Hospital Beds - Risk of Patient Entrapment

Starting date:

April 7, 2017

Posting date:

April 10, 2017

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals, General Public

Identification number:

RA-62960

• 
  Issue
• 
  Who is affected
• 
  Report health or safety concerns

Audience

Hospitals, Long-term Care Facilities, Nursing Homes

Key messages

• Incidents of patient entrapment in hospital beds, some of them leading to serious injuries or death, continue to be reported to Health Canada.
• Healthcare professionals are encouraged to perform a patient assessment to determine if the use of bed rails is appropriate for each individual patient and closely monitor patients for whom bed rails are used.
• To reduce the risk of patient entrapment in hospital beds, Health Canada is reminding healthcare professionals to:
  • Test beds for entrapment zones as per Health Canada Guidance document.¹
  • Contact the manufacturer for advice in case of non-compliance with the requirements on reducing entrapment hazards.
  • Replace bed mattresses and rails with the proper size and fit as recommended in the bed’s instructions manual.
  • Ensure all beds are routinely maintained according to the manufacturers’ instructions.

Issue

Health Canada continues to receive incidents of patient entrapment in hospital beds. Between August 2012, the date of the last Notice to Hospitals issued by Health Canada, and March 2017, 58 additional incidents of patient entrapment in hospital beds, including 11 deaths, have been reported to Health Canada.

Products affected

All hospital beds.

Background information

Bed entrapment is defined as an event involving a patient or a resident being caught, trapped or entangled in the bed rails, mattress or bed frame of a hospital bed. Several health conditions and patient characteristics have been associated with an increased risk of patient entrapment in hospital beds. These include, but are not limited to, cognitive and communication impairments, small and frail patients, agitation, pain, uncontrolled body movements and bladder and/or bowel dysfunctions.

Although limited information is available about the circumstances and factors leading to the specific cases of patient entrapment, all reported cases of death indicated the involvement of the bed rails in the entrapment. Consequently, the risk associated with the use of bed rails should be evaluated, taking into consideration the patient’s health conditions. Points to consider for the patient assessment are described below.

Bed system components have also been found to contribute to patient entrapment incidents. Notably, the mattress has been identified as a contributor to patient entrapment. The mattress is usually replaced before the bed frame, occasionally with an incorrect size or incompatible mattress which can create unsafe gaps. Old mattresses can also play a role in the entrapment risk. Over time the mattress can get compressed and can create unsafe openings or gaps. Incompatible bed rails or the design of some bed rails can also create hazardous spaces, thus increasing the risk of patient entrapment in hospital beds.

Health Canada has previously communicated on this safety issue via:

• February 2015 Hospital bed safety²
• August 2012 Notice to Hospitals³
• October 2009 Notice to Hospitals⁴
• June 2008 fact sheet entitled Bed Rails in Hospitals, Nursing Homes and Home Health Care⁵

Who is affected

Information for consumers

The use of bed rails in hospitals, nursing homes and home healthcare can help keep patients safe. However, in some situations, bed rails may also pose risks. One risk is entrapment, which involves a patient or a resident being caught, trapped or entangled in the bed rails, mattress or bed frame of a hospital bed. Bed system components have also been found to contribute to patient entrapment incidents. Notably, the mattress has been identified as a contributor to patient entrapment. The mattress is usually replaced before the bed frame, occasionally with an incorrect size or incompatible mattress which can create unsafe gaps.

Bed entrapment does not happen often, but when it does, it can result in serious injuries. In some instances, someone's head, neck or chest can get trapped. This can lead to trouble breathing and may even cause death.

In February 2015, Health Canada published an article called Hospital bed safety² to inform Canadians on the risks associated with hospital beds and to provide information on how to assess and mitigate those risks.

Bed entrapment can happen to anyone in any healthcare setting. The risk is greater for seniors, especially if they are frail, confused, restless or unable to control their body movements. The risk is also greater if the mattress does not fit the bedframe.

If you are concerned about the use of bed rails for a family member in a healthcare facility or in a private residence, talk to the healthcare team. Ask what steps they are taking to reduce risks, including the risk of bed entrapment. Health Canada recommends that high-risk patients be closely monitored when hospital beds or bed rails are used.

Information for healthcare professionals

In March 2008, Health Canada published a guidance document entitled Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards¹ to provide recommendations to assist healthcare facilities in assessing side rail latching reliability and other potential hazards including the mattress compatibility information.

Healthcare professionals are encouraged to perform a patient assessment to determine if the use of bed rails is appropriate for each individual patient and closely monitor patients for which bed rails are used. Points to consider for the patient assessment include, but are not limited to:

• Patient mental status (oriented, alert, confused, drowsy, disoriented, unconscious)
• Patient mobility status (immobile vs. complete independence)
• Patient risk of fall (previous falls, overweight, semi-conscious, partial paralysis, seizures or spasms, sedated, visual impairment, confused)
• Risk of fall injuries (older, osteoporosis, anti-coagulants, fragile skin, vascular disease, critically ill)
• Patient anxiety level upon bed rail use
• Patient medications

To reduce the risk of patient entrapment in hospital beds, Health Canada is reminding healthcare institutions to:

• Keep an inventory of all bed units with information such as the bed model, manufacturer, serial number, compatible mattress and bed rail models and last date of maintenance.
• Evaluate hospital beds to test for entrapment zones as per Health Canada’s Guidance document.¹
• Ensure all beds are routinely maintained according to the manufacturers’ instructions.
• Make sure to replace worn or broken parts, including the mattress and bed rail, with compatible ones.

Action taken by Health Canada

Health Canada continues to monitor incidents of patient entrapment in hospital beds and will take further action as deemed necessary.

Health Canada is communicating this important safety information to healthcare professionals via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect e-Notice email notification system.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of serious incident of bed entrapment or other serious or unexpected adverse incidents in patients using hospital beds or side rails should be reported to Health Canada using the Bed-related Entrapment and Fall Report Form, available on Health Canada's Web site.Forms can be sent to the address mentioned below.

Any suspected adverse incident can be reported to:

Regulatory Operations and Regions Branch

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Telephone: Regulatory Operations and Regions Branch Hotline: 1-800-267-9675

The  Health Product Complaint Form (FRM-0317) can be found on the Health Canada Web site.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

References

1. Guidance Document. Adult Hospital Beds: Patients Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards. Ottawa (ON): Health Canada; 2008 Mar 17 (accessed 2017 Mar 30).
2. Hospital bed safety. Ottawa (ON): Health Canada; 2015 Feb 20 (accessed 2017 Mar 30).
3. Hospital Beds – Risk of Patient Entrapment (Update) - Notice to Hospitals. Ottawa (ON): Health Canada; 2012 Aug 10 (accessed 2017 Mar 30).
4. Risk of Entrapment of Patients in Hospital Beds - Notice to Hospitals. Ottawa (ON): Health Canada; 2009 Oct 20 (accessed 2017 Mar 30).
5. Bed Rails In Hospitals, Nursing Homes and Home Health Care. Ottawa (ON): Health Canada; 2008 June 26 (accessed 2017 Mar 30).