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U.S. Department of Health and Human Services

Medical Devices

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Safety Concerns about Bed Rails

The U.S. Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA) have received many death and injury reports related to both adult portable bed rail products and hospital bed rails. Most of these reports were for entrapment and falls. It is important to consider the bed rail type and whether or not a bed rail type product is appropriate when creating a safe sleeping environment that accounts for medical needs, comfort, and desire for freedom of movement.

People who want to be safe in bed should understand the risks associated with using bed rail products, take steps to ensure that they are installed and used correctly, and be aware that certain individuals should not use bed rails.

Adult bed rails should not be used as a restraint. They are intended to be assistive and should be used to facilitate mobility for those who need assistance getting in and out of bed or repositioning in bed.

Adult portable bed rails and hospital bed rails are not for everyone, nor every situation. Deaths and serious injuries can happen when using these products and devices. Even when portable bed rails and hospital bed rails are properly designed to reduce the risk of entrapment or falls, are compatible with the bed and mattress, and are used appropriately, they can present a hazard to certain individuals, particularly to people with physical limitations or altered mental status, such as dementia or delirium.

Consumer Product Safety Commission (CPSC) Reports about Adult Portable Bed Rails

According to the CPSC’s report “Adult Portable Bed Rail-Related Deaths, Injuries, and Potential Injuries,” the agency received reports of 155 deaths and 5 injuries related to adult portable bed rails from January 2003 to September 2012. Of the deaths:

  • 143 were related to rail entrapment;
  • 11 were related to falls on the bed rail; and
  • 1 victim hit his head on the rail.

The ages of those who died ranged from 14 to 103 years old; however 129 of the 155 deaths occurred in people who were 60 years and older.

About half of the death reports indicated that the victim had a diagnosed medical condition. The most reported conditions (from highest to lowest) were:

  • cardiovascular disease
  • Alzheimer’s disease, dementia, or other mental limitations
  • seizure
  • mobility limitations or paralysis
  • Parkinson’s disease
  • Cerebral palsy
  • multiple sclerosis
  • taking medication

Most of the deaths and injuries occurred at home (94). The rest occurred at nursing homes (25), assisted living facilities (15), hospice facilities (3), other (5), or unspecified locations (13).

What were the cause of deaths and injuries?

The CPSC report “Adult Portable Bed Rail-Related Deaths, Injuries, and Potential Injuries,” indicates the two most common causes of deaths and injuries were rail entrapment (145) and falls (11).

Rail entrapment occurred when the victim was caught, stuck, wedged, or trapped between the mattress/bed and the bed rail, between bed rail bars, between a commode and rail, between the floor and rail, or between the headboard and rail. Based on the reports, the most commonly injured body parts were the neck and head and most of these events (143 out of 145) resulted in fatalities. Please visit the FDA’s Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment to view images of various types of entrapment.

Falls occurred when the victim fell off the bed rail, climbed over the bed rail, fell and hit the bed rail or fell due to an unraised bed rail. All fall events resulted in death.

The CPSC also reviewed bed rail injuries through the National Electronic Injury Surveillance System (NEISS), which gathers information about hospital emergency room visits and develops nationwide estimates based on the collected data. According to the NEISS, there were an estimated 36,900 adult portable bed rail-related injuries that were treated in U.S. hospital emergency departments from January 2003 to December 2011. Most injuries occurred to the head, lower leg and foot, and included cuts (laceration), bruising and scrapes (contusions/abrasions), and cracked or broken bones (fractures).

Food and Drug Administration Reports about Hospital Bed Rails and Portable Bed Rails

The FDA received medical device reports (also called MDRs) showing 901 incidents of patients caught, trapped, entangled, or strangled in hospital beds between January 1, 1985 and January 1, 2013. The reports included 531 deaths, 151 nonfatal injuries, and 220 cases where staff needed to intervene to prevent injuries, also called near misses. Most patients were frail, elderly or disoriented.

Additionally, seven death reports associated with portable bed rails were submitted to the FDA from 2005-2013.