AERs (automatic endoscope reprocessor) are free-standing units used in health facilities to disinfect flexible endoscopes and scope accessories between uses.  Custom Ultrasonic AERs should wash and high- level disinfect cleaned flexible endoscopes used in gastrointestinal and pulmonary tracts.   About 2,800 AERs manufactured by Custom Ultrasonics are in hospitals and outpatient clinics throughout the United States.

Since 2012, the Food and Drug Administration (“FDA”) has not authorized Custom Ultrasonics to resume manufacturing or distributing any AERs, though the company has continued to service them.  Due to an ongoing investigation into infections linked to AERS, the FDA has ordered Custom Untrasonics to recall all of its automated endoscope reprocessors due to continued violations at its facility.

The FDA’s November 13, 2015 recall order applies to all Custom Systems 83 plus, System 83 Plus, System 83 Plus 2 and System 83 Plus 9. “We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientific in the FDA’s Center for Devices and Radiological Health.  “The FDA’s recall order stemmed from the company’s continued violations of federal law and the consent decree and is necessary to protect the public health.”

The FDA Safety Communication stated:

“The FDA recommends that health care facilities currently using Custom Ultrasonics AER’s transition away from their use to alternative reprocessing methods as soon as possible.  Facilities are advised to identify and transition to alternative methods to reprocess flexible endoscopes, such as manual high-level disinfection, liquid chemical sterilization, alternative AERs, or other cleaning and sterilization methods, according to the endoscope manufacturers’ reprocessing instructions.”

The danger with the AER device and similar devices when the FDA takes a restrained and casual approach to dangers such as these present real exposures for patients. It would seem to us that if the device is not operating as it should, the FDA would take a more rigid approach of forbidding the device’s use, rather than warning against potential dangers, which might be caused by an admittedly defective medical device.