Device Linked to 'Superbug' Outbreak Still in Use

A research assistant walks past the entrance to the Ronald Reagan UCLA Medical Center in Los Angeles on February 19, 2015. Jonathan Alcorn/Reuters

It's like the plot of a biological horror film: An antibiotic-resistant bacterial "superbug" has infected a slew of patients at UCLA's Ronald Reagan Medical Center. In addition to the two people who died from exposure to the microbe, known as carbapenem-resistant Enterobacteriaceae (CRE), seven are now infected and 179 others at the hospital may have been exposed, as Newsweek reported Thursday.

The Centers for Disease Control and Prevention says CRE may "contribute to death in up to 50 percent of patients who become infected," due to its resistance to antibiotics and other drugs.

It's now suspected that a widely used device to treat gastrointestinal and gall disorders, the duodenoscope, is at the root of the outbreak, and that the Food and Drug Administration (FDA) knew for years that it contributes to the spread of bacterial disease but didn't issue a recall.

On Friday, health officials disclosed that they have known since at least 2009 that reusable medical materials, including the throat-insertion device, may have exposed patients worldwide to the bug, Reuters reports. On Thursday, the FDA issued a "safety communication" advising hospitals and physicians that the "complex design" of the device could inhibit it from being sterilized correctly.

The FDA is reluctant to pull the device from the market altogether. A spokeswoman, speaking on the condition of anonymity, told the Los Angeles Times that an immediate recall would "prevent hundreds of thousands of patients from accessing a beneficial and life-saving procedure. So at this time, the continued availability of these devices is in the best interest of the public health."

The device, which is outfitted with a lighted tube and camera, is used in roughly 500,000 procedures a year in the U.S. to treat gastrointestinal ailments, according to data from the American Gastroenterological Association. Duodenoscopes are manufactured by several companies based in Japan, including Fujifilm Holdings Corporation, Olympus Corporation and Pentax.

In the past two years, the FDA has received 75 complaints about "adverse effects" related to the devices' occasional contribution to the spread of pathogens. The FDA has advised hospitals to sterilize the duodenoscopes more intensely. Yet even when health care providers complied, some patients were still exposed to bacterial infections.

The problem has been ongoing for years and has been noted by health care and medical professionals. In 2009, 16 people in France contracted an anti-antibiotic pathogen after procedures involving duodenoscopes in 2009. Four years later, patients at two different hospitals in Tampa, Florida, came down with the same bacterial disorder, and in northeastern Illinois 44 people were infected with the same strain as that seen in patients at UCLA this month, the CDC reported last year. Eleven people died at Seattle's Virginia Mason Medical Center after the contaminated devices caused them to contract the bacterial infection from 2012 to 2014.

The FDA has confirmed that the devices may have contributed to the illnesses of 135 patients between January 2013 and December 2014, but acknowledged that the actual number may be far higher given that such reports are not always filed.

Leslie Wooldridge, a spokeswoman for the FDA, said the agency is looking into "additional potential strategies to reduce the risk of infections."

Experts say that properly sterilizing the devices with ethylene oxide gas is an option that may help to lower the contamination rate, as well as swabbing and quarantining the duodenoscopes to rid them of lingering germs. This may be the best option, as it doesn't look as if a total recall, which some experts are calling for, is happening anytime soon.

UCLA has disposed of the two confiscated scopes linked to the outbreak and will be enforcing more stringent sterilization measures for its devices, Newsweek reports.