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FDA Approves Validated Reprocessing Instructions for Olympus Scopes
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The FDA announced it has reviewed Olympus’s updated, validated manual reprocessing instructions for its TJF-160F and TJF-160VF duodenoscope models, and recommends facilities using the devices implement them as soon as possible.
Since the FDA’s initial safety communication issued in February 2015 — which warned that the complex design of duodenoscopes may prevent effective cleaning and potentially expose patients to serious infections — the Agency “has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect duodenoscopes.”
In March 2015 Olympus submitted protocols and data for validating the reprocessing instructions for the 160 F/VF duodenoscope models, after which the FDA determined that more rigorous testing was necessary to demonstrate adequate safety, according to the safety communication. Olympus then made further modifications and initiated testing, after which it submitted its cleaning and high-level disinfection reports to the FDA in the fall of 2015. The FDA then notified Olympus in January 2016 that the updated reprocessing instructions were adequate.
The updated instructions include more rigorous pre-cleaning, manual cleaning and high-level disinfection procedures, “specifically additional flushing, brushing and increased flushing volume.”
An additional reusable brush (Model MAJ-1534) for manual cleaning of the distal end and elevator recess area has also been incorporated into the updated instructions.
“The agency believes that when followed, these updated, validated reprocessing instructions demonstrate consistent and reliable cleaning and high-level disinfection of Olympus 160 F/VF duodenoscope models,” the communication said.
Olympus has sent letters to health care facilities and other users of these scope models that include the new instructions, an updated manual and a box of MAJ-1534 brushes.