After a “superbug” outbreak, Virginia Mason’s new protocol to stop the dangerous bacteria from spreading on medical scopes may be an option for other hospitals, a CDC official said.
Virginia Mason Medical Center’s new system to stop drug-resistant “superbugs” from being spread by contaminated medical scopes could soon be a model for other hospitals battling the potentially fatal infections nationwide.
Officials with the Centers for Disease Control and Prevention (CDC) say they’re developing a protocol that hospitals could use to detect bacterial contamination that may linger on devices known as duodenoscopes. They’re used in 500,000 procedures in the U.S. each year to treat problems with the pancreatic and biliary ducts.
The protocol includes a test-and-hold plan that calls for cleaning the scopes according to manufacturers’ directions, then culturing them for potential pathogens and quarantining them until they’re confirmed to be free of dangerous bacteria.
It’s a system that Seattle’s Virginia Mason launched in January 2014, after an outbreak of multidrug-resistant infections tied to the scopes infected 32 patients between November 2012 and early 2014. Eleven of the patients died, but it’s not clear whether the superbug infections were to blame.
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“Virginia Mason did pilot test a version of our culture protocol at their facility,” Dr. Alexander Kallen, a CDC infectious-disease expert and outbreak-response coordinator, said Tuesday by email. “This pilot provided valuable data about the process that has allowed us to refine the protocol.”
In the 13 months since then, the hospital has detected no new infections associated with duodenoscopes used for the procedures known as ERCP, or endoscopic retrograde cholangiopancreatography, said Dr. Andrew Ross, Virginia Mason’s section head for gastroenterology.
“We can make an initial assumption that this seems to achieve the end goal in that we do not place endoscopes in patients with any potential pathogens on them,” he said.
Virginia Mason officials didn’t initiate the procedure with the aim of becoming a CDC pilot study, Ross added. Instead, hospital officials were determined to stop the spread of dangerous bacteria during the procedures, which snake a lighted tube through the mouth, down the throat and into the gut.
Ross estimates the hospital spent at least $1 million to implement the new protocol for the 1,800 ERCP procedures performed at Virginia Mason each year. The hospital bought 20 new duodenoscopes manufactured by the Olympus Medical System Corp. at a cost of $37,500 each to stock enough scopes for rotation.
“There’s really no price that’s associated with increased patient safety,” Ross said.
CDC officials have been tracking infections spread by contaminated duodenoscopes since 2013, though reports of the problem date as far back as 2008. Between January 2013 and December 2014, at least 135 infections tied to the scopes were reported to the Food and Drug Administration (FDA).
In the most recent outbreak, contaminated devices spread infections to seven patients and contributed to two deaths at the University of California at Los Angeles Ronald Reagan Medical Center. Nearly 180 patients were warned they may have been exposed to the drug-resistant bacteria.
In that outbreak and others, the bacteria were identified as dangerous carbapenem-resistant Enterobacteriaceae, or CRE, which are resistant to front-line antibiotics.
In the Seattle outbreak, there were some carbapenem-resistant germs, but also unusual Hyper-AmpC producing E. coli, which were also drug-resistant.
The new CDC protocol could provide valuable guidance to other hospitals, Kallen said. “This might be an option for screening other facilities, but there are additional questions that need to be answered to ensure that the protocols are useful,” he said.
Last week, the FDA, which regulates medical devices, issued a safety-alert warning that duodenoscopes used for ERCP may not be able to be properly cleaned, even when manufacturers’ instructions are followed. In a blog posted Monday, the FDA’s Dr. William Maisel reiterated additional steps that echo the Virginia Mason effort.
“A duodenoscope that is suspected of being associated with a patient infection following ERCP should be taken out of service and meticulously cleaned and disinfected until it is verified to be free of pathogens,” wrote Maisel, who is the FDA’s chief scientist for its Center for Devices and Radiological Health.
Some hospitals, including UCLA, have relied on a toxic gas known as ethylene oxide to sterilize the scopes after cleaning. But Ross, at Virginia Mason, said it’s a procedure that’s fallen out of favor.
“EtO or gas sterilization is actually being removed from many medical centers — it’s a carcinogen that poses a danger to the staff,” Ross said. “It is not available in the Seattle area.”
However, Lawrence F. Muscarella, a patient-safety expert who has tracked problems with ERCP scopes, noted that there are concerns about the culture and quarantine plan, particularly in making sure the device is accurately and thoroughly tested for bacteria.
“This test-and-hold sampling procedure should only be performed by a skilled, knowledgeable microbiologist, and even then, the process can be more an art than a science,” he said. In fact, Muscarella said he favors the gas sterilization as a “valid, short-term fix.”
It’s a shame that it wasn’t done earlier” - Theresa Bigler
The CDC protocol is being drafted now, Kallen said. While the improvement is encouraging, it’s also bittersweet for patients and their families affected by the infections, said Theresa Bigler, of Woodway, north of Seattle.
Hospital officials chose not to tell patients or families they were part of the outbreak, but Bigler demanded to know. She learned last month that her 57-year-old husband, Rick Bigler, had a superbug infection in addition to pancreatic cancer when he died in August 2013. Perhaps, she said, this new protocol could have prevented that.
“It’s a shame that it wasn’t done earlier,” she said. “It’s better late than never.”