Under-fire FDA rushes to respond to superbug outbreak

Amid concerns over the response of the Food and Drug Administration (FDA) to a deadly outbreak of the superbug Carbapenem-resistant Enterobacteriaceae (CRE), the agency plans to modify the labels on duodenoscopes, the specialized medical devices blamed for spreading the bacteria, Reuters reported.

Though the FDA issued a warning last week about the duodenoscopes' infection risk following the revelation that CRE killed two patients at UCLA's Ronald Reagan Medical Center, some argue that the agency should have acted sooner.

Democratic Rep. Ted Lieu of California sharply criticized the FDA in a letter to the House Committee on Oversight and Government Reform, and has called for congressional hearings into the matter, FierceHealthcare reported.

And John Allen, M.D., the president of the American Gastroenterological Association, told CNN that duodenoscopes have been linked to superbug infections since 1987, when 10 of his patients became sick with the pseudomonas bacteria after undergoing a procedure with the devices, which are used to look at tiny ducts on patients' intestinal tracts.

"It certainly is disturbing that a fundamental design issue with these scopes would cause problems for this long," he said.

The design issue in question is the fact that bacteria such as CRE can remain on duodenoscopes even after staff follow the manufacturer-recommended reprocessing protocol, which despite the FDA's recent warning about the devices, has not been updated since the recent outbreaks, which first surfaced in 2012.

Thus the FDA is rushing to update risk information included on duodenoscope labels as well as establish better sterilization protocols, William Maisel, M.D., head of the FDA's Center for Devices and Radiological Health, told Reuters. The Centers for Disease Control and Prevention also is close to finalizing a new disinfection protocol for the devices.

The hospitals at the center of the most recent outbreak don't seem to be waiting for government agencies to update protocols. UCLA switched to gas sterilization of its duodenoscopes, FierceHealthcare previously reported, and Carolinas HealthCare System, where two patients died of CRE infections in recent months, has done the same, the Shelby Star reported. The North Carolina hospitals also isolate CRE-infected patients and have assigned a specific nursing staff to treat CRE patients at facilities that are at the highest risk, according to the newspaper.

These precautions haven't silenced calls for reform, however.

"The devices need to be designed better, the instructions need to be more clear, the hospitals need better training, and adequate time needs to be given in hospitals to ensure sterility is top notch," Mary Logan, chief executive of the Association for the Advancement of Medical Instrumentation, told Reuters.

To learn more:
- read the CNN article
- here's the Reuters report
- read the Shelby Star article