Duodenoscopes are a medical tool used in the treatment of gallstones, cancers, and other digestive disorders. Though they were originally considered by the medical community to be safe, there is growing evidence these devices can spread bacteria from patient to patient because of a design defect. Some hospitals even went as far as designing special sterilization rooms to allow for the proper cleaning of duodenoscopes to reduce the risk for infection.
Unfortunately, even with extreme precaution, duodenoscopes have been linked to the spread of a “superbug infection” that is able to resist antibiotic treatment and could potentially be fatal. Patients undergoing relatively routine treatments wound up with life-threatening illnesses because the tool used in the procedure exposed them to harmful bacteria
Hospitals and the FDA Accused of Ignoring Problems with Duodenoscopes
Patients affected by problems with duodenoscopes are now alleging hospitals using the tools and the FDA should have addressed safety issues faster. And since European hospitals were warned in 2013 about the risks, patients question why it took so long for the FDA to act. As a matter of fact, European hospitals were even given a cleaning brush to use on duodenoscopes to help prevent contamination of bacteria, but those same brushes were never given to US hospitals.
Additionally, hospitals in the United States were not provided with effective cleaning instructions by the manufacturers of duodenoscopes. Those treating patients affected by the outbreak claim they used correct cleaning procedures based on the information they did receive, but according to the safety warning issued by the FDA, following these instructions would not guarantee the scopes to be free of bacteria.
Following the first outbreak of disease, linked to Olympus duodenoscopes, the manufacturer responded by saying it had provided instructions and education to hospitals for how to clean the scopes properly. It also said the TJF-Q180V model required “careful attention” when cleaning, but the company failed to provide proof the scope could be properly cleaned.
Further allegations against the FDA claim the agency should not have allowed the devices on the market without proof of proper cleaning. Olympus's duodenoscope reached the market in 2010, but had never gained FDA approval. The company claimed it had redesigned a previously approved scope and did not believe it needed FDA approval for the new design.
Some consumer advocate groups claim the FDA is too secretive and offers protection to manufacturers, but not to the public. Following two failed attempts to meet sterilization guidelines, the agency granted Olympus a third attempt to prove its product was safe, which some advocates believe is “outrageous.”
The FDA has so far declined to recall or order Olympus to withdraw the scope from the market, despite the problems associated with the device. Following more than 500,000 medical procedures performed with the scope, many of which resulted in the spread of infection, the FDA has only issued a safety communication offering additional cleaning techniques for hospitals, but also admits these techniques do not guarantee the device is safe.
Scope Design is Likely the Problem
After an outbreak of the fatal superbug at the UCLA Ronald Reagan Medical Center which affected approximately 180 patients, the FDA, along with medical experts, conducted an investigation into the cause of the outbreak. They found the deadly outbreak was linked to the Olympus TJF-Q180V duodenoscope.
The agency then followed up with another investigation into two other duodenoscope manufacturers, Fujifilm Medical Systems and Pentax, and found the similar devices made by those companies posed the same threat.
Duodenoscopes are flexible scopes inserted through the throat (and sometimes the anus) that allows doctors to view the patient internally and diagnose and treat a variety of diseases. The TJF-Q180V scope is used during gallbladder, pancreatic duct, and bile duct procedures.
Legal action is now underway against all three manufacturers and legal experts continue to investigate the lack of action taken by the companies to warn the medical community about the threat.
Lawsuits allege Olympus, Fujifilm, and Pentax were aware of the risks associated with their devices and should be held accountable for:
• Selling a product without FDA clearance
• Manufacturing and marketing a defective product
• Knowingly selling a faulty product
• Wrongful death
In February 2015, three separate lawsuits were filed against Olympus in the Los Angeles County Superior Court, all claiming the company was negligent in making the difficult-to-clean scopes, which led to the superbug outbreak.