By Christina Orlovsky, senior staff writer
In a hospital environment risks abound—from the surgical suite to the bedside. In an effort to reduce any risks associated with the hospital bed, the United States Food and Drug Administration (FDA) published recommendations this spring to prevent potential strangulation and death from hospital bed entrapments.
The Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment resulted from years of research conducted by the Hospital Bed Safety Network, a partnership between the FDA and the Veterans Administration, Health Canada’s Medical Devices Bureau, Centers for Medicare and Medicaid Services, the Joint Commission on the Accreditation of Healthcare Organizations and numerous members of the hospital bed and medical device industries, patient advocacy groups and other health care organizations.
Central to the research were statistics that demonstrated the need for recommendations. In the decade between 1985 and 2006, the FDA received 691 incidents of patients caught, trapped, entangled or strangled in hospital beds, resulting in 413 deaths, 120 nonfatal injuries and 158 cases where staff needed to intervene to prevent injuries, according to the organization.
According to a statement from the FDA, these entrapments occurred in openings within bed rails, between bed rails and mattresses, under bed rails, between split rails and between the rails and the headboard or footboard. Because most patients who suffer hospital bed entrapment injuries are elderly, confused and frail, the majority of entrapments occurred in long-term facilities, although patients in other health care facilities are also at risk.
Among the information in the FDA’s guidance are identifications of the risk areas and the body parts at risk (head, neck and chest); dimension recommendations for new hospital bed systems (the gap between the bed and bed rail should be four inches); and risk assessment guidelines for nurses.
Guidance is also given to determine if the patient’s need for bed rails outweighs the risks, and recommendations are offered for monitoring the safety of patients when bed rails are indeed required. These recommendations include: lowering one or more sections of the bed rail, such as the foot rail; using a proper size mattress or mattresses with raised foam edges to prevent patients from slipping between the mattress and the rails; and reducing gaps between the mattress and side rails.
“This guidance will assist individuals, families and health care facilities in making better informed decisions to ensure a safe sleeping environment for people who need these beds,” explained Larry Kessler, Sc.D., a director at the Office of Science and Engineering Laboratories at the FDA’s Center for Devices and Radiological Health.
“While not all patients are at risk for an entrapment, and not all hospital beds pose a risk of entrapment, this new guidance will help ensure that new hospital beds are designed to reduce the potential for entrapment and that entrapment risks that may exist with current hospital bed systems are identified,” he added. “The dimensional assessment described in this guidance may be used as part of a manufacturer’s or facility’s comprehensive bed safety program.”
For more information or to read the full guidance, visit the FDA Web site.
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