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Risk of Entrapment of Patients in Hospital Beds - Notice to Hospitals

Starting date:
October 20, 2009
Posting date:
October 20, 2009
Type of communication:
Notice to Hospitals
Subcategory:
Medical Device
Source of recall:
Health Canada
Audience:
Healthcare Professionals
Identification number:
RA-170002048

Notice about Health Canada advisories

Notice to hospitals - Health Canada Issued Important Safety Information on the Risk of Entrapment of Patients in Hospital Beds

October 20, 2009

To: Hospital Chief of Medical Staff

Pease distribute to the relevant Departments of Biomedical Engineering, Geriatrics, Internal Medicine, Nursing, Intensive Care and other involved professional staff and post this NOTICE in your institution.

Subject: Risk of Entrapment of Patients in Hospital Beds

Since 2007, Health Canada has received reports of 4 patient deaths resulting from bed entrapments. 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.

Incidents involving other beds were caused by using a mattress that was too small for the bed. This resulted in an enlarged space between the mattress and the side rails of the bed.

Most hospital beds manufactured since 2000 are in compliance with the recommendations in Health Canada's guidance document on bed safety (see below) and pose a minimal entrapment risk for patients. However, some beds still used in Canadian health facilities are not in compliance with all of the dimensional criteria recommended in the guidance document, or with other standards recognized by Health Canada such as IEC 60601-2-38, Particular Requirements for the Safety of Electrically Operated Hospital Beds. This standard includes requirements for the spacing between split side rails.

Recommendations:
In order to reduce the risk of bed-related patient entrapment at health care facilities, Health Canada recommends the following:

  • Institutions that still use Stryker FL14E1 beds or other beds manufactured prior to the year 2000 are advised to contact the manufacturer for advice on reducing entrapment hazards. Many manufacturers offer covers which fit over the gap between split side rails.  Such covers are a simple and economical option for reducing the risk of entrapment.
  • Institutions should verify that replacement mattresses are the correct size for the bed frame.

In 2008, Health Canada published a guidance document entitled "Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards" which provides recommendations for reducing life-threatening entrapments associated with hospital bed systems. The guidance document characterizes the body parts at risk for entrapment, identifies the locations of hospital bed openings that are potential entrapment areas, and recommends dimensional criteria for many bed components. It also describes test methods that health care facilities can use to assess gaps in their existing hospital bed systems.

In particular, Health Canada's guidance document identifies 7 potential zones in which entrapment incidents are most likely to occur. These zones are described and shown as follow:

Risk of Entrapment of Patients in Hospital Beds
  • Zone 1: Within the rail
  • Zone 2: Under the rail, between the rail supports or next to a single rail support
  • Zone 3: Between the rail and the mattress
  • Zone 4: Under the rail, at the ends of the rail
  • Zone 5: Between split bed rails
  • Zone 6: Between the end of the rail and the side edge of the head or foot board
  • Zone 7: Between the head or foot board and the mattress end

Reporting bed-related incidents
Health care facilities are asked to report bed or side rail entrapment incidents to Health Canada by using the Bed-related Entrapment and Fall Report Form (PDF format), available on Health Canada's Web site.

For information regarding a specific hospital bed, Health Canada recommends contacting the bed manufacturer directly.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious entrapment or other serious or unexpected adverse incidents in patients using hospital beds should be reported to the manufacturer or Health Canada at the following addresses:

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Reporting Form and Guidelines can be obtained from the Health Canada web site.

For other inquiries related to this communication, please 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

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