1.20.09 | Mary Vanac

Steris proposes new sterilization system to FDA

MENTOR, Ohio — Mentor manufacturing and technology company Steris Corp. has asked the Food and Drug Administration to approve a new chemical sterilization system for sale.

Once approved, the yet unnamed system eventually will replace System 1, the first medical instrument sterilizer launched by Steris in 1988.

The premarket approval filing by Steris is aimed at putting to rest issues raised in a warning letter from the FDA in mid-May, Steris said in a written statement. The FDA said that Steris probably should have notified the federal regulator of substantial changes made to System 1 over the two decades it has been sold.

Steris will continue to service and support System 1 until at least 2011, said Steve Norton, corporate communications director for the company. “There’s no change in clinical practice required on the part of our customers,” Norton said.

“We’re in the process now of reaching out to all our U.S. customers to explain what we announced today,” he said.

Mary Vanac

Mary Vanac is a co-founder of MedCity News.

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Tags: Ohio, STERIS, U.S. Food and Drug Administration

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[...] STERIS filed aÂ 510(k)Â for a next-generationÂ System 1 in January. “We continue to work diligently with the agency toÂ answer questions regarding [...]

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[...] company said it had submitted for FDA review an updated version of the device. Once the new version is cleared, Steris would work with customers [...]

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[...] in January the companyÂ asked the FDA to approve a new chemical sterilization system for sale, partly to put to rest its ongoing disagreement withÂ the regulator. TheÂ new system eventually [...]

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[...] of making a new application to market System 1,Â STERIS applied to the FDA on Jan. 5 to sellÂ a next-generationÂ chemical sterilization systemÂ – essentially an updated and improved System 1 — largelyÂ to put to rest its ongoing [...]

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[...] year ago, STERIS asked the FDA to approve a kind of System 1.5. “While we are focused to assist customers as they look to transition from System 1, we [...]

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