CRE Outbreaks Draw Focus on ERCP, Device-related Infections
On Feb. 18, the University of California, Los Angeles Health System notified 179 patients of potential exposure to carbapenem-resistant Enterobacteriaceae during endoscopic procedures conducted at the Ronald Reagan UCLA Medical Center from Oct. 3, 2014, to Jan. 28.
Seven patients were confirmed to have infections, according to a UCLA statement, two of which may have contributed to the deaths of patients.
The health system reported that it followed national guidelines and sterilization standards specified by Olympus Medical Systems Group, the manufacturer of the instruments, and the FDA. Since then, separate cases of carbapenem-resistant Enterobacteriaceae (CRE) that followed a similar route of transmission have been reported at Cedars-Sinai Medical Center, Hartford Hospital, University of Wisconsin, Charité University Medicine and other institutions performing endoscopic retrograde cholangiopancreatography (ERCP).
Although these outbreaks would be enough to raise concern, the sudden spike in duodenoscope-related infections at major institutions also could be an indication that many more cases are going undetected, according to Venkataraman Raman Muthusamy, MD, director of interventional endoscopy at UCLA.
Venkataraman Raman Muthusamy
“My opinion is that this happens more often than we think,” Muthusamy told Healio Gastroenterology. “The sophisticated techniques that we used in our lab to confirm the duodenoscope-associated transmission of CRE are not available at many small hospitals, so it may be occurring, and they’re not able to detect it.”
Because of the increasing prevalence of CRE in a hospital setting, Muthusamy said tracing a specific route of transmission becomes more difficult for epidemiologists. In addition, the difficulty of removing CRE from devices often demands the full attention of hospital staff and infection control.
“The drug-resistant organism is the harbinger for us to recognize this,” Michael L. Kochman, MD, FACP, director of endoscopy training at the Perelman School of Medicine at the University of Pennsylvania and chair of the American Gastroenterological Association’s Center for GI Innovation and Technology, told Healio Gastroenterology. “It requires an active hospital surveillance system to be able to crosslink these rare and extremely concerning infections with procedures that may have been antecedent to these patients’ infections.”
While individual health care systems scrambled to identify and reduce the spread of infection, larger organizations also began to sound the alarm. After the news that the Olympus TJF-Q180V duodenoscope most frequently linked to these outbreaks did not apply for 510(k) clearance following modification, the FDA revised its guidelines for the approval of such reusable medical devices. Action was taken by the AGA, whose recently released practice recommendations highlighted the reduction of infection during ERCP and the importance of periodic culture surveillance of all reusable endoscopes.
“This series of infections that has occurred indicates a clear flaw in the reprocessing of these devices,” Kochman said. “Whether the flaw is surmountable by a change in the reprocessing technique, a redesign of portions of the duodenoscopes, or a change in the high-level disinfectant has yet to be seen. Some combination of the three is most likely.”
Although these changes may solve immediate device flaws, Muthusamy said further attention should be directed at the systematic review and approval of current and future devices.
“We need to come up with better ways to really document that we are doing what we say,” Muthusamy said. “It has come to my attention that the FDA relies on manufacturer data that says these are adequately able to be cleaned with the current process, and that you can get rid of the bacteria. It is my understanding that in the past they took them for their word, and that they actually don’t review the manufacturer data. So, a lot of this was more based on word of mouth and trust rather than a hard review of the evidence.
“In the future, I expect that the new techniques that we’re instituting to try to clean these scopes will be much more rigorously assessed.”
Despite these challenges, public attention stemming from these outbreaks should be seen as a benefit to the field, Muthusamy said. Before the cases at UCLA and other major institutions, little data were available concerning more complex infections resulting from ERCP. Along with a renewed focus on device function and approval, academic interest in this area could further refine what is already a successful life-saving procedure.
“Some data are now suggesting that even after scope reprocessing, 2% to 3% of scopes at Virginia Mason Hospital in Seattle were noted to have culture-positivity after they had undergone high levels of infection,” Muthusamy said. “Until this all happened, this kind of work wasn’t really being done to my knowledge, and certainly not being reported to the people that need to know about this.
“There are over 500,000 ERCPs done every year in the United States. It’s a procedure that has tremendous benefit and needs to be available broadly. It can’t be available at only a few university centers or major urban areas, and we must find ways to safely reprocess these instruments so this procedure remains available in a wide variety of practice settings.” – by Dave Muoio