March 5, 2015 — The LA Times has reported that at least 67 patients were exposed and 4 developed antibiotic-resistant “superbug” infections after undergoing medical procedures at Cedars-Sinai Medical Center in Los Angeles.
The hospital said one patient died, but they are still investigating whether the infection contributed to the death. All of the patients were exposed to carbapenem-resistant Enterobacteriaceae (CRE), a bacteria that has a 50% fatality rate, while undergoing procedures involving a duodenoscope made by Olympus.
That same Olympus scope has been linked to outbreaks of CRE at a hospital in Seattle, where more than 30 people were infected and at least 11 died since 2012. Just two weeks ago, UCLA’s Ronald Reagan Medical Center blamed the Olympus scope on 7 infections, two deaths, and 179 exposures since mid-2014.
Earlier this week, the FDA dropped a bombshell by admitting that the scope had been on the market since 2010 without proper clearance. Approval is still pending.
Meanwhile, similar scopes made by Pentax and Fujifilm have proper clearances and have not been linked to transmission of CRE. The FDA is reluctant to pull any of the devices off the market, fearing a shortage.
Duodenoscopes are used in about 500,000 procedures in the United States every year, mostly for the treatment of pancreatic and bile duct diseases like gallstones and cancer. From January 2013 to December 2014, the FDA received reports of 135 patients who developed infections when dirty duodenoscopes were used in their procedures.
According to MassDevice, the agency is now working to update the label on the devices, potentially to add more warnings and rigorous instructions for cleaning and disinfecting.