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.
Posted by: Kim Gerry

Re: Thermocoagulation and Health Canada Regulation - 01/15/18 03:49 PM

Thermocoagulation In British Columbia...

Before any of you decided to get further education on anything... a word of advice DO YOUR RESEACRH!

I was just made aware that an electrologists or estheticians in BC are not allowed under the College of Physicians and Surgeons of BC to treat any benign lesions such as skin tags or senile keratosis using thermo or electrocoagulation even with certification. I always get a physician referral before removing any lesions.

Any of you electrologists offer this service in your province? Any issues?

CPSBC allows us to treat telangiectasia, cherries or Campbell lesions ONLY.

I have downloaded the HPA but I cannot find specifics about thermocoagulation...

This is what my Health authority as sent to me in regards to CPSBC regulations on thermocoagulation.

"It has come to the College's attention that you are removing skin growths including skin tags and benign moles from clients using electrocoagulation...It is the College's position that performance of the above-noted services by a non-registrant constitutes a contravention of s.13(2) of HPA, which prohibits a person other than a college registrant from providing a service of medicine. Breach of s.13(2) is an offense under s.51(1) of the HPA. Accordingly, if you are providing these services, the College insists that you immediately cease providing these services..."

I was trained in Alberta from a Quebec based school.

Any feedback? I want to try and discuss this issue but would like to know if someone already tried...

Posted by: Michael Bono

Re: Thermocoagulation and Health Canada Regulation - 01/15/18 09:00 PM

The rationale from your BC authorities is "spot on." You cannot mistake a hair or a blood vessel for anything else; and so zapping them is relatively safe.

However, a therapist(let's say physicians) cannot identify potentially lethal lesions by just looking (guessing) at them. Even physicians, in my State, must perform a biopsy on specific tissues they remove from the skin.

Stunningly, those selling "skin treatment machines" (really re-named electrolysis units) tell potential customers that doing such medical treatments are legal. I know this chicanery is taking place, by hearing "with my own ears" at trade shows in California. "They" will say anything to make a sale!

Are schools also teaching people do perform these half-baked treatments?

When the old "shit hits the fan," a bunch of businesses, and potentially practitioners, are going to discover what facing lawsuits initiated by the State are all about.

For me? "They've got it commin'!"
Posted by: Iluv2zap

Re: Thermocoagulation and Health Canada Regulation - 01/15/18 11:09 PM

The school in quebec is likely academie-dectro. As well as manufacturing machines for treating skin anomolies, they have advanced skin care courses as well. Quebec has almost no laws on what estheticians can and cannot do.It sounds like BC is tightening up the rules a bit more than either quebec or ontario does. I dont actually know what the rules are for skin tag or mole removal is in ontario, so while I can DO a skin tag removal I dont offer it as a service and dont carry insurance to do it.

As a Side note, if your local health department is giving you this instruction , do not take it lightly. A couple years ago a local esthician here was doing things the board of surgeons didnt like in her clinc like botox injections (with beer served to the patient!) well the ontario medical board brought court action and shut her down completely.

Posted by: Kim Gerry

Re: Thermocoagulation and Health Canada Regulation - 01/27/18 05:01 PM

Hi Seana, indeed I am not taking Health Department lightly. I have stopped all treatment of raised skin lesions. I am doing my research but at the same time I feel confused as some parts of Canada thermo is allowed no problem...My insurance company has actually contacted me and allowed me to offer the service after being in BC for 7 years and an electrologists for 10. I used to offer it in Ontario. I know Alberta does it and Quebec of course!
BC has been tightening up many things. They also discredit the Prestige 2100 as a sterilizer! That's also been quite the shock when my health inspector said that! I own 2. Now I have disposable tweezers for ingrown hair removal(and lancet)...I did contact the manufacturer and they said that yes it is a medical grade steriliser. The only issue is that you must not bag instruments when using the Prestige 2100. I am not a big fan of not bagging so I put them through the cycle 2 times. Once unbagged and then bagged.

I will keep looing into these issues and posting here when I have more info.

Beer served to patients! WOW!that's quite the service! The only thing I offer is good old H20! Way better for the skin!!!
Posted by: Iluv2zap

Re: Thermocoagulation and Health Canada Regulation - 01/27/18 08:05 PM

they can take my peer vigour 3c tweezers from my cold dead hands. I cannot work as efficiently with any other tweezer most especially a "disposable". I've also always bagged instruments when using my prestige autoclave.

I had a super cool Castle 777 autoclave from the 50's that was actually passing spore tests but unfortunately it blew out a gasket in the rear of the chamber. I've purchased parts before for it ( there's one guy still selling them) but they were a nightmare to get shipped here, costly and took months.I went with the prestige because I canreadily get parts from my regular suppliers.

I have heard that BC has some strange new health code issues. It's strange, here they only start to inspect you once you recieve a complaint.Then they do it once a year. I've never had a complaint soI dont get inspected, but I have thoroughly scoured the infection control document for here in ontario and looked at all the reports for other firms that have failed to see where.