FDA: Olympus Issues New Reprocessing Instructions for Q180V Duodenoscope

WASHINGTON, D.C. — The Food and Drug Administration has announced that Olympus has issued new, validated manual preprocessing instructions for its Q180V duodenoscope in response to reports of multi-drug resistant bacterial infections in patients who have undergone procedures in which the device was used.

According to a March 26 Safety Communication, “key changes” have been made to the cleaning and disinfection reprocessing procedures for the device. Olympus says it has notified health care facilities of the new instructions and will soon be distributing revised user manuals.

Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, stomach, and …