STERIS acts in response to FDA's recent notice on SYSTEM 1 Sterile Processing System

STERIS Corporation (NYSE: STE) was notified on December 3, 2009 that the U.S. Food and Drug Administration (FDA) had issued a notice to healthcare facility administrators regarding the regulatory status of the STERIS SYSTEM 1^® Sterile Processing System, as well as actions healthcare facilities should take if they use this device.

“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.”

The FDA has stated that healthcare administrators should transition to acceptable alternatives to meet their sterilization and decontamination requirements. If they do not have an acceptable alternative, FDA has stated that Customers may continue to use SYSTEM 1 while they assess their sterilization requirements. FDA has also stated it is not aware of any confirmed cases of infection directly attributable to inadequate reprocessing by SYSTEM 1.

When considering the availability of acceptable alternatives to meet sterilization and disinfection needs, STERIS suggests that healthcare administrators include these considerations:

• Consult the device manufacturer’s written instructions for reprocessing procedures.
• Be aware that not all devices can be reprocessed using the same sterilization technology.
• Note that the healthcare facility’s validation/verification requirements will need to be reviewed.

As a result of the December 3, 2009 FDA notice, the Company is considering its available options and expects to have further discussions with the FDA. There is no assurance, however, that the FDA will not pursue an administrative or enforcement action or not seek other remedies, including the demand that STERIS stop further sales of the SYSTEM 1 device and any related services, accessories and sterilant. These actions by the FDA could possibly result in administrative orders or judgments requiring re-labeling or restriction on the manufacturing, sale, or distribution of products, or could require us to take other actions, including recalls, to pay significant monetary fines or civil damages, or to be subject to other governmental or third party claims or remedies, which could materially affect our business, performance, value, financial condition, and results of operations.