FDA: Companies' tests of superbug-linked scopes flawed

Amid recent news that specialized medical devices known as duodenoscopes contributed to a series of deadly superbug outbreaks in hospitals around the country, a Food and Drug Administration (FDA) official told Reuters that the device manufacturers' tests of their recommended cleaning procedures may bear part of the blame.

The current rash of Carbapenem-resistant Enterobacteriaceae (CRE) outbreaks began as early as 2012 in hospitals in Pittsburgh, Seattle and Chicago, FierceHealthcare has reported, and more recently have spread to UCLA's Ronald Reagan Medical Center in California and North Carolina hospitals. The CRE outbreak has sickened and even killed patients who underwent gastroenterological procedures in which contaminated dudodenoscopes--which are difficult to sterilize due to their unique design--were used.

The FDA has faced criticism for failing to issue a warning about the superbug danger linked to the scopes until after the UCLA outbreak. The agency's warning, issued Feb. 19, cautioned providers that the duodenoscope manufacturers' guidelines may not be enough to protect patients. 

Stephen Ostroff, M.D., the FDA's chief scientist, in an interview with Reuters, elaborated on the issues his agency found with how device makers Fujifilm Holdings Corp, Olympus Corp and Pentax developed their cleaning guidelines. In a review of the companies' cleaning test procedures the FDA conducted in early 2014, he said, the agency found that in some cases the cleaning protocols were improperly followed or the disinfection protocol failed despite being properly carried out, the news service reported.

This was a wake-up call to the FDA that it needed to update its guidelines for the manufacturers, Ostroff told Reuters. "We have set a higher bar to demonstrate adequate validation than was expected in the past based on evolving science and experiences with more recent outbreaks," he said. "What was acceptable a few years ago is not adequate today."

And the sooner the FDA updates its protocols, the better, as a recent letter issued by a California legislator calls for an investigation into how the agency handled the infection risk associated with duodenoscopes, FierceHealthcare previously reported.

To learn more:
- read the Reuters report