FDA orders recall for Custom Ultrasonics automated endoscope reprocessors

The FDA has ordered Custom Ultrasonics to recall automated endoscope reprocessors it has manufactured from health care facilities, according to a press release.

Custom Ultrasonics has repeatedly violated federal law and a consent decree between the company and the FDA, according to the agency.

“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the release. “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 recall order pertains to all automated endoscope reprocessors (AERs), which includes the System 83 Plus, System 83 Plus 2 and System 83 Plus 9. As detailed by the FDA, there are approximately 2,800 AERs manufactured by Custom Ultrasonics currently in clinics and hospitals throughout the United States.

In the release, the FDA cited numerous issues with Custom Ultrasonics, including violations discovered in a facility 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 agency stated. "In the months following the inspection, the FDA provided the company with an opportunity to correct inspection violations and requested additional validation data. Following a review of the company’s submissions, the agency determined that Custom Ultrasonics has not adequately addressed its continued violations, which could result in an increased risk of infection transmission to patients."

Custom Ultrasonics is required to submit a written recall proposal to the FDA within 7 business days of receiving the recall order.

The FDA recommends that facilities currently using a Custom Ultrasonic AER submit a report via MedWatch in any cases of suspected patient infection and transition to an alternative method.

"Identify and transition to alternate 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 manufacturer’s reprocessing instructions," the FDA stated. "Before transitioning to an alternative method, verify that the endoscopes used by the facility are compatible with the alternative method by referring to the endoscope manufacturer’s reprocessing instructions."