MENTOR, Ohio — Shares of STERIS Corp. rebounded slightly today from a 12 percent hit on Friday following a U.S. Food and Drug Administration safety alert for the company’s System 1 sterilizer. STERIS shares rose $1.06, or 3.6 percent, to $30.20 on the New York Stock Exchange.
On Thursday, the FDA said it had received some reports of System 1 malfunctions “that had the potential to cause or contribute to serious injuries to patients, such as infections.” The FDA also said it is aware of injury reports by workers who used System 1, a unit that uses chemicals rather than heat to sterilize medical instruments and endoscopes.
An FDA official acknowledged during a Friday conference call (pdf) with hospital administrators that “we’re not aware of any confirmed cases of infection directly attributable to inadequate processing” by System 1, according to an unofficial transcript of the call posted by STERIS. Nevertheless, the regulator has recommended that hospitals replace System 1 with alternative sterilizers.
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The latest FDA action stems from a May 2008 warning letter in which the regulator stated STERIS had made so many changes to System 1 since its 1988 launch that it no longer considered the device approved as safe and effective. The FDA now refers to System 1 as a “violating device.”
STERIS has consistently disagreed with the FDA’s stance on System 1. Friday evening, Walt Rosebrough, STERIS president and chief executive, issued a statement: “We disagree with the FDA’s recent notice and are working to engage in further dialogue with the agency about this matter. Since its introduction in 1988, we estimate that the SYSTEM 1 Sterile Processing System has safely and effectively sterilized more than 300 million devices when used as directed.”
STERIS posted a second letter to customers today.
However, in January the company asked the FDA to approve a new chemical sterilization system for sale, partly to put to rest its ongoing disagreement with the regulator. The new system eventually would replace System 1, if approved by the FDA.
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At that time, STERIS said it would continue to service and support System 1 until at least 2011, though it would stop selling new systems. About 23,000 System 1 units are in use worldwide, said Stephen Norton, corporate communications director for the Mentor, Ohio, manufacturer.
During the Friday conference call, an FDA official said STERIS has broken promises to help customers move to alternative devices.
“FDA believed that STERIS was in the process of transitioning customers to legally marketed alternative devices,” Timothy Ulatowski, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health, was quoted as saying. “Communications this year with STERIS and an inspection of their records revealed that this transition was not to our satisfaction.”
