Duodenoscope manufacturer Olympus Corp. warned European hospitals of device contamination nearly two years before the recent outbreaks at two Los Angeles medical centers, according to the LA times. But according to the article, Olympus made no effort to notify U.S. health care facilities or officials of the contamination risks. The new evidence intensified concerns about how much Olympus knew about the health risks posed by its hard-to-clean duodenoscopes and to what extent it failed to prevent “superbug” outbreaks like those seen in Los Angeles.
At the beginning of the year, it was found that two patients had died and up to 200 more had been infected after being exposed to a contaminated duodenoscope at the Ronald Reagan UCLA Medical Center. Duodenoscopes are a type of medical device used to diagnose and treat cancer, gallstones, and other digestive system problems. U.S. health officials say that because of the duodenoscope’s hard-to-clean design, highly antibiotic-resistant bacteria called Carbapenem-resistant enterobacteriaceae (CRE) were able to survive inside the device.
Just two weeks after the UCLA outbreak, four more patients were discovered with CRE infections at yet another LA hospital. The infected patients reportedly were exposed during duodenoscope procedures at Cedars-Sinai Medical Center. Health experts again pointed the finger at Olympus and other medical device companies’ defectively designed duodenoscopes and lax manufacturer guidelines for how to disinfect them.
Following these incidents, the U.S. Food and Drug Administration reported that it would begin enforcing stricter standards for reusable medical devices like duodenoscopes. The agency is now requesting that medical device manufacturers provide scientific data confirming that their products can be safely disinfected.
Instances of hospital-acquired infections such as these raise concerns about whether hospitals, device manufacturers, and health care regulators are doing enough to prevent hospital-acquired patient infection. Despite evidence of improvement in recent years, hospital-acquired conditions continue to be a problem in U.S. health care facilities. The federal Centers for Disease Control and Prevention estimate that 1 in 25 hospitalized patients acquire an infection, and roughly 722,000 hospital-acquired infections result in or contribute to 75,000 deaths each year in the United States.
Health administrators and medical device manufacturers alike have a duty to protect consumers from defective or dangerous products. If you or someone you know acquired an infection after undergoing a duodenoscope procedure, contact the attorneys at Lopez McHugh for a free consultation. You may be eligible to receive compensation through a duodenoscope lawsuit. Several patients and families of patients affected by the recent Los Angeles superbug outbreaks have already filed lawsuits against the responsible duodenoscope manufacturers.