FDA extends time to replace Steris sterilizing system

Accreditation Connection, February 8, 2010

Those healthcare facilities using the Steris© sterilizing system will now have an 18-month time period to switch to other methods, according to an official statement on The Food and Administration (FDA) Web site. Facilities using the Steris sterilizing system were originally told in December 2009 to switch to another means within a three-to-six month timeframe.

"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, American Hospital Association vice president for quality and patient safety, in an official statement on the AHA's Web site.

The FDA has no plans to take regulatory action against those facilities that do not make the switch on time, but hopes all facilities will make the change in a practical timeframe.

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