FDA Extends STERIS System 1 Transition
The U.S. Food and Drug Administration (FDA) is extending the transition period from STERIS System 1 Sterile Processing System to another alternative. Facilities now have up to 18 months to find a legally-marketed alternative to System 1.
On Dec. 3, FDA issued a notice claiming STERIS significantly modified System 1, which is used for sterilizing and disinfecting medical devices, and the modified product was not cleared or approved 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.
Facilities that had a readily available alternative to System 1 were asked to switch to it immediately. Facilities that didn’t have a readily available alternative were given three to six months to find an alternative.
FDA has decided to extend the transition period to 18 months to ease the burden on healthcare facilities. “The three- to six-month recommendation was based on discussions with a number of outside constituents,” according to the FDA notice announcing the extension. “Since then, agency staff has heard from many other healthcare providers and professional organizations. FDA now understands that a three- to six-month transition period may present significant difficulties for some healthcare facilities, which could, in turn, adversely affect patient care.”
STERIS has submitted a new premarket notification for an updated STERIS System 1, according to a letter from STERIS to customers. “This updated system includes the changes outlined in FDA’s original warning letter as well as other technology updates,” the letter reads. “STERIS submitted this new notification to FDA on January 5, 2009 and is continuing to seek clearance of this new device.”
To get a list of readily available alternatives to System 1, click here. STERIS has set up a dedicated portion of its website, available here, with updates on the situation.
For more information on how hospitals are responding to the System 1 notice, read this recent story in AAMI News.