SEATTLE — At least 250 people, mostly in the United States, 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-Wash., the committee's ranking member.
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.