Date Issued: March 15, 2016
Audience: Users of the Olympus TJF-160F and TJF-160VF duodenoscopes and reprocessing facilities including:
- 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 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 March 2015, at the Agency's request, Olympus submitted the test protocols and data used to validate the reprocessing instructions for the 160 F/VF duodenoscope models. The Agency reviewed this information and informed Olympus that more robust testing was necessary to demonstrate an adequate safety margin. Between April and June 2015, Olympus modified its reprocessing protocols and, upon acceptance of the updated protocols, Olympus initiated testing to validate the updated reprocessing instructions. In fall 2015, Olympus submitted its cleaning and high-level disinfection reports to the Agency; we continued to work with Olympus to clarify and ultimately confirm that their cleaning and high-level disinfection instructions met the Agency's expectations. In January 2016, the Agency notified Olympus that the updated reprocessing instructions for the160F/VF duodenoscope models were adequate.
The updated reprocessing instructions for the 160F/VF duodenoscope models include a more rigorous protocol for pre-cleaning, manual cleaning and high-level disinfection procedures, specifically additional flushing, brushing and increased flushing volume. They also incorporate the use of an additional reusable brush (Model MAJ-1534) to manually clean the distal end of the scope, including the elevator recess area. This new brush can be sterilized by autoclave following use, as outlined in the updated reprocessing manual. 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.
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.
Please note the key changes to the reprocessing procedure for both the Olympus160 F/VF duodenoscope models:
- Flush the elevator wire channel with water
- Additional brushing of the forceps elevator recess area and the elevator wire
- The revised cleaning procedure requires brushing of the forceps elevator recess. In addition to the brushes that are currently used to clean the elevator recess area, the MAJ-1534 is a new brush required for further cleaning of this area.
- The following brush models are required for the revised brushing steps of the TJF-160F/VF. When multiple brushes are provided, health care facilities have the option to use one of the brushes listed to clean the respective brushing point(s).
|Types of brush models||Brushing Point|
Channel-opening cleaning brush (MH-507 or MAJ-1339 or BW-412T)
Channel cleaning brush (BW-20T or BW-412T)
Cleaning brush (MAJ-1534)
- Additional flushing of forceps elevator recess area and the elevator wire
- Additional raising/lowering the forceps elevator
Manual High Level Disinfection:
- Additional manual flushing steps and increased flushing volume of each endoscope channel, as well as the elevator recess area
- Additional raising/lowering of the forceps elevator
In addition, the FDA has the following recommendations for facilities and staff that use and reprocess Olympus 160 F/VF duodenoscope models:
- Implement the updated manual cleaning and high level disinfection procedures for Olympus' 160 F/VF duodenoscope models in accordance with the updated reprocessing instructions.
- The new manual cleaning procedure involves the use of a new cleaning brush (MAJ-1534), in addition to the current brushes that should continue to be used to the clean the elevator recess area (see table above).
- Train appropriate staff on Olympus' updated reprocessing instructions and implement them as soon as possible.
- Contact Olympus directly with specific questions and concerns, to schedule a site visit with their Endoscopy Support Specialists or to obtain additional copies of the new Reprocessing Manual:
- Technical Assistance Center (TAC), 1-800-848-9024, option 1.
FDA's recommendations are based on currently available information. If new, important information becomes available, the FDA will update its recommendations.
The FDA continues to closely evaluate the association between reprocessed endoscopes and the transmission of infectious agents by:
- Working closely with duodenoscope and Automated Endoscope Reprocessor (AER) manufacturers as they validate their reprocessing instructions to a level adequate to clean and disinfect their devices.
- Proactively communicating recommendations to health care providers and end users to help mitigate the risk associated with infection transmission and reusable medical devices.
- Working with the health care community, professional societies, international public health agencies, federal partners and state and local governments to investigate the association between reprocessed reusable medical devices and cases of bacterial infection in health care facilities.
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.
Reporting Problems to the FDA:
Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Health care providers should submit voluntary reports of the transmission of an infection due to an inadequately cleaned duodenoscope to the agency via the Medical Device Reporting (MDR) process.
If a health care provider suspects bacterial contamination—either because of an increase in infections after ERCP, or because of the results of bacterial surveillance culturing of duodenoscopes—we encourage the health care provider to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Olympus Customer Notification Letter
- FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities. October 2015.
- Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. CDC Health Advisory. September 11, 2015.
- Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication. August 2015.
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff. March 2015. (PDF - 1.3MB)
- Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes: FDA Safety Communication. March 2015.
- Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication. February 2015.
- Infections Associated with Reprocessed Duodenoscopes: FDA website
- Information about Automated Endoscope Reprocessors (AERs) and FDA's Evaluation: FDA website
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.