Food and Drug Administration officials have issued new guidelines for device makers in the wake of “superbug” outbreaks tied to medical scopes in Seattle and across the nation.
Facing growing scrutiny over regulation of medical scopes linked to an outbreak of “superbug” infections at Seattle’s Virginia Mason Medical Center and across the nation, federal health officials Thursday issued long-awaited guidelines for design, disinfection and testing of the hard-to-clean devices.
The Food and Drug Administration (FDA) made final a 2011 plan that lists safety criteria that should be addressed in instructions for use of every device. Manufacturers also will be expected to conduct testing that validates that cleaning and disinfection or sterilization instructions will reduce nearly all microbial contamination — and to submit those tests to the FDA for review.
“This makes the testing more rigorous and provides a greater safety margin,” said Dr. William Maisel, the FDA’s chief scientist for the Center for Devices and Radiological Health.
In addition, FDA officials will hold a two-day meeting May 14 and 15 to gather expert opinion and public comment on the safety of the specialized endoscopes, which are used on thousands of Seattle-area patients every year, and about 500,000 nationwide.
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The moves follow growing criticism of the FDA’s oversight of the devices, known as duodenoscopes, which have been linked to the spread of sometimes dangerous infections among patients. The devices used to diagnose and treat problems with the pancreas and bile ducts include intricate parts with crevices where bacteria can linger, even after recommended cleaning and disinfection steps. The FDA warned last month that the scopes may transmit infections even after manufacturers’ cleaning instructions are followed.
In a Senate committee hearing this week, Sen. Patty Murray, D-Wash., asked FDA Commissioner Dr. Margaret Hamburg for a full agency review of the devices, after an earlier letter from Murray demanding FDA action on the problem. Hamburg said the agency learned of problems with transmission of drug-resistant infections linked to the devices in 2013.
But reports of potential problems with infections spread by scopes date back much further, critics say.
Murray applauded the FDA’s action Thursday, but she said more must be done to prevent infections like the outbreak at Virginia Mason.
“When someone gets sick, they must be able to trust not only their doctor to prescribe the best treatment, but also the FDA to ensure their treatment is safe and effective,” she said in a statement, adding: “I continue to be concerned about why these infections occurred in the first place and whether there is more we can do to prevent them from happening again. The FDA has committed to conducting a full review of these issues and I will continue monitoring that closely.”
In Seattle, the duodenoscopes were linked to an outbreak of multidrug-resistant E. coli infections tied to 32 infections between late 2012 and 2014. Eleven people in the outbreak died, though it’s not clear what role, if any, the superbug infections played in their deaths. That outbreak was first widely reported in January.
Since then, two Los Angeles hospitals and a hospital in Connecticut also have reported outbreaks associated with contaminated scopes.
Between 2013 and 2014, the FDA received 135 reports that microbial transmission from the scopes may have occurred, the agency said.
Critics, including doctors at Virginia Mason, have charged that the scopes should be redesigned to make them easier to clean This month, lawyers for a Seattle-area woman, Theresa Bigler, sued Virginia Mason and scope manufacturer Olympus America for damages linked to the 2013 death of her husband, Rick Bigler, 57, who was part of the Seattle outbreak.
The FDA has no authority to require Olympus or two other device manufacturers, Pentax Medical and Fujinon, to change the design, but the agency can withhold approval of updated or new applications to clear the scopes for market, Maisel said.
It’s a complicated problem because the scopes are used for lifesaving procedures known as ERCP, or endoscopic retrograde cholangiopancreatography. Without the devices, patients would have to undergo open surgery, with a much greater risk of potential problems, including infection. For that reason, the FDA declined to urge recalls of the devices, Maisel said.
“We believe the use of these devices outweighs the low risk of infection,” he said.
The final guidance released Thursday includes recommendations for several kinds of scopes, not just the duodenoscopes.
In addition to the FDA announcements, officials at the Centers for Disease Control and Prevention released interim protocol instructions for hospitals to conduct tests to determine whether potentially dangerous bacteria remain on the scopes after cleaning.
Virginia Mason launched a so-called test-and-hold protocol in 2014, after the outbreak was detected, in which the hospital cultures all ERCP scopes for bacteria and then quarantines them for 48 hours to determine whether germs remain. No infections have been identified since that system was put in place, and other area hospitals have adopted similar procedures.