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New Senate Report: Deadly Scope Infections Were Preventable

A new report by the U.S. Senate confirmed that the deadly infections tied to dirty scopes could have been prevented if hospitals, device manufacturers, and the U.S. Food and Drug Administration (FDA) were more proactive. The Congressional investigation also revealed that the outbreaks were far more prevalent than first reported.

As we have previously discussed on this San Diego Injury Blog, contaminated duodenoscopes have been linked to at least 25 different outbreaks of antibiotic-resistant infections and sickened at least 250 patients worldwide. In California, three patients died. All of the infected patients underwent endoscopy procedures at UCLA’s Ronald Reagan Medical Center.

According to the Congressional report, the infections were preventable, and there is a lot of blame to go around. The investigation concluded that Olympus, the device maker of 85 percent of the duodenoscopes used in the United States, knew that cleaning its closed channel duodenoscopes according to the manufacturer’s instructions failed to remove potentially dangerous bacteria. While Olympus was aware of the risk of infection in 2013, it did not alert hospitals and patients until February 2015, after the California outbreak made headlines.

The Senate report maintains that all three leading manufacturers of duodenoscopes “failed at every level to meet basic expectations of transparency and openness and to actively engage with FDA to address contamination issues.” The report added: “This disregard for the spirit, and sometimes the letter, of the law resulted in potentially preventable serious and potentially fatal illnesses in hospitals around the world.”

With regard to FDA oversight, the report states that the agency should have acted more quickly to investigate the link between the tainted medical devices and the deadly infections. Hospitals also neglected their duties, according to report. It notes that facilities that experienced outbreaks did not complete required injury reports, which could have alerted officials to the extent of the infections. “Not a single hospital that experienced infection outbreaks tied to the duodenoscopes appears to have sent the required adverse event form,” the report said.

“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,” said Sen. Patty Murray (D-Wash.), who commissioned the investigation.

As San Diego injury lawyers, we are also concerned. While patients should be able to trust that medical devices are safe and effective, manufacturers, regulators, and hospitals do not always take the necessary steps to protect the public.

If you or someone you care about has suffered serious harm due to a contaminated or otherwise defective medical device, don’t hesitate to contact a San Diego product liability lawyer at the Law Offices of Robert Vaage for a free consultation.