On the heels of a damning U.S. Senate report, Olympus has voluntarily recalled its TJF-Q180V duodenoscopes, implicated in superbug outbreaks in hospitals across the country.
The Center Valley, PA-based company will replace the forceps elevator mechanism in the reusable scopes to make them easier to clean, it said in a letter to customers. In all, it will recall some 4400 scopes, according to FDA. The company has also updated the scopes' operation and reprocessing manual, and advised users to follow the updated information immediately.
FDA has approved the modification to the scopes to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel, the agency said in a statement.
The Senate investigation, spearheaded by Senator Patty Murray, D-WA, found that Olympus and FDA failed to alert the U.S. public, even as hundreds became infected with superbugs.
At least 25 outbreaks sickened at least 250 patients in the United States and Europe between 2012 and 2015, according to the 301-page report released last week by Murray, the top Democrat on the Senate Health, Education, Labor, and Pensions Committee. Olympus waited nearly three years - until February 2015 - to notify U.S. hospitals of problems with cleaning the scopes, the report says.
The report also found faults in both FDA's 510(k) process and postmarket surveillance system. The report notes that Carbapenem-resistant Enterobacteriacea (CRE) kills almost half of those infected; Virginia Mason Medical Center in Seattle and UCLA's Ronald Reagan Medical Center are among the hospitals reporting deaths.
While it did not agree with all of its conclusions, Olympus called the Senate report "an important contribution to understanding the factors underlying reports of patient infections associated with multi-drug resistant organisms" such as CRE following procedures to diagnose and treat conditions in the pancreas, bile duct, and gallbladder.