Duodenoscope Recall Issued by Fujifilm For Older Models Linked To Infection Risk

Following problems with severe “superbug” infections linked to certain types of endoscopes, Fujifilm is removing older duodenoscopes from clinical use due to concerns that they may not be properly cleaned between patients. 

The FDA announced a Fujifilm 250/450 duodenoscope recall in a safety communication issued on January 13, indicating that the company is replacing the device with the ED-530XT.

Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, but difficulties cleaning device manufactured by several different companies have resulted in a number of recent hospital infection outbreaks involving aggressive, antibiotic-resistant “superbugs”, which have caused a number of severe injuries and deaths.

The safety of the devices came into question after a  duodenoscope infection outbreak at UCLA’s Ronald Reagan Medical Center in February 2015, involving carbapenem-resistant enterobacteriaceae (CRE) infections that resulted in at least seven infections and two deaths. At least 200 other patients had to undergo testing after being placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections were linked to problems with the “reprocessing” instructions provided by the manufacturer, which are used to clean the devices for use by another patient. FDA reviewers determined that the instructions sent out at the time were inadequate and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

In December 2015, Fujifilm issued new cleaning instructions for the ED-530XT model, which were confirmed as being effective by the FDA.

The recall affects the Fuji ED-250XL5, ED-250XT5, ED-450XL5 and ED-450XT5 legacy duodenoscope models. Fujifilm is asking they be removed from clinical use and says it will replace them with the ED-530XT.

In August 2015, the FDA posted a warning letter to Fujifilm, indicating that the company had failed to report links between the company’s devices and serious patient infections, injuries and deaths. The two other duodenoscope manufacturers, Pentax and Olympus, also received FDA warning letters.

The letters suggested that duodenoscope makers knew for years that their devices were linked to infection outbreaks, but failed to warn the FDA or address the problem. The companies are also currently under investigation by the Department of Justice..

Several duodenoscope infection lawsuits have already been filed  against Olympus over the infections linked to the UCLA outbreak, and it is possible that FujiFilm will face similar cases. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.

The FDA says it will continue to closely monitor links between duodenoscopes and infections.