Standards for Improved Fire Safety of Mattresses - Notice to Hospitals

Starting date:

April 1, 2009

Posting date:

April 2, 2009

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002073

Notice about Health Canada advisories

Notice to Hospitals

Health Canada Issued Important Safety Information on Standards For

Improved Fire Safety of Mattresses

April 1, 2009

To:

• Hospital Administrators
• Nursing Home Administrators
• Hospital Risk Managers
• Hospital Biomedical Engineering Departments
• Provincial Hospital Associations
• Canadian Healthcare Association
• Provincial Health Ministries

Please distribute to the relevant departments, and other involved professional staff and post this Notice in your institution.

Subject: Standards for Improved Fire Safety of Mattresses

In July, 2007, the United States Consumer Product Safety Commission (CPSC) implemented a new standard for open flame testing of mattresses that is mandatory for all mattresses manufactured, renovated or imported into the United States^{Footnote 1}.

The open flame test requirements of the US CPSC standard are widely regarded as an effective additional fire safety specification to make mattresses and box springs (mattress sets) safer in case of a fire. The goal of the standard is to minimize flammability when a mattress is ignited in a fire. Mattresses that meet the standard will make only a limited contribution to a fire, especially in the early stages of the fire. This will allow occupants more time to discover the fire and escape.

Underwriters' Laboratories of Canada (ULC) has published a new voluntary standard, CAN/ULC-S137, titled Standard Method of Test for Fire Growth of Mattresses (Open Flame Test)^{Footnote 2}, which is harmonized with the US CPSC standard. Some Canadian mattress manufacturers who export their products to the US are already in compliance with the US CPSC standard.

Hospital Beds

Mattresses designed expressly for hospital beds are deemed to be medical devices. There are no standards in Canada for flammability of hospital bed mattresses. However, the Medical Devices Bureau of Health Canada believes that conformance with the US CPSC standard and/or CAN/ULC-S137 will provide improved assurance of fire safety for hospital bed mattresses as well.

Recommendation

Health Canada recommends that when purchasing new mattresses, health care facilities consider those that comply with flammability standards CAN/ULC-S137 Standard method of test for fire growth of mattresses (open flame test) and/or the US CPSC Standard for the Flammability (Open Flame) of Mattress Sets.

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 or unexpected adverse incidents in patients using hospital bed mattresses and other medical devices should be reported to market authorization holder or to Health Canada at the following address:

Any suspected adverse reaction 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