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The FDA's Suggestions to Reduce Bed Rail Entrapments

The Dangers of Bed Rails
 

A bed seems like a safe place to be. However, for an elderly person who is in a nursing home bed with side rails a bed can be a very dangerous place to be. Between 1985 and 2008, 772 cases of entrapment were reported to the FDA including 460 fatalities. Since 1995 the FDA has warned patients and healthcare providers about the danger of entrapment by side bed rails.

In 1995, the FDA issued a Safety Alert about the Entrapment Hazards with Hospital Bed Side Rails. The safety alert described the 102 incidents of injury and death that occurred because of side rails between 1990 and 1995. The descriptions included 4 different ways in which people could become trapped by the guard rails. As a result of the identified risk, the FDA recommended beds with side rails be carefully inspected when they are set up and monitored periodically to make sure that dangerous gaps between the rails and the mattress are not present. Further, the FDA suggested additional safety measures for patients who might be at high risk of entrapment.

The FDA's Hospital Bed Safety Work Group was established in 1999 and consists of FDA representatives as well as representatives from the hospital bed industry, healthcare organizations, patient advocates and others. In June 2006, the FDA hospital bed safety work group published A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment. The Guide suggested the following seven steps to reduce the danger of entrapment:

  1. Assign responsibility;
  2. Determine high risk clinical units;
  3. Inventory bed systems;
  4. Evaluate bed systems for conformance to bed system entrapment dimensional guidance;
  5. Initiate corrective action;
  6. Guidance for purchasing beds; and
  7. Implement quality monitoring.

The FDA also published a document called, Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment - Guidance for Industry and FDA Staff in 2006. Again, the risk of death and serious injury by entrapment is discussed at length and the agency issued voluntary guidance for the nursing home industry.

As recently as February 2008, the FDA put out a brochure about Bed Safety Rails. The brochure encourages health care teams to carefully assess each individual patient to determine if bed rails are appropriate. It goes on to describe the benefits and risks of bed safety rails and propose alternatives to their use.

Despite the danger and all of the FDA warnings, there have not been any recalls of bed rails by the FDA. All of the guidance provided by the FDA has been nonbinding on the nursing home industry. Nursing homes may continue to legally use these devices that have caused and continue to cause serious injury and death. The failure of the FDA to require an appropriate response to the bed rail danger may result in more injuries and deaths in the future.

 

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