Medical Devices
Hospital Beds
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:
- 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.