FDA Pulls Approval of STERIS Surgical Tool Sterilizer

The U.S. Food and Drug Administration (FDA) has issued a warning to doctors and hospitals that surgical tool sterilizer System 1 made by STERIS Corp. is no longer “safe and effective” and should not be used. STERIS disagrees with the agency’s assessment.

The FDA said the device, which makes up about 10 percent of the company’s revenue, has lost its approval from 20 years ago because it has been significantly modified since then.

STERIS is working with the FDA to resolve the matter, but “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 CEO Walt Rosebrough.

The agency wants Mentor, Ohio-based STERIS to encourage customers to switch to other sterilizers, but the FDA said STERIS is not.

The company said healthcare administrators should consider the following:

• Consult the device manufacturer’s written instructions for reprocessing procedures.

• Be aware that not all devices can be reprocessed using the same sterilization technology.

• The healthcare facility’s validation/verification requirements will need to be reviewed.