Undisclosed superbug sickened dozens at Virginia Mason
An outbreak of multidrug-resistant superbugs spread by contaminated endoscopes infected at least 32 patients at Virginia Mason Medical Center between 2012 and 2014. Neither the hospital nor health officials notified patients or the public.
Seattle Times health reporter
An outbreak of drug-resistant superbugs spread by contaminated medical scopes infected at least 32 patients at Virginia Mason Medical Center in Seattle between 2012 and 2014, new reports show.
Eleven of those patients died, but it’s not clear what role, if any, the infections played, doctors said.
The rare bacteria likely were transmitted from patient to patient by specialized endoscopes, flexible tools used to treat pancreatic cancer and other gut problems, which had been cleaned according to manufacturers’ directions but still harbored the potentially deadly germs.
The Seattle outbreak appears to be among the worst so far in the U.S., where problems with dirty endoscopes have been tied to superbug infections in Chicago and Pittsburgh in recent years. Although the bacteria weren’t exactly the same, the situation raises new questions about the design, disinfection and regulation of the devices, critics charge.
Investigators found a rare type of multidrug-resistant bacteria on some scopes after disinfection that matched the same dangerous germs detected in dozens of already critically ill patients who had undergone a specific procedure.
Some of the bacteria were resistant to some carbapenem antibiotics, drugs of last resort, echoing other outbreaks of CRE — carbapenem-resistant Enterobacteriaceae — which may have a mortality rate as high as 50 percent, according to the Centers for Disease Control and Prevention.
Virginia Mason officials say they’ve overhauled their cleaning protocol for the devices, known as duodenoscopes, even though investigations by local and federal health officials found no breach in infection-control practice at the hospital.
“This makes us the safest place in the country to have this done,” said Dr. Andrew Ross, section head for the gastroenterology department.
Some patients may have been aware of their infections. However, neither the patients nor their families have been notified specifically about the outbreak or its source — not by Virginia Mason nor by Public Health — Seattle & King County. Officials said Wednesday there’s little the very sick people could have done in response to this information.
“Are you going to create unnecessary fear in the public about something we can’t do anything about?” said Dr. Chris Baliga, Virginia Mason’s medical director of infection prevention.
“Patients are at the same or higher risk all across the country,” said Dr. Jeffrey Duchin, King County interim health officer, who helped investigate the outbreak. “We didn’t feel like it was a new issue that warranted emergency notification.”
That couldn’t be further from the truth, said Lawrence F. Muscarella, a Philadelphia infection-control expert who has been monitoring endoscope-associated superbug outbreaks for several years.
“My concern now is that when we talk about there being a risk, there is no longer just a risk. It’s a reality. People are dying from it,” Muscarella said.
He’s worried that growing numbers of patients undergoing a special procedure known as endoscopic retrograde cholangiopancreatography, or ERCP, which examines and treats disease of the bile or pancreatic ducts, may be contracting the dangerous, hard-to-treat CRE infections spread by the medical devices.
Worse, Muscarella said, he’s convinced that the design of the scopes is to blame. The distal ends of the long, flexible scopes include so-called “elevator wire channels,” or tiny flaps that hold stents and other accessories — but may also harbor bacteria that can’t be cleaned, even with recommended disinfection techniques, Muscarella said.
That’s a view shared by officials at Public Health, Virginia Mason and the Centers for Disease Control and Prevention. In a report on Seattle’s outbreak, CDC officials said the complex design of the scopes “makes them difficult to clean with the potential for contamination persisting following reprocessing and subsequent transmission of pathogenic bacteria to patients.”
The CDC has reached out to officials at the Food and Drug Administration, which regulates medical devices. But so far, the FDA has issued no warning or recalls. Leslie Wooldridge, an agency spokeswoman, said the FDA is aware of and closely monitoring the association between CRE infection and reprocessed endoscopes.
But, she added, the design of the devices, including the elevator mechanism, allows changes in the angle of the accessory instruments that make certain treatments possible.
“The FDA feels that the lifesaving nature of ERCP, performed on more than 500,000 patients annually in the U.S., makes it important for these devices to remain available.”
The risk of infection is very low, she added.
News of the rare, multidrug-resistant infections at Virginia Mason was released this fall, more than two years after the first infections were detected, in a small abstract published at a conference of the Infectious Diseases Society of America.
Investigators with Public Health, Virginia Mason and the CDC said they’d identified at least 30 cases of a rare type of multidrug-resistant bacteria known as a hyper-AmpC producer, or HAC. Ten cases showed resistance to some carbapenem antibiotics, but most did not. That meant the infections were difficult, but not impossible to treat, doctors said. Seven patients died within 30 days of collection of the superbug samples, health officials said.
Investigators now say they have identified at least 32 cases and 11 deaths through March 2014, although they emphasize that the patients were critically ill, mostly with terminal pancreatic or colon cancer, and it’s not clear whether the superbug infections were to blame.
Since spring, however, Virginia Mason has taken steps to culture and quarantine all the duodenoscopes used in some 1,800 ERCP procedures performed there each year. Each device is held for 48 hours to make sure it’s free of CRE and other dangerous bugs.
Virginia Mason has bought 20 additional $37,500 devices made by the Olympus Medical System Corp., to allow time for some to be out of service.
“It’s way beyond what anybody else in the country is doing,” Duchin said. “We think that the steps they’ve put in place to culture and quarantine the scopes have been effective.”
CRE infections have been associated with scopes made by all three top manufacturers.
Art Caplan, a bioethicist at New York University’s Langone Medical Center, said hospital and public-health officials should have notified patients and the public about the outbreak far sooner.
“People have a right to know that’s intrinsic or inherent,” Caplan said. “If my spouse died because of an infected piece of medical equipment or dental equipment, I would like to know. I would even like to examine a lawsuit.”
Virginia Mason’s problem was first revealed by voluntary CRE surveillance conducted by state and local health officials, but the hospital is not alone in facing problems with potentially contaminated endoscopes, Duchin added.
“The truth is, nobody else is looking,” he said.
Dr. Michael Gluck, Virginia Mason’s chief of medicine, said the hospital would like to join groups putting pressure on the FDA and manufacturers to change the scopes to allow thorough cleaning.
“What we would like to see is a better design of the elevator,” he said.
Mark A. Miller, a spokesman for Olympus, said the firm is aware of reports of CRE infections after ERCP procedures and is “monitoring the issue closely.”
“All types of endoscopes require thorough reprocessing after patient use, and customers who purchase Olympus duodenoscopes, as with all of our products, receive instruction and documentation to pay careful attention to cleaning and reprocessing steps to ensure effective reprocessing,” he said in an email.
Meanwhile, health experts said patients who might need endoscopic exams or treatment, particularly ERCP procedures, should discuss the issue with their doctors.
The procedures carry risks and benefits that must be considered, Duchin said. The risk of transmission of a multidrug-resistant bug must be weighed against the risk of not receiving a necessary treatment.
“If you need the procedure because you have an obstructed biliary duct and are going to die without it, it’s worth the risk,” Duchin said.
Information in this article, originally published Jan. 21, 2015, was corrected Jan. 22, 2015. A previous version of this story incorrectly stated that at least 35 infections were identified at Virginia Mason Medical Center. King County health officials initially gave an incorrect number. At least 32 infections were identified in the county’s investigation. In addition, the story has been updated to clarify the type of drug-resistant bacteria detected.