Category: Noncritical

Response to the FDA’s Draft Guidance Document on the Reprocessing of Reusable Medical Devices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

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…