The Hospital Bed Safety Workgroup (HBSW) is a partnership among FDA, the medical bed industry, national health care organizations, patient advocacy groups, and other federal agencies (Centers for Medicare & Medicaid Services, Consumer Product Safety Commission, and the Veterans Administration). Its goal is to reduce the risk of side rail entrapment in hospital beds.
Between January 1, 1985 and January 1, 2008, FDA received 772 incidents of patients caught, trapped, entangled, or strangled in hospital beds. The reports included 460 deaths, 136 nonfatal injuries, and 176 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:
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.
HBSW/FDA Frequently Asked Questions (FAQ) on Entrapment Issues |
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A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment (Issued June 21, 2006) |
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| Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment - Guidance for Industry and FDA Staff (Issued March 10, 2006) | |
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| Press Release: FDA Issues Guidance on Hospital Bed Design to Reduce Patient Entrapment (Issued March 9, 2006) | |
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| HBSW Bed Safety Entrapment Kit Ordering Instructions (Issued March 9, 2006) | |
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Clinical Guidance for the Assessment and Implementation of
Bed Rails in Hospitals, Long Term Care Facilities and Home Care Settings |
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| Brochure: A Guide to Bed Safety; Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts | |
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| Bed Rail - Related Entrapment Deaths, Sentinel Event Alert, Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) Sentinel Event Alert, September 6, 2002 | |
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| Entrapment Hazards with Hospital Bed Side Rails, Food and Drug Administration Safety Alert, 1995 | |
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| CMS/FDA Letter regarding Physical Restraint Definition | |
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Updated April 21, 2008
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