Long-Term Care Survey Alert

Published on Fri Aug 27, 2010 PDF

FDA specifies these measurements for 4 of the zones.

The seven areas in the bed system where there is a potential for entrapment are identified in the drawing below.

Zone 1: Within the Rail

Zone 2: Under the Rail, Between the Rail Supports or Next to a Single Rail Support

Zone 3: Between the Rail and the Mattress

Zone 4: Under the Rail, at the Ends of the Rail

Zone 5: Between Split Bed Rails

Zone 6: Between the End of the Rail and the Side Edge of the Head or Foot Board

Zone 7: Between the Head or Foot Board and the Mattress End

Note: The above picture and exact verbiage appears on page 13 of "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment" at www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072729.pdf. On page 21, the FDA lists recommended dimensional limits for zone 1 through 4 (the zones involved in the majority of the entrapments reported to the FDA). These are as follows:

Zone 1: Within the rail

<120 mm (< 4 3/4 inches)

Zone 2: Under the rail, between rail supports or next to a single rail support

< 120 mm (< 4 3/4 inches)

Zone 3: Between rail and mattress

<120 mm (< 4 3/4 inches)

Zone 4: Under the rail, at the ends of the rail

<60 mm (< 2 3/8 inches) AND >60° angle

Additional resource: For a helpful set of FAQs related to bedrail safety, go to http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/HospitalBeds/ucm123467.htm.