New bed-safety guidance available
The Food and Drug Administration has released new guidance aimed at reducing the number of hospital-bed injuries.Nearly 700 incidents of bed entrapments have been reported to the FDA since 1985. In these reports, 413 people died, 120 were injured, and 158 were near-miss events with no serious injury, according to the FDA.
FDA notes that it is the elderly who are at the greatest risk of entrapment. And while entrapments have occurred in a variety of patient care settings, long-term care facilities have reported the majority of entrapments, according to the FDA. Entrapment can occur when a part or parts of the body become caught between pieces of the bed, such as the mattress and the side rail.
The guidance is targeted primarily at manufacturers of hospital beds and healthcare facilities faced with the task of evaluating both beds for purchase and "legacy" beds that have been in use. The FDA guidance document identifies key body parts at risk of entrapment, describes potential entrapment areas or zones, recommends dimensional limits of gaps or openings in hospital bed systems, offers information about reporting entrapment adverse events, and provides test methods for assessing gaps or openings in hospital bed systems.
The guidance is available online at www.fda.gov/cdrh/beds/guidance/1537.pdf.