US Senate Investigation Over Duodenoscope Risk Concludes

Scope-CleaningWrapping up a U.S. Senate investigation, authorities have concluded that dozens of medical patients were, unfortunately, infected with potentially deadly bacteria from exposure to tainted to medical scopes. More important, outbreaks of this bacteria persisted because device manufacturers, hospitals, and state regulators failed to report related outbreaks.

Through the investigation, authorities said they found at least 25 outbreaks associated with the medical device known as the duodenoscope. This is several incidences more than they expected to find, which has prompted authorities to report that these countless flaws in federal government medical device oversight continues to put patients at high risk for death.

Senator Patty Murray (D-Wash), who had initiated a probe of the scopes and after dozens of patients grew ill at a Seattle hospital, notes, “Patients should be able to trust that the devices they need for treatment are safe and effective.”

She goes on to say, “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.”

This new report details how the leading device manufacturer—Olympus Coproration—already had some awareness of this potential flaw, since the spring of 2012 because of an earlier independent investigation of an outbreak in the Netherlands.

However, neither Olympus nor the US Food and Drug Administration warned hospitals in America about this potential problem. Or, rather, they did not mention their discovery until February of 2015, and only after a report of a superbug outbreak taking place at the UCLA Ronald Reagan Medical Center. In that incident, dozens of patients had potential exposure (more than 100, at least) and 3 died.

The duodenoscope device assists in several thousand—maybe hundreds of thousands of—procedures, in the United States. They are designed to drain fluids from pancreatic and bile ducts which have been blocked by cancer tumors or gallstones, or various other conditions. In a standard procedure, this small, flexible, illuminated tube can be threaded down the throat and into the stomach and small intestine. These are different from endoscopes because duodenoscopes have an “elevator” mechanism that allows the examination instrument more maneuverability to improve success in treatment.

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