Steris Corporation says it has submitted to the U.S. Food and Drug Administration a new liquid chemical sterilization system for 510(k) clearance. The new submission follows discussions with the FDA regarding issues raised in a May 2008 warning letter relating to the company’s System 1 Sterile Processing System. The new liquid chemical sterilization system submitted to the FDA addresses the changes referenced by the FDA in the warning letter and includes additional technology updates, says the company.
Steris says it will continue supporting the existing System 1 installed base by providing accessories, sterilant, service and parts, and replacement processor units for at least two years. In the United States, Steris will continue sales of System 1 processors only as replacements for existing units.
"Customers can continue using System 1 without any change," says Steris in a news release. "The FDA has reviewed and accepted these actions and is not requiring modification of clinical practices or notification to doctors or patients. Once the new liquid chemical sterilization system is cleared for market use by the FDA, the company will work with customers to transition them to the new product."
—Dan O’Connor
