Duodenoscopes, which are used in more than 600,000 procedures per year to diagnose bile duct and small intestine disorders, have been linked to at least 13 deaths and dozens of infections related to a recent 'superbug' outbreak in the U.S.
In May 2015, an FDA panel unanimously found the scopes to be unsafe, but their use has not been banned, as they are necessary for many patients, according to a Bloomberg Business report. In light of the infection-spreading capacity of duodenoscopes, the FDA has released new safety protocols it recommends hospitals follow in addition to manufacturer's cleaning and disinfecting protocols.
"We recognize that not all healthcare facilities can implement one or more of these measures, which require specific resources, training, and expertise," FDA representatives wrote in the report. "Therefore, it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer's instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks. While the risk of infection transmission cannot be completely eliminated, the benefits of these devices continue to outweigh the risks in appropriately selected patients."
Read the new protocol in full here.