FDA reinforces terms of recall order for Custom Ultrasonics automated endoscope reprocessors

The FDA has released an update regarding the recall order requiring Custom Ultrasonics to recall all of its automatic endoscope reprocessors.

The recall order issued in November pertained to all of the company’s automated endoscope reprocessors (AERs), including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9, representing an estimated 2,800 AERs in U.S. clinics and hospitals. The FDA accused Custom Ultrasonics of repeatedly violating federal law and a consent decree.

“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.”

According to the updated safety communication, Custom Ultrasonics submitted a recall strategy to the FDA following the recall order in November, but the agency deemed it inadequate, and to date the company has made no additional recall strategy proposals.

The FDA subsequently sent the company a letter at the end of January, “reinforcing the terms of the recall order and requiring Custom Ultrasonics to remove its AERs from the market,” according to the updated safety communication. The agency warned it could take additional measures under the consent decree if the company fails to take required action.

“Because Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection, the Agency continues to recommend that health care facilities using Custom Ultrasonics AERs transition to alternative methods to reprocess flexible endoscopes as soon as possible, as emphasized in its November 13, 2015 safety communication.”

Reference:

FDA. FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm472462.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed February 25, 2016.