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FDA Approves First Disposable Duodenoscopes

— December 31, 2019

The first throw-away duodenoscopes have been approved by the Food and Drug Administration.

The Food and Drug Administration (FDA) recently approved the first disposable duodenoscopes, a medical device that is used in approximately 500,000 medical procedures every year.  After being alerted by the Centers for Disease Control and Prevention (CDC) to numerous outbreaks caused by duodenoscopes, the FDA urged hospitals to use models with disposable parts.  The new device, called Exalt and made by Boston Scientific, is designed to be used only once and should eliminate “the risk of potential infection due to ineffective reprocessing, the arduous cleaning process,” said Dr. Jeff Shuren, head of the agency’s Center for Devices and Radiological Health.

The FDA indicates, “On March 9, 2018, [the agency] issued Warning Letters to all three manufacturers (Fujifilm Medical Systems USA, Inc, Olympus Medical Systems Corporation, and Pentax of America), who make duodenoscopes sold in the U.S. for failure to provide sufficient data to address the post-market surveillance studies requirements under Section 522 of the Federal Food, Drug, and Cosmetic Act (the Act).  All three manufacturers responded to the warning letters and submitted plans that outlines how study milestones will be achieved including enrolling new sites and collecting samples.”

FDA Approves First Disposable Duodenoscopes
Photo by Piron Guillaume on Unsplash

Then, in August 2019, “the FDA issued a Safety Communication to provide an update on the mandated post-market surveillance study results for duodenoscopes” and issued the following protocol: “Recommending that hospitals and endoscopy facilities begin transitioning to duodenoscopes with innovative designs that facilitate or eliminate the need for reprocessing.; Issuing new mandated post-market surveillance study orders to manufacturers of duodenoscopes with disposable endcaps to gather more information and verify that the new designs reduce the contamination rate.  Upon completion of the post-market surveillance studies, the FDA expects the labeling on duodenoscopes with disposable endcaps to be updated with contamination rate data.; Warning health care facilities that adenosine triphosphate (ATP) test strips should not be used to assess duodenoscope cleaning.  To date, the FDA has not evaluated them for effectiveness for assessing duodenoscope reprocessing.  Manufacturers of ATP test strips are advised to submit data to support the legal marketing of these strips for this use.”

Reusable duodenoscopes were implicated in numerous infections in patients across the United States and Europe since 2012.  Many of these patients were infected with antibiotic-resistant bacteria.  The devices are used to perform endoscopic retrograde cholangiopancreatography, which is required to diagnose and treat diseases of several organs including the pancreas, bile duct and gallbladder.  The tube is inserted through the patient’s mouth and stomach, and into the first part of the small intestine.

Duodenoscopes are more difficult to clean than many other medical devices.  The cleaning process involves nearly 100 steps, and they are routinely disinfected with chemicals, but there are areas in which fluids and bacteria can easily be missed.  However, recent tests performed at the request of the Food and Drug Administration (FDA) still found one in twenty duodenoscopes retained bacteria like E. coli.

In the two-year period between 2012 and 2014, thirty patients in Seattle were sickened by duodenoscope procedures and eleven died.  In 2015, two patients in Los Angeles died and five were made ill from contaminated duodenoscopes.


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