Health Canada
www.hc-sc.gc.ca
Common menu bar links
Important Safety Information on the Use of Waist and Torso Patient Restraints - 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.
(PDF Version - 16 K)Contact MDB Enquiries
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.
March 16, 2007
To: Hospital Chief of Medical Staff, Nursing Homes
Please distribute to Departments of Geriatrics, Nursing, and/or other Departments as required and other involved professional staff and post this NOTICE in your institution.
Subject: Risk of fatal asphyxiations resulting from the use of waist or torso patient restraints
There have been several reports in Europe of fatal asphyxiations involving waist-fixating physical restraints. The European incidents happened predominantly when patients tried to leave the bed. The waist-fixating belt would then slide up over the patient's chest, which led to fatal asphyxiations by compression of the thorax. Some incidents occurred when patients slipped into the gap between split side rails. In most of the incidents, the side straps were not being used and the side rails of the bed were not in the raised position.
Following a review of the information provided by manufacturers and distributors selling waist restraints in Canada, and the incidents in Europe, Health Canada is making several recommendations on the use of waist restraints to prevent the occurrence of such incidents.
Recommendations for the use of waist and torso patient restraints:
- Perform a thorough assessment of the patient to determine the degree of restraint, the type of restraint and the appropriate level of patient monitoring needed. Many health care centres have a 'least restraint' policy that requires care givers to use the least restrictive option consistent with the patient's safety and comfort.
- Keep the side rails of the bed raised at all times when restraints are being used.
- Ensure that any gaps between split bed rails are blocked with a solid gap barrier that effectively prevents the patient from sliding through when restraints are being used.
- Ensure that the waist belt cannot slide up over the patient's chest. For those patients deemed at risk, consider using side straps or other accessories to limit patient movement from side to side and to limit "helicoptering" (i.e turning in bed head to toe).
- Ensure that the straps for the waist restraint are attached to the bed frame and not the side rails, and ensure that the part of the bed frame they are attached to moves with the patient as the bed height and articulation are adjusted. Otherwise, tightening or loosening of the restraint may occur as the bed's position is adjusted.
In response to the European incidents, one manufacturer, Segufix Systems Ltd., is recalling two models of its bed restraints - the Standard 2201 M and the Simplex 2200 M - and offering to modify them by permanently attaching lateral straps. This recall is still under way in Canada.
Another manufacturer, Pinel Medical, is also conducting a recall by modifying its instructions for use and is recommending that users use the side straps to ensure the patient remains centered on the bed.
Users of other waist restraints are advised to review the instructions for use or contact the supplier for further guidance if required.
Health Canada depends on health care professionals to report adverse incidents related to medical devices. Any serious or unexpected adverse incident related to medical devices should be reported to Health Canada at the following address:
Any suspected adverse incident can be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
The Medical Devices Problem Report Form and Guidelines can be obtained from the Health Canada web site.
For other inquiries related to this communication, please contact Health Canada at:
Medical Devices Bureau Enquiries
Email: mdb_enquiries@hc-sc.gc.ca
Tel: (613) 957-4786
Fax: (613) 957-7318
