Duodenoscope Models TJF-160F and TJF-160VF by Olympus: Safety Communication - Reprocessing Instructions Validated

[Posted 03/15/2016]

AUDIENCE: Risk Mananger, Gastroenterology, Nursing, Surgery, Infectious Disease

ISSUE: 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.

See the FDA Safety Communication for additional details regarding cleaning procedures.

BACKGROUND: 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 continues to closely evaluate the association between reprocessed endoscopes and the transmission of infectious agents.  Visit the Infections Associated with Reprocessed Duodenoscopes webpage for a listing of actions the Agency has taken on this issue. The Agency will continue to provide updates as appropriate.

RECOMMENDATION: FDA recommends that facilities using Olympus' 160 F/VF duodenoscope models train staff on the updated instructions and implement them as soon as possible.

Olympus sent a letter dated March 14, 2016 to health care facilities and other users of the 160 F/VF duodenoscope models outlining the updated, validated reprocessing instructions. An updated reprocessing manual and one box of MAJ-1534 brushes (3 brushes per box) required for the updated cleaning procedure accompanies Olympus' Customer Notification Letter. See the FDA Safety Communication for additional details regarding cleaning procedures.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/15/2016 -Safety Communication - FDA]