The Food and Drug Administration (FDA) on February 19 announced that it had reviewed updated reprocessing instructions and validation data issued by Pentax Medical (Montvale, New Jersey) for its ED-3490 Video Duodenoscope.
The FDA recommends that facilities train staff on the updated instructions and implement them as soon as possible.
The update includes a more rigorous protocol for precleaning, manual cleaning, high-level disinfection, and liquid chemical sterilization procedures. The instructions also include additional text, figures, cautions, and warnings intended to clarify the validated reprocessing procedure.
Posted 02/19/2016] AUDIENCE: Risk Manager, Gastroenterology, Surgery, Infectious Disease, Nursing ISSUE: PENTAX has issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling. The FDA reviewed these updated reprocessing instructions and the validation data and recommends that facilities using PENTAX ED-3490TK Video Duodenoscopes train staff on the updated instructions and implement them as soon as possible.Read More >>