When medical device maker Olympus Corp of Americas redesigned its duodenoscope to make it easier to use, it also inadvertently made the scope more difficult to clean, which has led to the alleged outbreak of the multidrug-resistant superbug carbapenem-resistant enterobacteriaceae (CRE). The FDA has also come under fire for allowing the redesigned Olympus TJF-Q180V duodenoscope on the market without evidence that the medical device could be cleaned properly between uses to avoid patient-to-patient transmission of bacteria. If you underwent an Endoscopic Retrograde Cholangiopancreatography (ERCP) using an Olympus duodenoscope, and you have since been diagnosed with a dangerous, drug-resistant bacterial infection, consult a reputable product liability lawyer today to discuss your legal options.
Even when the TJF-Q180V duodenoscope is cleaned according to Olympus’ instructions, experts warn that bacteria can still survive in the grooves of the device, possibly exposing patients to serious infections. In August 2015, Olympus provided hospitals with additional techniques they could use to clean the scopes, but admitted that it could still not guarantee that the new cleaning techniques would guarantee the safety of the medical devices. Unfortunately, because there are no alternative devices for ERCP at this time, the FDA indicated in October 2015, that “the continued availability of duodenoscopes is in the best interest of the public health.” However, according to the FDA, “the results of the postmarket surveillance studies could help inform […] new labeling for the devices to include different reprocessing instructions or other administrative or regulatory actions necessary to protect the public health.”
November 2009 – The FDA issues a safety communication cautioning doctors and patients about the potential for cross-contamination in endoscope processing.
2013 – The CDC notifies the FDA of a possible link between duodenoscopes and multidrug-resistant bacterial infections.
February 2015 – The Olympus TJF-Q180V scope is implicated in the deaths of two patients and the possible infection of close to two hundred others.
February 2015 – The FDA issues a safety communication warning that the complex design of ERCP duodenoscopes may impede effective cleaning, meaning the devices may not be properly disinfected or sterilized.
March 2015 – Cedars-Sinai Medical Center in Los Angeles and Hartford Hospital in Connecticut report several cases of superbug infections linked to the Olympus scope.
November 2010 – Endoscopes used for ERCP can act as a reservoir for extended-spectrum beta-lactamase (ESBL)-producing Klebsiella pneumoniae, a contamination that may be avoided with rigorous application of cleaning, disinfection and drying, according to research published in the medical journal Endoscopy.
June 2013 – A study published in the American Journal of Infection Control highlights the transmission of carbapenemase-producing Klebsiella pneumoniae by contaminated endoscopic instruments.
October 2014 – Exposure to duodenoscopes with bacterial contamination was associated with the apparent transmission of New Delhi metallo-β-lactamase (NDM)-producing E coli among patients at one hospital, according to a study published in The Journal of the American Medical Association.
October 2014 – An editorial published in The Journal of the American Medical Association poses the question of whether better approaches to cleaning duodenoscopes are needed, to prevent patient-to-patient transmission of bacteria.
Before it was linked to the deadly superbug outbreak, the TJF-Q180V duodenoscope manufactured by Olympus had been used in more than 500,000 procedures annually, which means the number of infections associated with the duodenoscope is likely underreported. “It’s highly likely many hospitals around the country have had outbreaks, and they haven’t been able to connect the dots until this problem was disclosed at UCLA,” said Lisa McGiffert, director of the Safe Patient Project at Consumers Union. “It’s just a little later – especially for those who got infections and maybe died as a consequence.” Lawsuits brought against Olympus for superbug infections allegedly caused by the TJF-Q180V duodenoscope include allegations that the device maker:
The Olympus TJF-Q180V duodenoscope first became available in 2010, and remained on the market for four years before federal health regulators realized the medical device had never been cleared by the FDA. Unfortunately, during that time, hundreds of thousands of patients were exposed to the duodenscopes, and may have suffered potentially deadly superbug infections. If you believe you have been adversely affected by side effects of the Olympus duodenoscope, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by potentially dangerous products, and can help put you in touch with an attorney who has experience handling duodenoscope infection claims.