The feds dawdle while patients die needlessly
Our dysfunctional federal government’s bungling is killing people.
Example: Every year, more than half a million patients undergoing a common medical procedure risk getting a superbug infection because their doctor is using a contaminated instrument. A doctor inserts a thin, tubular scope down your throat and into your digestive system to treat cancer and other problems. You assume the tube is clean. Think again.
The scope’s defective design allows bacteria to grow even after it’s rigorously cleaned between patients. The Food and Drug Administration, whose job is to ensure the safety of medical devices, has known about this problem since 2012 but dawdled while patients died. Three months ago, Olympus, the manufacturer of most of these specialized scopes (duodenoscopes), began recalling them.
Yet numerous hospitals are still using them, and patients are still getting infected and dying — eight more infections and two more deaths according to last month’s FDA data.
Even at prestigious institutions such as UCLA Medical Center, New York–Presbyterian, Hartford Hospital in Connecticut, Massachusetts General in Boston and Thomas Jefferson University Hospital in Philadelphia, patients have been infected with superbugs from contaminated duodenoscopes.
When hospitals fail to warn patients about the risk, it makes a mockery of the idea that patients are giving “informed consent” before the procedure, says medical-safety expert Lawrence Muscarella.
Worse, the FDA and another federal agency, the Centers for Disease Control and Prevention, go along with the hush-up about which hospitals are having a problem. These agencies are supposed to work for us — the public — but clearly they’re siding with the hospitals. The FDA is stonewalling about where the two most recent deaths occurred.
It’s been a multi-year saga of incompetence, cover-ups and dying patients. And it’s still going on, even after a US Senate report in January 2016 exposed the agencies’ blunders and called for reforms.
It began in the winter of 2012-2013, when 38 patients at a suburban Chicago hospital contracted the deadly superbug CRE (carbapenem resistant bacteria) after being treated with duodenoscopes. The CDC issued a perfunctory report in January 2013 but omitted the model number and manufacturer of the faulty scopes and referred to “hospital A,” concealing the identity of Advocate Lutheran General Hospital. The agency obviously didn’t care about alerting the public or doctors who want to protect their patients.
About the same time, 39 patients treated with the device contracted the same lethal superbug at Virginia Mason Medical Center in Seattle, and 18 died.
Amazingly, the FDA misplaced the paperwork about these early incidents, and therefore did nothing. Following more outbreaks of device-linked infections, the feds began investigating in September 2013. But even then the agency failed to alert hospitals, doctors or the public for another 17 months. Yikes. The delay was lethal.
In the interim, two patients died needlessly at UCLA Ronald Reagan Medical Center after being treated with the scopes. UCLA didn’t even begin using them until June 2014. Had doctors there been alerted, it’s likely these patients would have been spared.
That’s how deadly government dysfunction can be.
But, as the Senate report makes clear, hospitals are also to blame. Not one hospital promptly reported the problem to the manufacturer or the feds. The Senate investigation found that New York–Presbyterian waited seven months. The report rightly calls for hospitals that hide or delay reporting deaths caused by defective medical devices to be barred from Medicare.
The biggest problem is the unholy alliance between the hospital industry and federal bureaucrats. Publicizing infections is bad for hospital revenues and erodes the public’s misplaced confidence that the federal government is performing its oversight function.
Doctors were kept out of the loop about the defects in the scopes. But the real victims in this conspiracy of silence are trusting patients.
Betsy McCaughey is chairman of the Committee to Reduce Infection Deaths: hospitalinfection.org.