Reducing risk of entrapment in hospital beds

The FDA has published final guidance to reduce the risk of patients becoming entrapped in hospital beds. Entrapment can occur when part of a person's body gets caught between parts of the bed, such as in the space between the mattress and the side rail. This hazard can cause strangulation and death. Older people in hospitals and nursing homes, especially those who are frail, confused, restless, or who have uncontrollable body movement, are most vulnerable to entrapment.

The guidance provides design recommendations for manufacturers of new hospital beds. It also gives suggestions to facilities with existing beds, including hospitals, nursing homes, and private residences, on ways to reduce entrapment risk.

Key body parts at risk of entrapment are the head, neck, and chest. Potential zones of entrapment in a hospital bed are

* Zone 1: Within the rail

* Zone 2: Under the rail, between the rail supports, or next to a single rail support

* Zone 3: Between the rail and the mattress

* Zone 4: Between the rail, at the ends of the rail

* Zone 5: Between split bed rails

* Zone 6: Between the end of the rail and the side edge of the headboard or footboard

* Zone 7: Between the headboard or footboard and the mattress end.

"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," says Larry Kessler, Sc.D., director of the Office of Science and Engineering Laboratories within the FDA's Center for Devices and Radiological Health. The guidance will also help caregivers identify entrapment risks that may exist with current hospital beds, adds Kessler.

The guidance results from the efforts of the Hospital Bed Safety Workgroup (HBSW). Formed in 1999, the HBSW is a partnership among the FDA, the Veterans Administration, other federal agencies, Health Canada's Medical Devices Bureau, national health care organizations and provider groups, patient advocacy groups, and medical bed and equipment manufacturers.

The FDA has received 691 reports of entrapment over a period of 21 years, from Jan. 1, 1985, to Jan. 1,2006. The reports included 413 deaths, 120 nonfatal injuries, and 158 near-miss events where staff intervened to prevent serious injury.

See www.fda.qov/cdrh/beds/for more information.