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FDA: STERIS device could cause ‘serious injuries’ to patients

The U.S. Food and Drug Administration has issued a safety alert for a sterilization device from Steris Corp., warning that the device has the potential to cause “serious injuries,” such as infections to patients.

Updated 9:36 a.m., Dec. 5, 2009.

MENTOR, Ohio — The U.S. Food and Drug Administration has issued a safety alert for a sterilization device from STERIS Corp., warning that the device has the potential to cause “serious injuries” such as infections to patients.

The FDA said it has received reports of malfunctions by STERIS’ System 1 Processor, which is used to sterilize heat-sensitive medical instruments such as endoscopes, according to a safety alert the agency issued to hospital risk managers and other health providers.

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Additionally, the FDA said it had received “reports of injuries, mostly burns from exposure to the sterilant solution, to health care facility staff operating the device.”

The company’s stock plummeted more than 15 percent in early trading Friday as a result of the news. The shares ended the day on the New York Stock Exchange down $4.17, or 12.5 percent, at $29.14.

Stephen Norton, a STERIS spokesman, acknowledged that the company had received the FDA’s notice. Company officials made a statement early Friday evening:

“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 latest warning from the FDA isn’t the first time the System 1 Processor has caused trouble for STERIS. In January, the company said it was discontinuing new sales of the device as the result of an agreement with the FDA. STERIS said at the time that it would sell the device in the U.S. “on a replacement basis only.”

The company said it had submitted for FDA review  an updated version of the device. Once the new version is cleared, STERIS would work with customers to transition them to the replacement device.

In May 2008, the FDA sent a warning letter  to STERIS saying that because the company had modified the device, STERIS would be required to seek new approval from the agency to sell it. STERIS said it disagreed with the FDA’s assessment, according to a regulatory filing.

Health facilities currently using the device should transition to “an acceptable alternative,” if possible, to ensure patient safety, the FDA said in its latest warning. Facilities that don’t have an alternative device on hand should “take steps to obtain legally marketed substitutes,” the agency said.

In it’s late Friday statement, STERIS gave customers some guidance on selecting an alternative sterilizer: Consult the device manufacturer’s written instructions for reprocessing procedures; be aware that not all devices can be reprocessed using the same sterilization technology; and note the health care facility’s validation and verification requirements should be reviewed.

STERIS issued a separate letter to customers (pdf), which referenced the FDA warning.