Thermocoagulation and Health Canada regulation

Posted by: Kim Gerry

Thermocoagulation and Health Canada regulation - 10/24/17 02:38 PM

I have been a certified electrologist for over 10 years and 2 years ago I certified for thermocoagulation treatments with Dectro (great program BTW!). I have just heard that the senior II or any other electrolysis machine from Dectro are not regulated to provide any skin lesion treatments (thermocoagulation). I searched online to see if Health Canada as posted anything but I cannot find articles or clauses that stipulate that regulation. As anyone else heard or seen anything on Health Canada about that? Does that mean insurance will not cover you if you use anything but the machine (Elipsia+) that Dectro has been approved by Health Canada to perform thermocoagulation.
Posted by: Michael Bono

Re: Thermocoagulation and Health Canada regulation - 10/24/17 07:45 PM

(For US readers)

I'm excruciatingly familiar with the twists-and-turns of all the "esthetician units" that treat skin lesions. All of the dedicated units are re-labeled thermolysis units that are being used "off label."

Were any company to claim their dedicated unit was anything other than an electrolysis unit (and already certified as such), they would have to present evidence of this being something new. Thus, they would have to spend many thousands of dollars for an FDA test. If they claim the unit is equivalent to, say, the Hyfrecator or Bovie (both medical devices), then the unit could only be sold (after testing) to medical doctors. So you see, it's a "catch 22."

If you directly ask any of the "dedicated unit" sellers, they are going to give you a bunch of baloney. So far, no agency has made much ado about this little issue ... however, one good fat lawsuit and that will bring all of this crashing down. The fat lawsuit will probably have something to do with a non-medical person removing a skin cancer and the patient not seeking timely treatment ... with bad results.
Posted by: Michael Bono

Re: Thermocoagulation and Health Canada regulation - 10/24/17 07:49 PM

Additionally Kim, it's not the machine that is "certified" it's the practice of removing lesions with thermolysis.

They are certifying YOU not the machine."Thermocoagulation" can be accomplished by many many devices ...
Posted by: Kim Gerry

Re: Thermocoagulation and Health Canada regulation - 10/27/17 01:00 AM

Indeed Mike! I looked at the health Canada form needed to label a machine as a medical device and it's quite the elaborated process. Thank you for taking the time to clear this up for me.