Template for Notice to Hospitals - Medical Device

Revised Date: Revised Date: 2012-07-27

Also available in French: Modèle d'avis aux hôpitaux - Instrument médical

Notice to Hospitals - Health Canada Endorsed Important Safety Information on [Medical Device]

[Sponsor logo]

[Date (mm/dd/yyyy)]

[Version Number]

[Salutation]

[Insert the following text: Please distribute to relevant Departments [Surgery, Emergency Medicine, Pharmacy, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Dentistry, Intensive Care and/or other Departments as required], and other involved professional staff and post this notice in your institution.]

Subject: Association of [insert Name of Medical Device] with [insert specific adverse incident]

[Paragraph 1 - Description of health risk]

• [Key message 1 - Describe the health risk]
• [Key message 2 - State what health professionals can do about the health risk]
• [Key message 3 - Provide any other important information]
• [Key message 4 - Optional]

[Paragraph(s) including additional detailed instructions on how to use the new safety or therapeutic effectiveness information]

[Paragraph(s) describing risk management measures]

[Paragraph including adverse incident reporting instructions. The following statement should be included:]

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-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious [specific adverse incident] or other serious or unexpected adverse incidents for medical devices in patients using [brand name] should be reported to [name of sponsor] or Health Canada at the following addresses:

[Name and address of sponsor in Canada]

To correct your mailing address or fax number, contact [name of sponsor].

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: 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, contact Health Canada at:

Lead Directorate

E-mail: (Generic email address)

Telephone:

Fax:

<Closing>

Original signed by

<Name>

References:

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