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Guide to Hospital Bed Design Issued by FDA

WASHINGTON, DC — June 9, 2006 — From 1985 through 2005, the Food and Drug Administration (FDA) received reports of 691 incidents of patients caught, entangled or trapped in hospital beds. Many of these patients were frail or elderly nursing home residents. The reports included 413 deaths, 120 nonfatal injuries, and 158 cases where the staff was able to intervene just in time to prevent injuries.

“While these numbers appear small, we believe they are signals about significant adverse events. Often, adverse events such as these go unreported to the FDA, making it likely our counts of these tragic adverse incidents are lower than the number that actually occurs,” said Larry Kessler of the FDA’s Office of Science and Engineering Laboratories (FDA News, March 9, 2006).

In response to the figures about hospital bed incidents, the FDA published a guide entitled “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.” The guide covers manual and hydraulic adjustable beds, wheeled stretchers, and patient transfer devices. It identifies hospital bed problems, provides design recommendations for bed manufacturers, and includes suggestions to help nursing home and hospital staff who work with patients in hospital beds.

How Patients Become Entrapped in Bed Rails

Bed rail design has been a problem for some nursing homes and hospitals. A patient’s head, neck or chest can get caught within the rail, under the rail, between the rail and mattress, between the rail and the bed head, or between the rail and foot board. Many beds currently in use may no longer have the original mattress/bed rail combination, and may present an entrapment hazard because of gaps between various components of the bed system. The guide recommends that nursing homes and hospitals check with bed system manufacturers to identify compatible mattresses, rails, and accessories.

Nursing home residents who are confused, in acute pain, or with uncontrolled body movements or urinary problems may try to exit a bed during the night. If the patient tries to climb over or through the bed rail, he or she may fall or become caught in the rail. The failure of nursing home staff to toilet a disabled patient in a timely manner may contribute to the problem.

Deciding When to Use Bed Rails

Bed rails may prevent nursing home residents or hospital patients who are normally able to get out of bed from performing routine activities such as getting something from a closet or table. They can make patients feel isolated. When bed rails are used as a restraint, they may actually encourage agitated behavior.

Bed rails should not be used automatically, according to a clinical guidance document written by the Hospital Bed Safety Group (HBSG), an organization composed of the FDA, patient advocacy groups, the medical bed industry and several federal agencies. Instead, the patient’s individual health and history must be considered. A nursing home should inspect, maintain and upgrade equipment such as beds, mattresses, and bed rails and match the equipment to patient needs.

Most nursing home residents can be in bed safely without bed rails, according to the HBSG (Guide to Bed Safety: Bed Rails in Hospitals, Nursing Homes and Home Health Care). The group recommends the following for these residents:

Use beds that can be raised and lowered.
Keep the bed in a low position with wheels locked.
Place mats next to the bed if the patient is at risk of falling.
Use the proper transfer or mobility aids.
Monitor patients or residents frequently.
Offer food and fluids, schedule toileting appropriately, and provide pain relief.

When bed rails are used, HBSG makes these recommendations:

Lower one or more sections of the bed rail.
Use a proper size mattress.
Reduce the gaps between mattress and side rails.

Learning More About Bed Safety

The full text of the HBSG clinical guidance document about bed rails can be found on the web site of Untie the Elderly, a group dedicated to eliminating the use of physical restraints in nursing homes. You will need to obtain a copy of Adobe Acrobat Reader to open this file. If you do not already have this software, you may download a free copy at the Adobe Acrobat web site.

If you have questions about the legal rights of an elderly loved one in a nursing home or hospital, please feel free to contact us at Brayton Purcell. We can review your potential case free of charge and advise you of your legal choices. Our firm is experienced in all aspects of elder abuse law, including nursing home violations, elder neglect, negligence, and pain management issues.

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