December 23, 2015
Users and reprocessors of the FUJIFILM Medical Systems, U.S.A., Inc. (Fuji) ED-530XT duodenoscope, as well as users of Fuji’s ED-250XL5, ED-250XT5, ED-450XL5 and ED-450XT5 duodenoscopes including:
- Gastrointestinal surgeons
- Endoscopy nurses
- Staff working in endoscopy reprocessing units in health care facilities
- Infection control practitioners
- Facility risk managers
Gastroenterology, Infection Control
Fuji issued revised, validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. The FDA reviewed the revised reprocessing instructions and the validation data and determined they meet the Agency’s expectations. We recommend that facilities using Fuji’s ED-530XT duodenoscope train staff on the new instructions and implement them as soon as possible.
While formal validation testing with the revised reprocessing instructions is ongoing for Fuji’s 250 and 450 duodenoscope models, FDA encourages health care facilities to apply the revised reprocessing instructions for the ED-530XT duodenoscope to reprocess the 250 and 450 duodenoscope models. FDA believes that the revised reprocessing instructions for the ED-530XT duodenoscope are more robust because of additional pre-cleaning, cleaning and high-level disinfection steps and, for that reason, should increase the safety margin of the 250 and 450 duodenoscope models. We recommend implementing the revised reprocessing instructions as soon as possible.
Summary of Problem and Scope:
As noted in 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. 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 May 2015, Fuji initiated testing to validate the revised reprocessing instructions and provided the cleaning validation reports to FDA in July 2015. Between July and October 2015, the Agency continued to work with Fuji to clarify and ultimately confirm that their cleaning and high-level disinfection instructions met the Agency’s expectations. In October 2015, the FDA notified Fuji that the validation data for the ED-530XT duodenoscope were acceptable and worked with the company as they developed revised instructions for use.
The revised instructions include a more rigorous protocol for pre-cleaning, manual cleaning and high-level disinfection procedures. They also incorporate the use of an additional disposable brush (Model WB1318DE) to manually clean the distal end of the scope. The agency reviewed the validation data and believes that when followed, the revised, validated reprocessing instructions demonstrate consistent and reliable cleaning and high-level disinfection of the Fuji ED-530XT duodenoscope.
Please note the key changes to the reprocessing procedure for Fuji’s ED-530XT duodenoscope:
- During immersion of the scope tip in detergent solution, move the forceps elevator back and forth and aspirate detergent solution while the forceps elevator is raised and while lowered.
- Additional brushing of the distal tip, forceps elevator and elevator recess first using the existing Fujifilm valve cylinder cleaning brush (Model WB11002FW2) and then using the new disposable (Model WB1318DE) cleaning brush.
- Additional flushing of detergent and rinse water onto the forceps elevator/recess while the elevator is both raised and lowered.
- Additional flushing steps and increased channel flushing volumes of detergent and rinse water.
Manual High Level Disinfection:
- Additional flushing of disinfectant and rinse water onto the forceps elevator/recess while the elevator is both raised and lowered. Additional raising and lowering of the elevator while immersed in disinfectant solution and rinse water.
- Additional flushing steps and increased flushing volumes of disinfectant and rinse water through the duodenoscope’s internal channels.
In addition, the FDA recommends the following for facilities and staff that use and reprocess the Fuji ED-530XT as well as Fuji’s 250 and 450 duodenoscope models:
- Implement the manufacturer’s revised cleaning and high level disinfection procedures for the Fuji ED-530XT duodenoscope, and apply them to Fuji’s 250 and 450 duodenoscope models while validation testing continues for those models.
- Train appropriate staff on Fuji’s revised reprocessing instructions and implement them as soon as possible.
- Contact your Fuji Endoscopy Division sales representative if you have any questions or concerns regarding the updated duodenoscope reprocessing instructions.
- Contact Fuji’s Senior Manager of Clinical Education and Product Coordination at (316)-281-5625 or via email at email@example.com to schedule a site visit with Fuji Clinical Sales Specialists (CSS) for an in-service training regarding these updated duodenoscope reprocessing instructions.
FDA’s recommendations are based on currently available information. If new, important information becomes available, FDA will update its recommendations.
Fuji sent customer notification letters dated December 23, 2015 to health care facilities and other users of the ED-530XT duodenoscope outlining the revised validated reprocessing instructions. Fuji also sent customer notification letters dated December 23, 2015 to health care facilities and other users of Fuji’s 250 and 450 duodenoscope models notifying them that they should use the revised reprocessing instructions for the ED-530XT duodenoscope when reprocessing the 250 and 450 duodenoscope models.
Updated operation manuals containing revised reprocessing instructions and new brushes accompanied the notification letters that Fuji sent to all customers using the ED-530XT, 250 and 450 duodenoscope models. Fuji will provide new distal end brushes (Model WB1318DE) at no charge for six months after the release date of the notification letters. Additional copies of the operation manuals and boxes of brushes can be requested through your facility’s local sales representative.
The FDA continues to closely evaluate the association between reprocessed endoscopes and the transmission of infectious agents. 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.
As part of our ongoing evaluation, the FDA has taken the following recent actions:
- In October 2015, the FDA ordered the three companies that manufacturer duodenoscopes marketed in the U.S. (Fuji, Olympus, Pentax) to conduct 522 postmarket surveillance studies so the Agency can better understand how duodenoscopes are reprocessed in real-world settings.
- In August 2015, the FDA issued 483s and Warning Letters to all three firms that manufacture duodenoscopes (Fuji, Olympus, Pentax) describing violations to the Federal Food, Drug and Cosmetic Act based on inspection findings.
- During Fuji’s inspection, the FDA became aware that the firm made modifications to the ED-530XT duodenoscope that could significantly affect the safety or effectiveness of the device without obtaining a new 510(k) clearance. The FDA notified Fuji that a new 510(k) must be submitted. Fuji submitted a 510(k) for this device in August 2015 and the FDA is currently reviewing the submission.
- Visit the Infections Associated with Reprocessed Duodenoscopes webpage for a complete listing of actions the Agency has taken on this issue.
The FDA continues to:
- Work closely with duodenoscope and AER manufacturers as they validate their reprocessing instructions to ensure that they are adequate to clean and disinfect devices.
- Proactively communicate recommendations to health care providers and end users to mitigate the risk associated with infection transmission and reusable medical devices.
- Work 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.
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, 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.
Fuji Customer Notification Letter to ED-530XT duodenoscope customers. December 23, 2015. Fuji Customer Notification Letter to 250 and 450 duodenoscope customers. December 23, 2015.
- FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities. October 2015.
- Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication. September 2015.
- Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. CDC Health Advisory. September 11, 2015.
Fujifilm Corp 510k Status Letter - August 12, 2015(PDF - 604KB)
- 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 - 792KB)
- Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication. February 2015.
- Infections Associated with Reprocessed Duodenoscopes: 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.