Over the past year, we have been keeping an eye on the progress of duodenoscope reprocessing. In early 2015, the practice was called into question after the deaths and infections of patients from being exposed to a multidrug-resistant “superbug” related to the reprocessing of these single-use medical devices. The Association for the Advancement of Medical Instrumentation (AAMI) acknowledged the risk of this process on May 20, 2015, with their publication discussing the reclassification of duodenoscopes as critical devices.
Later, on August 4, 2015, the U.S. Food and Drug Administration (FDA) released supplemental measures in a safety communication, addressing the health concerns of these devices. Now, it has been discovered that the number of patients harmed by duodenoscope reprocessing far exceeds previous estimates. A Senate report this past Wednesday revealed that at least 250 people have been infected with disease across the world from 2012 to 2015.
This report also calls for changes aimed at helping officials identify and combat these issues more efficiently. Currently, there is an inadequate warning system that fails to alert federal regulators about outbreaks, which delays identifying the problem and alerting the public. The FDA has released a statement that mitigating the risks of infections is a top priority, and they have been actively notifying doctors and hospitals of the difficulty associated with sanitizing duodenoscopes between uses.
More information on the Senate report and duodenoscope reprocessing risks can be found in National Posts’s article, Tainted medical scopes have sickened hundreds, U.S. Senate probe finds.