X-Ray Machine in USA (scenario)

[DysonDepplbom]

I have really struggled to find concrete information regarding the owning of an x-ray machine as a hobbyist. I am no lawyer and all information is just theoretical from the mindset of a curious hobbyist.

Let me paint a theoretical scenario here...

A hobbyist gets recommended videos on building x-ray machines due to the youtube algorithm. The hobbyist is now interested in getting an x-ray machine due to the simplicity and beneficial uses of the project.

He/She then finds cheap complete x-ray machines are on eBay.  He/she orders either a complete system or parts to build working system. There is no thought into the legality of doing so at this point.

About a month or so later the hobbyist gets confused on why used and working scientific equipment is so cheap. Literally a $100,000 dollar piece of equipment to a few hundred bucks in a few years is reasonable.

After researching he/she finds that there are state and FDA regulations. Those regulations seem to contradict each other, and they don’t make sense. A quick google search says that the selling of used medical devices is a “grey market” . That appears to mean it’s perfectly legal as long as you jump through loopholes in the system.


I'm no lawyer but does this seem accurate?
1.) You can buy anything legally (MIR, X-ray or any Class-III medical device) for SCRAP or PARTS.
2.) The FDA controls any radiation producing device. (that doesn’t make sense, cathode tubes anyone?)
3.) Some states say any non-medical x-ray device can be operated 50 days per calendar year. So, if someone owns 10 x-ray machines they can operate at 365 days a year. That's weird.

the FDA controlling any radiation producing device doesn't make sense to me. What about all the old cathode tubes? what if I blow/build the x-ray tube itself?  Is there a radiation limit? Where the hell is the line drawn if it's against regulations to own any x-ray producing device.

Ok then. Lets than assume a hobbyist can’t own a x-ray producing device in the US.

Does anyone have any evidence of someone getting in “trouble” for owning, using, or selling a x-ray producing device?

If so, what is the story or how did they get in trouble? 

How could someone get in trouble if the FDA doesn’t track every of the 1000’s of medical devices being sold on eBay?

Is the buyer or seller liable or both?

What would the NRC do if a “concerned citizen” complained about a hobbyist owning a x-ray device? Is that the protocol? Or is the FDA called? Police involved?

You can see how a normal citizen never thinks of the legality of owning this type of equipment and wouldn’t realize if they put themselves in bad position. Or maybe nobody cares about it and it’s just some written rules that don’t make sense in a modern era due to the fact they were written in 1976.

What are your thoughts?

[amyk]

According to your profile you are in Germany but you are referring to the FDA...?

I think it's mainly a "don't be stupid" type of thing --- if you're not directly putting anyone's lives in danger, they probably don't care nor have the time to investigate. Especially right now.

[Bicurico]

My thoughts:

I would NOT want my neighbar (germinated house) to own and operate an X-RAY machine for his hobby. This would raise safety concerns: is the shielding effective? Is my family and me receiving doses of radiation from my neighbour? Does he know what he is doing? Is the machine certified, i.e. operating within legal limits? Etc.

If I knew my neighbour had such a machine, I would immediatly file a complaint at my condominium adminstration and to the local police station.

There is a good reason why the ownership and use of X-RAY machines is highly regulated: they can cause severe health problems and death, without the victim even sensing the exposure.

Also, don't forget that you need to be qualified in order to operate a X-RAY machine!

So yes, I think you would be in trouble if the authorities know about you having such a machine.

That said, I guess it comes down to this: no whitness, no investigation.

Regards,
Vitor

[DysonDepplbom]

According to your profile you are in Germany but you are referring to the FDA...?

I think it's mainly a "don't be stupid" type of thing --- if you're not directly putting anyone's lives in danger, they probably don't care nor have the time to investigate. Especially right now.

I spend about half the year in each. My interest is mainly in US regulations. I figured that it's  just a "grey" area as long as safety is followed.

My main curiosity is if anyone has any stories of how someone else may have gotten either in trouble, a warning, or how it would/could happen. 

