The U.S. Food and Drug Administration has given STERIS (NYSE: STE) customers an additional six months to transition from the company’s recalled System 1 sterilization device.
Customers have been given until Feb. 2 to make the change to an alternate processing system, according to a regulatory filing from Mentor, Ohio-based STERIS. The company said it would continue to support System 1 customers in the U.S. until that date.
STERIS has been battling issues related to its flagship System 1 device since December 2009, when the FDA issued a safety alert warning that the device could be harmful to patients. System 1 is a liquid chemical sterilizing system used by hospitals, surgical centers and other healthcare facilities to sterilize heat-sensitive medical instruments.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The company has been working to transition customers to its new System 1E product, but another FDA-related holdup is creating problems around the replacement device.
STERIS said it asked the FDA for the System 1 extension while the agency is in the midst of reviewing a 510(k) application for clearance of an accessory part to the replacement system. That part, called a biological indicator, isn’t necessary to operate the System 1E, though many customers prefer to use it. The part indicates the presence of biological materials on equipment to be sterilized.
STERIS spokesman Steve Norton declined to say exactly when the company filed a 510(k) application with the FDA for the biological indicator, but said it happened after April 2010, when the company received clearance for System 1E.
STERIS said it couldn’t make any assurances about if or when the device might be cleared by the FDA. The company’s financial outlook regarding revenue, System 1E shipments and earnings remains unchanged.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Last month, STERIS decreased its projection for full-year revenue, citing lower-than-anticipated shipments of the System 1E. The company shipped about 50 System 1E units through the end of last quarter and expects to ship about 1,000 this quarter, CEO Walt Rosebrough said at the time.
Rosebrough admitted that STERIS was “behind schedule” in shipments of System 1E, primarily due to the FDA’s review of the accessory part.
