Guidance for Industry and Food and Drug Administration; Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment." This 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, recommends dimensional criteria for bed systems, provides information about legacy beds including information to include when reporting entrapment adverse events, and provides the Hospital Bed Safety Workgroup (HBSW) test methods for assessing gaps.