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Health Canada-Approved Products and Medical Devices
I work at a cosmetic clinic that offers thread-lifts to clients. Can I use Polydioxanone (PDO) threads that are approved by the U.S. Food and Drug Administration (FDA), but not yet approved by Health Canada?
No, although some PDO threads are FDA-approved, this approval is not applicable in Ontario. Health Canada is responsible for the approval of medical devices and products for use in Canada through a process that monitors and evaluates their safety, effectiveness, and quality.
As noted in the Code of Conduct, nurses seek and use the best available evidence to inform their practice. Before engaging in a procedure, nurses are accountable to have the necessary knowledge, skill, and judgment and must ensure they have knowledge of the products they use and whether they are approved for use by Health Canada.
We encourage nurses and their broader health care team to review Health Canada’s Drug and health product review and approval and Medical Devices webpages. If a product or medical device is not included in the list approved by Health Canada, nurses should refrain from using it until they have consulted with Health Canada directly to determine their safety.
The use of non-approved Health Canada products and medical devices may create risks to client safety and nurses using them may be investigated for professional misconduct.
Related Links
- Health Canada’s Compliance and Enforcement Policy for Health Products (POL-0001)
- Medication practice standard
- Scope of Practice standard
