At least 35 patients have become ill and 11 have died after becoming infected with carbapenem-resistant Enterobacteriaceae (CRE) as a result of contact with contaminated endoscopes. From 2012–2014, patients at Virginia Mason Medical Center in Seattle, WA who underwent specialized endoscopies using duodenoscopes were exposed to CRE, although hospital personnel state that the devices were cleaned in accordance with the manufacturer’s instructions. Bacteria on the duoendocopes matched cultures taken from ill patients but patients and their families were not notified about the cause of the infection at the time of illness. It is unclear what role the bacteria had in these illnesses, as most of the patients were critically ill with colorectal or pancreatic cancer.
It is believed that the device’s design (elevator wire channels that contain the device components) may have played a role in the spread of CRE, making it difficult to clean thoroughly. The hospital has since changed their protocols for cleaning and each device is held for 48 hours to ensure that it does not contain CRE or other pathogens.
The Centers for Disease Control and Prevention (CDC) has contacted the Food and Drug Administration (FDA) regarding the contamination, but the FDA has not issued a warning or recall for this duodenoscope.
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