MENTOR, Ohio—In response to recent concerns the U.S. Food and Drug Administration has expressed about the STERIS SYSTEM 1 Sterile Processing System, STERIS has released the following letter to its customers:
December 6, 2009
Dear Valued U.S. Customer:
I want to take this opportunity to update you regarding the December 3, 2009 FDA notice to healthcare facility administrators concerning the regulatory status of the STERIS SYSTEM 1 Sterile Processing System.
All of us at STERIS share your deep commitment to patient safety, and we are proud that the SYSTEM 1 processor has been safely used for more than 300 million cycles over more than 20 years. As the FDA stated in its December 3rd Q&A, they are not aware of any confirmed cases of infection directly attributable to SYSTEM 1 that would require patient notification.
Upon receiving the December 3rd FDA notice, STERIS began discussions with the FDA on a number of important issues affecting your continued use of SYSTEM 1. We greatly respect the FDA, its mission and its important responsibilities, and we are continuing to work with the Agency to clarify these issues and develop an effective transition plan. As part of that plan, we are seeking to address any confusion these events may have caused you.
When considering acceptable alternatives to meet your sterilization and disinfection requirements, you should review and consider the FDA’s Q&A, including the section entitled “What factors should I consider in selecting an alternative product?”