February 2, 2016

FDA posts updated information on duodenoscope reprocessors

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on February 1 posted updated information on which manufacturers of automated endoscope reprocessors (AERs) for duodenoscopes have completed validation testing with adequate results.

There are five companies in the US that manufacture AERs labeled to reprocess duodenoscopes. Companies that have completed their testing with adequate results are:

  • Medivators—Advantage Plus and DSD Edge
  • Steris Corporation—System 1E Liquid Chemical Sterilant Processing System.

 

FDA3

Automated Endoscope Reprocessors (AERs) are important devices widely used in the health care setting to reprocess endoscopes, such as duodenoscopes, and endoscope accessories, to decontaminate them between uses. AERs are designed to kill microorganisms in or on reusable endoscopes by exposing their outside surfaces and interior channels to chemical solutions.

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