WIKIMEDIA, BRUCEBLAUSA type of intestinal imaging device, called a duodenoscope, has been linked to dozens of antibiotic-resistant infections in recent years, yet the device’s maker and the US Food and Drug Administration (FDA) were slow to report those cases. That’s the conclusion of a report from a Senate investigation led by Senator Patty Murry (D-WA), published this week (January 13).
“Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented,” Murray told The Los Angeles Times.
Olympus, the world’s largest producer of the duodenoscopes, knew of concerns about the ability to properly sterilize the devices back in 2013, according to the Senate’s report, but “never brought this information to FDA, and did not alert hospitals, physicians or patients in the U.S. to the risk of infection until February 2015.”
On top of that, hospitals that experienced drug-resistant infections associated with the duodenoscopes never contacted device manufacturers, and the FDA itself waited 17 months to alert hospitals, doctors, and the public to the ...
