FDA approves new Steris device processing system

The Food and Drug Administration (FDA) has approved a new alternative to the Steris System 1 device processing system to process endoscopes and other reusable heat-sensitive medical devices. Steris Corp. said it expects to begin delivery of the new Steris System 1E Liquid Chemical Sterilant Processing System by second quarter of fiscal year 2011. The FDA last December told health care facilities that use the Steris' System 1 that they must transition to other processing systems within three to six months, citing unapproved changes to the system. In response to concerns from the American Hospital Association and others, the FDA later gave facilities until August 2011 to transition to legally marketed alternatives to the Steris System 1.

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