FDA faces more scrutiny in Congress over response to superbug outbreaks
Joining others in Congress, Sen. Patty Murray has called on the Food and Drug Administration to fully investigate medical scopes tied to recent superbug outbreaks at hospitals across the country.
Speaking at Senate Health, Education, Labor and Pensions Committee hearing Tuesday, the Washington Democrat asked FDA Commissioner Margaret Hamburg to conduct a “full review” of the duodenoscopes blamed for helping spread antibiotic-resistant infections.
UCLA’s Ronald Reagan Medical Center and, more recently, Cedars-Sinai Medical Center have reported patients being infected by contaminated scopes during a procedure known as ERCP.
Murray has been pressing the FDA for answers since January, when an outbreak that sickened more than 30 patients at Virginia Mason Medical Center in Seattle was disclosed.
At the hearing, Murray asked Hamburg if she would “commit to a full FDA review so we can fully understand how this happened and protect against it happening.”
Hamburg said a full review was underway and that the agency plans to hold an advisory committee meeting on the issue shortly.
“We are actively engaged in trying to come up with better strategies for disinfection and recommendations to increase the margin of safety,” she said.
“A lot of activities are going to be happening moving forward as we continue to try to strengthen the safety of patients and improve what are very important medical devices for care,” she added.
Hamburg, who is stepping down as FDA commissioner at the end of the month, also noted the importance of the medical instruments in question for ERCP, or endoscopic retrograde cholangiopancreatography.
Nationally, about 500,000 ERCP procedures are done annually.
The FDA has said that more harm would be done by removing the devices from the market because they are an essential medical tool for doctors and patients.
“Duodenoscopes are very important medical devices that serve a critical role in patient care,” Hamburg said at the hearing.
Last week, 10 House members -- six Democrats and four Republicans -- sent a four-page letter to the FDA demanding answers about what the agency knew about the infection risk beforehand and for how long.
One of the primary criticisms of the FDA is that it didn’t respond sooner to numerous red flags about the difficulty of cleaning the medical devices of antibiotic-resistant bacteria, such as CRE.
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