Should vaporizers be classed as medical devices?

[Mrbinky]

I find the explanation plausible but skepticism is good. I'm equally skeptical that someone did a burnoff and witnessed burnoff vapor for 15 cycles, I wasn't there to witness that either.

Does anyone else find humor in the self righteous indignation from some for a product that has only just started shipping (which is based on a single observation/observer)?

We here at FC take pride in our self righteous indignation. We wear it as a badge of honor.

I spent many years in the pharmaceutical and medical device industry.

Frankly, no, I do not find it at all amusing or ironic that people on this board are concerned about the health implications of outgassing and burn-off. And would like to have full disclosure about any components in the vapor path.

If this were an FDA regulated product, do you think that it would receive any less scrutiny? Would you expect that GH labs would be able to get away with not not fully disclosing the exact design and manufacturing process, and 100% of the materials, solvents, etc., used? Would they be able to ship product without extensive testing? Would they be able to assemble these parts without taking whatever means necessary to ensure they were absolutely clean and free of contamination?

At the end of the day, I don't actually see why vaporizers are NOT considered medical devices. Aren't they? Aren't you essentially sucking their output right into your lungs? If they are contaminated with industrial solvents, or whatever, isn't there a potential for injury?

Frankly, we are letting them off lightly. Because we are all paying for the privilege to participate in a clinical trial. Unmonitored, uncontrolled, by people whose qualifications are questionable...but they probably don't have any medical training.

 

[pakalolo]

I spent many years in the pharmaceutical and medical device industry.

Frankly, no, I do not find it at all amusing or ironic that people on this board are concerned about the health implications of outgassing and burn-off. And would like to have full disclosure about any components in the vapor path.

If this were an FDA regulated product, do you think that it would receive any less scrutiny? Would you expect that GH labs would be able to get away with not not fully disclosing the exact design and manufacturing process, and 100% of the materials, solvents, etc., used? Would they be able to ship product without extensive testing? Would they be able to assemble these parts without taking whatever means necessary to ensure they were absolutely clean and free of contamination?

At the end of the day, I don't actually see why vaporizers are NOT considered medical devices. Aren't they? Aren't you essentially sucking their output right into your lungs? If they are contaminated with industrial solvents, or whatever, isn't there a potential for injury?

Frankly, we are letting them off lightly. Because we are all paying for the privilege to participate in a clinical trial. Unmonitored, uncontrolled, by people whose qualifications are questionable...but they probably don't have any medical training.

The GH isn't a clinical trial. You said yourself it is unmonitored and uncontrolled. How do you justify calling it a clinical trial? How do you know their qualifications are questionable? Qualifications for what?

I have trouble understanding your position. Are you advocating that all vapourizers should be classed as medical devices requiring FDA approval?

 

[Spinuch]

If the herb or material you vaporize is a medicine than absolutely it should be classified as a medical device. When a needle holds medicine to be administered into someone it is a medical device. If people are using vaporizers as medical devices the industry should absolutely cater to them. Sadly not many people share this view. They seem to not really care about the safety of their vaporizer.

I know many people that use cannabis as a medicine. Once they try vaporizers they usually stop smoking, I feel as though it's a gateway to using cannabis medically. Clearly we need more studies and testing on vaporizers. It's all very new. Hopefully in a decade things like fuming will be frowned upon like a doctor not being hygienic.

When my stomach hurts the first thing I want to do is make sure my vaporizer is charged. Because cannabis is truly a miracle when it comes to stomach pain or tension. I obviously fell off point here somewhere.

If you use medicine in a vaporizer it is for medical use.

 

[pakalolo]

If the herb or material you vaporize is a medicine than absolutely it should be classified as a medical device. When a needle holds medicine to be administered into someone it is a medical device. If people are using vaporizers as medical devices the industry should absolutely cater to them. Sadly not many people share this view. They seem to not really care about the safety of their vaporizer.

I know many people that use cannabis as a medicine. Once they try vaporizers they usually stop smoking, I feel as though it's a gateway to using cannabis medically. Clearly we need more studies and testing on vaporizers. It's all very new. Hopefully in a decade things like fuming will be frowned upon like a doctor not being hygienic.

When my stomach hurts the first thing I want to do is make sure my vaporizer is charged. Because cannabis is truly a miracle when it comes to stomach pain or tension. I obviously fell off point here somewhere. My point stands. If you use medicine in a vaporizer it is for medical use.

Yeah that wasn't really what I was trying to get at. There is no problem with having a classification procedure that will certify a design as a medical device. There are lots of problems with declaring all vapourizers to be medical devices that require certification.

