An investigation by Sen. Murray into contaminated medical scopes at Virginia Mason Medical Center and other hospitals confirmed that these devices were spreading antibiotic-resistant bacteria or “superbugs”: LINK

Passed today 94-5 by the Senate, the 21st Century Cures Act includes Sen. Murray’s legislation to give the FDA authority to withhold premarket clearance of reusable medical devices, including medical scopes, that fail to meet key standards

Bill now headed to President’s desk to be signed into law 

Sen. Murray: We must continue working to combat the alarming rise of drug-resistant infections and to ensure all medical devices that patients need for treatment are safe and effective.  

(Washington, D.C.)Today, Senator Patty Murray (D-WA), the top Democrat on the Senate health committee, applauded the Senate passage of a bipartisan bill, the 21st Century Cures Act, which invests in a wide range of health care priorities, including measures pushed by Senator Murray to help protect patients and families from the growing threat of infection from antibiotic-resistant bacteria or “superbugs.” The Cures Act will provide additional tools to review and ensure the safety of reusable medical devices after a type of medical scope, known as duodenoscopes, were linked to life-threatening, antibiotic-resistant infections at Virginia Mason Medical Center in Seattle and other hospitals across the country.

An investigation led by Senator Murray into these incidents showed that manufacturers knew the medical scopes could not be reliably cleaned and could present a threat to patients’ lives. The bill includes legislation introduced by Senator Murray to give the Food and Drug Administration (FDA) clear authority to require that before manufactures go to market with their reusable devices, they must demonstrate that the devices can be reliably decontaminated between uses and remain safe. 

The bill also strengthens antimicrobial stewardship activities at the Centers for Disease Control and Prevention (CDC), and provides a new pathway to encourage the development of advanced antibacterial and antifungal drugs that can treat serious infections in patients with little or no options, such as those with drug-resistant infections. The Secretary of Health and Human Services will be required to review the overall use of these products, place clear labels and statements on these drugs in order to help ensure physicians use them appropriately, and monitor changes in bacterial resistance.

“Superbug outbreaks have had tragic impacts on patients and families in my home state and across the country, which is why I made it my priority to ensure the medical devices used on patients are safe and that we encourage the development of more effective antibiotic drugs,” said Senator Murray. There is much more work to do to combat the alarming rise of drug-resistant infections, and I hope we can build on this bipartisan bill with additional efforts to ensure we put the health and safety of patients and families first.”

More on Senator Murray’s work on duodenoscopes in Washington state below and HERE.

Following the January 2015 announcement of a tragic outbreak of antibiotic-resistant infections linked to contaminated duodenoscopes at Virginia Mason Medical Center in Seattle, Murray called for a full review of FDA practices surrounding duodenoscopes and other medical devices, urged the agency to provide health care professionals with updated guidance, and pressed scope manufacturers linked to the outbreaks for answers and accountability. Following the investigation that highlighted multiple weaknesses in the safety monitoring system for medical devices, Olympus recalled the medical scopes. The FDA then cleared a newly redesigned duodenoscope to improve patient safety.