FDA Issues Guidance on Hospital Bed Design to Reduce Patient Entrapment

FDA Issues Guide on Hospital Bed Design to Reduce Patient Entrapment

March 15, 2006

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The U.S. Food and Drug Administration (FDA) published final guidance designed to reduce the occurrence of hospital bed entrapments, which can cause injury and death. Entrapment occurs when part of a patient's body becomes caught between parts of the bed.

The guidance - Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment - identifies special issues associated with hospital bed systems, provides design recommendations for manufacturers of new hospital beds and offers suggestions for health care facilities on ways to assess existing beds.

The guidance also:

Identifies body parts at risk for entrapment.
Identifies the locations of hospital bed openings that are potential entrapment areas.
Recommends dimensional criteria for new hospital bed systems.
Provides information about reporting entrapment adverse events.
Describes recommended test methods for assessing gaps in hospital bed systems.

The final guidance, Guidance for Industry and FDA Staff; Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment, is available on FDA's website at http://www.fda.gov/cdrh/beds/.

Source: U.S. Food and Drug Administration (FDA).