Custom Ultrasonics Signs Consent Decree
MedSun: Newsletter #12, February 2007
Company agrees to stop manufacturing devices that wash and disinfect endoscopes until it corrects problems
Custom Ultrasonics, Inc. (CUI), has signed a consent decree of permanent injunction in which it has agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System Plus 83 Mini-flex Washer/Disinfector until it brings the methods and controls used to manufacture the devices into compliance with FDA's Current Good Manufacturing Practice requirements of its Quality System (QS) regulation. In addition, the company has agreed to develop and implement adequate written medical device reporting procedures. The consent decree was signed by Judge Timothy J. Savage and entered on January 25, 2007, in the U.S. District Court for the Eastern District of Pennsylvania.
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. FDA is not aware of any adverse events but advises health care providers using these products to discontinue using them if another option is available and to contact the firm for more information. Other options include using an alternative device or following appropriate protocols to manually wash and disinfect the device. If no alternative is available, health care providers should carefully weigh the risks and benefits of using these products.
For more information, go the FDA Web site at