- FDA officials say they are working to fast-track label updates for duodenoscopes to show new warnings and more stringent instructions for disinfecting them, due to their apparent role in the spread of drug-resistant CRE.
- The agency had recently warned that the design of the devices was making disinfection difficult, even when manufacturers' instructions were properly followed. However, it is facing criticism for taking more than three years to issue definitive guidelines on disinfecting such devices, a delay that may have contributed toward the current infections.
- "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."
Some observers find it frustrating that the FDA issued draft guidance on the labeling of reusable medical devices such as duodenoscopes in May 2011, but never finalized it despite the rising concern about their connection to CRE.
"The draft guidance would have made a difference if it had been finalized," Mark Duro, director of sterile reprocessing operations at New England Baptist Hospital in Boston, told Reuters. "This was asking the manufacturers to give us more information about how to reprocess the [duodenoscopes], and every bit of additional information would be better than we have now."
CNN reports claims that the FDA has known about the issues with disinfecting duodenoscopes since as far back as 1987.