Source Pravda.Ru

FDA Disapproves of Steris Corp. Device

The Food and Drug Administration is far from being satisfied with Steris Corp. device and urge doctors to use other apparatus to sterilize surgical tools.

The company's modified SS1 sterilizer device has not been cleared as safe and effective. Users have reported problems that could result in patients becoming infected from unsterile instruments, according to an FDA a statement released late Thursday.

The FDA recommends physicians begin using alternative devices as soon as possible.

Steris shares plummeted $4.17, or 12.5 %, to close at $29.14 Friday. The company did not return a call for comment.

The FDA warned Mentor, Ohio-based Steris in May 2008 about the problems with its devices, and the company was supposed to begin transitioning customers to alternative products.

"FDA is not satisfied that the firm has been working effectively to transition its customers," the agency said. Steris representatives have been "reassuring customers that there is no need for a change in their clinical practice."

The Associated Press has contributed to the report.

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