Product News and Recalls

Federal Panel Declares Poorly Designed Duodenoscopes Unsafe

duodenoscopes ruled unsafe as designedA federal panel has concluded that the duodenoscopes involved in two Los Angeles “superbug” outbreaks are unsafe as designed. According to a Los Angeles Times article, the government is urging the U.S. Food and Drug Administration (FDA) to do more to ensure patient safety.

The outbreaks occurred earlier this year after patients at two Los Angeles hospitals underwent procedures involving contaminated duodenoscopes. At the Ronald Reagan UCLA Medical Center, two patients died after being exposed to Carbapenem-resistant enterobacteriaceae, a type of dangerous gut-dwelling bacteria, and up to 200 more were infected. Just two weeks later, four more patients were sickened by contaminated duodenoscopes at Cedars-Sinai Medical Center. The infections were found to have been caused by the same antibiotic-resistant bacteria and transmitted by the same type of defectively designed duodenoscope. Scientists concluded that due to the hard-to-disinfect design of the duodenoscopes, it is possible for deadly bacteria to build up inside the devices and spread to patients treated with them.

Consumers, health officials, and government regulators were quick to point fingers. The companies manufacturing the faulty duodenoscopes, including Olympus, Pentax Medical, and Fujifilm, were blamed for distributing dangerous and inadequately tested medical devices. The FDA reportedly accelerated the pace of its new medical device safety guidelines, and in March released stricter standards for approval of reusable medical instruments, requiring that manufacturers provide scientific evidence proving their products can be safely disinfected.

The FDA also came under fire. These outbreaks, along with reports of 32 infections and 11 deaths at Virginia Mason Medical Center in Seattle between 2012 and 2014, were used to illustrate the agency’s failure to protect consumers and hospital patients. According to a 2011 estimate by the federal Centers for Disease Control and Prevention, 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. Many medical professionals and policymakers claim that the FDA is not doing as much as it can to protect U.S. patients.

According to the Los Angeles Times, while the federal panel committee did not outright urge the FDA to end all use of the duodenoscopes, its decision “marked a high-profile rebuke . . . to the FDA for failing to impose sufficient measures to stop the spread of dangerous bacteria from patient to patient.”

The decision will also come as a blow to Olympus Corp., the number-one maker of duodenoscopes. Olympus has already been the target of wrongful death lawsuits filed by families of those who allegedly died from infection, and an official government condemnation of its devices will doubtless prove damaging to the company. Although Olympus released an updated cleaning guide for its duodenoscopes at the end of March, the effectiveness of this new procedure has allegedly not been proven.

Federal health administrators and medical device manufacturers have a responsibility to ensure the safety of consumers and patients. If you or a loved one was infected by a contaminated duodenoscope, call Lopez McHugh to discuss your legal options free of charge with an experienced medical device lawyer. You may qualify for damages through a duodenoscope lawsuit.