by Fujifilm Medical Systems: Safety Communication - Certain Older Models
Removed From Clinical Use
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
2015 remain 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
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
- 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
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
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
Read the MedWatch safety alert, including a link to the
FDA safety communication, at: