Dive Brief:

• FDA on Friday granted 510(k) clearance to the first ever fully disposable duodenoscope, a device manufactured by Boston Scientific.
• Center for Devices and Radiological Health Director Jeff Shuren touted the new device as a "major step forward" for patient safety. Boston Scientific plans to commercialize the device in a "limited market release" during the first quarter of 2020. The company told MedTech Dive it has not yet determined a price for the device.
• Reusable duodenoscopes, used during endoscopic retrograde cholangiopancreatography,  procedures to diagnose or treat bile duct, liver, gall bladder and pancreas issues, have been linked to persistent contamination issues tied to multiple patient deaths. More than 1.5 million duodenoscope procedures are performed each year, according to Boston Scientific.

Dive Insight:

Boston Scientific's senior vice president of endoscopy, Art Butcher, told investors in June 2018 the single-use duodenoscope could represent more than a $1 billion market opportunity. The device was previously granted a breakthrough device designation by FDA, which may help it more quickly gain reimbursement from Medicare.

Shuren said the availability of the single-use duodenoscope is a critical development for patient safety due to the elimination of the need to reprocess the scope.

"Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn't need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing," Shuren said.

During an FDA advisory committee meeting in November, experts said the process to clean a reusable scope depends on low-paid workers, who face challenging work conditions, to follow hundreds of complex steps to reprocess the devices.

"Duodenoscopes are complex medical devices with many small working parts that can be difficult to clean. The device can trap contaminated tissue or fluid in its crevices and, if not thoroughly cleaned and disinfected, it can transmit infection-causing bacteria between patients," FDA said.

Between Oct. 15, 2018, and March 31, adverse event reports showed three deaths, 45 patient infections and 159 instances of device contamination related to inadequate reprocessing of duodenoscopes.

And in August, the agency recommended health providers start transitioning to duodenoscopes with features that "facilitate or eliminate the need for reprocessing."

It is unclear how much a transition to the single-use device would cost providers. A company spokesperson told MedTech Dive "pricing and purchasing programs are still being developed and will be finalized prior to full commercial launch" for the single-use Exalt Model D Duodenoscope.

"We intend to price the single-use device to appropriately reflect the value it brings to physicians and the healthcare system," the spokesperson said.

Ambu, a Danish company developing its own single-use duodenoscopes, told investors Nov. 13 it now estimates it will be able to launch during the fiscal fourth quarter of 2020, which runs July through September.

The company decided to build its own direct sales force for U.S. distribution instead of appointing Cook Medical as its distributor. Ambu said it expects the list price for its single-use duodenoscope to be between $1,400 and $1,600.

Correction: In a previous version of this article, the timeframe for Ambu's expected launch was misstated. It is set to launch during the fiscal fourth quarter.