Fujifilm ED-530XT Duodenoscope Recall: Infection Risk

In the wake of problems with severe and sometimes deadly “superbug” infections linked to certain types of scopes used during ERCP (endoscopic retrograde cholangiopancreatogram) procedures, Fujifilm is recalling its ED-530XT duodenoscopes. 

The Fujifilm duodenoscope recall was announced in a safety communication issued by the FDA on July 21, after the manufacturer issued an Urgent Medical Device Correction and Removal notice (PDF) that same day, indicating that it will replace certain parts to allow easier cleaning between patients.

Duodenoscopes are a specific type of endoscope used during ERCPs, but difficulties cleaning devices manufactured by several different companies have resulted in a number of recent hospital infection outbreaks in recent years, involving aggressive, antibiotic-resistant “superbugs” that 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 injuries 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 by the FDA as being effective.

This new update includes replacement of the forceps elevator mechanism, including the O-ring seal and distal end cap, as well as the release of a new operation’s manual with the updated cleaning instructions.

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. Health care facilities are being asked to acknowledge the Fujifilm notice, identify affected products, and remove and replace older manuals once the new manual is obtained. Customers with questions can contact Fujifilm by calling 973-686-2479.