Hospitals and government officials are racing to address the threat posed by antibiotic-resistant superbug Carbapenem-resistant Enterobacteriaceae (CRE), which grabbed headlines late last week when reports surfaced that two California patients died after coming into contact with contaminated medical scopes, and now has been linked to two more patient deaths in North Carolina.
In response to the recent outbreak at UCLA's Ronald Reagan Medical Center, which sickened five patients and killed two, the Food and Drug Administration (FDA) on Thursday issued a warning about specialized devices called duodenoscopes, which are used for procedures performed on patients with digestive system disorders, gallstones and certain types of cancers, FierceHealthcare reported. The warning advised hospitals that the design of the devices can hinder effective cleaning, even if they are cleaned according to manufacturer standards.
In addition to the patients infected in UCLA--as well as other outbreaks in recent years in Pittsburgh, Seattle and Chicago--the superbug also has infected 18 patients in North Carolina this year, two of whom died, the Charlotte Observer reported. Fifteen of the affected patients had existing CRE conditions and three contracted the bacteria at Carolinas HealthCare System hospitals, according to the newspaper.
While the UCLA hospital responded to its outbreak by switching to gas sterilization of its duodenoscopes, Carolinas HealthCare has started to screen patients from populations likely to have CRE as well as isolate infected patients and decontaminate their rooms after they're released, the Observer reported. North Carolina hospital adminstrators say they use "standard methods" to disenfect equiptment, according to CNN.
Both infection prevention methods have their limits, however. The ethylene-oxide gas used in gas can be highly toxic to employees and patients, which can require hospitals to resort to the time-consuming method of outsourcing the cleaning of duodenoscopes, according to the L.A. Times. As for screening patients for CRE, Lisa McGiffert, director of the Safe Patient Project at Consumers Union, told National Public Radio that "I find it highly unlikely that many hospitals are doing that."
In addition, NPR reported, only 10 states monitor the prevalence of superbugs like CRE outside of healthcare facilities, and the federal government does not publicly report CRE infection rates at individual hospitals.
For its part, the Centers for Disease Control and Prevention issued a statement Friday that re-emphasized the threat posed by what it has previously dubbed a "nightmare bacteria," noting that "while CDC has warned about CRE for more than a decade, new information shows that these germs are now becoming more common." The agency also is working on a new set of guidelines for how to properly use and clean duodenoscopes, Reuters reported, leading one expert to question why the FDA itself has yet to issue stricter regulations.
"If the CDC, which does not have regulatory authority, is doing more than the FDA, which does have that authority, it raises the question of who's running the ship here," Lawrence Muscarella, an endoscopy consultant and author of a 2014 paper on duodenoscopes' pathogen-transmission risk, told Reuters.