Investigation linking duodenoscopes to superbug were cleaned with FDA approved AER

A USA Today investigation found that in cases where duodenoscope-linked CRE broke out in hospitals, the hospitals actually relied on an automated endoscope reprocessor for disinfection which was actually cleared by the FDA 10 years ago.

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Until just a few weeks ago, the FDA did not reach out to manufacturers of the reprocessors for updated data to make sure the AER met requirements, reports USA Today.

The FDA is investigating the duodenoscopes to find if certain crevices trap bacteria that was passed to patients.

Olympus, FujiFilm and Pentax, the companies that manufacture the scopes, are also beings asked again by FDA to provide data on the cleanliness of their produces, according to USA Today.

 

Read more on ASC news…

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