FDA is slow to respond
At least 250 people, mostly in the U.S., developed life-threatening “superbug” infections linked to contaminated medical scopes during the past three years — more than previously estimated by federal regulators, according to a new report from the Senate Health, Education, Labor, and Pensions (HELP) Committee. The report was the result of a year-long investigation, initiated by Senator Patty Murray (D-Washington) in January 2015, into the cause of and response to outbreaks of antibiotic-resistant infections linked to contaminated duodenoscopes at hospitals nationwide.
Murray’s investigation found that duodenoscopes spread life-threatening, antibiotic-resistant infections, including superbug infections, among patients in a number of hospitals throughout the U.S. and Europe in 2013 and 2014. Outbreaks occurred at hospitals in California, Connecticut, Florida, Illinois, Massachusetts, New York, North Carolina, Pennsylvania, Washington, and Wisconsin.
The new report documents a slow response by the FDA to growing evidence that duodenoscopes could not be reliably decontaminated between patient use, and makes clear that the agency’s current system to monitor medical device safety is unable to effectively identify device problems when they occur.
The report also recommends a series of legislative and regulatory changes to ensure that the FDA is able to effectively monitor and evaluate the post-marketing safety of medical devices, including:
- Calling on the agency 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 the FDA to more quickly identify risks associated with a given device.
- Strengthening FDA guidance regarding clearance of modified medical devices by manufacturers.
After an outbreak of antibiotic-resistant infections linked to contaminated duodenoscopes at Virginia Mason Medical Center, where 11 patients died, Murray called for a full review of FDA practices regarding these devices, and urged the agency to provide health care professionals with updated guidance and best practices. In June 2015, Murray also pressed scope manufacturers linked to outbreaks for answers and accountability.
Huntington Memorial Hospital in Pasadena, California, was among the other hospitals that said some of its patients contracted antibiotic-resistant superbugs linked to scopes. In August 2015, it notified public health authorities after several patients who had undergone procedures using Olympus duodenoscopes were found to have the bacteria.
“Patients should be able to trust that the devices they need for treatment are safe and effective,” Murray said in a statement.
By early 2013, Olympus, the manufacturer of 85% of the duodenoscopes used in the U.S., knew that the scopes could harbor dangerous bacteria but didn’t warn U.S. hospitals until early 2015, according to the new report.
Murray sought records from Olympus, Pentax Medical, and Fujifilm Medical Systems to understand ongoing concerns about the scopes used in approximately 700,000 procedures a year in the U.S., often to avoid invasive surgery.
Sources: HELP Committee(link is external); January 13, 2016; and Associated Press(link is external); January 13, 2016.
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