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FDA Warns against Use of Endoscope Reprocessor

On Aug. 17, the Food and Drug Administration (FDA) issued a notice that hospitals and other health care facilities should no longer use Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) to clean duodenoscopes.

Last year, the federal government ordered manufacturer Custom Ultrasonics to recall all automated endoscope reprocessors from hospitals and other health care facilities. In announcing the recall, FDA cited an increased risk of infection transmission by the company’s equipment due to repeated violations of federal law.

In an earlier notice this month, FDA said health care facilities by now should have transitioned to using alternative duodenoscope reprocessing methods. However, the new notice clarifies that the System 83 Plus AER still can be used to reprocess other types of endoscopes.

The ECRI Institute listed dirty endoscopes as the top health technology hazard in 2016 for patients in hospitals and other health care facilities.

Contact Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Michelle Rosenfeld is manager of communications at America's Essential Hospitals.

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