More Time Granted for Sterilizing System Replacement

FDA this week told health facilities they have 18 months to switch from the STERIS System 1 to alternatives, three times longer than it recommended previously. STERIS Corp. continues to seek clearance for the new device.

The Food and Drug Administration is giving health care facilities 18 months, three times longer than it recommended previously, to switch to alternative systems if they are using STERIS Corporation's System 1 processor, a tabletop liquid chemical system that sterilizes endoscopes, bronchoscopes, and other medical devices between patient uses. FDA issued a warning letter in May 2008 to STERIS, which is based in Mentor, Ohio, that says changes the company made in the processor could affect its safety and effectiveness, and thus the product currently being marketed has not been cleared or approved by FDA.

STERIS has posted a Feb. 3 letter to customers stating that it submitted a new premarket notification for an updated System 1 to FDA on Jan. 5 and continues to seek clearance of the new device. In the letter, STERIS says it "is committed to continuing to support existing SYSTEM 1 units throughout the FDA's extension."

When FDA told health care facilities in December 2009 to switch to alternatives, STERIS President and CEO Walt Rosebrough said the company disagreed with the action and estimated the System 1 had been used safely and effectively to sterilize more than 300 million devices, when used as directed, since its introduction in 1988. He said Feb. 2 that STERIS continues to work with FDA to resolve the issue and to develop a plan to help facilities transition to alternatives.

The American Hospital Association (AHA) asked for more time and thanked FDA for granting it. "We appreciate this announcement by the FDA, which will permit these transitions to be done in a manner that maintains patient safety, employee safety, and allows for the production of a sufficient supply of alternative systems," said Nancy Foster, AHA's vice president for quality and patient safety.

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