Category: Liquid Chemical Sterilization

Response to the FDA’s Draft Guidance Document on the Reprocessing of Reusable Medical Devices

February 5, 2015 —¬†This article presents Dr. Muscarella’s response submitted in August 2011 to the federal Food and Drug Administration (FDA), in reply to the Agency’s request earlier that same…

The Use of Biological Indicators to Monitor Liquid Chemical Sterilants: The FDA’s Position, 2014

November 25, 2014 — The proper use of “BIs” – or biological indicators – in the healthcare setting is crucial to assess the effectiveness of the sterilization process.¬† Failure to…

The STERIS System 1E Liquid Chemical Sterilant Processing System: Looking Back and Forward

July 1, 2015 — Almost four years ago, on April 5, 2010, the Food and Drug Administration (FDA) cleared the STERIS System 1E Liquid Chemical Sterilant Processing System, or “SS1E,”…