Tag: FDA

Response to the FDA’s Draft Guidance Document on the Reprocessing of Reusable Medical Devices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

Superbugs, Contaminated Gastrointestinal Endoscopes, and a Growing Number of Hospital Infections: Is an FDA Action Imminent?

December 2, 2014 — Two superbug outbreaks of carbapenem-resistant Enterobacteriaceae were recently linked to contaminated gastrointestinal (GI) endoscopes. These “nightmarish” bacteria are often abbreviated as CRE. These two outbreaks were…