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| Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia |
Less than a week after the FDA warned healthcare providers that endoscopes' design could make them more difficult to clean, contributing to the spread of drug-resistant bacteria, Olympus is facing the first two patient suits over the devices stemming from a "superbug" outbreak at the UCLA Health System in California.
Aaron Young, a Los Angeles patient who underwent procedures with a duodenoscope at the Ronald Reagan UCLA Medical Center in October and January, claimed Olympus' U.S. unit did not provide doctors and hospitals with proper instructions on how to sanitize the device. The company's Q180V scope requires cleaning and disinfecting before it can be used on a new patient. But after the product was redesigned in 2014, Olympus--the largest maker of the devices and UCLA's supplier--only gave healthcare providers cleaning directions for the older version of the product, which had a significantly different design, Bloomberg reports.
The older cleaning process did not remove all residual bodily fluids and organic debris from the device, exposing patients to serious risks, including lethal infections, Young alleged in a suit filed in a Los Angeles state court.
The family of Antonio Cerda, another patient who died after being infected with drug-resistant bacteria at the UCLA Health System, has also filed suit against Olympus. While both suits allege fraud and negligence on the part of Olympus, Cerda's suit also includes wrongful death and injury claims, Reuters reports.
The legal action comes amid a superbug outbreak at UCLA Health System in California, which has infected 7 patients, contributed to two deaths and exposed another 179 individuals to the carbapenem-resistant Enterobacteriaceae bacteria (CRE) from October through January. A similar infection has also cropped up at a North Carolina hospital and may have caused two additional deaths.
Companies such as Olympus, Fujifilm Holdings and Pentax Medical make the devices, and Olympus told the Los Angeles Times that it is working with the FDA and healthcare systems to address the public's concerns.
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| William Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health |
Meanwhile, the FDA is cracking down on the devices and responding to reports that the agency ignored problems with duodenoscopes for years. Last week, the FDA issued a warning regarding duodenoscopes, or flexible tubes that are threaded through the mouth, throat and stomach or the top of the small intestine to drain fluids from blocked pancreatic or biliary ducts. Cleaning and disinfecting the products should reduce the risk of passing on infection, but it "may not entirely eliminate it," the FDA noted in its warning.
The agency said this week it is working to revise labels for duodenoscopes linked to the recent UCLA Health Center "superbug" outbreak, planning to speed up modifications and update risk information, Dr. William Maisel, chief scientist in the FDA's Center for Devices and Radiological Health, told Reuters. The FDA is also asking duodenoscope device manufacturers to hand over evidence that disinfection methods are working, The New York Times reports.
UCLA hospital administrators are responding to public outcry, using the toxic gas ethylene oxide to ensure thorough cleanings of the devices. No new outbreaks have been reported since the facility started using the gas, but Maisel pointed to a few potential problems with the hospital's approach. The gas' residue can be harmful to patients if it remains on devices after cleaning, or even damage the scopes themselves, he said.
UCLA spokeswoman Dale Tate said Olympus recommends using the gas as an alternative to sterilization and that it does not harm endoscopes. The hospital is also waiting for the gas to fully dissipate from the device before using it in patients, reducing its toxicity.
- read the Bloomberg story
- here's the NYT article (sub. req.)
- and here's the Reuters story