FDA Did Not Approve Superbug Scopes
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
Olympus Corp., manufacturer of endoscopes related to the dangerous superbug outbreak, did not receive approval to sell the medical device. According to the Food and Drug Administration, Olympus began selling these devices in 2010. However, the FDA did not take notice that Olympus was not granted the required permissions until late 2013. The FDA did not give a statement on why this clearance process had not been regulated more thoroughly.
The contaminated Olympus Corp. scopes have been linked with two superbug CRE (carbapenem-resistant Enterobacteriaceae) related deaths at the Ronald Regan UCLA Medical Center.