Notice - Classification Advisory and Labelling Recommendations to Promote the Safe Use of Denture Cleansers

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Contact: Device Licensing

December 22, 2009
Our file number: 09-137011-337

Notice

To: Manufacturers, importers and distributors of denture cleansers

Subject: Classification Advisory and Labelling recommendations to promote the safe use of denture cleansers

All denture cleansers are considered to be accessories to medical devices and are classified as Class I medical devices.

Persulfates, which are known allergens, are one of the most commonly used ingredients in denture cleansers. There have been reports of allergic reactions as well as severe adverse effects resulting from the misuse of denture cleansers containing persulfates.

All medical devices must have a label which provides the information specified in Section 21(1), (a) to (j) of the Medical Devices Regulations. Specifically, Section 21(1)(i) requires the directions for use, unless directions for use are not required for the device to be used safely and effectively.

As defined in the Medical Devices Regulations:
"directions for use", in respect of a medical device, means full information as to the procedures recommended for achieving the optimum performance of the device, and includes cautions, warnings, contra-indications and possible adverse effects.

This is the information supplied to the lay person and/or the health care professional enabling these persons to use the device without causing unnecessary harm to themselves or another person and to achieve the desired result. The directions for use should be written at a level commensurate with the training of the expected users.

Health Canada recommends that all manufacturers, importers and distributors of denture cleansers include cautionary information on their label indicating that the product contains persulfates. Health Canada also recommends improving the directions for use in order to reduce misuse. These actions should minimize the risk of adverse effects.

It is suggested that the following be included on the product labelling:

• identification of the product ingredients;
• if the product contains persulfate, the label should indicate that the product may cause allergic reactions and/or serious burns if misused;
• cautionary statements to the effect that the product is for “external use only”, “do not drink solution”, “not for natural teeth or in-mouth use” and “rinse thoroughly under running water for one minute before inserting denture into mouth” should also be included (inclusion of diagrams would be appropriate); and
• the label should contain instructions for what actions to take if the product is accidently consumed for example First Aid instructions, for example:“If accidently swallowed, do not induce vomiting. Seek medical advice immediately.”

Reporting Adverse Effects Related to Denture Cleansers

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 consumers using denture cleansers should be reported to the manufacturer or Health Canada at the following addresses:

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: 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
Facsimile: 613-952-7738

Additional Information

References

1. For additional guidance and examples on labelling, please refer to the Guidance for the Labelling of Medical Devices under Section 21 to 23 of the Medical Devices Regulations.