FDA: Reprocessing instructions validated for Olympus duodenoscope models TJF-160F and TJF-160VF

Editor's Note

The Food and Drug Administration (FDA) on March 15 announced that Olympus (Center Valley, Pennsylvania) has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160 VF duodenoscope models to replace those provided in the original device labeling.

The FDA reviewed the updated reprocessing instructions and the validation data and determined they met the agency’s expectations.

The FDA recommends that facilities train staff on the updated instructions and implement them as soon as possible.

Posted 03/15/2016] AUDIENCE: Risk Mananger, Gastroenterology, Nursing, Surgery, Infectious Disease ISSUE: Olympus Corporation of the Americas (Olympus) has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160VF duodenoscope models (160 F/VF duodenoscope models) to replace those provided in the original device labeling.