European hospitals were warned about contaminated duodenoscopes in 2013, and there remains confusion as to why the U.S. wasn’t warned about the potential for superbugs at that time. In January 2013, Olympus issued “important safety advice” to European hospitals and recommended a specific cleaning brush to help prevent contamination on its TJF-Q180V duodenoscope.
In the fall of 2013, the Centers for Disease Control and Prevention (CDC) notified the FDA of a potential association of multidrug resistant bacterial infections and duodenoscopes, but no further action was taken.
The FDA has since noted that from January 2013 to December 2014, it received 75 medical device reports involving around 135 patients who suffered a possible microbial transmission from duodenoscopes; patients in at least 8 hospitals were infected by bacteria linked to duodenoscopes.
Still, it wasn’t until February 19, 2015, that the FDA issued an actual warning that the complex design of these duodenoscopes may prevent proper sanitization, even when manufacturer guidelines are followed. “Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it,” the FDA stated.
In an update to their Safety Alert, on March 4, 2015, the FDA stated that although a specific model of duodenoscope manufactured by Olympus (the TJF-Q180V) does not currently have a 510(k) clearance (pending), the FDA is not recommending that healthcare providers cancel ERCP procedures for their patients who need them nor taking corrective action against the manufacturer while clearance is pending since they “believe that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year.
On March 26, 2015, Olympus sent its customers notice that it would be sending ‘Supplemental Flushing Instructions’ and new cleaning brushes no later than May 8, 2015.
On May 6, 2015, Olympus sent its customers the new ‘Supplemental Flushing Instructions’ and cleaning brushes.
As of May 8, 2015, Olympus suspended all ‘normal’ sales for 6 months in an effort to ensure that they would have an adequate supply of the new brushes for existing customers.
At this time, the FDA claims to have no evidence that the lack of a 510(k) clearance of the Olympus duodenoscopes is associated with the infections. Further, the duodenoscope-associated infections to date have occurred in patients who have had procedures with devices from all manufacturers.