The U.S. Food and Drug Administration (FDA) received approximately 691 entrapment reports from January 1985 to January 2006. Of those reports, more than 60% resulted in death. Residents have become caught, trapped, or entangled in the space in or around the bed rail, mattress, or bed frame, often resulting in serious injury and sometimes even death. Entrapment can occur when a resident attempts to move in or exit their bed without assistance as a result of delirium, confusion, agitation or pain. |
Residents most vulnerable to entrapment are those who are frail, confused, restless, or who have uncontrolled body movement.
The guidance defines a hospital bed system — which could be used for patients in acute care, long term care, or homecare settings — as “the bed frame and its components, including the mattress, bed side rails, head and foot board, and any accessories added to the bed”.
All hospital bed owners are encouraged to read the FDA guidance. Please visit the FDA’s Hospital Bed Safety page (http://www.fda.gov/cdrh/beds/), where you will find many resources, including a link to the new Guidance (http://www.fda.gov/cdrh/beds/guidance/1537.pdf); ordering instructions for a Testing Kit (http://www.fda.gov/cdrh/beds/entrapmentkit.html) which you can use to determine whether your beds are in conformance with the guidance; and a discussion of Clinical Guidance (http://www.ute.kendal.org/learning/documents/clinicalguidance_SideRails.pdf),which you can use to assess an individual patient’s needs when using a side rail. These resources will supply you with the knowledge to evaluate the safety of the hospital beds you currently own. All our beds are designed in full compliance with the FDA’s Hospital Bed System Guidance to Reduce Entrapment.