FDA Approves Endoscope With Disposable Cap To Prevent Duodenoscope Infections

Federal health regulators have approved a new type of duodenoscope, which features a disposable cap that is designed to help avoid problems with serious “superbug” hospital infections that have surfaced in recent years, due to difficulty cleaning the endoscopes between patients.

The FDA issued a news release on September 20, announcing the approval of the Pentax ED34-i0T model duodenoscope.

The device has a detachable, disposable distal cap; a part that proved difficult to clean in earlier models, and is believed to have contributed to the spread of antibiotic resistant infections in hospitals nationwide.

Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, but difficulties cleaning the devices, manufactured by several different companies, have resulted in a number of recent hospital infection outbreaks, 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 hospital 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 even if the hospital followed the recommended steps to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

Having a disposable distal cap means that the hard-to-clean part of the scope does not have to be reprocessed, reducing the risk of exposing patients to infectious materials that may have been present in those previously treated with the devices.

“We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the press release. “Improving the safety of duodenoscopes is a top priority for the FDA, and we encourage companies to continue to pursue innovations that will help reduce the risk to patients.”

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 concerns led to an 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.