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FDA tells how to prevent hospital bed hazards

Patient Safety Monitor Alert, September 8, 2004

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There are seven hazardous zones in hospital bed systems that can trap patients, according to new draft guidelines designed to help hospitals and healthcare providers identify life-threatening bed entrapment risks.

The U.S. Food and Drug Administration (FDA) released the guidance, Draft Guidance for Industry and FDA Staff; Hospital Bed system Dimensional Guidance to Reduce Entrapment, on August 31.

The document identifies seven zones in hospital bed systems where there is a potential for patient entrapment and makes specific recommendations or asks for comments on dimensional limits for spaces around and between the rails and bed boards and mattress. It is the most recent in a series of steps the agency has taken over the past decade to address the ongoing problem of patient entrapment in hospital bed rails.

The FDA has received 575 reports of patient entrapment in the past 19 years, including 358 deaths, 111 injuries and 106 near misses. The entrapment most often occurred among the elderly and others who are frail, confused, handicapped and otherwise especially vulnerable. Incidents have been reported at hospitals, nursing homes and private homes.

FDA first alerted the hospital and nursing home community to this problem in 1995. Since then, its Hospital Bed Safety Work Group, comprised of representatives from the FDA, hospital bed manufacturers, healthcare organizations such as the American Nurses Association and the American Healthcare Association, consumer groups, and other government agencies, have investigated the problem, its causes, and potential solutions.

Once the guidance is final, the Hospital Bed Safety Work Group will provide detailed measurement tools and test methods that manufacturers and healthcare facilities can use to assess the risk of existing bed systems. The group will also provide healthcare facilities and homecare providers with information on how to modify systems to reduce the risk of entrapment

The FDA already offers voluntary clinical guidance for bed rail use.

The FDA received 390 reports of bed entrapment events from January 1985 to March 2000.

The FDA invites public input on the guidance. Comments are due no later than November 29.

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