospital safety consultant in Montgomeryville, Pennsylvania, according to the L.A. Times. "We don't know how wide the Justice Department is casting its net."
Olympus controls the vast majority of the scope market in the U.S., according to the article, and federal health officials said 6 of 9 U.S. superbug outbreaks involved Olympus products. Hospitals in California, North Carolina, Seattle, Pittsburgh and Chicago have reported sometimes-deadly outbreaks of CRE tied to used of duodenoscopes, FierceHealthcare has reported.
Pentax Medical, another scope manufacturer, would neither confirm nor deny whether it was the subject of a similar investigation. The DOJ was already in the process of investigating accusations that Olympus improperly marketed to doctors and other clients in the period from 2006 to 2011. The company confirmed earlier in May it has set aside $450 million, anticipating a settlement of the earlier investigation.
The recent outbreaks tied to Olympus have highlighted the increased need for effective infection control in healthcare settings, with data from the Centers for Disease Control and Prevention indicating 1 in 25 hospital patients acquires at least one hospital-associated infection.
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