FDA ISSUES GUIDANCE ON HOSPITAL BED SYSTEM DANGERS
The FDA has issued a guidance to reduce potential injury associated with the hospital bed system.
Entrapment can occur when part of a patient's body becomes caught between parts of the bed, such as in the space between the mattress and the side rail, the guidance said. It identifies key parts of the body at risk for entrapment, describes potential entrapment areas or zones and recommends the maximum and minimum dimensional limits of gaps or openings in hospital bed systems.
The guidance also encourages manufacturers to use the guidance when designing new beds to help ensure compliance with FDA regulations.
The FDA received approximately 691 entrapment reports over a period of 21 years, from Jan. 1, 1985 to Jan. 1, 2006, the guidance states. 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 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 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.
For more information visit http://www.fda.gov/cdrh/beds/ (http://www.fda.gov/cdrh/beds/). ()a href="http://www.fdanews.com/ddl" target=_blank>