The FDA said Custom Ultrasonics is in violation of a consent decree entered in January 2007 due to continued violations of federal law.
In a Safety Communication, the FDA asked healthcare facilities to transition away from using Custom Ultrasonics AERs and use alternative reprocessing methods as soon as possible.
According to an FDA inspection in April 2015:
“Violations include the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. The identified violations could result in an increased risk of infection transmission.”
In 2012, the FDA ordered Custom Ultrasonics to recall all its AERs after the company failed to get approval for significant changes to the software operating system.
After the company got clearance, the devices were allowed to remain in service. Custom Ultrasonics has not been authorized to make or sell the AERs since then, but has continued to provide service.
The FDA has increased scrutiny of AERs after several deadly outbreaks of infection were linked to endoscopes that were not sterilized between uses. The risk of disease-transmission is low, but several people died when they were infected with antibiotic-resistant “superbugs” like carbapenem-resistant enterobacteriaceae (CRE).