The FDA has cleared the Steris System 1E Liquid Chemical Sterilant Processing System for marketing. The SS1E is considered the successor to the company's SS1, which the FDA said has been modified to such a degree that it's no longer approved or cleared. SS1 owners have until next August to buy a replacement.
The SS1E is indicated for liquid chemical sterilization of cleaned, immersible and reusable critical and semi-critical heat-sensitive medical devices such as endoscopes and their accessories that cannot be processed using steam. The FDA notes that the SS1E's rinse water is tap (potable) water that has been filtered and exposed to ultraviolet rays. "It is not sterile," says the FDA. "Therefore, the final processed devices are not sterile." Steris will begin accepting orders for the SS1E as soon as the transition plan is announced, with delivery of the first units expected by the 2nd quarter of 2011.
"This is good news for our customers and we look forward to working with them as they continue their transition to acceptable alternative technologies," says Steris President and CEO Walt Rosebrough in a statement.
Steris says it continues dialogue with the FDA to close out the remaining SS1 issues and expects to announce a transition plan in the near future.
