FDA MedWatch - Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use

AUDIENCE: Gastroenterology, Nursing, Risk Manager

ISSUE: Fuji informed the FDA of its plans to remove legacy 250/450 duodenoscope models from clinical use based on the limited number currently in use.

The validated manual reprocessing procedures for the ED-530XT duodenoscope outlined in December 2015remain the same. Health care facilities should continue to use these validated instructions when reprocessing Fuji ED-530XT duodenoscope models. The validated reprocessing instructions when followed correctly, are intended to effectively clean and high-level disinfect the Fuji ED-530XT duodenoscope.

Fuji will replace the 250/450 duodenoscope models with the ED-530XT model, in addition to necessary accessories (i.e. brushes) at no cost.

BACKGROUND: In December 2015, Fuji issued validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. At that time, the FDA recommended that users and health care facilities apply the revised reprocessing instructions for the ED-530XT duodenoscope to reprocess the older 250/450 duodenoscope models while formal validation testing continued for these particular models.

Visit the Infections Associated with Reprocessed Duodenoscopes webpage for a complete listing of actions the Agency has taken on this issue. The Agency will continue to provide updates as appropriate.

RECOMMENDATION: In addition to the recommendations in the December 2015 Safety Communication, the FDA also recommends that facilities and staff do the following:

• Remove from circulation and return your facility’s 250/450 duodenoscope models to Fuji as outlined in Fuji’s Customer Notification Letter.
• Train appropriate staff on Fuji’s validated reprocessing instructions for the ED-530XT model and implement them as soon as possible.
• Implement the reprocessing procedures for Fuji’s ED-530XT duodenoscope in accordance with the manufacturer’s reprocessing instructions issued in December 2015.
• Immediately remove from service to assess, repair and/or replace any duodenoscope that shows signs of damage. Examples of damage may include: loose parts, damaged channel walls, kinks or bends in tubing, holes in the distal end, or other signs of wear or damage.
• Contact your Fuji (FMSU-ESD) sales representative if you have any questions or concerns regarding this removal, a damaged device, or the validated reprocessing instructions for the ED-530XT duodenoscope.

FDA’s recommendations are based on currently available information.

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

Read the MedWatch safety alert, including a link to the FDA safety communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm536994.htm