What do you need to know about automated endoscope reprocessors?

Information about Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation Automated Endoscope Reprocessors (AERs) are important devices widely used in the health care setting to reprocess endoscopes, such as duodenoscopes, and endoscope accessories.

What kind of endoscope is the renatron II reprocessor?

Puricore Aers Renal Systems Hemodialysis Concentrates Centrisol® Hemodialysis Concentrate(45x) RENASOL™ Hemodialysis Concentrate(36.83x) Pvc Suction Hose Drum Wrench Lutz® Pump And Motor Dialyzer Reprocessing Renatron Ii 100 Series Station Renatron® Ii 100 Series System

How is hydrogen peroxide used in endoscope reprocessing?

The patented technology in the STERRAD NX ® System and STERRAD ® 100NX System deliveries a concentrated load of hydrogen peroxide sterilant through long and narrow lumens to terminal sterilize flexible endoscopes.

Can a Aer be used to reprocesse a duodenoscope?

Also on April 10, 2018, the FDA issued a Safety Communication (2018) advising health care facilities that Custom Ultrasonics’ System 83 Plus AERs may be used for reprocessing of certain duodenoscopes. This Safety Communication is an update of the FDA’s August 2016 Safety Communication (2016)

What does an AER do to an endoscope?

AERs are designed to kill microorganisms in or on reusable endoscopes by exposing their outside surfaces and interior channels to chemical solutions. AERs are Class II devices cleared through the premarket notification [510 (k)] pathway.

When to use AER in duodenoscope cleaning cycle?

These actions are effective on August 8, 2017. Given duodenoscopes’ complex design and rigorous manual cleaning instructions, the FDA recommends that the AER cleaning cycle only be used as a supplement to thorough manual cleaning according to the duodenoscope manufacturer’s instructions.

How is an Aer cleared by the FDA?

AERs are Class II devices cleared through the premarket notification [510 (k)] pathway. The FDA is looking into all critical factors contributing to patient infections associated with exposure to duodenoscopes and how best to mitigate them, including how AERs are used in clinical settings.