A dangerous problem

Thursday, Aug. 26, 2010 | 2:05 a.m.

In 2006, Johannah Back’s daughter, Chloe, was born prematurely at a Las Vegas hospital, and Chloe almost died in the aftermath. A nurse mistakenly attached a bag of breast milk to an intravenous tube, and Chloe formed blood clots, bled profusely and suffered seizures.

The New York Times, which Saturday explained what happened to Chloe, also revealed that mistakes such as this are neither uncommon nor new. For years, the medical industry has known about the problem: The tubes that deliver or extract medicine, nutrition, blood or gases to various parts of the body are typically interchangeable, and that can lead to potentially fatal mix-ups.

Since 1996, experts and advocacy groups have asked for regulations that would make tubes for different functions incompatible, similar to the way gas pumps have different nozzles so drivers don’t put the wrong fuel in their vehicles. But medical device manufacturers have been reluctant to change, and federal regulators have been unwilling to force the issue. In the meantime, people have been harmed and some have died because of mistakes.

No one knows the extent of the harm because this type of injury is rarely reported, but a survey of hospitals in 2006 reported that 16 percent had seen feeding tube mistakes. Other mistakes can happen because the tubes can be hooked up to one another. For example, tubes to inflate air cuffs can be hooked to intravenous tubes, leading to potentially fatal consequences.

The result is that a busy or tired nurse can make a mistake, particularly on patients with multiple tubes running into their bodies. The Times detailed cases in which simple mix-ups were either life-threatening or fatal.

“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 has called for changing the system. “The nuclear power and airline industries would never tolerate a situation where a simple misconnection could lead to a death.”

Instead of mandating change, the Food and Drug Administration has tried to get manufacturers and the standard-setting organizations for medical devices to work things out, but so far, there hasn’t been much movement.

“The regulators have been waiting for the manufacturers to come up with a solution,” Pratt said, “and the manufacturers won’t spend the money to design and produce something different until the regulators force them to. And now the international standards organization is taking forever to get the whole world onto the same page.”

This is ridiculous. The FDA shouldn’t abdicate its responsibility to the medical device industry — it should act. There is an obvious problem, and there are simple fixes, like making tubes different sizes so they’re incompatible or color coding them so they’re easily identified. It’s time for the FDA to do its job and order changes to protect patients.