FDA has instructed Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs), and recommended that health care providers find alternative processing methods "as soon as possible."
FDA has found that the company Custom Ultrasonics (Ivyland, PA) has continually violated federal law and a consent decree entered with the company in 2007. According to the terms of a consent decree cited in the recall, FDA in 2012 ordered Custom Ultrasonics to stop manufacturing and distributing automated endoscope reprocessors (AERs) and AER components.
The agency also said it ordered their recall after the company failed to obtain FDA clearance following a "significant change" to the software operating system for one of its AERs. After Custom Ultrasonics obtained clearance for the "significant change" to the software operating system, FDA permitted the devices to remain on the market.
Reprocessed endoscopes are used to wash and high-level disinfect endoscopes to decontaminate them between uses. They have been linked to superbug outbreaks in which patients at hospitals across the country fell ill or died following procedures using reprocessed scopes. Endoscopes reprocessed by Custom Ultrasonics' AERs have been used in health care facilities that reported the transmission of serious bacterial infections, FDA said in a statement.
Since the 2012 order, FDA has not authorized Custom Ultrasonics to resume manufacturing or distributing AERs, though the company has continued to service them. An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the United States. The FDA's recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9.
The System 83 Plus Washer/Disinfector "has not been linked to any transmission of infection from the endoscope to the patient," the company said in a statement to customers. "Custom Ultrasonics has no safety concerns regarding the safety and efficacy of the System 83 Plus Washer/Disinfector."
An April 2015 FDA inspection of the company's facility documented "continued violations," the agency said, including the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. After reviewing the company's submissions following the inspection, the agency determined that Custom Ultrasonics has not adequately addressed the violations, it said in a letter to the company.
Custom Ultrasonics said it has been complying with FDA requests.
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