Cracks and Gaps in Pentax Duodenoscopes Can Lead To Infection Risk, FDA Warns

A Pentax-brand duodenoscope could have cracks and gaps that allow the spread of infectious material to be spread from one patient to another, even if the device is cleaned between patients, federal health regulators warn. 

The FDA issued a safety communication about the Pentax ED-3490TK duodenoscope on January 17, indicating that design issues could increase the risk of patients getting infected by biological material from previous patients. The agency is warning health care professionals that following the standard cleaning rules and high-level disinfect procedures may not be enough to prevent such infections.

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. The update issued this week flushes out that warning after the FDA received additional information from Pentax on its ED-3490TK model.

“Cracks and gaps in the adhesive that seals the device’s distal cap to its distal tip can occur, which can lead to microbial and fluid ingress,” the FDA warns. “These areas can be challenging to clean and high-level disinfect and may increase the risk of infection transmission among patients.”

The agency noted that despite the warning, the validated manual cleaning procedures recommended for the duodenoscope remain the same. However, it is advising that facilities and staff can opt to use the ED-3490TK with an Automated Endoscope Reprocessor that has been validated by the agency.

The FDA also suggests that they immediately remove the devices from service for assessment, repair or replacement of any that show visible signs of damage, such as loose parts, damaged channel walls, kinks or bends in the tubing, holes in the distal end, and signs of cracking or gaps in the adhesive seal on the distal cap.

The agency also recommends training staff on the validated reprocessing instructions and contacting Pentax Medical Sales representatives if training and in-servicing on those procedures are needed.

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.