 

[jojo monkey]

It is the wild west... this is what happens with black market drugs, you get black market devices. Got to wait on the feds for anything.

I trust glass.

 

[Mister G]

If you want to completely halt any progress, innovation or momentum, yes, please get the government more involved in the vaporizer business.

 

[Solomon]

Yeah that wasn't really what I was trying to get at. There is no problem with having a classification procedure that will certify a design as a medical device. There are lots of problems with declaring all vapourizers to be medical devices that require certification.

In fact, I would guess that in a few years when medicinal marijuana is so widely accepted that it can be universally prescribed by physicians and covered by insurance, that many vaporizer companies will actively seek FDA approval for their devices as a medical devices. There's probably a billion $$ market there for those that do.

 

[Spinuch]

Yeah that wasn't really what I was trying to get at. There is no problem with having a classification procedure that will certify a design as a medical device. There are lots of problems with declaring all vapourizers to be medical devices that require certification.

Good companies should have standards. I sort of thought GH would have those standards but i'm not surprised. I'm sure they're working very hard without a set of procedures to maintain perfection so I understand. I don't like government regulation, especially when it comes to something that could be considered taboo but shouldn't be.

I was basically just commenting on the thread tittle. I agree it would be a bad thing if every vaporizer required certification.

 

[TeeJay1952]

I have a nephew on the Dole. He was attacked and knifed and never fully recovered. He is on the Fentenal Patch which he gets for $2.60 a month. It costs the State thousands. I asked if was interested in Medical MMJ and he said he could get his card but the Public Assistance would not pay for MMJ. Penny wise, Pound foolish.

 

[jackmormon]

If the FDA ever gets involved with certifying/regulating the vape industry it will quash innovation and options. We will be left with 2 or 3 companies that have the resources to comply with the regulations.

A forecast on the most likely scenario is that we would end up with FDA approved vapes and FDA approved dosage capsules that go into the vapes. Those dosage capsules/cartridges (whatever) will be the only choice to use with the devices. Lobbyists for potential device manufacturers and pharma companies that could potentially manufacture the "doses" would effectively write the legislation. That is how it works folks. Making non-approved devices "illegal" would be inevitable.

Hope it never happens. (Real vaporizers would be driven to the black market.)

 

[Solomon]

Keep in mind - there are 2 distinct markets - medical and recreational.

While few states have gone full "rec legal", many more states are reducing or eliminating penalties for personal use, so there will always remain a large (larger than med) market for non-FDA approved devices. That's what I'd envision - a set of expensive FDA approved devices, and then everything else.

Not sure about those FDA approved "doses" - most medical delivery systems are independent of the "medicine" they deliver - in fact, most aren't even handled by the same company. Devices and medications also go through a different approval process.

@jackmormon you did get me thinking about it though...heh.

Also...vapes aren't only for weed, and there are all those e-cig devices too...

 

[pakalolo]

Also...vapes aren't only for weed, and there are all those e-cig devices too...

E-cigs are being conflated with vapourizers a lot, and that's wrong. They are completely different delivery systems. In Ontario, they are considering a law that will put vapourizers under the same restrictions as smoking. This is a completely misguided knee-jerk reaction to e-cigs, but cannabis vapourizers are caught in the net.

 

[Been Vapin]

In Canada the Volcano is certified medical device. According the Enrico in a VICE interview, the Sublimator is on the way to being certified as a medical device in Canada believe it or not. Canada's selection system must be similar to High Times Cup on how winners are determined.

 

[lwien]

While I totally understand the health concerns of vaping through an unregulated device like a vaporizer, what about the unregulated product that we put into those vaporizers?

This isn't meant as a derail but I'm just pointing out that, as an example, while the 'Cano may be a certified medical device in Canada, what good is that if we are putting into the 'Cano that could be contaminated with pesticides or growing agents that may, in fact, be toxic?

To me, that is an even bigger issue, eh.

But back to medical grade vaporizers. There are some manufacturers that claim that there vaporizers meet these standards such as the Volcano and the MiniVap and their retail pricing reflects it. Are there any others?

One other thing to keep in mind. Any manufacturer that seeks certifications, be they safety certifications or medical certifications, needs to be prepared to pay for them and then pass those additional costs to the consumer. Those products will always be more expensive than non-certified products, hence, there will be a market for both..............and, btw, I think the same thing could hold true for the bud as well.

 

[Been Vapin]

Fast forward to 9:20 for Sublimator part.

