The Cedars-Sinai Medical Center in Los Angeles is the latest to report an outbreak of the CRE superbug. At least 4 patients at the facility were infected, and 67 others may have been exposed; contaminated medical devices called duodenoscopes are believed to have passed the bacteria.
What’s the Problem?
News of the CRE infections at Cedars-Sinai comes just 2 weeks after a similar outbreak was reported at the Ronald Reagan UCLA Medical Center in which 7 patients were infected, 2 of whom died. As a result of these problems, Cedars has stopped performing endoscopic procedures requiring the use of a duodenoscope and launched its own investigation. The hospital said the CRE bacteria were likely transmitted through a duodenoscope made by Olympus Corp., the same device suspected in the UCLA outbreak.
One of the patients infected at Cedars-Sinai died, but doctors believe the cause was an underlying medical condition not related to the superbug. The 3 other patients have been discharged from the hospital, according to the LA Times. The hospital said there’s no evidence that additional patients are at risk, but the facility is sending free home-test kits to 67 patients who were treated with duodenoscopes as a precaution.
FDA, Device Manufacturers Criticized for Failing to Act Sooner
The CRE superbug outbreak has put pressure on the U.S. Food & Drug Administration (FDA), which is already under fire for ignoring warnings about duodenoscopes. Olympus is facing similar scrutiny for marketing an instrument that is hard to disinfect, even when following recommended cleaning procedures.
“It’s highly likely many hospitals around the country have had outbreaks, and they haven’t been able to connect the dots until this problem was disclosed at UCLA,” said Lisa McGiffert, director of the Safe Patient Project at Consumers Union. “It’s just a little late — especially for those who got infections and maybe died as a consequence.”
No Recall for Medical Scopes
Hospitals across the U.S. have been plagued with CRE outbreaks in recent years. Between Jan. 2013 and Dec. 2014, the FDA received reports of at least 135 infections linked to contaminated medical scopes. The agency has acknowledged that the duodenoscopes’ design makes them hard to disinfect, but it is reluctant to pull them off the market because they are considered indispensable medical devices, and are credited for saving many lives.
How are Duodenoscopes Spreading the Superbug?
In lawsuits filed against Olympus and other duodenoscope manufacturers, plaintiffs allege the devices were defectively designed. Recent duodenoscopes include a design change near the tip, known as the “elevator channel.” Bacteria can become lodged in this area and spread from patient to patient, as the elevator channel is difficult to clean during reprocessing.