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U.S. Department of Health and Human Services

Medical Devices

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FDA and CPSC Activities

  • The FDA and CPSC are working together with manufacturers, health care practitioners, and consumer representatives to develop voluntary consensus standards that would apply to all portable adult bed rails, whether they are regulated by the FDA or the CPSC, to assure there are no gaps in federal oversight of the safety of these products.
  • The FDA oversees bed rails used on hospital beds as part of hospital bed systems and certain transfer bars or assistive devices. This oversight applies to all bed rails used on hospital beds, even when hospital beds are used in a person’s home or other non-clinical setting, such as an assisted living facility. The FDA provides manufacturers of bed rails with guidance on the design of safe and effective hospital beds and bed rails and requires manufacturers to adhere to certain medical device regulations, such as the timely reporting to the FDA of problems associated with bedrails.
  • The FDA has worked proactively with its partners for many years to make hospital bed systems safer by providing health care providers and manufacturers with tools to identify and mitigate risks and to improve the design of hospital bed systems and their rails, including the FDA Hospital Bed website with many resources on bed rail safety. Of particular note, the FDA released the Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment on March 10, 2006. Since that time, the overall number of reports of hospital bed entrapments has generally decreased. In 2005, the FDA received 85 entrapment reports (35 deaths, 4 serious Injuries and 46 near miss events), while in 2012, the FDA received 16 entrapment reports (5 deaths, 4 Serious Injury and 7 near miss events).
  • The CPSC oversees portable bed rails not designed as part of the bed by the manufacturer, and installed on or used along the side of a bed. The CPSC’s mission is to protect the public against unreasonable risks of injuries and deaths associated with consumer products.