FDA Fails To Protect

For decades, the FDA and medical personnel have known of the risks of using the same tubing connections for every device. The risk is death if devices are hooked up incorrectly, such as an air pump hooked into an IV tube which will cause a deadly air embolism, putting liquid food directly into veins:

Instead of snaking a tube through Ms. Rodgers’s nose and into her stomach, the nurse instead coupled the liquid-food bag to a tube that entered a vein.

Putting such food directly into the bloodstream is like pouring concrete down a drain. Ms. Rodgers was soon in agony.

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Their deaths were among hundreds of deaths or serious injuries that researchers have traced to tube mix-ups. But no one knows the real toll, because this kind of mistake, like medication errors in general, is rarely reported.

At gas stations, the nozzles at diesel pumps are a different size than unleaded, those reducing the chance of mistake. In the medical world, the FDA has everything be the same:

Experts and standards groups have advocated since 1996 that tubes for different functions be made incompatible — just as different nozzles at gas stations prevent drivers from using the wrong fuel.

But action has been delayed by resistance from the medical-device industry and an approval process at the Food and Drug Administration that can discourage safety-related changes.

“Nurses should not have to work in an environment where it is even possible to make that kind of mistake,” said Nancy Pratt, a senior vice president at Sharp HealthCare in San Diego who is a vocal advocate for changing the system. “The nuclear power and airline industries would never tolerate a situation where a simple misconnection could lead to a death.”

Since the FDA can't protect consumers, is it time to admit that government regulation is a failure?