The U.S. Food and Drug Administration has known since at least 2009 that the medical devices responsible for the UCLA "superbug" outbreak can spread lethal infections, but the agency failed to recall the device or recommend increased safety measures, according to Reuters.
The reusable device responsible for the latest outbreak is referred to as a duodenoscope, and is inserted down the throat to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors or other gastrointestinal conditions.
But the device may be so flawed that even high-level disinfection can't entirely eliminate the risk of transmitting infection, the FDA said.
So far, two people have died from exposure to the microbe, carbapenem-resistant Enterobacteriaceae (CRE), seven have been infected, and as many as 179 patients at UCLA's Ronal Reagan Medical Center in Los Angeles could have been exposed, according to Newsweek.
Despite knowing about the faulty device for years, it's still being used around the world, and the FDA took action only after The New York Times reported this week the death of two patients, according to the Los Angeles Times. The agency finally released a "safety communication" on Thursday warning of the associated dangers.
An FDA official told the LA Times that an immediate recall would "prevent hundreds of thousands of patients from accessing beneficial and life-saving procedure. So at this time, the continued availability of these devices is in the best interest of the public health."
In the past two years alone, the FDA received 75 complaints regarding "adverse effects" associated with the device and its transmission of pathogens. Those reports indicated that 135 patients had potentially been infected. But that number is likely an understatement since not all health care providers submit report, the FDA said, according to Reuters.
Medical experts and safety advocates have been reporting problems for years, noted the LA Times.
In 2009, 16 patients in France were infected with a pathogen after undergoing the procedure, prompting the FDA to issue its first warning.
The University of Pittsburgh Medical Center had an outbreak in 2012, in which contaminated scopes infected 32 people over two years, resulting in 11 deaths.
In 2013, physicians reported that the device had transmitted an antibiotic-resistant pathogen at two Tampa hospitals, and there was also an outbreak near Chicago, where 44 patients were infected with an antibiotic resistant bacteria, according to Reuters.
FDA spokeswoman Leslie Wooldridge said the agency is looking for "additional potential strategies to reduce the risk of infections."
For now, experts say that one of the most effective methods is to sterilize the devices with ethylene oxide gas, and thoroughly swab and quarantining the devices to get rid of remaining germs.
