Steris Corp. (NYSE:STE) landed special 510(k) clearance to modify its System 1E sterilizers, the replacement systems for the troubled System 1 devices that were the center of a 2-year row with the FDA.
The Mentor, Ohio-based device maker won the FDA’s approval to update existing SS1E devices in the field with modified software, which will also be applied to all new shipments, effective immediately.
The SS1E is a newer generation and replacement for Steris’ SS1 endoscope sterilization system, which landed in "violating device" status after the FDA in December 2009 ordered hospitals across the country to stop using the devices.
That unusual action by the FDA followed more than 18 months of legal wrangling, ending in a de-facto recall of a product that hadn’t been linked to any cases of infection or injury.
The federal watchdog agency warned that Steris made significant modifications to the SS1 without seeking additional 510(k) clearance, but Steris denied in letters to customers that changes to the device merited a new application.
In a February 2010 letter the FDA further warned all endoscope makers that they must change the labeling on any devices that claimed they could be reprocessed using the SS1 system, and even suggested they add language indicating that "The Steris System 1 (SS1) is not a legally marketed device."
Steris won FDA clearance for the next-gen SS1E system in April 2010, and later that month reached an agreement with the agency in setting up a transition plan that enabled U.S. customers – mostly hospitals and surgical centers – to trade in their SS1s for rebates. The transition deadline, which has been shifted a few times, is now set to August 2012.
The newest 510(k) win allows the company to make unspecified software modifications to existing and new SS1E systems, the details of which were not available in regulatory filings.
The good news didn’t garner much love from Wall Street, where STE shares were trading 2% lower at $30.40 as of about 2:00 p.m. today.
Steris did not immediately return requests for comment.