Maker Of Device In 'superbug' Outbreak Lacked FDA Clearance

WASHINGTON (AP) -- The manufacturer of a medical instrument at the center of a recent "superbug" outbreak in Los Angeles did not receive federal clearance to sell the device, according to officials from the Food and Drug Administration.

The FDA confirmed that Olympus Corp. did not seek FDA clearance for the latest version of its specialized endoscope, which it began selling in 2010. FDA clearance is required for all substantive updates to medical device sold in the U.S.

Despite the lack of clearance, the FDA said doctors should continue using the device because it's not clear that federal review would have prevented the recent infections reported in patients.

Olympus said in a separate statement that it determined in 2010 that it didn't need to submit its changes for FDA review. The company has since filed an application which is now pending at the FDA.

The company's hard-to-clean device is believed to be responsible for infections in seven people - two of whom died - who contracted an antibiotic-resistant strain of bacteria after undergoing endoscopic procedures at Ronald Reagan UCLA Medical Center between October and January. Two Olympus devices used at the UCLA hospital were found to have "embedded" infections even though they had been cleaned according to manufacturer's instructions. The specialized device, known as a duodenoscope, is a flexible fiber-optic tube that is inserted down the throat to enable a doctor to examine internal organs.

MORE...

http://hosted.ap.org/dynamic/stories/U/US_SUPERBUG_OUTBREAK_FDA?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2015-03-05-12-07-49