The U.S. Food and Drug Administration is working to update the labels for duodenoscopes linked to the recent "superbug" outbreak that were inadequately cleaned, according to a Reuters report. The problem has been ongoing for years, with the agency, until now, simply referring hospitals to the cleaning methods on the existing product labels from the U.S. manufacturers of duodenoscopes: Pentax Medical, Fujifilm Holdings and Olympus.
Now under intense public scrutiny, the agency seems to be acknowledging that those labels offer inadequate cleaning instruction that needs to be updated. In 2013 and 2014, at least 135 U.S. patients may have been infected via contaminated endoscopes, which were possibly cleaned according to the proper protocol.
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| William Maisel |
"We are working to expedite modifications to the label," Dr. William Maisel, chief scientist in the FDA's Center for Devices and Radiological Health, told Reuters. "We are also talking about updating the risk information."
At the UCLA Health System in one of the latest outbreaks, at least 7 patients were infected with the "superbug" carbapenem-resistant Enterobacteriaceae (CRE) bacteria. Two of them died, with another 179 patients exposed to the bacteria from October through January. A similar CRE infection has also been reported in a North Carolina hospital that is being blamed for two additional deaths.
UCLA hospital administrators started using the toxic gas ethylene oxide to ensure thorough cleanings. No new outbreaks have been reported since the facility started using the gas, according to the latest report from the Los Angeles Times. But the FDA's Maisel warned against that practice due to potential toxic residue that could be harmful to patients or possible damage to the scopes themselves. Some other hospitals are opting to wait for a period of time like 48 hours to re-test the duodenoscopes for bacterial growth before reuse.
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| Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia |
The devices in question are endoscopes specifically designed to view the duodenum, the first section of the small intestine. More than half a million endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed in the U.S. annually with duodenoscopes.
Pentax told Reuters that it's in the process of talking to the FDA about updating its cleaning and sterilizing instructions for duodenoscopes. Any changes in cleaning methods for the manufacturers would be reflected in the product labels for the devices that are approved and updated by the FDA.
Reportedly, the U.S. Centers for Disease Control and Prevention (CDC) is in the process of developing a new cleaning protocol.
- here is the Reuters story
- and here is a CNN opinion piece critical of the FDA and its role in the ongoing problem