FDA clears its first duodenoscope with a disposable head to cut infection risks

The FDA has cleared its first duodenoscope designed to make the intricate, moving and difficult-to-clean parts in the head of the device sterile and disposable—a milestone in the agency’s years-long push to cut down the risks of infection carried by reprocessed and reusable endoscopic hardware.

Pentax Medical’s Video ED34-i10T2 duodenoscope is indicated for accessing and visualizing a person’s upper gastrointestinal tract, to help diagnose and treat disorders of the bile duct, pancreas, liver and elsewhere.

Flexible duodenoscopes typically include an internal, mechanical lever that protrudes or retracts tools from the tip of the device during a procedure. This elevator area is used to help collect samples or perform other tasks and can be particularly difficult to fully clean and disinfect: its recessed area has nooks and crannies that can harbor bacteria and biomatter between uses.

“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said the FDA’s device center director, Jeff Shuren, in an agency statement.

“We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess,” Shuren said.

Pentax's duodenoscope with
disposable parts. (Pentax)

RELATED: Too tough to clean—FDA urges industry transition to disposable duodenoscopes

This past August, the FDA named several models from endoscope manufacturers Olympus, Fujifilm and Pentax as products to avoid, all with fixed, rigid end caps and tight crevices that can be difficult to access and fully clean.

Pentax’s predecessor to its newly cleared device, the ED34-i10T, was the first duodenoscope OK’d by the agency to feature a disposable plastic end cap. Since it received the green light in September 2017, Fujifilm obtained a clearance for its own similar model.

Going forward, the FDA is urging the industry to transition toward fully disposable duodenoscopes once they become available. According to the agency, duodenoscopes are used in more than 500,000 procedures annually.

RELATED: FDA clears duodenoscope sheath for protection against infections

Earlier this year, the FDA reported new data from safety surveillance studies of contamination and infection transmission rates from reprocessed duodenoscopes. Up to 5.4% of samples taken from the reusable devices tested positive for “high concern” organisms, such as E. coli and Staph infections. But in terms of overall infection rates, the FDA said it has seen dramatic declines, though patient deaths and disease outbreaks have been reported.

In October, the FDA cleared a disposable cover for duodenoscopes, GI Scientific’s ScopeSeal, that is designed to reduce patient-to-patient contamination without interfering with the endoscope’s elevator area. The sterile cap allows instruments to pass through the device without contacting the device’s internal mechanisms.