Down the Tubes

Compatibility is usually a good thing–but not compatibility among common hospital medical tubes and tube connectors.

For instance, when the tube from a liquid-food bag can be easily inserted directly into a vein (yes, it happens, and, yes, it’s fatal), then compatibility is madness.

But a medical system that uses identical plastic tubing with compatible connectors shouldn’t be THAT hard to change, right?

Wrong.

The international medical device industry and the FDA (which regulates the U.S. arm of that industry) have built a Tower of Babel.

Unfortunately, change is expensive, so it’s in the best interest of industry to keep the babble going.

Dysfunction junction

According to an article published earlier this year by the Medical Device and Diagnostic Industry, mistakes like the liquid-food-in-vein tragedy described above have happened more than 1,200 times over the past decade.

And if 120 incidents per year doesn’t sound like much, keep in mind that there are no reporting requirements for this sort of thing–all these events were voluntarily reported from only a small fraction of U.S. hospitals.

In other words, it happens all the time.

Tubing misconnection problems go back many years, even decades. But it’s only been 15 years since advocacy groups started lobbying medical device makers and the FDA. But a decade-and-a-half is a LONG time to get a very limited response when you’re simply calling for some basic common sense action to prevent injury and save lives

So what’s the hold up?

Nancy Pratt, a California health care professional, told the New York Times that the FDA has been waiting for the industry to devise a solution. But she adds, “The manufacturers won’t spend the money to design and produce something different until the regulators force them to.”

Yeah–that could be a VERY long wait. And the reason is all too familiar: As with the drug industry, the FDA has a sweet-n-cozy relationship with medical device makers.

A former FDA device reviewer told the Times: “FDA could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die.”

While we’re waiting for this insane standoff to end, here’s an important point to remember: Never EVER do it yourself. Case reports on the FDA website show that tube mix-ups are usually caused by harried, exhausted doctors and nurses. But in some cases the patients or family members reattach disconnected tubes themselves.

BAD idea! It’s a slightly better idea than waiting for the FDA or medical device industry to do something. But better to press the nurse call-button (and hope she’s not at the end of a double-shift).

To Your Good Health,

Jenny Thompson

Sources:

“U.S. Inaction Lets Look-Alike Tubes Kill Patients” Gardiner Harris, New York Times, 8/20/10, nytimes.com
“New York Times Slams FDA for Failure to Act on Look-Alike Tubes Used in Hospitals” Paul Napoli, The Injury Board, 8/21/10, newyorkcity.injuryboard.com
“Medical Device Safety Calendar 2009” FDA, fda.gov


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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