Medical Devices

Hospital Beds

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.

Contact FDA

1 (800) 638-2041
(301) 796-7100
Information-Medical Devices / Radiation Products

Division of Industry and Consumer Education

CDRH-Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Page Last Updated: 05/10/2016
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