Fujifilm Recalls Duodenoscopes to Update Design and Labeling

Seeking to limit spread of infections, FDA clears improved device and manual

As the FDA continues its drive to prevent the spread of infections by hard-to-clean duodenoscopes, Fujifilm has voluntarily recalled all of its ED-530XT devices to institute design changes.

Fujifilm issued an “urgent medical device correction and removal” notification informing customers that changes to the ED-530XT duodenoscopes would include replacement of the forceps elevator mechanism and its 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.

The FDA issued a safety communication in February 2015 noting that the complex design of duodenoscopes may impede effective reprocessing—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 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.

Fuji customers were asked to identify affected products in their facilities. When they receive new operation manuals, they should replace and destroy the older ones. Customers should continue to use the manual reprocessing procedures outlined by the FDA in December 23, 2015, for Model ED-530XT duodenoscopes. When followed correctly, those procedures are intended to effectively clean and disinfect the Fujifilm ED-530XT duodenoscope.

In January 2017, Fuji told the FDA that it planned to remove older “legacy” duodenoscope models (the ED-250XL5, ED-250XT5, ED-450XL5, and ED-450XT5) from clinical use based on the limited number currently in use. Fuji said it would replace the 250/450 duodenoscope models with the ED-530XT model, in addition to necessary accessories, at no cost.

Sources: FDA; July 21, 2017; FDA; January 13, 2017.