Bed Rail Death

By ThinkReliability Staff

A patient’s death in 2006 at an assisted living facility in Vancouver, Washington has helped spurred a review of the safety of bed rails.  The patient’s death was due to strangulation when her neck got caught in side rails on her bed.  The side rails had been provided by her family at the suggestion of the assisted living facility.

A recent Consumer Product Safety Commission (CPSC) review of bed rail fatalities indicates that there have been 155 deaths due to the use of bed rails between 2003 and May 2012 but until now, regulation of the use and design of bed rails has been somewhat haphazard.  We can examine the issues that led to the 2006 death – and have likely contributed in many of the other bed rail-related deaths, in a Cause Map, or visual root cause analysis.

We begin by considering the impacts to the goals.  The patient safety goal is impacted due to the patient strangulation and death.  The patient services goal is impacted because of the patient getting stuck in the bed rail.  Indeed, injuries resulting from bed rails are far more common than deaths, with about 36,000 injuries requiring emergency room treatment reported since 2003.  There is a concern about potentially inappropriate use of bed rails, which can be considered a property goal and the ensuing review of bed rail deaths can be considered a labor impact.

We begin with the patient safety goal and ask “Why” questions to determine the cause-and-effect relationships that resulted in the impacted goals.  The patient death was due to being trapped in bed rails.  This occurred due to her illness – about half of patients who die in bed rail incidents have medical problems, a gap between the bed rail and mattress, and the use of bed rails.  The gap can be attributed to the design of the bed rail and/or the incompatibility between the mattress and bed rail.  In this case, the bed rail was purchased by the family and the mattress provided by the facility.  ASTM standards for bed rails are voluntary and regulations governing bed rails are insufficient in their current state.

Bed rails are used primarily to keep patients from falling out of bed and to assist patients in getting in and out of bed.  However, hospitals and nursing home use has decreased since dangers have become more well known.    Most deaths (61%) attributed to bed rails occur at home.  It is suggested that a decrease in availability of caregivers may increase the use of bed rails.

When the FDA issued a safety alert regarding bed rails in 1995, it adopted voluntary guidelines and did not require safety labels or recall of any types of bed rails.  At the time, there was political support for less regulation, industry was concerned about legal issues and resistant to any tougher regulation and there was – and still is – confusion over which regulatory agency is actually responsible for bed rails.  The CPSC maintains that bed rails are medical devices and not under their authority.  However, the FDA claims that if no medical claims are made associated with the bed rails, they are not within their regulatory authority either.  Additionally, because deaths and injuries related to bed rails are not necessarily reported, and problems not highlighted to consumers, the issues are not well known.  Some are hoping to change that.

Representative Edward J. Markey has called for the formation of a task force to address the issue.  The CPSC completed a report on deaths, which has been provided to the FDA.  And, manufacturers say that newer designs and safety straps will reduce the risk of patient death.

To view the Outline, Cause Map, and Solutions, please click “Download PDF” above.  Or click here to read more.