Pentax has updated its reprocessing instructions for the ED-3490TK video duodenoscope in order to replace the instructions from its original labeling. The FDA reviewed the update and recommended that staff using the ED-3490TK be trained as soon as possible.
The updated reprocessing instructions for the ED-3490TK call for a more meticulous protocol for precleaning, manual cleaning, high-level disinfection and liquid chemical