FDA: Complex Design of Certain Duodenoscopes May Impede Reprocessing

February 25, 2015 | Strategic Insights for Health System

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The design of duodenoscopes used for endoscopic retrograde cholangiopancreatography procedures may impede efforts to effectively clean them, states a February 19, 2015, safety communication from the U.S. Food and Drug Administration (FDA). According to FDA, although the complex design of these devices improves the efficiency and effectiveness of the procedure, it causes challenges for reprocessing and high-level disinfection. Specifically, some parts of the scopes, such as the elevator mechanism, can be extremely difficult to access, and complete cleaning of these areas may not be possible. The safety communication mentions that from January 2013 through December 2014, FDA received a total of 75 medical device reports encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes. To reduce the possible infection risk posed by these devices, FDA recommends that healthcare organizations strictly adhere to all manufacturer instructions for cleaning and processing.

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