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Hospital Bed System Dimensional and Safety Requirements to Reduce Patient Entrapment

This guidance provides recommendations to reduce life-threatening entrapments associated with hospital bed systems, including bed frames, mattresses, bed side rails, head and foot boards, and accessories. It applies to hospital beds used in acute care, long-term care, and home care settings. The guidance characterizes body parts at risk for entrapment, identifies potential entrapment areas/zones, and recommends dimensional criteria for these devices.

  1. Implement dimensional testing program for zones 1-4 using provided test methods
  2. Develop comprehensive bed safety program including:
    • Patient risk assessment
    • Regular bed system inspection
    • Staff training on entrapment risks
    • Documentation procedures
  3. Evaluate compatibility when replacing components (mattresses, rails, etc.)
  4. Report entrapment events to FDA with detailed information
  5. Consider mitigation measures for beds that fail dimensional tests
  6. Regularly reassess bed systems when:
    • Components show wear
    • Accessories are added/removed
    • Components are replaced
  7. Maintain records of testing and mitigation actions
  8. Ensure therapeutic benefits outweigh entrapment risks when using specialty surfaces
  9. Follow infection control procedures during testing
  10. Train staff on proper use of measurement tools and test procedures

Key Considerations

Non-clinical testing

  • Test methods provided to measure and assess gaps in zones 1-4 of hospital bed systems
  • Dimensional limits recommended for zones 1-4 where majority of entrapments occur
  • Testing should be done with bed in flat position except where noted
  • Testing should be done without patient in bed
  • Testing should include all rail positions (fully raised, intermediate)

Human Factors

  • Population most vulnerable to entrapment: elderly patients who are frail, confused, restless or have uncontrolled body movement
  • Key body parts at risk: head (120mm), neck (60mm), chest (318mm)
  • Assessment of patient risk factors recommended as part of bed safety program

Safety

  • Seven potential zones of entrapment identified and characterized
  • Dimensional limits recommended to prevent entrapment in zones 1-4
  • Regular assessment of bed system condition recommended
  • Comprehensive bed safety program recommended

Other considerations

  • IEC 60601-2-38: Medical Electrical Equipment – Part 2-38: Particular Requirements for the Safety of Electrically-Operated Hospital Beds
  • EN 13451: Swimming Pool Equipment – Part 1: General Safety Requirements and Test Methods

Original guidance

  • Hospital Bed System Dimensional and Safety Requirements to Reduce Patient Entrapment
  • HTML / PDF
  • Issue date: 2006-03-10
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket
  • ReguVirta summary file ID: 3568d4152391b41b0e8f2af08425c072
This post is licensed under CC BY 4.0 by the author.