Cryotherapy

Learn about the risks of cryotherapy and what Canada is doing to protect your health and safety.

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What is cryotherapy?

Cryotherapy involves exposing a person's whole body to cold air for 2 to 4 minutes. The cold air used during cryotherapy has been cooled either electrically or through liquid nitrogen and is usually below -85°C.

This is a service typically provided by spas and clinics, and is done using:

  • cryocabins
  • cryotherapy chambers
  • cryosaunas (also known as a cold sauna)

Manufacturers of these devices and the spas where they're used may make claims that cryotherapy:

  • reduces cellulite and wrinkles
  • controls pain and swelling (inflammation)
  • improves blood circulation and metabolism
  • treats fibromyalgia and other immune disorders

These claims haven't been proven. However, because of the health claims made, an instrument used for cryotherapy would be considered a medical device. 

What's a medical device?

Medical devices are regulated by the:

  • Food and Drugs Act
  • Medical Devices Regulations

They're defined as any health or medical instrument used for disease or condition:

  • control
  • diagnosis
  • treatment
  • prevention

The Medical Devices Regulations classify devices used on people into categories of risk. They range from class I, which represents the lowest risk, to class IV, which represents the highest risk.

To sell or import class II, III or IV devices in Canada, the manufacturer must get a medical device licence. Before being authorized for sale in Canada, these medical devices must meet regulatory requirements for:

  • safety
  • quality
  • effectiveness

If licensed, a cryotherapy instrument would be a class III device because it exposes a person to extremely cold temperatures. This may cause severe health effects. 

In the past, unlicensed cryotherapy instruments have been sold to clinics in Canada.

Regardless of licensing, the use of this type of device can put your health and safety at risk.

What are the risks?

The federal government does not recognize the health claims made about cryotherapy instruments. This is because no license applications have been received to date, and the science hasn't been validated.

If you use a cryotherapy instrument, you may experience:

  • cold burns from direct contact with a cold object
    • the skin layer and tissue may be affected and could result in permanent damage
  • tissue death (frostbite) from both direct and indirect contact with a cold object
    • this leads to permanent tissue or muscle damage
  • heart, blood circulation or brain problems

If the device fails, it may also lead to suffocation or the worsening of the listed risks. 

How can you minimize your risk?

Ask your health care provider about the risks of cryotherapy treatment or other medical treatments offered by businesses like spas.

You may also check if the cryotherapy instrument is licensed by searching the Medical Devices Active Licence Listing (MDALL).

If the medical device is purchased from an importer or distributor, it should have a valid medical devices establishment licence (MDEL). This information can be checked in the Medical Devices Establishment Licence Listing.

If you have any questions or concerns about a medical device, you can contact an inspector at 1-800-267-9675.

What is Canada's role in regulating medical devices?

Before a medical device is licensed for sale in Canada, the federal government assesses it.

Once the device is on the market, we verify if it's compliant by monitoring and investigating complaints.

When we identify an unlicensed medical device, we take appropriate corrective action. If necessary, we will communicate safety information about medical devices to health care professionals and the public.

Provincial and territorial regulation

The federal government regulates the importation for sale and the sale of medical devices in Canada. However, provincial and territorial governments regulate their use. The use of medical devices is considered practising medicine and is regulated at the provincial and territorial level.

Ongoing protective measures

We worked with importers to recall the unlicensed cryotherapy devices supplied to the Canadian market. We also contacted clinics that have purchased an unlicensed medical device to advise them against its further use.

The importation or sale of cryotherapy devices is banned in Canada until importers and manufacturers get the proper licensing. We will continue to inform Canadians of the risks associated with their use as necessary.

What are the shared responsibilities for health and safety?

The health and safety of Canadians is a shared responsibility between government, industry and health care professionals.

Industry

Manufacturers of medical devices are responsible for the safety, effectiveness and quality of the health products they:

  • sell
  • import
  • distribute
  • manufacture

They must comply with all Canadian regulations. Before advertising or selling any class II, III, or IV device in Canada, a manufacturer must:

  • get a device licence
  • label its products properly

Importers and distributors of medical devices must:

  • hold a valid MDEL to import and sell medical devices in Canada
  • ensure the medical device they're importing or distributing meets regulatory requirements in Canada

Health care professionals

Health care professionals have a responsibility to confirm that medical devices have been authorized for sale in Canada. This is also true of the people working in a clinic or spa.

You should report any problems related to the use of medical devices and other health products. Use the health product complaint form (FRM-0317) or call 1-800-267-9675.

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