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News From the Food and Drug Administration
April 5, 2016

Another Call to Switch Reprocessors

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Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(13):1328. doi:10.1001/jama.2016.2757

The FDA has reinforced its call for health facilities to stop using automated endoscope reprocessors (AER) from Custom Ultrasonics, of Ivyland, Pennsylvania, and find other methods to clean and disinfect endoscopes.

“Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection,” agency officials said in a statement (http://1.usa.gov/21s8NJK).

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