CUSTOM ULTRASONICS SIGNS CONSENT DECREE WITH FDA

The FDA and Custom Ultrasonics have signed a consent decree regarding the company's endoscope-cleaning devices, according to the agency.

Under the consent decree, the firm has agreed to stop manufacturing and distributing its System 83 Plus washer/disinfector and the System Plus 83 Mini-flex washer/disinfector.

The consent decree was signed by Judge Timothy Savage and entered in the U.S. District Court for the Eastern District of Pennsylvania Jan. 25.

Under the agreement, the firm must bring the methods and controls used to manufacture the devices into compliance with the agency's current good manufacturing practice requirements of its quality system regulation, the FDA said. The firm has also agreed to develop and implement adequate written medical device reporting procedures.

"The company's actions posed a potential public health hazard because endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients, causing life-threatening infections," the agency stated. "The FDA is not aware of any adverse events."