Bed Side Rails Spanish BLUE Sheet

$12.00

* IMPORTANT NOTICE: On March 10, 2006, the FDA issued a Guidance For Industry titled Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. The guidance provides recommendations intended to reduce life-threatening entrapments associated with hospital bed systems. It characterizes the body parts at risk for entrapment, identifies the locations of hospital bed openings that are potential entrapment areas, and recommends dimensional criteria for these devices.

Not all patients are at risk for an entrapment, and not all hospital beds pose a risk of entrapment. The FDA suggests that HME facilities and other providers determine the level of risk for entrapment and take steps to mitigate the risk. Evaluating the dimensional limits of the gaps in hospital beds is one component of an overall assessment and mitigation strategy to reduce entrapment. As a result, HME and other healthcare facilities may use this guidance as part of a bed safety program to help identify entrapment risks that may exist with current hospital bed systems. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. To review the entire guidance, please go to: http://www.fda.gov/cdrh/beds/guidance/1537.html