FDA warns medical scopes linked to 'superbug' outbreak

The Food and Drug Administration is cautioning doctors around the country about a medical device that led to an outbreak of a potentially deadly “superbug” in California.

Federal officials issued a warning Thursday that certain medical scopes, likely those used in the California hospital affected, are extremely difficult to disinfect and even thorough cleanings “may not entirely eliminate” the risks.


The warning from the FDA comes one day after California’s largest hospital informed nearly 180 patients that they might have been exposed to a potentially deadly infection called CRE. At least seven people have been infected and two people have died.

The medical scopes have been shown to spread drug-resistant bacterial infections “even when manufacturer reprocessing instructions are followed correctly,” the FDA said.

There have been at least 75 reported cases of “superbug” infections caused by the medical scopes between January 2013 and December 2014, the FDA added, though some cases likely went unreported.

“The FDA continues to actively monitor this situation and will provide updates as appropriate,” the agency wrote.

Both the Los Angeles County Department of Health Services and the California Department of Public Health are also responding to the outbreak. A representative for the CDC did not return requests for comment about the agency’s response.