Sunday, July 12, 2020
Home News Healthcare Administrator News FDA Clears First-Ever Disposable Duodenoscope to Reduce MDR Infections

FDA Clears First-Ever Disposable Duodenoscope to Reduce MDR Infections

On Monday, the U.S. Food & Drug Administration approved a groundbreaking disposable duodenoscope, a device used in endoscopic retrograde cholangiopancreatography (ERCP).

Boston Scientific’s EXALT Model D single-use duodenoscope received Breakthrough Device designation from the FDA, according to a news release. It has several advantages over the reusable ones currently in circulation.

How Does the Device Work?

First, EXALT eliminates the need for repairs and reprocessing. Next, and more importantly, it permits providers to use a sterile, new device for each procedure. Last, it builds on the design of reusable duodenoscopes so there’s a minimal learning curve new users. In the U.S., providers perform more than 500,000 ERCP procedures each year with a duodenoscope.

EXALT(tm) Model D Single-Use Duodenoscope from Boston Scientific. (PRNewsfoto/Boston Scientific Corporation)

RELATED: Inpatient vs. Outpatient — Which Leads to More Preventable Medical Errors?

Although reusable duodenoscopes go through an intensive disinfection process between uses, in a small number of cases, contaminated devices have transmitted infections between patients. Most procedures relying on these devices end safely, but infection can occur, even if providers follow established cleaning protocols, because duodenoscopes are complex and include many small parts.

What is the FDA doing about infections from duodenoscopes?

The FDA is trying to address this concern by working with duodenoscope manufacturers, medical societies, healthcare providers and other stakeholders, and has issued a recommendation that healthcare providers move toward using duodenoscopes that either have disposable components or are fully disposable.

EXALT(tm) Model D Single-Use Duodenoscope from Boston Scientific.

In the fall of 2013, the Centers for Disease Control and Prevention (CDC) alerted the FDA about a potential link between duodenoscopes and multi-drug resistant bacteria. An investigation revealed that these cases of infection happened even though users correctly followed the instructions for cleaning, disinfection and sterilization of the units.

RELATED: Is Hand Sanitizer as Effective as Hand-Washing to Prevent the Flu?

What does this mean for HCPs?

In August 2019, a Safety Communication from the FDA recommended that hospitals and endoscopy facilities start transitioning to duodenoscopes with innovative designs that either eliminate or facilitate the need for reprocessing. The Boston Scientific duodenoscope is expected to be in limited market release in the first quarter of 2020.

“With the Exalt Model D duodenoscope, I can perform the same high-quality ERCP procedure with the added benefit of using a brand-new sterile device for each patient,” Raman Muthusamy, MD, medical director of endoscopy and professor of clinical medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, said in a news release. “I believe the development of this device is a significant advancement in the evolution of endoscopy.”


Boston Scientific Receives FDA Clearance For World’s First Single-Use Duodenoscope, EXALT™ Model D, Boston Scientific.

Infections Associated with Reprocessed Duodenoscopes, U.S. Food & Drug Administration.

The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication, U.S. Food & Drug Administration.

Subscribe to Newsletter


Must Read

New Treatment Offers Hope to Mesothelioma Patients

New treatment for advanced mesothelioma may improve the quality of life for patients who have few options. Transarterial chemoperfusion treatment for malignant pleural mesothelioma...


Sign up to receive our weekly newsletter. Based on your profession, we hand-pick stories outlining simple solutions to propel your daily clinical practice – and your career as a whole.