FDA Clears Two Scope Reprocessors

FDA has cleared two manufacturers' duodenoscope reprocessors in its ongoing efforts to reduce contamination of the reusable scopes, which have been linked to superbug outbreaks.

Nancy Crotti

To date, FDA has approved two of five automated endoscope reprocessors in the wake of Senate report that found that a wave of infections linked to duodenoscopes was worse than reportd.

The agency said it validated testing results for Medivators' Advantage Plus and DSD Edge automated endoscope reprocessors (AER), and Steris Corporation's (Mentor, OH) System 1E Liquid Chemical Sterilant Processing System. Little Falls, NJ-based Cantel Medical owns Medivators.

FDA is still considering the results of three more AER makers' tests.In November, it ordered Custom Ultrasonics to recall all of its AERs, used in many of the hospitals that experienced infections.

Twenty-one people have died and dozens more were sickened by scope-related infections in Los Angeles, Pittsburgh, Seattle, and Washington, D.C. Other outbreaks have been reported in Philadelphia, Milwaukee and Worcester, MA, according to USA Today. A U.S. Senate report found in January that major duodenoscope maker Olympus and FDA failed to alert the U.S. public, even as superbugs infected hundreds. Drug-resistant bacterial strain carbapenem-resistant Enterobacteriaceae (CRE), implicated in the illnesses and deaths, kills almost half of those infected.

Also sold in the United States by manufacturers Fujifilm and Pentax, duodenoscopes are threaded down through the digestive tract and into the small intestine. They provide the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. The duodenoscopes' movable "elevator" mechanism, located at the tip, improves efficiency and effectiveness but has proven challenging to disinfect, according to FDA.

Problems with the 510(k) process also played a role. The Senate investigation found that Olympus, Pentax, Fujifilm, and Custom Ultrasonics failed to meet their regulatory obligations.

In early 2015, FDA issued a warning on duodenoscope reprocessing that also divulged Olympus' TJF-Q180V closed-channel duodenoscope had initially made it to market without a 510(k) clearance. By March, FDA was reporting that Olympus had "issued new, validated manual reprocessing instructions for the TJF-Q180V" as part of the review of a 510(k) application for the device, which FDA allowed Olympus to continue marketing while the application was under review.

On January 15, FDA cleared the TJF-Q180V's 510(k) with design modifications to the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel. Olympus notified its customers about design and labeling changes and its strategy to repair the device's elevator mechanism.

FDA has focused its guidance for healthcare providers on the human aspect of cleaning used duodenoscopes before mechanical reprocessing.Some have questioned why the agency did not focus sooner on AERs' possible role in duodenoscope contamination, according to a report in USA Today, which has been investigating the deadly outbreaks.

"If the manufacturers (of AERs) didn't have acceptable validation data to prove that these scopes could be reprocessed safely, then it's fair to ask why the FDA hadn't determined this well before these (infection) problems became an issue," medical device safety consultant Lawrence Muscarellatold the newspaper.

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