UPDATED 01/15/2016. The Agency is redistributing the March 26, 2015 Safety Communication with updated status information about the Agency's 510(k) clearance decision and Olympus Corporation of the America's Customer Notification.
On March 4, 2015, the FDA provided Updated Information for Health care Providers Regarding Duodenoscopes. At that time, Olympus had a pending 510(k) application for its TJF-Q180V duodenoscope. The company continued to market this device while its application was under review. On January 15, 2016, the FDA cleared the TJF-Q180V duodenoscope 510(k) with design modifications to the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.
Also on January 15, 2016, Olympus notified its customers by issuing a Customer Notification Letter that:
Includes information about the TJF-Q180V duodenoscope’s design and labeling changes per the cleared 510(k);
Outlines Olympus’ strategy to repair all customers’ TJF-Q180V elevator mechanism in accordance with the new design; and
Informs customers that Olympus will set up a return schedule with them for duodenoscope repair.
The validated manual reprocessing procedures outlined in the March 26, 2015 Safety Communication ‘Validated Manual Reprocessing Procedure' section remain the same. Health care facilities should continue to use these validated instructions when reprocessing Olympus TJF-Q180V duodenoscopes.
AUDIENCE: Gastroenterology, Surgery, Nursing, Risk Manager, Biomedical Engineering, Patient
ISSUE: Olympus has issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope to replace those provided in the original labeling. The FDA has reviewed these new reprocessing instructions and the validation data as part of its ongoing review of the 510(k), and recommends that any facilities that are using Olympus’ TJF-Q180V duodenoscope train staff on the new instructions and implement them as soon as possible.
BACKGROUND: Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA is closely monitoring the possible association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli. 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’s investigation into the possible association between inadequately reprocessed duodenoscopes and patient infections, including the agency’s recommendations for health care facilities, is more fully discussed in the following recent communications: February 2015 Safety Communication and FDA’s Updated Information for Healthcare Providers Regarding Duodenoscopes issued March 4, 2015.
RECOMMENDATION: Olympus sent letters dated March 26, 2015 to health care facilities and other users of the TJF-Q180V outlining the new, validated reprocessing instructions, and will soon be distributing revised user manuals. Key changes have been made to the Precleaning, Manual Cleaning, Manual High Level Disinfection reprocessing procedures for Olympus’ TJF-Q180V duodenoscope. Please see the FDA Safety Communication for more details. In addition, FDA has the following recommendations for facilities and staff that use and reprocess the Olympus TJF-Q180V:
- Implement the new manual cleaning and high level disinfection procedures for the Olympus TJF-Q180V duodenoscope in accordance with the manufacturer’s reprocessing instructions.
- Train appropriate staff on Olympus’ new reprocessing instructions and implement them as soon as possible.
- Contact Olympus directly with specific questions and concerns or to schedule a site visit with their Endoscopy Support Specialists Technical Assistance Center (TAC), 1-800-848-9024, option 1 Monday - Friday between 7AM EST - 8 PM EST.
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
[01/15/2016 - UPDATED FDA Safety Communication - FDA]
[02/19/2015] - Related MedWatch Alert - FDA]