You can read stories regarding people misusing MIRTs and getting in trouble. There doesn't seem to be any of those stories regarding scientific devices. So one might ask "Who is doing the looking?" and "what are they looking for?"

[Kilrah]

A CRT is not an intentional radiator and is shielded to block the unwanted radiation as much as possible. Nothing to do with an X-ray machine

[free_electron]

first of all, i am not a lawyer . so take the following at own risk !!


The whole thing about grey market medical stuff is to prevent people, who are not licensed to perform medical practice, get their hands on medical machinery. Yes, there is such a thing as back-alley surgery and all kinds of treatments... or even hairdressers offering skin treatments using second hand medical lasers, for which they have no training.
So machinery has to be sold for scrap. (and most often : disabled. some critical element will be removed. that 100$ MRI machine will have been quenched... it is now a very heavy paperweight. Same for radio therapy machinery. The capsule will have been removed. They learnt their lessons after what happened in Goiana,  Brazil in the 80's ...  https://en.wikipedia.org/wiki/Goi%C3%A2nia_accident )

If you are a business you need to have the right paperwork to own and operate such machines. Each machine type comes with its own 'red tape' ...
For example that clause you mention where an x-ray can only be run for 50 calendar days is nonsense. Any pcb assembly house runs x-ray machines 356 days a year. 8 hours or more a day. and they frequently only have only 1 machine. But : they have PAPERWORK !

That is the whole pivotpoint : do you have PAPERWORK and are you licensed to operate it.

[DysonDepplbom]

My thoughts:

I would NOT want my neighbar (germinated house) to own and operate an X-RAY machine for his hobby. This would raise safety concerns: is the shielding effective? Is my family and me receiving doses of radiation from my neighbour? Does he know what he is doing? Is the machine certified, i.e. operating within legal limits? Etc.

If I knew my neighbour had such a machine, I would immediatly file a complaint at my condominium adminstration and to the local police station.

There is a good reason why the ownership and use of X-RAY machines is highly regulated: they can cause severe health problems and death, without the victim even sensing the exposure.

Also, don't forget that you need to be qualified in order to operate a X-RAY machine!

So yes, I think you would be in trouble if the authorities know about you having such a machine.

That said, I guess it comes down to this: no whitness, no investigation.

Regards,
Vitor

 I agree entirely. If someone was living in a small apartment complex and their neighbor is using a device like that it could pose serious health issues. Not only that, the neighbors would never know.

My curiosity stems from why this information is hard to find. One might assume it's just a non issue to authorities in a "if a tree falls in a forest and no one is there to hear it..." scenario.  It's also weird that eBay allows the sale of these devices even though they could pose a threat.

[Kilrah]

eBay doesn't care, they're not selling anything, just connecting a seller and a buyer who both bear the responsibility of what they trade.

[DysonDepplbom]

first of all, i am not a lawyer . so take the following at own risk !!


The whole thing about grey market medical stuff is to prevent people, who are not licensed to perform medical practice, get their hands on medical machinery. Yes, there is such a thing as back-alley surgery and all kinds of treatments... or even hairdressers offering skin treatments using second hand medical lasers, for which they have no training.
So machinery has to be sold for scrap. (and most often : disabled. some critical element will be removed. that 100$ MRI machine will have been quenched... it is now a very heavy paperweight. Same for radio therapy machinery. The capsule will have been removed. They learnt their lessons after what happened in Goiana,  Brazil in the 80's ...  https://en.wikipedia.org/wiki/Goi%C3%A2nia_accident )

If you are a business you need to have the right paperwork to own and operate such machines. Each machine type comes with its own 'red tape' ...
For example that clause you mention where an x-ray can only be run for 50 calendar days is nonsense. Any pcb assembly house runs x-ray machines 356 days a year. 8 hours or more a day. and they frequently only have only 1 machine. But : they have PAPERWORK !

That is the whole pivotpoint : do you have PAPERWORK and are you licensed to operate it.

