CHANGE OF HEART The FDA is backing off its recall on Custom Ultrasonics' System 83 Plus AER.

The Food and Drug Administration is backing off its recall of about 2,800 Custom Ultrasonics automated endoscope reprocessors used at more than 1,000 facilities nationwide, saying they can be used to reprocess certain endoscopes but that they shouldn't be used to clean or high-level disinfect duodenoscopes until further notice.

This is quite a U-turn for the FDA, which just a few months ago said that the recall was necessary to protect patients. The FDA originally issued the recall on Custom Ultrasonics' AERs in November 2015, citing continued safety violations and questions on effectiveness. After a Senate report linked the duodenoscope outbreak to the company's machines a few months ago, the FDA reiterated the recall. The Senate's report found that while the design of the scopes made them difficult to clean, Custom Ultrasonics' machines were used by at least 9 of the 16 U.S. hospitals that had scope-related infections.

Now, the FDA has reversed course, with a spokesperson telling Outpatient Surgery that, "Based on information provided by the company, the FDA has determined that the products may remain in the field for reprocessing other endoscopes during this validation. We expect that the company will be providing additional information to its customers regarding its corrective action in the near future." The FDA declined to provide any further information.

In an April 29 letter on its website, Custom Ultrasonics told customers that it was still working with the FDA to address concerns with the System 83 Plus AER, but it still could be used in a limited manner.

"The System 83 Plus AERs will remain in use in the field for reprocessing certain endoscopes," reads the letter to customers. "However the System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice."

Kendal Gapinski