Questions about jurisdiction may have held federal regulators back from investigating potential hazards that bed rails in hospitals and nursing homes present for seniors, the New York Times reports.
The rails are metal bars that assist patients in pulling themselves up and prevent them from rolling out of bed. They can be hazardous when patients, especially those with Alzheimer’s, get confused and trapped between a bed rail and a mattress.
According to the New York Times, the U.S. Food and Drug Administration first issued warnings about the rails in 1995. Since then, about 550 bed rail-related deaths have occurred, including 27 last year alone.
Although experts says more warnings are needed, there is a technical question about whether the rails are medical devices under the purview of the FDA, or consumer products regulated by the Consumer Product Safety Commission.
The report says a working group was formed in 1999 to look at the issue, made up of medical device makers, researchers, patient advocates and FDA officials.
Group members considered requiring bed rail makers to add warning labels. But manufacturers resisted and the FDA eventually decided against it, citing legal issues.
As a compromise, the FDA issued voluntary guidelines in 2006. The agency also instructed hospitals and nursing homes on the use of bed rails, recommended size limits for the gaps and openings in the rails, and identified body parts most at risk for getting stuck.
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