Mentor, Ohio - STERIS Corporation today announced that it has submitted to the U.S. Food and Drug Administration (FDA) 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.
The company is communicating to customers that STERIS will continue supporting the existing SYSTEM 1 installed base by providing accessories, sterilant, service and parts, and replacement processor units for at least a two-year period. In the U.S., STERIS will continue sales of SYSTEM 1 processors only as replacements for existing units. Customers can continue using SYSTEM 1 without any change. 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.
“Our highest priorities are patient safety, legal and regulatory compliance, and customer satisfaction,” said Walter Rosebrough, president and chief executive officer of STERIS Corporation. “We are pleased that our discussions with the FDA have resulted in the submission of a new liquid chemical sterilization system and a path forward in resolving the warning letter related to SYSTEM 1. We look forward to working with the Agency to obtain clearance of our new system, and resolving any remaining regulatory issues.”
For fiscal 2009, ending March 31, 2009, the company anticipates that this development will not have a material impact on its consolidated financial results. Beginning in fiscal 2010, the company anticipates that annualized revenues will be modestly impacted by approximately $10 million until the new product is cleared and commercialized.
Source: STERIS Corporation