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

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

---

Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

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

Please 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:

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:

• 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, 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: