FDA has received approximately 691 entrapment reports over a period of 21 years from January 1, 1985 to January 1, 2006 . In these reports, 413 people died, 120 were injured, and 158 were near-miss events with no serious injury as a result of intervention. These entrapment events have occurred in openings within the bed rails, between the bed rails and mattresses, under bed rails, between split rails, and between the bed rails and the head or food boards. Elderly patients in hospitals and nursing homes, especially those who are frail, confused, restless, or who have uncontrollable body movement, are most vulnerable to entrapment. Entrapments have occurred in a variety of patient care settings, including hospitals, nursing homes, and private homes. Long-term care facilities reported the majority of the entrapments.

"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 is lower than the number that actually occurs," said Dr. Kessler.


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/.

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