SCOPES: Murray Releases New Report Following Yearlong Investigation of Outbreaks in Washington State and Nationwide
Murray calls for policy changes to improve medical device monitoring and protect patients
Investigation outlines failures that led to infections in Washington state and around the country
Murray: I am going to keep fighting to protect patients
(Washington, D.C.) – Today, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) released a new report: “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.” The report is the result of a yearlong investigation, initiated by Murray in January 2015, into the cause of and response to outbreaks of antibiotic resistant infections linked to medical devices called duodenoscopes at Virginia Mason Medical Center and other hospitals nationwide.
Senator Murray’s staff investigation demonstrates that duodenoscopes spread life-threatening, antibiotic-resistant infections, including superbug infections, among patients in a number of hospitals throughout the United States and Europe in 2013 and 2014. It documents a systemic and unacceptably slow response to growing evidence that duodenoscopes could not be reliably decontaminated between patient use, and makes clear that FDA’s current system to monitor medical device safety is unable to effectively identify device problems when they occur, which poses an unacceptable risk to patients.
“Following the tragic impacts outbreaks have had on patients and families in my home state and across the nation, I made it my priority to ensure we fully understood how this could have happened in the first place, and what could be done to protect patients going forward,” said Senator Murray. “Patients should be able to trust that the devices they need for treatment are safe and effective. 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. This report lays out steps to address these failures and ensure FDA can appropriately respond to device safety issues, and I am going to continue fighting to protect patients.”
The report also recommends a series of legislative and regulatory changes to ensure the FDA is able to effectively monitor and evaluate the postmarketing safety of medical devices, including:
· calling on FDA to evaluate whether repairs to closed-channel duodenoscopes are necessary to prevent the spread of infections, and if so, requiring manufacturers to implement those repairs through a phased recall;
· requiring that unique device identifiers (UDI) be included in medical data to allow FDA to more quickly identify risks associated with a given device;
· and strengthening FDA guidance regarding clearance of modified medical devices by manufacturers.
Following a tragic outbreak of antibiotic-resistant infections linked to contaminated duodenoscopes at Virginia Mason Medical Center, Murray called for a full review of FDA practices surrounding duodenoscopes, and urged the agency to provide health care professionals with updated guidance and best practices. In June, Murray also pressed scope manufacturers linked to the outbreaks for answers and accountability.
