At least 250 people, mostly in the U.S., were sickened with potentially deadly infections linked to contaminated medical scopes in the past three years, according to a new Senate committee report released Wednesday.
The number of infections, including those that sickened dozens at Seattle’s Virginia Mason Medical Center, is far higher than federal investigators previously estimated.
The report from the Senate Committee on Health, Education, Labor and Pensions was commissioned Sen. Patty Murray, D-Washington, the committee’s ranking member, following a yearlong staff investigation into outbreaks of antibiotic-resistant infections linked to the medical devices.
Between 2012 and spring 2015, at least 25 incidents of antibiotic-resistant infections linked to specialized duodenoscopes sickened at least 250 people worldwide — nearly double the 142 infections identified since 2010 by the federal Food and Drug Administration, The Seattle Times reported.
The new figures include the outbreak at Seattle’s Virginia Mason Medical Center, where 18 died between 2012 and 2014 after being infected with multidrug-resistant infections spread by scopes that could not be properly cleaned, even after following manufacturers’ directions.
“Patients should be able to trust that the devices they need for treatment are safe and effective,” Murray said in a statement. “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.”
The report recommends a number of legislative and regulatory changes. It urges Congress to adopt unique identifiers to better track medical devices, and it calls on the FDA to quickly evaluate scope design and implement a recall to fix or modify the tools.
“We appreciate the report from Senator Murray and will carefully consider its recommendations, many of which FDA is already taking steps to address,” FDA spokeswoman Deborah Kotz wrote in an email.
The report also found that at least 16 U.S. hospitals traced antibiotic-resistant infections directly to the devices, called duodenoscopes, but that the hospitals generally did not raise alarms about these infections with federal regulators.
The report found that by early 2013, Olympus, the manufacturer of 85 percent of the duodenoscopes used in the United States, knew that the scopes could harbor dangerous bacteria but didn’t warn U.S. hospitals until early 2015.
Olympus spokesman Mark Miller told the Times on Tuesday that it would be premature to comment without seeing the full report.
The devices are snaked down the throat and into the gut, where they’re used to diagnose and treat problems, including cancers and blockages in bile and pancreatic ducts. Tests by Virginia Mason and others found the closed channel at the end of the scopes retains bacteria, even after rigorous cleaning, and can spread germs among patients.
Gale Robinette, a Virginia Mason spokesman, told the Times that hospital officials were eager to read the report. “We will evaluate any guidance the report offers as an opportunity to further improve our processes. Patient safety and quality care are the highest priorities at Virginia Mason,” he said in an email.
