FDA issues Safety Communication on ED-3490TK duodenoscope by Pentax

Editor's Note

The Food and Drug Administration (FDA) on January 17 issued a Safety Communication to inform Pentax ED-3490TK video duodenoscope users of updated recommendations to help prevent the spread of infection associated with the use of these devices.

Since a February 19, 2016, Safety Communication to inform users about a design issue with the duodenoscope that could increase the risk of infection, the FDA has received additional information related to this risk.

The FDA continues to recommend that facilities train staff on Pentax’s February 2016 updated manual reprocessing instructions, which replaced those in the original device labeling. 

Posted 01/17/2017] AUDIENCE: Risk Manager, Gastroenterology, Surgery, Infectious Disease, Nursing ISSUE: FDA is providing an important update to the February 19, 2016 Safety Communication to inform users about a design issue with the PENTAX ED-3490TK duodenoscope that could increase the risk of patient infection.