FDA extends Steris sterilizer replacement deadline again

January 05, 2012
by Brendon Nafziger, DOTmed News Associate Editor
The Steris System 1 saga continues. In a late December update, the Food and Drug Administration said facilities that have put in orders for replacements for the medical device sterilizer and have signed a Certificate of Transition can continue to use the device through Aug. 2. This also means they can get fresh shipments of sterilant. Previously, the deadline to drop the devices was Feb. 2, although that still applies to facilities that haven't already made plans to swap out their current SS1.

A little history: In May 2008, the FDA sent warning letters to Mentor, Ohio-based Steris Corp., noting that because of changes to its STERIS 1 system made over the product's lifetime, the agency could no longer vouch for the effectiveness of the machine. In December 2009, the FDA then told customers to begin looking for alternative products. And in April 2010, Steris received FDA's OK for a successor device, the Steris System 1E Liquid Chemical Sterilant Processing System.