Product News and Recalls

FDA Releases More Measures for Duodenoscope Safety

fda issues measures for duodenoscope safetyThe U.S. Food and Drug Administration (FDA) has released a safety communication detailing additional measures for medical staff to follow when cleaning duodenoscopes. The agency encourages hospitals to follow supplemental guidelines, as well as adhere strictly to the manufacturer’s disinfection instructions.

Duodenoscopes are a type of medical device used in endoscopic surgery to help diagnose and treat gallstones, cancer, and other complications in the bile and pancreatic ducts. The FDA estimates that duodenoscopes are used in half a million procedures each year in the United States. Recently the devices have achieved some notoriety after a cluster of infections at two Los Angeles hospitals. The duodenoscopes, which were found to be harboring a highly antibiotic-resistant and potentially fatal strain of bacteria, were linked to two deaths and up to 200 infections at the Ronald Reagan UCLA Medical Center earlier this year. Just a few weeks later, contaminated duodenoscopes were blamed for four infections at Cedars-Sinai Medical Center.

Researchers were quick to attribute the duodenoscopes’ contamination to their hard-to-clean design. This touched off a flurry of government activity and consumer outcry. In May the FDA officially condemned the duodenoscopes as unsafe in their current state, but not before the agency had been criticized for how it handled the situation.

With its new safety communication, the FDA hopes to further limit any infection caused by inadequate cleaning of duodenoscopes. It has provided four supplemental guidelines to make for safer reprocessing: microbiological culturing; ethylene oxide sterilization; use of a liquid chemical sterilant processing system; and repeat high-level disinfection. According to the agency, these additional instructions resulted from the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee it held in mid-May. The FDA says it will continue to actively monitor the duodenoscope situation, and is currently collaborating with other health organizations, such as the CDC, to find better ways to limit duodenoscope infections.

Families and friends of those infected have already begun filing duodenoscope lawsuits. If you or someone you know believes they were infected by a contaminated duodenoscope, contact Lopez McHugh to discuss your case free of charge with a duodenoscope lawyer. You may be entitled to legal damages through a duodenoscope lawsuit.