Product News and Recalls

FDA investigating defective-designed bed rails after 27 deaths

Although federal investigators are now studying the safety risk that bed rails present for residents of nursing homes, an article in the New York Times says regulators have long been aware of that risk and have done little to crack down on their manufacturers.

The rails are metal bars used on beds and in hospitals and nursing homes, which assist patients in pulling themselves up and prevent them from rolling out of bed. Sometimes patients, especially those with Alzheimer’s, can get confused and trapped between a bed rail and a mattress. That can lead to serious injury or even death by suffocation or strangulation.

The article cites data compiled by the federal consumer safety commission, drawing on death certificates and hospital emergency room visits from 2003 through May 2012. Investigators found that 150 mostly older adults died after they became trapped in bed rails. And the problem is ongoing–last year at least 27 people died.  On average, 4,000 mostly older adults are treated in emergency rooms for injuries caused by bed rails.

And federal investigators believe the problem is probably under-reported, because nursing homes, coroners and emergency room doctors don’t always list bed rails as a cause of death or injury.

The U.S. Food and Drug Administration issued safety warnings about the devices in 1995, the New York Times writes, but did not issue and recalls or require manufacturers to put safety labels on them because of resistance both from industry and from Congress. The agency adopted only “voluntary guidelines” in 2006.

The report quotes Dr. Steven Miles, a professor at the Center for Bioethics at the University of Minnesota, as saying: “This is an entirely preventable problem.”

See the story here: