Class 1 Recall: Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes

Date Issued: March 26, 2015

Audience: Users of the Olympus TJF-Q180V 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 model TJF-Q180V

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.

Summary of Problem and Scope:

As noted in FDA’s February 2015 Safety Communication, the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. FDA 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 the duodenoscopes.

In September 2014, Olympus initiated testing to validate new reprocessing instructions. The cleaning validation reports were provided to FDA in October 2014. While FDA found Olympus’ cleaning validation data acceptable, initial high level disinfection reports did not demonstrate an adequate safety margin, and so Olympus conducted additional testing. At the end of February 2015, Olympus submitted new high level disinfection validation data to FDA. The agency has reviewed this data and believes that, when followed, the new, validated reprocessing instructions for the Olympus TJF-Q180V duodenoscope are robust, and demonstrate consistent and reliable cleaning and high-level disinfection. At FDA’s request, Olympus has issued the new, validated instructions for reprocessing the TJF-Q180V duodenoscope.

To validate reprocessing instructions for duodenoscopes, manufacturers should soil their device with bacteria to simulate use in a procedure and then demonstrate that the device can be adequately disinfected through a sufficient reduction in microbes when the reprocessing instructions are correctly followed. To support high level disinfection of duodenoscopes, the disinfectant should result in a six-log reduction in the number of microbes at each of several locations on the scope – that is a one million-fold reduction; or a reduction of 99.9999%.

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 its February 2015 Safety Communication.

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.

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