FDA warning forces alternative sterilization methods
Briefings on Infection Control, February 1, 2010
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On December 3, 2009, the FDA issued a safety alert to healthcare providers concerning adverse reports from users of the STERIS System 1® (SS1) processing system, a device most commonly used for surgical and endoscopy equipment disinfection. The FDA advised healthcare facilities using the device to find an alternative method and transition to that alternative as soon as possible to ensure patient safety. If facilities cannot find an acceptable alternative, steps should be taken to obtain legally marketed substitutes for the SS1.
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