Parker Waichman LLP

Dangers posed by bed rails largely ignored by FDA, other federal officials

After likely hundreds of deaths in the last 10 years and tens of thousands of injuries, the Food and Drug Administration and other health and consumer products regulators have failed to issue warnings about the dangers posed by bed rails. Bed rails are actually designed to keep patients safe in their beds, namely older patients […]

bed rail injuryAfter likely hundreds of deaths in the last 10 years and tens of thousands of injuries, the Food and Drug Administration and other health and consumer products regulators have failed to issue warnings about the dangers posed by bed rails.

Bed rails are actually designed to keep patients safe in their beds, namely older patients in assisted-living, nursing home, and hospital settings. These rails extend along a bed. For many patients who are prone to roll out of bed for various reasons, these beds could be a life-saver but for many more people each year, they’ve become a serious health hazard.

According to a New York Times report this week, there are about 4,000 injuries that require emergency room care that are blamed on bed rails. Among them, about 150 people a year die as a result of being trapped in a bed rail. The Consumer Product Safety Commission has received at least 36,000 reports of injuries blamed on bed rails between 2003 and May of this year. Most of the injuries are among elderly people, often in controlled settings like hospitals or nursing homes.

If a patient would happen to fall out of a bed with certain types of bed rails, they could become trapped in the openings through the rails, causing them to suffocate or suffer other serious injuries depending upon how they become trapped.

The Times found that the FDA and CPSC have repeatedly balked at issuing warnings or requiring that safety labels be placed on all bed rails that would at least make most consumers aware of the potential dangers. Experts interviewed by the source believe that many of the injuries and deaths caused by these bed rails could have been avoided with more awareness.

The FDA did issue a warning about the potential hazards of bed rails in 1995 but only issued voluntary guidelines for their use instead of requiring a warning label in 2006. Again, as the injury and death reports continue to accumulate, both federal agencies are being bucked to require that safety labels be placed on these ubiquitous devices.

Newer model bed rails aimed to prevent many of these injuries and some health care facilities have made their employees aware of these potential dangers have reduced the rate of injuries blamed on bed rails since 1995, but many facilities and home health patients still rely on older model rails.

Last year, according to the Times investigation, at least 27 people have died due to being trapped in their bed rails. Many of the injuries and deaths may not be reported though, as some may not be aware that the devices could be blamed for injuries.

The FDA has continued to balk at requiring safety labels on any – new or older models – bed rails, mostly due to pressure from manufacturers against them.

 

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