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No FDA clearance for device linked to superbug

The sale of a medical instrument to hospitals around the nation might be effecting those in Louisiana and other states as the endoscopes made by Olympus Corporation are linked to the recent "superbug" that does not respond to antibiotics. It appears that the device was sold even though the manufacturer did not receive clearance from the Food and Drug Administration.

Companies must receive clearance when making or updating medical devices for sale in the U.S., and the FDA reported that the endoscopes that the company started selling in 2010 were an updated version of an older model that did not receive clearance. It has been reported that the manufacturer has a pending application for clearance with the FDA as of March 2015, and physicians associated with the agency said others should continue using the endoscopes since a review might not have prevented the infections anyway.

A resistant bug has been linked to the endoscope, and this device is hard to clean even when following the proper instructions as two of the cleaned tubes at a UCLA hospital still carried embedded infections. The tubes function as duodenoscopes that drain fluids in the small intestine and stomach when inserted down the throat. While the design of this device makes it a flexible and useful medical tool, particles like bodily fluids can remain in the device even after cleaning. The devices may be responsible for seven infections, which have resulted in two fatalities so far.

When a defective medical product causes injuries, victims may be able to seek compensation from the manufacturers and others for expenses related to the injury. Consumers expect that products are tested and safe for use, and companies may be held liable when this is not the case.

Source:The Houston Chronicle, "Maker of device in 'superbug' outbreak lacked FDA clearance", Matthew Perrone, March 5, 2015

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