Olympus Validates Updated Reprocessing Instructions for Duodenoscope

Date Issued: March 15, 2016

Audience: Users of the Olympus TJF-160F and TJF-160VF duodenoscopes and reprocessing facilities including:

  • Gastroenterologists
  • Gastrointestinal surgeons
  • Endoscopy nurses
  • Staff working in endoscopy reprocessing units in health care facilities
  • Infection control practitioners
  • Facility risk managers

Medical Specialties: Gastroenterology, Infection Control

Device: Olympus duodenoscope models TJF-160F and TJF-160VF

Olympus Corporation of the Americas (Olympus) has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160VF duodenoscope models (160 F/VF duodenoscope models) to replace those provided in the original device labeling. The FDA reviewed the updated reprocessing instructions and the validation data and determined that they meet the Agency’s expectations. We recommend that facilities using Olympus’ 160 F/VF duodenoscope models train staff on the updated instructions and implement them as soon as possible.

Summary of Problem and Scope:

As noted in the FDA’s February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection. If these residual fluids contain microbial contamination, subsequent patients may be exposed to serious infections. The FDA has been working

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