Medical device manufacturer Olympus America recalled its controversial TJF-Z180V duodenoscope in January 2016 to update it with a new design and new labeling. The changes were taken after reports linked the duodenoscopes to serious “superbug” bacterial infections in patients. The new design and labeling were intended to make the devices more resistant to bacterial contamination.
Now, new reports have indicated that even the redesigned Olympus duodenoscopes can transmit dangerous bacteria from one patient to another. According to the FDA’s adverse event report database, the devices have been linked to a new superbug outbreak that affected five patients who all tested positive for potentially deadly bacteria.
Olympus Redesigned Duodenoscope Tied to Superbug Infection
Olympus initiated their original duodenoscope recall because of reports of superbug infections sickening at least 250 patients worldwide. In a 2016 report by the U.S. Health, Education, Labor, and Pensions Committee, the medical devices were linked to serious infectious outbreaks in 16 U.S. hospitals, including the Virginia Mason Hospital in Seattle, Washington, and the Advocate Lutheran General Hospital in Park Ridge, Illinois.
The duodenoscope is a small, tube-like medical device that is used to examine the stomach and small intestine and can diagnose health problems in the liver, pancreas, and bile ducts. It’s meant to be cleaned and disinfected after each use and then reused in the next patient. Olympus created a “closed-channel” version of the device in 2010, which was intended to keep infectious material out of the scope, but the design was flawed because dangerous bacteria could settle into the device and remain after the device has been cleaned.
The FDA approved the new design in 2016. Olympus created a sealing mechanism that was supposed to create a tighter seal and reduce the risk of leakage of patient fluids into the scope.
The Improved Duodenoscopes May Still Cause Infections
Despite the design improvements, Olympus duodenoscopes may still be linked to dangerous infections. According to a new FDA report, Olympus was informed that five patients at a foreign medical facility tested positive for Klebsiella pneumoniae, a strain that is resistant to most antibiotics. The facility had updated the duodenoscope in October 2016.
Of particular concern, Olympus controls over 80 percent of the market share for duodenoscopes. On April 3, 2017, U.S. Senator Patty Murray (D-WA) wrote a letter to the Olympus Corporation asking about the report, noting that the outbreak is “particularly alarming because your company recalled and reportedly fixed the device in question after an investigation by my staff revealed a dangerous flaw in the design of Olympus duodenoscopes that could put patient safety at risk.”
Senator Murray requested information to help determine whether these newer Olympus duodenoscopes are, indeed, safe and to determine if the oversight for medical device safety in the U.S. is “operating as it should.”