Carbapenem-resistant Enterobacteriaceae (CRE) have infected at least seven patients—two of whom died—at California’s Ronald Reagan UCLA Medical Center in recent months. Another 179 patients were possibly exposed, and health officials suspect contaminated endoscopes are to blame.
The hospital conducted an internal review of its cleaning process and found that CRE could remain on the instruments, suggesting “that the routine processes we were using just weren’t adequate,” Zachary Rubin, the medical director of clinical epidemiology and infection prevention at UCLA Medical, told CNN.
The US Food and Drug Administration (FDA) has now issued a warning that the reuse of these particular devices, called duodenoscopes, may spread antibiotic-resistant bacteria even when cleaning protocols are properly followed. According to the safety message: “Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone [endoscopic retrograde cholangiopancreatography] with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly.”
Fujifilm Medical Systems USA and Olympus Corp, two manufacturers of duodenoscopes, told CNN they are working with FDA to address the concerns. The companies’ official “disinfection recommendations were approved by the FDA,” Reuters reported.