March 5, 2015 — Cedars-Sinai Medical Center in Los Angeles has reported that four patients were infected with an antibiotic-resistant “superbug” after undergoing procedures with a duodenoscope that is very difficult to sterilize.
Cedars said 67 other patients may have been exposed, including 1 patient who died. They are still investigating whether the infection contributed to the death, according to the LA Times.
Patients may have been exposed from one Olympus duodenoscope in use from August 2014 to mid-February, according to the hospital.
The announcement came just two weeks after UCLA’s Ronald Reagan Medical Center reported that the same Olympus scope was responsible for exposing 179 patients to the bacteria, including seven who were infected and two who died.
Another hospital, Virginia Mason Medical Center in Seattle, blamed the scope on over 30 infections and at least 11 deaths since 2012.
Earlier this week, the FDA reported that the scope had been on the market since 2010 without approval or clearance from the agency. Similar scopes made by Pentax and Fujifilm have not been implicated in superbug outbreaks and have the necessary clearances.
The “superbug,” known as carbapenem-resistant Enterobacteriaceae (CRE), is resistant to nearly all antibiotics. Last month, the FDA acknowledged that the complex design of duodenoscopes can make it hard to clean.
Between January 2013 and December 2014, the agency has received reports of 135 patients who may have been infected by contaminated scopes during procedures for pancreatic and bile-duct diseases like cancer and gallstones.
The FDA is now working to speed label changes for duodenoscopes, possibly to include new warnings and more stringent cleaning and disinfecting instructions, according to a senior official who spoke with MassDevice.