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.
Recommended Actions
- Implement dimensional testing program for zones 1-4 using provided test methods
- Develop comprehensive bed safety program including:
- Patient risk assessment
- Regular bed system inspection
- Staff training on entrapment risks
- Documentation procedures
- Evaluate compatibility when replacing components (mattresses, rails, etc.)
- Report entrapment events to FDA with detailed information
- Consider mitigation measures for beds that fail dimensional tests
- Regularly reassess bed systems when:
- Components show wear
- Accessories are added/removed
- Components are replaced
- Maintain records of testing and mitigation actions
- Ensure therapeutic benefits outweigh entrapment risks when using specialty surfaces
- Follow infection control procedures during testing
- 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
- Guidance applies to both new and legacy (in-use) beds
- Risk-benefit analysis recommended when implementing mitigation measures
- Mattress compressibility and compatibility should be considered
- Regular reassessment recommended when components are worn/changed
Relevant Guidances
- Design Considerations for Medical Devices Intended for Home Use
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
Related references and norms
- 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
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