February 22, 2016

FDA: Pentax validates reprocessing instructions for ED-3490 TK Video Duodenoscope

By: Judy Mathias
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Editor’s Note

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.

 

FDA3

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.

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