Date Issued: July 21, 2017
Audience: Users and reprocessors of the FUJIFILM Medical Systems, U.S.A., Inc. (Fujifilm) ED-530XT duodenoscope 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: Fujifilm duodenoscope model ED-530XT is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Purpose: The FDA is issuing this communication to provide updated status information about FDA clearance of Fujifilm's ED-530XT and to amplify Fujifilm's Urgent Medical Device Correction and Removal notice, issued on July 21, 2017.
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 December 2015, Fujifilm issued validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. The FDA worked with Fujifilm as they modified and validated reprocessing instructions for the ED-530XT duodenoscope to show with a high degree of assurance that the instructions, when correctly followed, will lead to effective cleaning and disinfection of the ED-530XT duodenoscope. At that time, Fujifilm had a pending 510(k) premarket notification for its ED-530XT.
On July 21, 2017, Fujifilm issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-530XT duodenoscopes. This action includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The FDA cleared the updated design and labeling for the ED-530XT on July 21, 2017.
Recommendations for Health Care Facilities:
- Acknowledge Fujifilm's Urgent Medical Device Correction and Removal and identify affected products in your facility.
- Indicate if you do NOT have any affected duodenoscopes or Operation Manuals.
- Upon receipt of the enclosed new Operation Manuals, remove and replace any older operation manuals from your facility, and destroy and dispose of properly.
- Be aware of the manual reprocessing procedures outlined in FDA's December 23, 2015 Safety Communication "FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes."
- Continue to use these validated instructions when reprocessing Fujifilm ED-530XT duodenoscope models. The validated reprocessing instructions, when followed correctly, are intended to effectively clean and high-level disinfect the Fujifilm ED-530XT duodenoscope.
FDA's recommendations are based on currently available information.
The FDA continues to closely monitor the association between reprocessed endoscopes and the transmission of infectious agents by:
- Working closely with duodenoscope and Automated Endoscope Reprocessor manufacturers as they validate their reprocessing instructions to a level adequate to clean and high-level disinfect duodenoscopes.
- Proactively communicating recommendations to health care providers and end users to help reduce 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 FDA's Infections Associated with Reprocessed Duodenoscopes webpage for a complete listing of actions the Agency has taken on this issue.
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 the use of 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. User facilities participating in the FDA's Medical Product Safety Network (MedSun) should report all of their device-related adverse events through the MedSun reporting site, not through MedWatch.
- FUJIFILM Urgent Medical Device Correction and Removal: Replacement of Forceps Elevator Mechanism, Distal End Cap, and New Revision of Operation Manuals. July 22, 2017
- FUJIFILM Corp 510(k) clearance letter
- FUJIFILM Medical Systems, U.S.A., Inc. removes certain older duodenoscope models from clinical use: FDA Safety Communication
- FUJIFILM Customer Notification Letter to 250 and 450 duodenoscope customers. July 21, 2017
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- Design of Endoscopic Retrograde Cholangiopancreatograpy (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication
- Fujifilm Corp 510k Status Letter - August 12, 2015
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.