FDA Warns Of Sterilization Device Issues

Mon, 12/07/2009 - 5:00am

According to the Food and Drug Administration, doctors and hospitals should stop using a device from Steris Corp. to sterilize surgical tools. The company’s SS1 sterilizer device has reportedly been malfunctioning, which has lead to patients becoming infected from unsterile instruments.

The FDA recommends physicians begin using alternative devices, while Steris representatives have been reassuring customers about future usage.

Steris has also offered these comments. "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," said STERIS President and Chief Executive Officer, Walt Rosebrough. "We understand our customers' concerns and apologize for the inconvenience the FDA notice will cause to their sterilization and decontamination processes."

STERIS has also established a dedicated hotline for more information: (440) 392-7223 and will continue to update customers via their website as more information becomes available.


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