Olympus, the manufacturer of the endoscope involved in two superbug deaths at UCLA, never had FDA approval to sell the device. The device is used in patients with gastrointestinal complaints.
The FDA was unaware, until 2013, that Olympus started selling its TJF-Q180V duodenoscope (or ERCP endoscope) in 2010, without receiving clearance from the “oversight” agency to bring it to market, according to Karen Riley of the FDA’s Office of External Affairs.
“Devices need to be more vigorously regulated. This is really disturbing,” said Dr. Steven Nissen, chief of cardiovascular medicine at Cleveland Clinic, who testified to Congress about device safety problems.
Olympus released a statement saying it didn’t know FDA approval was needed to sell the device, but it has since applied for permission at the request of the agency. The application is pending.
UCLA Outbreak
From October to January, seven patients at Ronald Reagan UCLA Medical Center were infected with the deadly superbug carbapenem-resistant Enterobacteriaceae or CRE, which is extremely resistant to all types of antibiotics. Two of those patients died.
The patients contracted CRE following routine endoscopic treatment. According to hospital officials, two medical scopes still carried the deadly bacteria even after disinfection guidelines were followed. Another 170 others who had endoscopic procedures during the same months have been contacted by the medical center and offered home tests to screen for the bacteria.
Four patients at Cedars-Sinai Medical Center have also been infected with the superbug and linked to a contaminated duodenoscope. The scope was used on all four patients during August and January 2015.
Sixty-four other patients who had a procedure with the same scope have been notified by mail, “out of an abundance of caution.”
FDA Rules
A manufacturer must seek clearance for new models if it includes “significant changes that can affect the safety or effectiveness of the device.”
The newer model of the Olympus sealed the elevator channel, with the intention of making it imperious to infection. And, while the company made these changes to make the device safer, it appears it is not safer.
The agency is reluctant to remove the device from the market because the procedures can be lifesaving says, Riley.
“More than 500,000 of these procedures are done every year in the U.S., and the risk of bacterial transmission is actually really very, very low,” she said. “We believe the benefits outweigh the risks.”
Fujifilm and Pentax, two other duodenoscope manufacturers, applied for and were granted clearance to market devices similar to Olympus’ TJF-Q180V.
Disinfection Protocols under Scrutiny
The agency is requesting all three companies submit evidence showing the scopes can be cleaned thoroughly; but it doesn’t look promising.
Twice the companies submitted data that failed to show that cleaning could get rid of 99.9999% of all microbes on the scope- the FDA’s standard for disinfection, said Riley.
It is yet to be determined if Olympus will be penalized by the FDA for failure to get approval before selling the device.
What Should Patients Do?
Patients that have undergone a procedure involving use of a duodenoscope should discuss the benefits and risks of the procedure and any alternatives with their health care provider.
Rick Shapiro has practiced personal injury law for over 30 years in Virginia, North Carolina, and throughout the Southeastern United States. He is a Board-Certified Civil Trial Advocate by the National Board of Trial Advocacy (ABA Accredited) and has litigated injury cases throughout the eastern United States, including wrongful death, trucking, faulty products, railroad, and medical negligence claims. During his three-decade career, Shapiro has won client appeals before the VA Supreme Court, VA Court of Appeals, NC Supreme Court, SC Supreme Court, WV Supreme Court, TN Supreme Court, and three times before the United States Court of Appeals for the Fourth Circuit, underscoring Shapiro’s trial achievements. In addition, he and his law firm have won settlements/verdicts in excess of $100 million. His success in and out of the courtroom is a big reason why he was named 2019 “Lawyer of the Year” in railroad law in U.S. News & World Report's Best Lawyers publication (Norfolk, VA area), and he has been named a “Best Lawyer” and “Super Lawyer” by those peer-reviewed organizations for multiple years. Rick was also named a “Leader in the Law, Class of 2022” by Virginia Lawyers Weekly (total of 33 statewide honorees consisting of lawyers and judges across Virginia). And in September 2023, Rick was selected as a recipient of the National Board of Trial Advocacy (NBTA) 2023 President’s Award. Although many nominations were submitted from across the country, Rick was just one of eight attorneys chosen by the prestigious National Board which certifies civil trial attorneys across the U.S. Rick was also recently named to Virginia Lawyers Weekly 2024 Virginia’s Go To Lawyers Medical Malpractice. The attorneys awarded this honor are nominated by their colleagues and chosen by a panel from the publication.
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