Updated 2:02 p.m.
WASHINGTON, D.C. — The U.S. Food and Drug Administration has posted a notice on alternatives to System 1, the medical instrument sterilizer made by STERIS Corp. in Mentor, Ohio, that the administration considers a “violating device.”
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The lengthy list of alternative sterilizers, posted on Monday, comes after the FDA issued a safety alert about System 1 on Dec. 3, saying the administration had received some reports of malfunctions “that had the potential to cause or contribute to serious injuries to patients, such as infections.” The FDA also said it was aware of injury reports by workers who used the system.
Last week, ECRI Institute, a nonprofit organization that seeks to apply scientific research to improve patient care, posted its recommendations, as well as a side-by-side product comparison chart, to help hospitals find alternative devices.
The System 1 saga began in May 2008 when the FDA sent STERIS a warning letter telling the manufacturer that it had made so many changes to its first sterilizer since its 1988 launch, the administration no longer considered the device approved as safe and effective.
STERIS disagreed with the FDA, saying changes made to System 1 through the years did not warrant a new market application and the changes complied with FDA requirements when they were made. In January, STERIS applied to the FDA to sell a next-generation chemical sterilization system — essentially an updated and improved System 1 — largely to put to rest its ongoing disagreement with the regulator.
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The new system eventually would replace System 1, if approved by the FDA. STERIS said it would stop selling System 1, but continue to service and support it through 2011.
The FDA has acknowledged several times this month that it is unaware of any confirmed cases of infection caused by inadequate processing by System 1. Still, it has recommended that hospital leaders plan to replace 23,000 System 1 sterilization units worldwide.
STERIS is keeping a running tab of FDA communications on System 1 at its Web site.
The company also is “engaged in daily discussions with the FDA, including the sharing, review and input on information to be shared with health care administrators,” said Stephen Norton, corporate communications director for STERIS, in an emailed response to a reporter’s questions. “We expect to communicate and carefully coordinate” information with the FDA, “and it is likely that we will continue to publish information to our respective Web sites.”
Shares of the Mentor manufacturer have dropped 17 percent to $27.74, as of noon today, since the FDA’s recent actions on System 1 began. Prior to Dec. 3, STERIS shares had gained 28 percent from mid-year, partly on the sales strength of hand sanitizers used to ward off H1N1 infections.
