Unauthorized soft-shelled hyperbaric chambers may pose serious health risks

Ottawa – Health Canada is advising Canadians that soft-shelled hyperbaric chambers that are promoted online or offered as a service to treat a variety of medical conditions—including autism, cerebral palsy and migraines—are unauthorized medical devices and may pose serious health risks, including death.

Oxygen therapy using hard-shelled hyperbaric chambers is a well-established medical treatment where patients are placed in an oxygen-rich and pressurized environment. While Health Canada has licensed five hard-shelled hyperbaric chambers for sale in Canada, it has not licensed any soft-shelled devices, meaning they have not been evaluated for safety, quality and effectiveness.

To date, Health Canada has not received any evidence supporting the benefits of the soft-shelled version of these devices, and manufacturers have not demonstrated that the soft-shelled models are effective for treating any medical conditions.

Potential risks associated with the use of soft-shelled hyperbaric chambers include:

• fire or explosion as a result of static discharge within an elevated oxygen environment;
• disease spread through cross-contamination between users;
• damage to the ears, eyes, sinuses, lungs and teeth; and
• changes to blood sugar levels.

The risk of fire is significantly increased when the device is used in combination with an oxygen concentration device.

Under the Medical Devices Regulations, it is illegal in Canada to advertise medical devices for sale, to import them for sale, or to sell them without appropriate licensing.

To learn more, visit Health Canada’s Hyperbaric Oxygen Therapy webpage.