Tuesday, July 9, 2013

Bed Rails That Kill

As attorneys, many of us have consulted with clients and their families as a result of a fall from a hospital or nursing home bed. These falls result in fractured arms, legs, and hips, and often even more serious injuries such as skull fractures. The patient’s (or family’s) immediate reaction to these unfortunate injuries is to blame the hospital, nursing home, nursing staff, or attending physicians for the failure to have bed side rails raised and in place to prevent such falls. This typical reaction is based upon the assumption that bed rails, when properly used, will prevent the patient/resident from falling out of the bed and suffering injury. However, bed rails are not benign safety devices and this article will address the dangers created by their use.

Bed side rails have been in existence for years and are manufactured by several different companies with numerous configurations and designs. A quick search of the Internet discloses a number of medical supply companies which manufacture and sell these products. The most common bed rail designs include full-length rails, three-quarter-length rails, half-length rails, quarter-length rails, and split-rail configuration (often the most dangerous design).

Bed rails are used extensively in hospitals and nursing homes. In hospitals, their use is typically a nursing decision rather than based upon a physician’s order. However, in nursing homes, Federal regulations require a physician’s order if bed rails are to be used, as the regulations recognize side rails as a form of restraint. Notwithstanding the requirement for nursing homes, physician’s orders are often not obtained because of the belief that bed rails are simply a safety device. This is a misconception: bed rails often cause injury or death.

There has been little study or publication about the risks and benefits of bed rails. However, the reports of adult deaths and injuries from bed rails on file with the U.S. Consumer Products Safety Commission (CPSC) (incidents from 1993 to 1996) provide significant information for attorneys investigating a potential negligence claim. The CPSC information reflects that seventy-four patients died as a result of the use of bed rails. Moreover, it in not unrealistic to conclude that the actual number of patient deaths far exceeded the reported deaths. Regardless of the true frequency of deaths, 70% of the reported patient deaths resulted from entrapment between the mattress and the bed rail such that the patient’s face was pressed against the mattress. 18% percent of the reported deaths were the result of entrapment and compression of the neck within the bed rails. Finally, 12% twelve percent of the reported deaths were caused by being trapped by the rails after sliding partially off the bed, resulting in neck flexion and chest compression.

The second source of significant information comes from the U.S. Food and Drug Administration. The FDA issued a Safety Alert in August of 1995 regarding the entrapment hazards and safety concerns which accompany the use of bed side rails. The Safety Alert was communicated to hospital administrators, hospital associations, nursing homes, risk managers, bio-medical/clinical engineers, and directors of nursing. The Alert was not specific to any one manufacturer or particular design of side rail but warned health care providers that the FDA had received 102 reports of head and body entrapment incidents involving side rails between 1990 and 1995. The 102 reports of entrapment resulted in 68 deaths, 22 injuries, and 12 entrapments without injury. These unfortunate events occurred in hospitals, nursing homes, and private homes. The majority of the entrapments involved elderly patients.

In part, the FDA’s Safety Alert recommended the following actions to prevent deaths and injuries from entrapment in hospital bed side rails:

Inspect all hospital bed frames, bed side rails, and mattresses as part of a regular maintenance program to identify areas of possible entrapment. Regardless of mattress width, length, and/or depth, alignment of the bed frame, bed side rail, and mattress should leave no gap wide enough to entrap a patient’s head or body. Be aware that gaps can be created by movement or compression of the mattress which may be caused by patient weight, patient movement, or bed position. Be alert to replacement mattresses and bed side rails with dimensions different than the original equipment supplied or specified by the bed frame manufacturer. Not all bed side rails, mattresses, and bed frames are interchangeable.

The entire FDA Safety Alert may be found at: [http://www.fda.gov/cdrh/bedrails.html]. In 1999 the FDA, in conjunction with representatives from the hospital bed industry, national healthcare organizations, and patient advocacy groups formed the Hospital Bed Safety Workgroup. The Workgroup’s goal was to improve the safety of hospital beds for patients in all healthcare settings who are most vulnerable to the risk of entrapment. In April of 2003 the Workgroup published the results of its research in an article entitled, “Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities, and Home Care Settings.” The guidelines published by the Workgroup are too lengthy to discuss in detail in this short article but do set forth valuable considerations with regard to patient choice, nurse training and education, policy considerations, and specific bed rail safety guidelines. The bed rail safety guidelines recommend:

1. The bars within the bed rails should be closely spaced to prevent a patient’s head from passing through the openings and becoming entrapped. 2. The mattress to bed rail interface should prevent an individual from falling between the mattress and bed rails and possibly smothering.

3. Care should be taken that the mattress does not shrink over time or after cleaning. Such shrinkage increases the potential space between the rails and the mattress.

4. Check for compression of the mattress’ outside perimeter. Easily compressed perimeters can increase the gaps between the mattress and the bed rail.

5. Ensure that the mattress is appropriately sized for the selected bed frame, as not all beds and mattresses are interchangeable.

6. The space between the bed rails and the mattress and the headboard and the mattress should be filled either by an added firm inlay or a mattress that creates an interface with the bed rail that prevents an individual from falling between the mattress and bed rails.

7. Latches securing bed rails should be stable so that the bed rails will not fall when shaken.

8. Older bed rail designs that have tapered or winged ends are not appropriate for use with patients assessed to be at risk for entrapment.

9. Maintenance and monitoring of the bed, mattress, and accessories such as patient/caregiver assist items should be ongoing.

For information about the Hospital Bed Safety Workgroup, see the FDA’s web sight at [http://www.fda.gov/cdrh/beds/]. If you are confronted with a serious injury or death as a result of a patient’s entrapment in a bed side rail, the information contained in the FDA Safety Alert as well as the guidelines established by the Hospital Bed Safety Workgroup are essential. Consideration should be given to naming both the hospital/nursing home facility as well as the manufacturers and distributors of the side rails as defendants if a personal injury or wrongful death action is pursued. First, nurses often receive little, if any, training on the proper use of side rails. Secondly, it has been this author’s experience that facilities often “mix and match” beds, mattresses, and side rails from different manufacturers leading to poor and unsafe integration of the various parts. Finally, the manufacturers have known of the dangers posed by bed side rails since the late 1980’s or early 1990’s and have taken few steps to make the bed rails safer or warn the end user of the danger. A quick search of Lexis or Westlaw will reveal prior litigation against the manufacturers.

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