Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Hospital Bed System Dimensional Guidance to Reduce Entrapment." This draft guidance provides recommendations intended to reduce life-threatening entrapments associated with hospital bed systems.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 bed systems.