 

[Mrbinky]

I think that the problem as it currently stands is that vaporizer manufacturers are forced to officially pretend that their products are not used in the way that they were actually designed and purchased to be used. And, manufacturers also have zero liability in case they are not fit or safe to be used for that purpose.

Look, even something as simple as making sure that the unit, when it is shipped, has no toxic chemicals or other contaminants. Nothing that could scorch or burn in the vapor path. Or loose bits that could get inhaled. Or that the temperature is regulated and evenly disbursed to prevent accidental combustion. I could go on...

As things currently stand, who is watching out for us? Nobody but ourselves. And, in case you do happen to get injured by a defective or dangerous unit, I'm not sure what legal recourse you would have. The manufacturers know this, and they are pretty cavalier about our health and safety.

Someone stated that this wasn't like being a subject in a clinical trial. You are right, it is not the same thing. It is, unfortunately, much worse. If a particular model of vaporizer increased blood carbon monoxide or inflammatory or liver damage markers, it's very likely that we'd never find out about it. If it increased the risk of cancer or COPD over other models, we'd never know it. If it caused burns to lips or mucus membranes in the mouth, throat or larynx, people would complain about it "getting hot" or causing tickles or burning, but (unfortunately) those are common problems with vaporizers, and people blame their own sensitivity rather than the units.

Look, I know that smoking has a lot of these same concerns, some more seriously. But that's why we don't (or try not to) smoke. We want a "safe" alternative. And it seems to me that with careful design, that should be possible to achieve. I honestly believe that a properly designed vaporizer can be 100% safe, and almost 100% immune to "operator error or misuse". Right out of the factory, without any need for special cleaning or burn-off.

As an example, check out the amount of research, testing and QC that went into making the Afrezza: https://www.afrezza.com/

That degree of quality and safety is what we should be aiming for, but how do we get there if the manufacturers have zero oversight, do not properly QC and test their products, and refuse to share with us 100% of the design and materials used? Do we just count on their "good nature" to provide us with safe and foolproof vaporizers? Since when did that ever work in "real life"? Keep in mind that the FDA had to be created specifically because, left to their own devices, companies largely didn't care about public safety and well being: they only cared about their profit margins!

Yes, I am passionate about this, because I think we all deserve nothing less than the best. I feel the same way about Herb, FYI. Of course is should be 100% pure, clean, and tested for potency. But that's a subject for a different thread.

 

[lwien]

Keep in mind that the FDA had to be created specifically because, left to their own devices, companies largely didn't care about public safety and well being: they only cared about their profit margins!

To some degree, the same thing could be said for the FDA themselves.

 

[Mrbinky]

To some degree, the same thing could be said for the FDA themselves.

True. They are far from perfect and not loved by all. Least of all by pharma or medical device companies.

On the whole, we are all better off with regulation, imperfect though it may be.

 

[Hippie Dickie]

Well, i'm sure onboard with complete transparency with respect to my vape ... the vapor path is nothing but bud and glass ... now and forever ... (get it? transparent glass) ... but even so, all construction details and complete parts list and program code are open source for the Bud Toaster.

now, moving forward to a medical device rating is waiting for the laws to evolve ... drug paraphernalia is still federally illegal.

 

[mikek9]

In Canada the Volcano is certified medical device. According the Enrico in a VICE interview, the Sublimator is on the way to being certified as a medical device in Canada believe it or not. Canada's selection system must be similar to High Times Cup on how winners are determined.

Yeah the "volcano medic" is a class 2 certified medical device. But it is a particular model with a special medic one way valve. The temp is also limited to 410 f

I have one.

It is a different model from the volcano digital and volcano classic - those are not certified medical devices in Canada.

I wondered if I could write it off on my taxes?

 

[herbivore21]

It is complicated. I would argue that most vapes I have used would not qualify as a medical device.

It would be best determined by a team of qualified medical/other scientists to sit down and define factors that would be required from a medical class vape.

For example: any chance of combustion = not a medical device.

Any offgassing = not a medical device etc

As a medical user, I'd love to see proper peer-reviewed scientific certification of vapes that fit the bill of being the safest and most effective possible administration tools for mmj.

 

[mvapes]

In short, no. In long, possibly?

 

[herbivore21]

In short, no. In long, possibly?

That was actually seriously going to be my original post lol

 

[mikek9]

For example: any chance of combustion = not a medical device.

I think that's why they dialed down the Volcano Medic to only 410 F to ensure there is no chance of combustion.

 

[herbivore21]

I think that's why they dialed down the Volcano Medic to only 410 F to ensure there is no chance of combustion.

You could be right on that one, my friend, I can certainly say that the same temp ranges work to prevent combustion in the Mighty/Crafty