Staci Simos of Newport Beach Sues Olympus Over Device Blamed for Superbug Outbreak
Say, isn't that Carbapenem resistant Enterobacteriaceae (CRE)?
Centers for Disease Control and Prevention (CDC)
A Newport Beach woman is suing a medical device maker for allegedly causing her to be infected with a superbug last October at Ronald Reagan UCLA Medical Center in Westwood.
Staci Simos' becomes at least the fourth lawsuit filed in Los Angeles Superior Court against Olympus America Inc. after the outbreak of Carbapenem resistant Enterobacteriaceae (CRE), which infected at least seven patients, two of whom died. Simos' suit, which seeks unspecified damages, blames her CRE infection on UCLA doctors' use of an Olympus' Q18OV scope during her endoscopic procedure.
"After each use, the Q18OV scope necessarily requires cleaning and disinfecting before it can be used on a new patient," reads the Simos complaint. "A manufacturer of a medical device like an endoscope ... has an obligation to develop and validate a (cleaning) protocol and to incorporate this protocol into the product's labeling." Olympus "failed to take these critical steps with the redesigned Q18OV scope," the suit alleges.
The complaint does not blame UCLA, which earlier this year notified 179 patients who underwent endoscopic procedures between October and January that they may have been exposed to the superbug that was traced to a pair of Olympus scopes.
Suits like Simos' filed across the country maintain a non-FDA approved redesign of the Olympus scope called for a new cleaning protocol. City News Service reports that company spokesman Mark Miller previously said FDA approval was not sought for the changes made to the device because it was not required.
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