2016-02-22 18:19:46 UTC
Feb. 23, 2016
FDA has validated the company’s updated reprocessing instructions for the ED-3490TK Video Duodenoscopes.
If you use PENTAX scopes, be aware that the company has issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling. The updated instructions include added safety measures to eliminate the potential for transmission of infectious agents.
FDA recommends that facilities using PENTAX ED-3490TK Video Duodenoscopes train staff on the updated instructions and implement them as soon as possible.
The updated reprocessing instructions for the ED-3490TK Video Duodenoscope include a more rigorous protocol for pre-cleaning, manual cleaning, high-level disinfection and liquid chemical sterilization procedures. In addition, updated instructions include additional text, figures, cautions and warnings intended to clarify the validated reprocessing procedure.
More information is available in this FDA Safety Communication.
The AGA Center for GI Innovation and Technology has been working closely with FDA, endoscope manufacturers and other GI, epidemiology and infectious disease experts to develop a path forward to prevent scope-associated infections. The center will continue to keep you updated on new safety protocols to ensure safe patient care.