In a notice to hospitals issued Monday, Health Canada said 12 incidents have been reported of patients becoming trapped in hospital beds since 2009, including three deaths. Four similar deaths were reported between 2007 and 2009.
The notice said unprotected side rails and unfitted mattresses are the main hazards for patients, while beds made prior to the year 2000 are identified as being particularly problematic.
Health Canada said in one incident, a patient became trapped in the opening between the split side rails of a Stryker Model FL14E1 long-term care electric bed, which is no longer manufactured but is still in use.
In an email to The Canadian Press, the agency identified specific injuries that ranged from a dislocated shoulder to less serious injuries such as cuts requiring stitches.
Eight out of the 12 cases of injuries and deaths since 2009 have occurred in nursing homes or long-term care facilities, while three incidents happened in hospitals and one at home.
Health Canada also said that between 1980 and 2008 it received 67 reports of life-threatening bed entrapments, 36 of which led to death.
"Bed rails can provide important safety advantages for patients. However, ongoing patient evaluation and monitoring are very important for minimizing the risk of patient entrapment," a spokeswoman for the agency said.
"Healthcare professionals and caregivers are reminded to monitor the patient on an ongoing basis and closely monitor high-risk patients."
The agency said the risk of bed entrapment has been recognized for several years and a number of risk mitigation measures have been put in place in Canada as well as internationally, but provided no specifics.
Health Canada added that a previous notice aimed at hospitals in 2009 "substantially reduced" the number of incidents and that most reports received since 2009 have occurred in nursing homes.
"Health Canada has targeted the Notice issued today to these institutions, to further increase awareness among these facilities and prevent future incidents," the agency said.
The agency added that the responsibility for these incidents lies with the companies that manufacture and sell these products to provide proper labelling and appropriate measures if potential safety risks are identified and the institutions that make use of these beds in their facilities to ensure proper use and maintenance.
Despite this, they said Health Canada oversees the regulation of health products in Canada, which includes medical devices such as hospital beds.
"When Health Canada identifies a potential safety concern, Health Canada will take appropriate action. This includes communicating safety information to Canadians as necessary," the agency said.
The agency advises health-care facilities that still use beds made before 2000 to contact manufacturers for advice on reducing entrapment hazards, while beds used in a homecare setting should be carefully selected with a health-care professional.
Other measures include using covers to fit over the gaps between rails, ensuring that replacement mattresses are the correct size for the bed frame, reducing the gaps between mattresses and side rails and reporting incidents to Health Canada using the bed-related entrapment and fall report form on their website.Suggest a correction