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After Deadly Superbug Outbreak, FDA Requires Proof that New Reusable Devices Can be Sterilized Effectively

Mar 16, 2015

Following a deadly superbug outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is requiring device makers to prove that their duodenoscopes and other reusable devices can be cleaned reliably. LA Times reports that the announcement comes as the agency is being criticized over its delayed response to the situation. Now, the agency is finalizing draft guidelines for cleaning duodenoscopes.

Dr. William Maisel, chief scientist at the FDA's Center for Devices and Radiological Health, said "This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective,"

Duodenoscopes were recently implicated in two superbug outbreaks, one at UCLA's Ronald Reagan Medical Center and the other at Cedars-Sinai hospital. The devices, which are inserted down the throat to diagnose and treat disorders of the digestive tract, spread the antibiotic-resistant bacteria carbapenem-resistant Enterobacteriaceae (CRE). In both outbreaks, a total of 11 patients were infected and 246 more may have been exposed.

The FDA has been under scrutiny in light of the outbreaks. The agency has been criticized for not responding to earlier evidence that the scopes cannot be effectively sterilized of antibiotic-resistant bacteria. The FDA first published guidelines for cleaning the devices in 2011, and is now finalizing them. The work was “accelerated” by the recent infections, said Dr. Stephen Ostroff, the agency's chief scientist. The FDA received a letter from ten house members asking about what the agency was aware of before the outbreaks and for how long.

In addition to requiring testing to prove that duodenoscopes can be cleaned effectively, the FDA is advising that hospitals and medical providers regularly test the scopes for bacterial growth after they have been cleaned. The agency, however, did not recall the scopes and also stated that it did not have the authority to require manufacturers to re-design the devices.

The FDA has also been criticized over the fact that Olympus, the largest manufacturer of duodenoscopes, has been able to sell its redesigned TJF-Q180V scope without government approval since 2010. Olympus sold the scopes linked to the deadly outbreaks at UCLA and Cedars-Sinai. The company says it did not think approval was necessary. An application has since been filed, and is pending..

Last month, the FDA warned health care providers that the complex design of duodenoscopes can inhibit reliable cleaning. The notification also said that even if manufacturers' instructions are followed, harmful bacteria can still be spread.

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