FDA warns of problems with sterilization device

AP News
Posted: Dec 04, 2009 4:27 PM

Doctors and hospitals should stop using a device from Steris Corp. to sterilize surgical tools after reports of malfunction, according to the Food and Drug Administration.

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 percent, to close at $29.14 Friday. The company did not return a call for comment.

FDA officials told reporters Friday that they are "considering all available options," against Steris, but did not elaborate on a specific actions.

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.

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"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."