FDA Issues Guidance on Hospital Bed Design to Reduce Patient Entrapment

The Food and Drug Administration (FDA) this week published draft guidance for hospital bed manufacturers designed to reduce the occurrence of patient entrapment.

Manufacturers may use this guidance to assess current hospital beds and assist in the design of new beds. The guidance may also be used by healthcare facilities and homecare providers to identify entrapment risks.

The draft guidance is the most recent in a series of steps the agency has taken over the past decade to address the ongoing problem of patient entrapment in hospital bed rails.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 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.

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.

The FDA first alerted the hospital and nursing home community to this problem in 1995. Since then the 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 such as the AARP, and other government agencies have worked together to investigate the problem, identify its causes, and find solutions.

The draft guidance, "Draft Guidance for Industry and FDA Staff; Hospital Bed system Dimensional Guidance to Reduce Entrapment," is available on FDA's Web site at www.fda.gov/cdrh/beds. FDA is seeking industry, health professional and patient advocate comments on the draft before publishing a final document.

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.

Source: FDA