FDA Investigates Bed Rails to Stop the Sleep of Death

Bed RailsBed rails are supposed to protect elderly and frail patients from the risk of serious injury or even death from falling out of bed. However, bed rails actually cause injury and death. Regulators know it. Bed rail manufacturers know it. And health care providers know it, but until now little has been done.

With regulators and others slow to act, product liability lawyers have taken action. According to the New York Times, the FDA is starting an investigation into the dangers of bed rails, but only after 550 deaths since the agency’s first warning about the issue in 1995. Despite voluntary guidelines, injuries and deaths seem to be increasing. Since 2003, more than 36,000 patients have been treated in the emergency room for bed rail-related injuries, and last year alone, 27 people were killed by bed rail incidents.

What Are the Dangers?

Bed rails are used to prevent elderly and frail patients from falling out of bed during the night. They can also be used as a form of restraint for patients with dementia. Bed rails do work to some extent for these purposes. Dr. Steven Miles, a bed rail expert at the University of Minnesota, notes that bed rails can reduce the risk of falls by 10 to 15 %.

However, Dr. Miles also notes that bed rails increase your risk of injury in any fall by 20% because they change the geometry of falls. Patients who are trying to climb over bed rails fall further and are more likely to fall on their head or spine.

But the most common fatal danger is entrapment by the bed rail, resulting in suffocation. According to incident reports from 1993 to 1996, patients can become trapped so that:

  • Their face is pressed against the mattress (70% of entrapment deaths)
  • They are compressed between the bed rails (18%)
  • They have partially fallen out of bed, but their head and neck remain caught (12%)

According to Dr. Miles, bed rail entrapment represents “an entirely preventable problem.”

How Long Have These Dangers Been Known?

Theoretically, entrapment by bed rails should be an obvious danger, since it is essentially the same problem that results in infant crib entrapment recalls. Well-designed bed rails should anticipate this danger and be designed to avoid it.

Practically, bed rail entrapment incidents have been reported since 1985, though many early reports went only to the Consumer Product Safety Commission and not the FDA. By 1995, the problem had become serious enough that the FDA issued a safety alert that noted the danger of death by entrapment. It issued safety guidelines for care providers, which it said was part of a “cooperative effort between FDA, the healthcare industry, and manufacturers to resolve the problem.”

However, it was clear by 1999 that the warnings were not enough to prevent further deaths and additional action was necessary.

Why Do Deaths Continue?

Although entrapments deaths by bed rails are “an entirely preventable problem,” they have not stopped. Why?

  • Manufacturers have resisted attempts to get universal requirements for bed rail design and manufacture. Voluntary standards issued in 2006 have not resulted in wide-scale safety improvements.
  • Nursing homes, hospitals, and other care providers continue to use out-of-date bed rails.
  • Family members who purchase bed rails for home use are not warned about the dangers of entrapment and death.
  • Beds and rails are often sold separately. Mismatch between the two components leads to increased risk.
  • Understaffed nursing homes and other care facilities do not have enough personnel to properly monitor patients with bed rails.

It is hoped that the FDA investigations will result in bed rail safety improvements. In the meantime, product liability lawyers are attempting to persuade manufacturers to take their responsibility seriously. As Dr. Miles notes, this may be the most effective course after all: “Government sanctions cost a couple thousand bucks. A lawsuit can cost $500,000 to a million. It gets more attention.”

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