Response to the FDA’s Draft Guidance Document on the Reprocessing of Reusable Medical Devices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and Drug Administration (FDA), in reply to the Agency’s request earlier that same year that the public comment on its draft guidance document...

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Impact of Hydraulic Fluid on the Sterilization of Surgical Instruments: Were Affected Patients Told of the True Infection Risk?

January 4, 2013 — Two community hospitals in North Carolina in 2004 unwittingly used a oil-based hydraulic fluid instead of a detergent to “clean” surgical instruments prior to terminal sterilization and their reuse. These improperly cleaned instruments — slick with hydraulic Read More …