SCOPES: Murray Statement on Draft FDA Guidance Regarding Emerging Postmarket Device Signals

FDA announcement follows Murray’s call for full FDA review of scopes linked to deadly infections in Washington state 

(Washington, D.C.) – Today, U.S. Senator Patty Murray (D-WA), ranking member of the Senate Health, Education, Labor, and Pensions Committee, released the following statement on draft guidance from the FDA regarding emerging postmarket device signals, which could help raise awareness among doctors and patients about potential safety risks associated with medical devices.

“When the FDA becomes aware that there may be a safety risk associated with a medical device, doctors, patients, and families absolutely need to know as soon as possible. I’m glad that the FDA is taking steps to ensure doctors and patients have emerging safety information that could be critical to making informed treatment decisions, but there is much more that needs to be done. As I’ve made clear over the past several months, patients and families deserve to know that the devices used in their care are safe and effective, and that's what I'm going to continue fighting for."

Following a tragic outbreak of antibiotic-resistant infections linked to contaminated duodenoscopes at Virginia Mason Medical Center, Murray called for a full FDA review of practices regarding duodenoscopes and urged the agency to provide health care professionals with updated guidance and best practices. To read Murray’s March 2015 letter to the FDA, click here.