The following is a shortened, incomplete version of an article originally published by The Seattle Times on August 10, 2015. An updated version of this article was then subsequently posted the next day. Click here to read in its entirety the Times’ updated article, which is entitled “VA can’t rule out ‘superbug’ infections tied to dirty scopes”.
BREAKING — Dozens of patients treated with specialized medical scopes at nearly 40 VA centers between 2010 and 2015 tested positive for multidrug-resistant infections, and officials said they couldn’t rule out the possibility that the devices may have been a factor in some cases.
Potentially deadly “superbug” infections like those spread by contaminated medical scopes at civilian hospitals in Seattle and elsewhere may have occurred at U.S. Veterans Affairs medical centers as well — though the risk is very low — a federal investigation has found.
This federal probe’s report may be read by clicking here.
Nearly 100 patients treated with specialized medical scopes at nearly 40 VA centers between 2010 and 2015 tested positive for multidrug-resistant infections known as CRE, and officials said they couldn’t rule out the possibility that the devices may have been a factor in at least a dozen cases.
We cannot definitively rule out the possibility that these patients developed their infection as a result of their procedure, however, as there were no additional patients found at these sites, there was not a clear linkage to a duodenoscopy procedure.” — Department of Veterans Affairs
However, officials with the Veterans Health Administration Office of Public Health reported that an analysis of more than 40,000 patient records found no widespread evidence of the problem, and concluded that “any transmission appears highly unlikely.”
The investigation results, released in response to a public-records request by The Seattle Times, are the VA’s first acknowledgment that infections tied to hard-to-clean duodenoscopes — similar to those detected at Seattle’s Virginia Mason Medical Center — may have occurred within the veterans’ medical system.
Previously, VA officials in Washington, D.C., said they didn’t know whether any infections from carbapenem-resistant Enterobacteriaceae, or CRE, tied to the scopes had occurred at federal centers. Local officials said none had been reported.
“There have been no CRE infections at any VA facility, according to the National Office of Sterile Processing,” Chad Hutson, a spokesman for the VA Puget Sound Health Care System, said in a March 4 email, noting he was referring to local sites.
A patient-safety advocate and prominent critic of the scopes called the VA report “a bombshell” in light of the agency’s previous position.
“The VA’s statement raises questions about what the VA knew and when they knew it,” said Lawrence F. Muscarella, a Philadelphia expert on contaminated duodenoscopes.
The new analysis of nearly 56,000 procedures in more than 40,000 veterans between January 2010 and February 2015 detected nearly 5,000 CRE isolates in 2,300 patients.
Note: The text of this article, which was originally published by The Seattle Times on August 10, 2015, is incomplete. Click here to read the Times’ updated article, dated August 11, 2015, in its entirety.
“We cannot definitively rule out the possibility that these patients developed their infection as a result of their procedure, however, as there were no additional patients found at these sites, there was not a clear linkage to a duodenoscopy procedure,” the report said.
(This duodenoscopy procedure is often referred to endoscopic retrograde cholangiopancreatography, or ERCP.)
There were several limitations to the report, including uncertainty over whether all VA centers were correctly identifying CRE, inability to use molecular fingerprinting to determine whether patients were infected with the same strain of bacteria, and lack of consistency in identifying the make and model of the scopes.
The VA launched an investigation this past spring into about 150 medical centers and associated sites after reports of outbreaks of multidrug-resistant infections at hospitals in Seattle, Los Angeles and elsewhere tied to the scopes. Health officials determined that the devices could not be cleaned even after medical staff followed manufacturers’ directions.
Note: The majority of these duodenoscopy procedures performed within the VA medical system most certainly used the Olympus TJF-Q180V duodenoscope, which has been on the market in the U.S. since 2010. This model’s design has been implicated in a number of superbug outbreaks, both in the U.S. and Europe.
Yet, to date, it has not received a legal clearance or approval from the FDA. This duodenoscope’s safety and effectiveness, therefore, cannot be assured. Click here to read a CNN report discussing this device’s regulatory status.
To date, no potentially infected patients within the VA medical system have been informed of the increased risk of deadly superbug infections following ERCP.
VA officials did not disclose the locations of the 39 medical centers with CRE-infected patients. But Hutson, spokesman for the Puget Sound center, said no infections tied to ERCP have been reported at that site.
In fact, it is possible that the risk of CRE infections following ERCP is relatively high. — Lawrence F Muscarella, PhD, healthcare expert and infection control preventionist.
The federal Food and Drug Administration and the Centers for Disease Control and Prevention have issued guidelines aimed at helping hospitals prevent the spread of infections by contaminated scopes. Last week, the FDA issued additional guidelines, while also acknowledging that it might be impossible to clean the scopes as they’re designed.
FDA officials and now VA officials have said that the risk of contracting deadly infections is low. FDA officials say that the benefits of using the duodenoscopes outweigh those risks, and that they’re lifesaving procedures in people who need them.
But Muscarella noted that the VA report is more evidence that there could be more potentially deadly infections tied to the devices than suspected.
“In fact, it is possible that the risk of CRE infections following ERCP is relatively high,” he said.
JoNel Aleccia: 206-464-2906 or jaleccia@seattletimes.com. On Twitter @JoNel_Aleccia
* The original version of this Seattle Times article of the same title was published on August 10, 2015. The Times subsequently updated this article on August 11, 2015, to include additional insights and more quotes. Its most current, updated version can be read in its entirety by clicking here.
Quality and Safety Services for Hospitals, Manufacturers, Patients: Click here to read about Dr. Muscarella’s quality services committed to reducing the risk of healthcare-associated infections, including CRE outbreaks linked to contaminated endoscopes and other reusable medical equipment.
Posted on August 12, 2015; updated August 14, Rev A. By: Lawrence F Muscarella, PhD: LArry@LFM-HCS.com. On Twitter @MuskiePhD