Between January 1, 1985 and January 1, 2013, FDA received 901 incidents of patients caught, trapped, entangled, or strangled in hospital beds. The reports included 531 deaths, 151 nonfatal injuries, and 220 cases where staff needed to intervene to prevent injuries. Most patients were frail, elderly or confused.
The efforts of the FDA and the Hospital Bed Safety Workgroup have culminated in FDA's release of Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. This guidance provides recommendations for manufacturers of new hospital beds and for facilities with existing beds (including hospitals, nursing homes, and private residences).
Healthcare facilities developing comprehensive bed safety programs should consider:
- following the Clinical Guidance for the Assessment and Implementation of Bed Rails to assess an individual patient's needs when using a side rail; and
- consulting with the hospital bed manufacturer and their facilities’ risk managers.
The HBSW has developed a Bed Safety Entrapment Kit containing information and tools that can be used to assess the risk of entrapment in hospital beds. Additional information about the kit is also provided in the FDA Guidance.
- Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment - Guidance for Industry and FDA Staff (PDF - 978KB)
- Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities and Home Care Settings (PDF - 302KB)
- HBSW Hospital Bed Safety Entrapment Kit Ordering Instructions
- FDA and CPSC Letter to Manufacturers About Voluntary Standard Development For Adult Portable Bed Rails (PDF - 210KB)
- HBSW/FDA Frequently Asked Questions (FAQ) on Entrapment Issues
- A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment
- CMS/CDRH Letter Regarding Physical Restraint Definition