STORY FROM: Drugs & Medical Devices
FDA Advises Health Care Facilities to Stop Using Custom Ultrasonics Reprocessors to Clean Duodenoscopes
August 17, 2016
WASHINGTON, D.C. — The Food and Drug Administration has advised heath care facilities to stop using Custom Ultrasonics’ System 83 Automated Endoscope Reprocessors to clean duodenoscopes in light of the company’s urgent May 6 recall of the AERs.
In an Aug. 17 Safety Alert, the agency revised its February Safety Communication to state that the System 83 Plus AERs remain in service for reprocessing endoscopes other than duodenoscopes.
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, stomach, and into the top of the small intestine (the duodenum). They contain a hollow channel that allows the injection ...