Product News and Recalls

Maker of Contaminated Duodenoscopes Releases Updated Cleaning Guide

contaminated duodenoscopes have caused multiple deaths in CaliforniaOlympus America, maker of the contaminated duodenoscopes allegedly responsible for the recent “superbug” outbreaks at two LA hospitals, has released new cleaning instructions for its product. Olympus sent out the updated guidelines to hospitals on March 26, and is urging customers to begin using them immediately. They call for the use of a smaller cleaning brush and include additional steps to flush out debris and disinfect hard-to-clean parts of the product like crevasses and joints. Olympus plans to get the new brush to customers by May 8.

In February, two patients at the Ronald Reagan UCLA Medical Center were found to have died after infections from contaminated duodenoscopes. More than 179 other patients may also have been infected. Upon examination, scientists found that the duodenoscopes, which were being used in a complex endoscopy procedure, had been harboring a type of highly antibiotic-resistant bacteria known as Carbapenem-resistant enterobacteriaceae (CRE). CRE infections are difficult to treat and oftentimes result in death. According to the CDC, CRE are frequently transmitted to patients in intensive care and long-term programs by contaminated medical devices.

Less than a month later, four more patients were found with hospital-acquired CRE infections at Cedars-Sinai Medical Center, also in Los Angeles. Moreover, the infectious bacteria were found to have been transmitted by contaminated duodenoscopes. Duodenoscopes are a type of medical device used to diagnose and treat cancer and gallstones. Some duodenoscopes have drawn criticism for their design, which makes it difficult to reliably disinfect them. As a result, deadly bacteria such as CRE can survive in the devices and be passed on to patients.

As a result of these outbreaks, the FDA redoubled its efforts to raise product approval standards for reusable medical devices, and in March released new guidelines requiring that manufacturers like Olympus provide scientific evidence that their products can be safely disinfected.

Despite efforts by health care regulators and lawmakers, hospital-acquired infections such as those caused by the contaminated duodenoscopes continue to be a problem in U.S. medical facilities. According to a 2011 estimate from the federal Centers for Disease Control and Prevention, 1 in 25 hospitalized patients acquires an infection, and roughly 722,000 hospital-acquired infections result in or contribute to 75,000 deaths each year. While decreasing rates of hospital-acquired conditions suggest that the U.S. health care system is moving in the right direction, many medical professionals still claim that more can and should be done.

If you believe you or a loved one acquired a hospital-related infection from a contaminated duodenoscope, you should contact the attorneys at Lopez McHugh for a free consultation. You may qualify for compensation through a medical malpractice or product liability lawsuit.