Category: Noncritical

Response to the FDA’s Draft Guidance Document on the Reprocessing of Reusable Medical Devices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

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…

The Reprocessing of Sheathed “ENT” Endoscopes, Cystoscopes, and Other Types of Flexible Endoscopes

A number of years ago this blog’s founder – Dr. Lawrence F Muscarella – wrote the Food and Drug Administration (FDA) requesting the Agency review for clarity and consistency, among…