US FDA issues device safety alert following "superbug" outbreak – Reuters

Posted: Thursday, February 19, 2015

Feb 19 (Reuters) – The complex design of endoscopes that
have been linked to a “superbug” outbreak at the UCLA Health
System in California may hinder proper cleaning, the U.S. Food
and Drug Administration warned on Thursday.

The hospital system said seven patients were infected with a
potentially deadly, drug-resistant strain of bacteria and that
more than 100 may have been exposed to it between October and
January. The bug may have contributed to the death of two
patients, UCLA said.

The FDA said it wanted to raise awareness among healthcare
professionals that the complex design of the devices – flexible
tubes that are threaded through the mouth, throat and stomach to
drain fluids from blocked pancreatic and biliary ducts – is
associated with a risk of multidrug-resistant infections even
when a manufacturer’s cleaning instructions are followed

Makers of the devices, known as duodenoscopes, include
Olympus Corp, Fujifilm Holdings Corp and
Pentax Medical.

Leslie Wooldridge, a spokeswoman for the FDA, said the
agency has been actively working with federal partners,
manufacturers and other stakeholders “to better understand the
issues that contribute to the infections and what can be done to
mitigate them.”

(Reporting by Toni Clarke in Washington; Editing by Frances


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