Thanks for the reply.

Ok then. Let's assume that no medical equipment was used. The hobbyist built everything from the x-ray tube to the HV power supply. Now is that perfectly legal?

What about a x-ray tube kit selling from "United Nuclear.com". They sell the X-ray tube* and 30kv supply that produces enough radiation to cause harm but that is perfectly legal. That company also got raided a few years ago by the NRC I believe. If they continue to sell x-ray kits it must be OK at some level.

http://unitednuclear.com/index.php?main_page=index&cPath=2_13

[DysonDepplbom]

eBay doesn't care, they're not selling anything, just connecting a seller and a buyer who both bear the responsibility of what they trade.

It appears to be that way. It seems eBay just wants you to post that "FDA blah blah" in your post with your address. However many sellers don't even do that. It also says something along the lines of  "I will identify you as a authorized purchaser of this item.."


What does that mean? As far as I can tell eBay does not tell you at all how to "identify someone as a authorized purchaser".


There are many brand new x-ray devices being sold on eBay, coming in from China. FDA clearly says that's a no no. Yet they are still for sale and even sold at Amazon.  Checking amazon reviews the negative reviews generally stem from the FDA not regulating it.

Seems odd that even Amazon is taking part in this too.

Thanks

[tpowell1830]

In the US, any items that are emitting noise, like radiation, coming from a house or a neighborhood where there are houses used to be monitored by the FCC, who, again, used to go around at regular intervals with a van full of monitoring equipment to see if there are any strange emissions coming from houses. The FDA regulates the sale of medical equipment, but the FCC looks for emissions, whether they are radio or simply electrical noise. I am sure there are more modern methods to monitor such emissions than a van, but a van would still be viable.

Hope this helps...

[jogri]

I don't think that the NRC will bat an eye as long as you don't endanger others or brag about it on the internet... That being said, operating a DIY X-ray would be a rather stupid thing to do as shielding it would be quite a challenge. But if you publish videos about enriching uranium (or doing similar shenanigans) they will come to you (that happened to Cody from the YT channel CodysLab).

Btw, old MRIs pose no threat as the liquid helium (and nitrogen) used to create the superconductors has to be vented before it can be shipped. And even if they didn't vent it on purpose the helium will be gone in a few months as you have to refill it quite regulary, and no one is going to refill your DIY MRI with helium.

What about a x-ray tube kit selling from "United Nuclear.com". They sell the X-ray tube* and 30kv supply that produces enough radiation to cause harm but that is perfectly legal. That company also got raided a few years ago by the NRC I believe. If they continue to sell x-ray kits it must be OK at some level.

They probably got away because they
a) technically sell you a vacuum tube that just "happens" to be particularly good at projecting an xray beam in one direction. No one can stop them from producing shitty vacuum tubes that need extreme voltages and just happen to have this design quirk

b)use rather low voltages and currents: their supply is rated for 25kV and >1mA while medical xray machines operate at 60-140kV (and up to 10+mAs). That's way softer radiation that doesn't penetrate as deep as the 140kV would. (CRTs here in germany can operate at 27kV max, just to set it in perspective)

[DysonDepplbom]

I don't think that the NRC will bat an eye as long as you don't endanger others or brag about it on the internet... That being said, operating a DIY X-ray would be a rather stupid thing to do as shielding it would be quite a challenge. But if you publish videos about enriching uranium (or doing similar shenanigans) they will come to you (that happened to Cody from the YT channel CodysLab).

Btw, old MRIs pose no threat as the liquid helium (and nitrogen) used to create the superconductors has to be vented before it can be shipped. And even if they didn't vent it on purpose the helium will be gone in a few months as you have to refill it quite regulary, and no one is going to refill your DIY MRI with helium.

What about a x-ray tube kit selling from "United Nuclear.com". They sell the X-ray tube* and 30kv supply that produces enough radiation to cause harm but that is perfectly legal. That company also got raided a few years ago by the NRC I believe. If they continue to sell x-ray kits it must be OK at some level.

