Secrecy of hospitals, FDA results in fatal superbug infections

Every year, more than a half-million patients in the U.S. are unknowingly put at risk of contracting a superbug infection during a common medical procedure. A doctor threads a tube-like 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 lurk within, even after rigorous cleaning between patients. The federal Food and Drug Administration has known about this problem since 2012, yet dawdled. Three months ago, the manufacturer of most of the scopes, Olympus, began recalling them.

But 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.

Patients have contracted infections linked to the contaminated scopes (duodenoscopes) at prestigious institutions such as UCLA Medical Center, NewYork-Presbyterian, Hartford Hospital in Connecticut, Massachusetts General in Boston and Thomas Jefferson University Hospital in Philadelphia.

Hospitals don’t warn their patients about the risk, which 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 hospital industry instead. The FDA refuses to reveal where the two most recent deaths occurred.

It’s been a four-year saga of incompetence, cover-ups and dying patients. And it’s still going on, even after a U.S. Senate report in January exposed the agencies’ blunders and called for reforms. The agencies “have known about this for so long and people are still dying,” laments Glenn Smith, whose teenage son nearly died from a superbug infection after being treated with the device.

In the winter of 2012-13, 38 patients at a suburban Chicago hospital contracted the deadliest superbug, carbapenem-resistant Enterobacteriaceae, after being scoped. The CDC issued a perfunctory report in January 2013, but omitted the model number and manufacturer of the faulty scope, referred to “hospital A” instead of naming Advocate Lutheran General Hospital. Forget alerting the public, or doctors who want to protect their patients from a similar fate.

At the same time, at least 39 patients contracted the same type of lethal superbug at Virginia Mason Medical Center in Seattle, and 18 died, all after being treated with the dirty scope. After initially losing the paperwork regarding these early incidents, the FDA began investigating in September 2013, but took no steps to alert hospitals, doctors or the public about the risk for another 17 months.

That’s why two patients died needlessly at the UCLA Ronald Reagan Medical Center after being treated with bacteria-laden scopes. UCLA didn’t even begin using these scopes until June 2014. Had doctors there been alerted, it’s likely these patients would have been spared.

That’s how deadly government dysfunction and secrecy can be.

But, as the Senate report makes clear, the hospital industry is to blame as well. Not a single hospital where the device-related infections occurred reported the problem quickly to the manufacturer or the FDA, as required. The Senate investigation found that NewYork-Presbyterian waited seven months. The Senate’s 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 complacent federal bureaucrats. They all want to keep problems quiet. 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 dangers of these scopes. But the real victims in this conspiracy of silence are trusting patients.

Betsy McCaughey is a senior fellow at the London Center for Policy Research and author of “Government by Choice: Inventing the United States Constitution.”

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