Following Infection Outbreaks, Pentax Duodenoscope Recall Design And Label Changes Approved By FDA

Following recent concerns about hospital infection outbreaks linked to endoscopes, federal regulators have approved design changes and label warnings for Pentax duodenoscopes, to help facilities effectively clean and disinfect the devices between patients.

On Wednesday, Pentax issued an ED-3490TK duodenoscope recall notice to healthcare professionals, indicating that it is recalling devices to replace the forceps elevator mechanism and other parts.

On the same day, the FDA issued an updated safety communication for the Pentax ED-3490TK duodenoscope, indicating that it has approved the new design changes and label warnings, which should help prevent the spread of “superbug” infections between patients if the devices are properly cleaned.

The recall and FDA update follows a January 17 warning that design issues could increase the risk of patients getting infected by biological material from previous patients even after the device was cleaned according to instructions. The FDA had warned that the device could have cracks or gaps where contaminants could avoid standard cleaning practices.

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 in recent years, typically 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.

The FDA first issued a safety warning about the Pentax duodenoscopes in February 2016, indicating that design problems could increase patient infection risks.

“On February 7, 2018, FDA cleared an updated design for the ED-3490TK duodenoscope (K161222),” Pentax wrote to healthcare providers. “The current voluntary recall/corrective action is being taken to replace the forceps elevator mechanism, the O-rings, and the distal end covering with materials and processes consistent with the design features of the cleared updated ED-3490TK.”

In August 2015, the FDA posted a warning letter to Pentax, 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, Fujifilm 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 Pentax 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.