Senate Health, Education, Labor, and Pensions (HELP) Committee ranking member Patty Murray (D-WA) has 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 such as CRE linked to duodenoscopes at Virginia Mason Medical Center and other hospitals nationwide.
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,” says 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
- strengthening FDA guidance regarding clearance of modified medical devices by manufacturers
Following an 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 healthcare professionals with updated guidance and best practices. In June, Murray also pressed scope manufacturers linked to the outbreaks for answers and accountability.
Mark A. Miller, vice president of corporate and medical communications for Olympus Corporation of the Americas, released the following statement in response to the report: "For the past several months, Olympus has cooperated with the Committee staff by providing numerous documents, answering questions, and conducting a duodenoscope demonstration and briefing for the staff. We appreciate that the staff report noted Olympus' cooperation and that the report demonstrates the shared responsibilities of duodenoscope manufacturers, hospitals, manufacturers of automated endoscope reprocessors, and the Food and Drug Administration, each of which can contribute to increasing patient safety. Although we do not agree with all of the report's conclusions, we are closely reviewing the recommendations in the report as part of Olympus' ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes."