Federal fiddling lets superbugs kill
Seven patients at UCLA’s Ronald Reagan Medical Center contracted a deadly superbug from an utterly routine medical procedure.
Two have died; a third, an 18-year-old boy, fights on for his life after 83 days in the hospital, mostly in intensive care.
All this suffering was preventable. The Centers for Disease Control and the Food and Drug Administration knew that a specific device had already caused lethal infections in Chicago, Seattle and elsewhere.
But rather than issue a clear national alert to properly warn UCLA and other hospitals, the agencies swept it under the rug.
In the procedure, a flexible tube with a camera on the end is threaded down your throat to treat gallstones, ulcers and the like. Around half a million Americans undergo the procedure each year.
But this specialized type of endoscope turns out to have a design flaw that prevents proper sterilization. Germs can lurk inside the device.
That’s what happened at UCLA, where as many as 179 patients were exposed to the particularly deadly germ Carbapenem-resistant bacteria. The CDC nicknamed it “nightmare bacteria” because few if any antibiotics work against it. Close to half those infected by it die.
(The device is only one way this particular superbug spreads. The New York area has been the epicenter for this Carbapenem-resistant “nightmare bacteria” for over a decade. Hospitals here are plagued with it.)
The real outrage: UCLA didn’t start using the ill-designed scopes until last June. That’s six months after the CDC knew that 91 patients in a suburban Chicago hospital had fallen victim to the same problem.
The CDC responded to the Chicago outbreak with secrecy and inaction, merely issuing a January 2014 report that conspicuously failed to name the model number or manufacturer of the scope.
At the time, I called the CDC and pushed; eventually, I was told it was the Pentax 3490 TX. But doctors and hospitals everywhere should have had that information.
The report also referred to “hospital A,” rather than name the Chicago-area hospital, and never mentioned that some infected patients had died.
The proper response to the Chicago outbreak would’ve been to raise the alarm about the mis-designed devices.
Instead, the CDC lamely suggested that any hospital experiencing an outbreak “should consider the possibility of endoscopic transmission.”
That’s not prevention, just after-the-fact explanation. Are hospitals supposed to wait until after patients get sick, and then look at their medical devices? That’s crazy.
Chicago wasn’t even the first warning the bureaucrats ignored. The CDC also stifled news about an outbreak in Seattle, where 32 patients at Virginia Mason Medical Center contracted the same superbug from similarly contaminated scopes from 2012 to 2014.
There, 11 patients died.
Just as troubling, the FDA – supposedly responsible for the safety of medical equipment – stayed mute as these outbreaks popped up across the country.
For three years, the agency has been sitting on at least 75 reports of patients endangered by these contaminated devices.
It wasn’t until last month that the FDA made the underwhelming announcement that the problem is “on the agency’s priority list for guidance documents we intend to publish in 2015.” It noted that “effective cleaning of all areas” of these devices “may not be possible.”
Too little, too late for the victims in Los Angeles and elsewhere.
The FDA now says it’s working with three manufacturers – Pentax, Olympus and FujiFilm – on a solution.
Yet it has also issued a stunning blanket statement that the benefits of the procedure outweigh the risks of infection.
Not so: That’s for patients and their doctors to decide. The FDA had an obligation to inform them of the risk. It failed big time.
Our FDA and CDC bureaucrats have a lot of explaining to do to the grieving families in Los Angeles.
Just as at the VA, heads need to roll at these agencies. And if either fails to publicly examine and reform the bureaucratic deceptions and dysfunctions that led to these unnecessary deaths, Congress should take all steps necessary to excise the rot.