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Device related to superbug outbreak was not cleared by FDA

March 11, 2015

Kentucky residents may have heard that a recent outbreak of infections by the superbug, carbapenem-resistant Enterobacteriaceae, has raised concerns in hospitals across the country. The current outbreak, which began in Los Angeles, highlights the need for better reporting of CRE infections nationwide. Increased reporting cases will help the federal government gain a better understanding of the disease and its causes, including risk factors like the use of the duodenoscope implicated in the outbreak.

Officials from the Food and Drug Administration have reported that the device, a redesigned version of a specialized endoscope made by Olympus Corporation, did not have federal clearance. Olympus began selling the redesigned scope in 2010 but did not submit an application for clearance until October 2014 after it was instructed by the FDA to do so. Reports suggest that the device is hard to clean, and even when hospitals follow the manufacturer’s cleaning instructions, infectious bacteria can remain. Such embedded infections were found on two Olympus devices at the UCLA hospital where the outbreak originated.

Ten members of Congress have raised questions about the FDA’s performance in the oversight of medical equipment such as the duodenoscope. They assert that if proper cleaning procedures cannot be developed, the best solution would be to create a new device. The FDA announced that it will not withdraw the Olympus device because of concerns that it would create shortages of instruments required in about half a million procedures per year.

The potentially dangerous health outcomes for victims of a CRE infection may raise questions about product liability. An attorney with experience in the area could assist a victim of a hospital-acquired infection in establishing the cause of the infection and assessing the potential for a negligence suit.

Source: The Houston Chronicle, “Maker of device in ‘superbug’ outbreak lacked FDA clearance,” Matthew Perrone, March 5, 2015