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Drugs and Health Products

Summary Safety Review - Hospital Beds - Assessing the Potential Risk of Patient Entrapment

April 10, 2017

Product

Hospital beds

Potential Safety Issue

Patient entrapment

Key Messages

  • Health Canada has closely monitored the issue of patient entrapment in hospital beds for over 20 years and has taken actions to raise awareness of the risk and to ensure safety of patients.
  • Health Canada’s recent review concluded that it is possible to improve the safety of hospital beds by increasing the awareness of the risk of patient entrapment.
  • Health Canada will work with manufacturers to help ensure that hospital beds continue to meet safety standards. Health Canada will continue to monitor the issue of patient entrapment and will publish a Health Product Risk Communication to remind healthcare professionals about the importance of this issue and to outline identified risks for entrapment and specific mitigation measures.

Overview

  • Hospital beds are used in a wide range of locations, including hospitals, long-term care facilities, nursing homes and private residences.
  • Patient entrapment is when a patient or a resident becomes caught, trapped or entangled in the bed rails, mattress or frame. Health Canada has closely monitored the issue of patient entrapment in hospital beds for over 20 years and has taken actions to raise awareness of the risk. This included an article in 2015 and a notice to hospitals, nursing homes and long-term care facilities in 2012. Several incidents have been reported in Canada over the last years and Health Canada continues to monitor this risk.

Use in Canada

  • Hospital beds are designed for hospitalized patients, long-term care facility or nursing home residents or for any individual receiving care.
  • Bed rails can be used to help a patient change positions and can reduce the risk of falling from the bed.

Safety Review Findings

  • At the time of the review, Health Canada had received 44 reports of patient entrapment in hospital beds that occurred over the last three years (from July 2013 to June 2016):
    • 13 patients were not injured,
    • 16 patients suffered injuries including cuts and bruising,
    • 1 patient was found unresponsive, but was successfully revived,
    • 6 patients died, and
    • for 8 patients, the outcome was unknown.
  • Together, the reports above involved 21 hospital bed brands from 7 different manufacturers.
  • Several health conditions and patient characteristics were associated with an increased risk of patient entrapment in hospital beds. These included impaired mental state and communication, small size and fragility, their level of agitation and pain, uncontrolled body movements, and bladder and/or bowel dysfunctions.
  • Certain parts of the hospital bed were also found to contribute to the risk of patient entrapment by allowing for unsafe openings or gaps, such as:
    • mattresses that are in poor condition or that have an incorrect size, compatibility, or position with respect to the bed frame, and
    • bed rails that are incompatible with the bed frame.

Conclusions and Actions

  • Health Canada’s review concluded that it is possible to improve the safety of hospital beds by increasing the awareness of the risk of patient entrapment.
  • Health Canada will work with manufacturers to help ensure that hospital beds meet safety standards. Health Canada will publish a Health Product Risk Communication to remind healthcare professionals about the importance of assessing each patient to determine the risks and benefits of bed rail use given the patient’s health conditions or characteristics.
  • Mattresses should also have the proper size and fit, and all beds should be maintained as recommended in the bed’s instructions manual.
  • Health Canada encourages consumers and healthcare professionals to report any incidents of patient entrapment in hospital beds by using this dedicated form.
  • Health Canada will continue to monitor safety information involving patient entrapment in hospital beds, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international safety information and what is known about the use of these devices both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.