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.
What You Need to Know? 👇
What are the key dimensional limits for hospital bed entrapment zones?
FDA recommends specific dimensional limits for four critical entrapment zones: Zone 1 (within rail) and Zones 2-3 (under/between rail and mattress) should have openings less than 120mm (4¾ inches) to prevent head entrapment. Zone 4 (under rail ends) requires gaps less than 60mm (2⅜ inches) with angles greater than 60 degrees to prevent neck entrapment.
How should legacy hospital beds be assessed for entrapment risks?
Legacy beds should undergo comprehensive dimensional testing using HBSW-validated test methods with cone and cylinder tools. Healthcare facilities should conduct risk-benefit analyses, check manufacturer compatibility for mattresses and rails, and implement bed safety programs that include patient assessment, regular reassessment when components change, and mitigation strategies for identified risks.
What body parts are most at risk for hospital bed entrapment?
The three key body parts at highest risk are the head (120mm/4¾ inches breadth), neck (60mm/2⅜ inches diameter), and chest (318mm/12½ inches depth). These dimensions, based on international anthropometric data for vulnerable populations, form the basis for FDA’s dimensional limit recommendations to prevent life-threatening entrapments.
Which hospital bed types are excluded from these dimensional guidelines?
Total exclusions include air fluidized therapy beds, bariatric beds, pediatric beds, infant cribs, and examination tables. Partial exclusions apply to kinetic treatment tables, LDRP specialty beds, and pressure reduction therapeutic products due to special design requirements or technical measurement difficulties with highly compressible surfaces.
What information should be included when reporting entrapment adverse events?
Reports should specify the exact entrapment zone location, entrapped body part and size, rail positions and types, bed deck articulation, mattress specifications, rail height from mattress top, and gap measurements. Complete descriptive reports help FDA monitor hospital bed safety and identify contributing factors to entrapment events.
How do articulated bed positions affect entrapment risk assessment?
Current dimensional recommendations apply to beds in flat position with rails fully raised, except where noted. FDA recognizes that articulation creates complex geometries affecting entrapment risk. For Zone 2 testing specifically, beds should be positioned where the largest gap occurs during articulation, while patient assessment procedures are recommended for clinical care in articulated positions.
What You Need to Do 👇
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