Category: Device Classifications

Response to the FDA’s Draft Guidance Document on the Reprocessing of Reusable Medical Devices

February 5, 2015 —┬áThis 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…

California Health Alert: Failure to Disinfect Reusable Semicritical Instrumentation Poses an Increased Risk of Infection

September 16, 2013 — In 2007 the Health and Human Services Agency Department of Health Services for the state of California advised facility administrators and infection prevention and control professionals,…

Disinfection or Sterilization of a Contaminated Reusable Instrument?

Selection of the “right” sterilization or disinfection process, or technology, for reprocessing a specific type of reusable instrument may not always be straightforward. This is often because the instrument is…