This medical device may cause serious health risks and even death, Health Canada warns

A person receives hyperbaric oxygen therapy.

Soft-shelled hyperbaric chambers may spread infectious diseases, suffocate users and even cause death, Health Canada warns in a new public advisory. The federal department said people should not use the devices, though the hard-shelled version has proven benefits.

Soft-shelled hyperbaric chambers are portable chambers with zippers, according to the website of the National Hyperbaric Treatment Centre in Palm Harbor, Fla. They were originally designed for divers and mountain climbers to help with fatigue and other health issues related to their activities, the centre stated.

However, the soft-shelled version of the medical devices is increasingly popping up in wellness centres and may be advertised as treatment for various medical conditions, such as migraines, autism and cerebral palsy, Health Canada said.

“These devices are unlicensed, may be ineffective for the purposes for which they are advertised and may pose serious health risks for users and those in close proximity, including death,” according to Health Canada in the notice published Tuesday.

Soft-shelled hyperbaric chambers may catch fire, especially when used with an oxygen concentration device, the federal agency added. Health Canada said the devices may also damage ears, eyes, sinuses, lungs and teeth, and change blood sugar levels.

Health Canada said it is following up on several complaints related to the use of the device, noting it “will take compliance and enforcement actions, as needed.”

CTVNews.ca asked Health Canada on Wednesday whether there are any reported injuries or deaths as a result of using these devices and will update the story upon receiving a response.

Advice for consumers

Health Canada advises those who have used the device and have concerns about their health to consult a health-care practitioner.

The federal department said people should only use licensed medical devices and check whether they are authorized for sale on its website.

Individuals are advised to report complaints related to the devices to Health Canada.

‘Illegal to import, sell and advertise’

The medical devices are regulated under the Food and Drugs Act and Medical Devices Regulations, according to the federal agency. But Health Canada stated that they are not authorized for sale in the country so far due to the lack of evidence showing that they meet the federal agency’s safety, effectiveness or quality requirements.

“As a result, it is illegal to import, sell and advertise soft-shelled hyperbaric chambers in Canada,” according to Health Canada.

Difference with hard-shell hyperbaric chambers

While soft-shelled hyperbaric chambers pose concerns, it’s a different case with the hard-shell version of the devices. Oxygen therapy using hard-shell hyperbaric chambers is a “well-established medical treatment” in which patients are placed in an “oxygen-rich and pressurized environment,” according to Health Canada. Hard-shell hyperbaric chambers are proven to treat 14 conditions, it added.

Health Canada previously issued alerts about the “serious health risks” of soft-shelled hyperbaric chambers that were sold online or offered as a service in October 2019 and November 2020.