Elder Law FAX -- March 27, 2006

FDA Issues Guidance on Hospital Bed Design to Reduce Patient Entrapment
A Richmond, Virginia, skilled nursing facility was cleared of charges that a patient was not asphyxiated because his head was entangled in the bed rail. Instead, the patient's death was determined to be more likely the result of asphyxia caused by compression of the chest cavity compounded by a heart condition. Testing of the bed showed that the rail and the older mattress in use met safety requirements.

According to the ruling by the Appeals Board of the U. S. Department of Health and Human Services, the Richmond Health and Rehabilitation Complex-Kenwood provided residents with an accident-free environment in compliance with Medicare regulations, and no enforcement penalty should be imposed due to the death of the patient.

Every year the U. S. Food and Drug Administration receives dozens of incidents of patients being caught, trapped, entangled, or strangled in hospital beds.

Between January 1, 1985, and January 1, 2006, the reports included 413 deaths, 120 nonfatal injuries, and 158 cases where staff needed to intervene to prevent injuries. 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 such as nursing homes reported the majority of the entrapments.

To help prevent these injuries, the FDA has released "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment." This guidance provides recommendations for manufacturers of new hospital beds and for facilities with existing beds (including hospitals, nursing homes, and private residences).

The guidance characterizes the 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, and includes a description of recommended test methods for assessing gaps in hospital bed systems.

Key body parts at risk of entrapment are the head, neck, and chest.

Potential zones of entrapment in a hospital bed system 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 head or foot board
* Zone 7 : Between the head or foot board and the mattress end

"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," said Larry Kessler, Sc.D., Director, Office of Science and Engineering Laboratories, 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. The dimensional assessment described in this guidance may be used as part of a manufacturer's or facility's comprehensive bed safety program," said 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 Web site at: http://www.fda.gov/cdrh/beds/.

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