FDA OKs First Duodenoscope With Disposable Cap

September 20, 2017

The US Food and Drug Administration (FDA) today approved the first duodenoscope with a disposable, single-use distal cap, which will make it easier to decontaminate the device and thereby reduce the threat of spreading deadly antibiotic-resistant infections.

The new duodenoscope, called the Pentax ED34-i10T, is made by Pentax Medical. It's designed for visualizing the upper gastrointestinal tract to diagnose and treat disorders of the bile and pancreatic ducts.

Duodenoscopes are hard to clean and disinfect between uses because of their many small, hard-to-reach parts. Outbreaks of infections in hospitals caused by dirty duodenoscopes date back to 2012. The FDA has pushed manufacturers to make scopes that are easier to clean and urged hospitals and clinicians to double down on reprocessing the reusable devices.

In July, a jury ordered Olympus to pay a Seattle hospital almost $6.6 million after a cancer patient died of an infection linked to a contaminated duodenoscope. The jury found that Olympus didn't provide the hospital with adequate warnings and instructions about the scope. The hospital was ordered to pay the deceased patient's family $1 million.

In January, the FDA warned clinicians that a design problem with a Pentax duodenoscope called the ED-3490TK invited contamination. The adhesive that seals the scope's distal cap onto the main body could develop cracks and gaps that would permit fluids and tissues to leak inside, according to the agency.

The disposable distal cap on the Pentax ED34-i10 will make it easier to access the device for decontamination, the FDA said in a news release. The scope also comes with a simpler user interface, improved ergonomics, and better image quality.

"We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices," said William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health. "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."

More information on today's FDA announcement is available on the agency website.

Follow Robert Lowes on Twitter @LowesRobert

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