FDA, STERIS Grapple with System 1 Issue

Healthcare users are working to transition from the STERIS System 1 Sterile Processing System to abide by a notice from the U.S. Food and Drug Administration (FDA).

The FDA issued the notice on Dec. 3, 2009, claiming that STERIS significantly modified System 1 and that FDA has not approved or cleared the modified product as safe or effective for its labeled claims. FDA is not taking action due to any reported safety concerns with the system, but because of what it deems a lack of regulatory compliance.

STERIS did not recall System 1, which is primarily used for sterilizing and disinfecting medical devices, but voluntarily discontinued sales of the product except for one-for-one product replacement and the sale of accessories and parts to maintain existing products, FDA’s notice reads.

If a user has an acceptable alternative to System 1, FDA recommends users transition to it as soon as possible. FDA does not recommend that users cancel surgical procedures if they don’t have a suitable alternative readily available. FDA gave users three to six months to find an alternative. “But we understand there may be individual cases in which healthcare facilities cannot complete the transition within this time frame,” said Tim Ulatowski, director of FDA’s office of compliance, Center of Device and Radiological Health (CDRH). “We want to be advised of obstacles to the transition. Ideally, we will work with healthcare associations to resolve those obstacles.”

Guidance on selecting an acceptable alternative and other information related to System 1 can be found in this question and answer document from FDA. The agency also put together a list of FDA-cleared, legally-marketed alternatives to System 1, which is available here.

The FDA does not expect to take action against healthcare facilities solely because they continue to use System 1 after the transition date, Ulatowski said.

STERIS responds that it is “continuing to work daily with the FDA to help SYSTEM 1 users meet the agency’s requirements and make a smooth transition to an acceptable alternative,” said Walt Rosebrough, STERIS President and Chief Executive Officer.  “We apologize for any difficulties this situation is causing in healthcare facilities and we will continue to work as quickly as we can with the FDA on a transition plan.”

During this transition period, STERIS will continue to provide SYSTEM 1 Customers with S-20 sterilant and accessories, parts and service.

STERIS has set up a hotline at 1-800-548-4873, prompt 7, if System 1 users have any further questions or require more information. To get the latest updates from STERIS on System 1, visit www.steris.com/ss1.

Source: AAMI