FDA Orders Custom Ultrasonics to Recall AERs Used to Clean Duodenoscopes
The U.S. Food and Drug Administration (FDA) has ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs), devices used to sterilized special medical scopes such as duodenoscopes. According to a Nov. 13 announcement, the recall is being issued due to “continued violations of federal law and a consent … [Read more...] about FDA Orders Custom Ultrasonics to Recall AERs Used to Clean Duodenoscopes
Emails Show FDA Was Warned of Duodenoscope Infection Risks Six Years Ago
The Food and Drug Administration (FDA) received warnings nearly six years ago about the risk of “superbug” infection from specialized medical scopes. The devices have been tied to a series of deadly superbug outbreaks. In 2009, after duodenoscopes were linked numerous drug-resistant infections in Florida hospital patients (and to … [Read more...] about Emails Show FDA Was Warned of Duodenoscope Infection Risks Six Years Ago
