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FDA says Firms have Failed Twice to Show Scopes can be Rid of Superbugs

Medical device testing to find superbug

After two patients died at UCLA's Ronald Reagan Medical Center from contaminated duodenoscopes during a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography, and five more were infected by an antibiotic-resistant superbug, including 179 others who may have been exposed, the FDA has been pushing manufacturers to prove their devices can be cleaned of this deadly bacteria.

On March 2nd, the FDA stated that it did not request the information until Spring 2014 and has given the device manufacturers three chances to validate their cleaning protocols.

The FDA said it is aware of 135 possible patient infections from January 2013 to December 2014 linked to these scopes. This has led to some criticism for the FDA as some consumer advocates and federal lawmakers believe they should have acted earlier, seeing as they were aware of these outbreaks for years.

Read the full story here.

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