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FDA Warns of Duodenoscope Infection Risk
After receiving more than 75 incident reports involving 135 patients, the FDA has issued an official warning to doctors and hospitals that duodenoscopes “may facilitate the spread of deadly bacteria.” According to recent media reports, at least two of the duodenoscope models were sold in the US prior to receiving FDA approval.
Duodenoscopes Linked to Deadly “Superbug” Infection
Since 2009, the use of dirty duodenoscopes has been linked to at least five outbreaks of “superbug” infections because the tips of the device are difficult to sanitize. In February of 2015 at least 179 people were exposed to a deadly strain of superbug known as Carbapenem-Resistant Enterobacteriaceae (CRE) due to duodenoscope use. Superbugs like CRE are resistant to antibiotics, and are fatal in nearly 50% of cases.
Duodenoscope Use is Widespread
Duodenoscope use during ERCP procedures are common among patients suffering from gallstones and pancreatic cancer, and the devices are used during an estimated 500,000 procedures per year. Olympus Corporation manufacturers most duodenoscopes sold in the US, but the products are also made by FujiFilm and Pentax. Duodenoscopes manufactured by all three companies are similar in design and risk infection due to difficulty sterilizing the product.
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