Easily Mixed-Up Medication Tubes Cause Patient Deaths and Injuries

For years, patient safety experts have known that medical devices, like tubes that deliver food and drugs to hospitalized patients, need to be designed so that predictable mix-ups don’t hurt patients. If a tube is safe if it goes through the nose to deliver food to the stomach, it should not be possible to hook up the same tube to a line that delivers medication to a blood vessel, since that could kill the patient.

But this basic safety philosophy — which permeates other high-risk industries like aviation and nuclear power — still hasn’t penetrated the medical industry, as a new report in the New York Times documents in distressing detail.

Partly to blame is the U.S. Food and Drug Administration, which could set up uniform rules that would bar as unsafe any medical devices where fatal mix-ups could be easily made by hurried nurses or other caregivers.

The way the agency does its work is the problem. When the FDA has tried to act on a case-by-case basis with an application from a manufacturer for a new product, efforts by FDA safety reviewers to solve the problem have been met with cries from the new manufacturer that it is being unfairly singled out.

Efforts to have industry-wide regulations have met with years of bureaucratic delay and industry resistance.

Here’s a quotable quote from former FDA official Dr. Robert Smith:

“F.D.A. could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die.”

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