Medical Oversight and Patient Safety? You be the Judge

Duodenoscopy at its most basic

Duodenoscopy at its most basic

We’re guessing that when you, personally, take a loved one to your local hospital, neither of you have the slightest expectation that the upcoming examination might end up causing serious injury or kill you. But if you have been reading Medical Miscreants at all, you should certainly be properly informed by now.

Over the past 10 years, thousands of citizens have been sickened and some have been killed, for no other reason than hospital acquired infections linked to contaminated medical examination scopes. And making this ridiculous situation worse is the undeniable fact that many of these cases might never have happened at all, if the Food and Drug Administration had simply done its job with a greater sense of urgency. You see, our tax money funds this organization, and they are the folks charged with the responsibility of ensuring medical equipment safety.

What the FDA has done instead is wait half a decade before publicizing a safety announcement regarding at least one particular device, known as a duodenoscope – a flexible tube which is inserted into the mouth and throat of patients in order to see and treat gall bladder  blockage. The safety announcement came along six years after the FDA first learned that this particular device, among others, is difficult to disinfect and has been the cause of lethal infections that afflicted dozens of patients in the state of Florida alone. This, according to a USA TODAY investigation. And while they twiddled their medical thumbs, 15 patients died.

This appalling medical dollar play – as so many dollar plays do – played out behind the scenes with no public scrutiny, with troubling questions about the way medical devices are cleared for sale and their safety overseen. Legally, newly designed medical equipment that is similar to products already in existence, receive less scrutiny than new devices. That much makes sense. But what is truly stupid is a so-called ‘public safety’ policy that allows the manufacturers to police themselves.

The FDA is foolish enough to depend on manufacturers to quickly report safety problems. And when these companies refuse to ‘fess up, dangerous medical equipment permeates thousands of hospitals for years. Perhaps even worse, the FDA hides identifying information from reports to the public, which makes it nearly impossible for patient advocates to spot dangerous trends. The end result? Well in this case, people died.

In April 2009, federal health officials quietly urged the FDA to alert hospitals about the risk of duodenoscope-related infections after the Florida cases surfaced. One public health official warned in an email that “this is likely not an issue limited” to Florida. More than 650,000 scope procedures happen each year in the U.S.

Seven months later, the FDA included two sentences buried in the 57th paragraph of a general advisory on cleaning all kinds of medical scopes. It was hardly what was needed to get hospitals’ attention.

By 2010, infections linked to the scopes surfaced in Europe. By 2014, outbreaks linked to them sickened patients in Pittsburgh, Seattle, Los Angeles and other cities.

The FDA’s major safety alert and cleaning guidance finally came out this February, a month after the first story in an investigative series by USA TODAY’s Peter Eisler appeared, as news broke of infections in Los Angeles.

Other players failed to do their jobs, too.

Olympus, which holds a majority of the duodenoscope market, did not have FDA clearance before selling the scopes, a violation of agency regulations. The FDA has failed to pursue sanctions against the company.

Scope makers are supposed to report safety problems within 30 days of their appearance, but the FDA often got reports late. Many hospitals where infections occurred have done very little to alert the public or even their own patients.

The outbreaks also highlight an emerging medical danger: bacteria that are resistant to most, and sometimes all, antibiotics. Scientists have warned for years that the overuse of antibiotics in humans and farm animals has spawned the growth of bacteria resistant to these wonder drugs. They include CRE, one bacteria that tainted the duodenscopes and has a 40% mortality rate.

The FDA has not recalled this device, announcing that it remains a safer choice than surgery for treatment of certain conditions. That makes sense.  And with advice from experts, the FDA has recommended more effective ways to disinfect or sterilize these complex, costly scopes. Some hospitals are already following those procedures. But the scopes, as one hospital official told Eisler, are “a nightmare” to clean.

We believe it is past time for Congress to order the FDA to stop pretending it gives a damn about safety and explain before the cameras why it fails to do its watchdog job.

Don’t hold your breath. In the monastic world of government oversight patient safety is not the priority. Money and power are the priorities. Patients are a dime a dozen, and they keep right on coming through the clinic doors, as hopeful and intellectually lazy as always.

Pity.

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