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FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
Custom Ultrasonics Signs Consent Decree
Company agrees to stop manufacturing devices that wash and disinfect endoscopes until it corrects problems
The Food and Drug Administration (FDA) announces that 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. The FDA is not aware of any adverse events. An endoscope, which is a tube inserted into the body, enables doctors to visualize internal organs. Endoscopes are used in many areas of the body, including the digestive tract, the respiratory tract and the urinary tract.
FDA 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 then health care providers should carefully weigh the risks and benefits of using these products.
In addition to Custom Ultrasonics, Inc., the complaint names as defendant, Frank J. Weber, President and Chief Executive Officer of Custom Ultrasonics, Inc.