Notice - Infrared Thermometers

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May 21, 2009

Notice

Our file number: 09-112852-354

Subject: Infrared Thermometers

Application

This notice affects:

• manufacturers of infrared thermometers

Definitions

As defined in the Medical Devices Regulations:

"manufacturer" means a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.

Context

Infrared thermometers are classified as Class II medical devices in Canada. Through the review of recent scientific literature and adverse event reports, it has come to Health Canada's attention that these devices may provide inaccurate temperature readings. There have been 2 events reported in Canada, and 7 incidents reported in the United States where infrared thermometers have provided inaccurate readings.

To minimize the chance of inaccurate readings, Health Canada is requiring that under Section 21 to 23 of the Medical Devices Regulations that the following information be contained in the labelling as part of the directions for use for all infrared thermometers. Effective the date of this notice, manufacturers must include the following as part of their labelling:

• instructions on the cleaning of the probe
• instructions on how to position the probe during reading; special attention should be taken on how to position the ear thermometer
• a notice that infrared thermometers should not be used shortly after exercise, bathing or coming indoors
• a notice that infrared thermometers should not be used on children under 2 years of age. For older children infrared thermometers should not be used to manage important health concerns
• a notice that parents should not rely only on temperature readings; if they have concerns they should seek medical advice

A transition period will be granted until May 1, 2010 to allow manufacturers time to meet these labelling requirements.

Additional Information

For questions or additional information please contact:

Device Licensing Services Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Room 1605 Main Building
150 Tunney's Pasture Driveway
Address Locator 0301H1
Ottawa, Ontario
K1A 0K9

Telephone: 613-957-7285
Fax: 613-957-6345
Email: device_licensing@hc-sc.gc.ca