Thank you for visiting the news and information site about the FDA Notice to Healthcare Facility Administrators Concerning the Regulatory Status of the STERIS SYSTEM 1^® Sterile Processing System. This site will be updated frequently and we encourage you to check back regularly for the latest news and Information. This information is primarily for U.S. Customers. Get the latest STERIS SYSTEM 1^® Sterile Processing System updates for European, Middle Eastern and African Customers here.

STERIS SYSTEM 1 UPDATES:

NEW!	February 2, 2010 - FDA Notice: STERIS System 1 Processor: Extension of Recommended Time Period for Healthcare Facilities To Transition to Legally-Marketed Alternatives

February 3, 2010 - Customer Letter

 

February 3, 2010

 

Dear Valued U.S. Customer:

We want to take this opportunity to update you on SYSTEM 1^® matters. On February 2, 2010, the FDA updated its December 10, 2009 information by extending to 18 months the total recommended time period for transitioning from SYSTEM 1 to acceptable alternative devices.

In early December, FDA requested feedback on the timeline and obstacles to transition from SYSTEM 1. Based on that feedback and the difficulties that this transition may present to some healthcare facilities, the Agency has now recommended this extended transition period. FDA also recommends that healthcare facilities continue to transition to alternative reprocessing devices as soon as practicable. As further stated in the February 2nd notice from FDA, the Agency expects that STERIS will continue to support existing SYSTEM 1 units through the extended transition period, and STERIS is committed to continuing to support SYSTEM 1 units throughout the FDA’s extension.  We thank you for providing your input, and we appreciate the Agency’s response to your views and its efforts to support the public health.

In addition, as previously communicated by the FDA and STERIS, STERIS submitted a new premarket notification for an updated STERIS SYSTEM 1. This updated system includes the changes outlined in the May 15, 2008 FDA warning letter as well as other technology updates.  STERIS submitted this new 510(k) to FDA on January 5, 2009 and is continuing to seek clearance of this new device.

We also continue to communicate with the FDA about a transition plan for SYSTEM 1 users and we will notify you of further developments as soon as we can.  Meanwhile, please direct questions you may have to your STERIS representative, contact STERIS at 1-800-548-4873, or visit www.steris.com/ss1.

  

Sincerely,

Walt Rosebrough
President and Chief Executive Officer
STERIS Corporation

 

Archives

December 10, 2009 - Customer Letter

December 10, 2009 - Official Transcript of FDA 12-10-09 Teleconference

December 6, 2009 - Customer Letter

December 4, 2009 - Unofficial Transcript of FDA Call to Hospital Administrators

January 20, 2009 - Customer Notification