FDA restricts endoscope disinfection system
OSHA Healthcare Connection, February 13, 2007
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Custom Ultrasonics, Inc., has signed a consent decree of permanent injunction to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System Plus 83 Mini-flex Washer/Disinfector for cleaning endoscopes, according to a February 7 Food and Drug Administration (FDA) news release. The injunction will continue until the company brings the methods and controls used to manufacture the devices into compliance with FDA's Current Good Manufacturing Practice requirements of its quality system regulation. The FDA advises healthcare providers to discontinue using the two disinfection systems if other options are available and to "carefully weigh the risks and benefits of using these products." "We are cooperating fully with the FDA and expect very shortly to have this matter resolved and to be in full compliance with all of the FDA's regulations," says Custom Ultrasonics in a letter to customers, which appeared on the company's Web site the day after the FDA announcement.
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