Written by Andrea Martin. Media by Matt Miller.
Two fatalities have occurred at the University of California, Los Angeles after intrinsic procedures were performed in which a “super bug” has been identified as the main cause for the deaths.
UCLA released a statement Wednesday, February 18 that the super bug was linked to medical scopes that had not been thoroughly cleaned. Seven others have been infected and 179 others have been exposed. The two deaths occurred at Ronald Reagan UCLA Medical Center in Los Angeles. Between October and January nearly 200 hundred procedures took place at UCLA.
The super bug has been identified as carbapenem-resistant Enterobacteriaceae, or CRE. Some of the infected patients experienced symptoms such as fever, chills, and severe sepsis. The bacterium is extremely resistant to antibiotics and can kill up to 50% of those that are infected.
The infections may have been transferred from patient to patient after two contaminated endoscopes were used to diagnose and treat pancreatic and bile duct problems. Even after being cleaned according to manufacturer’s instructions, the instruments still were found to be positive for the super bug. Five other scopes were cleared, though.
On Thursday, February 19, the Food and Drug Administration issued an alert about the devices involved, but the administration has taken heavy criticism for their lack of recalling the devices. The flaw of the scopes is that they cannot be cleaned thoroughly, which would be a red flag for the FDA to take action, but there hasn’t been much done on their part.
Apparently, the FDA knew of the scopes’ potential flaw since 2009, but did not address the problem until The Times released a story about the two fatalities at UCLA.
“FDA didn’t do its job,” said Diana Zuckerman, president of the nonprofit National Center for Health Research.
The FDA addressed the criticism by saying that the benefits far out-weighed the risks.
“If we pulled the devices from the market, we would prevent hundreds of thousands of patients from accessing a beneficial and life-saving procedure,” a spokeswoman for the FDA said. “So at this time, the continued availability of these devices is in the best interest of the public health.” The FDA also acknowledged that the complexity of the scopes may make it almost impossible to effectively clean them.
The devices, called duodenoscopes, feature a tiny camera at the end of a tube, which is then inserted into a person’s digestive tract to screen the stomach and top part of the small intestine. The camera is moveable via a remote, but the crevices of the camera cannot be properly cleaned. Body fluids and other organic debris can then be harbored on the scope and can potential affect other patients.
Olympus is the top manufacturer of the scopes and released a statement saying it would send educational material to patients about endoscopes, which would also include a checklist with video demonstrations. “We are working with the FDA, relevant medical societies and our customers regarding these concerns,” the company reported.