Practitioners Must Only Use Authorized Medical Devices

A Health Canada consumer advisory about the safety of an unauthorized device should also serve as a warning to aesthetics practitioners. Be careful. Be safe.

Never purchase or use any medical device that hasn’t been approved by Health Canada.

First and foremost, it’s about patient safety. That must be our top priority as medical professionals

It’s also about liability. A practitioner risks serious legal and career repercussion in the event of a botched treatment with an unapproved medical device. An insurance company might not cover the legal costs of a lawsuit. Culpable practitioners could also be reported and lose their license.

If you are wondering if a laser, derma filler or any other medical device used in cosmetic treatments has been approved for particular treatments, do some research to make absolutely sure. Before it’s too late.

Health Canada issued the warning about the potential negative effects of a type of cosmetic device called a plasma pen.N

Health Canada is advising consumers that plasma pens (also known as ‘fibroblast’ devices), promoted for cosmetic skin treatments such as eyelid lifts, wrinkle reduction and removal of moles, skin tags, scars and spots, may pose health risks.

Plasma pens are small hand-held medical devices that focus electricity on the skin and cause a controlled burn that spreads heat throughout the targeted area.


Marketed for eyelid lifts and wrinkle reduction, plasma pens are not approved for sale in Canada.

Even when used properly, Health Canada said the plasma pen can cause pain, redness or swelling in the treated area, and can leave skin sagging,peeling or crusting.

Companies that market plasma pens as “a revolutionary method for a perfect face and body rejuvenation” have primarily targeted medical spas and estheticians.

But even professional injectors can be swayed by savvy reps promoting something shiny and new and exciting.

Our advice: use caution sprinkled with healthy dose of cynicism when dealing with company reps. Just because it’s supported by some sort of study doesn’t automatically mean it’s safe to use.

Make sure the device is supported by independent studies and, most importantly, that Health Canada has given it approval for specific treatments.

Check whether medical devices have been authorized for sale by searching Health Canada’s Medical Devices Active Licence Listing(MDALL). Also check Recalls and Safety Alerts database for advisories on illegal health products that have been found on the Canadian market. Report complaints involving medical devices, including the sale of unauthorized devices, to Health Canada.

Devices that have been approved in Canada have been evaluated for safety, effectiveness or quality.

Obviously, it makes good sense and promotes safe practices to do your homework. Make that part of your medical aesthetics education and training. No-one wants to see a patient get hurt. No-one wants to their business and reputation in tatters.

Be careful. Be diligent. Be safe.



Health Canada approvals are among the various topics taught and discussed in a THMA Consulting New Practitioner Course on Business Ethics & Industry Standards.