They probably got away because they
a) technically sell you a vacuum tube that just "happens" to be particularly good at projecting an xray beam in one direction. No one can stop them from producing shitty vacuum tubes that need extreme voltages and just happen to have this design quirk

b)use rather low voltages and currents: their supply is rated for 25kV and >1mA while medical xray machines operate at 60-140kV (and up to 10+mAs). That's way softer radiation that doesn't penetrate as deep as the 140kV would. (CRTs here in germany can operate at 27kV max, just to set it in perspective)

Thanks for your reply. I'm gonna do more research into that YT channel situation. One of the reasons I started this post is because the YT channel "Applied Science" stopped posting stuff regarding x-rays and he hinted that it might be for security reasons but I cannot confirm that. He has posted really interesting info regarding the building of a DIY backscatter imaging device. I was also curious regarding the other YT creators that have been shown using medical x-tubes and devices.

Ben from Applied Science said a viewer/supporter might come out and "certify" his setup. Whatever that means.

Thanks for the MIR information. I find them interesting but don't know much about them. I saw three weeks ago a MIR machine with "warm magnet" was not selling on ebay about three weeks ago. It was pick up only and the seller didn't have any bids at $1000.

[jogri]

Thanks for the MIR information. I find them interesting but don't know much about them. I saw three weeks ago a MIR machine with "warm magnet" was not selling on ebay about three weeks ago. It was pick up only and the seller didn't have any bids at $1000.

"Warm magnet" is probably a synonym for "we f**ed up and someone activated the emergency quench". No wonder that this didn't sell as the emergency quench just opens a valve connecting the liquid helium tank to the outside-> pressurized helium gets released->temperature rises as helium level drops->the current (>10A) still circling inside the magnetic ring suddenly encounters conductors with a finite resistance-> Ohms law kicks in->conductor gets hot->helium and nitrogen boil off explosively->fun times.

Chances are that you have to get new magnets as they probably got damaged whenever you punched that emergency quench button (remember: the conductors do not have an electrical resistance so the diameter of said conductor can be rather small as it will never heat up due to the current [except when you quench it]->small conductors do not react well to extreme currents).

Btw, that is the reason why MRIs have two seperate emergency shutdown switches:
One that will just kill the power, but leaves the magnets running->normal safety switch
One that will quench the magnet and therefore make sure that the magnetic field collapses->only for MAJOR fuck-ups as the cleanup is rather costly

Here is a video where they quenched an old MRI magnet:


One a sidenote: MRIs aren't actually the machines with the most powerfull superconducting magnets out there, that honour goes to NMR spectrometers: Those reach up to 24T while MRIs "only" go up to 7T. But that's not really a fair comparison as NMR spectrometers can only fit 5mm wide test tubes while an MRI can fit a person.

[Sal Ammoniac]

If I knew my neighbour had such a machine, I would immediatly file a complaint at my condominium adminstration and to the local police station.

Sure, if you live in a condominium you probably wouldn't want your neighbor operating an X-Ray machine. But how about my case? I live on 4 hectares and my only neighbor is 250 meters away. Should I be allowed to operate an X-Ray machine on my property for hobby purposes?

Laws try to be one-size-fits-all, but that's not how things always work out in the real world.

[james_s]

The way it typically works in the USA is it's legal to own almost anything, but in the case of an xray machine it may not be legal to actually operate it. I've bought several different dental xray heads and never had any issues. I got a complete machine for free at one point and just had to sign a waiver releasing the business that gave it to me of any liability. There are all sorts of regulations around operating one in a business but I have not really looked into what would be required to legally operate one at home. There are fully enclosed interlocked machines such as those used for mail inspection that are less tightly regulated than the medical/dental diagnostic systems.

The main thing if you do decide to do this is to take great care to NEVER expose someone to radiation, that is going to open a huge can of liability worms. If you are taking xrays of inanimate objects in your basement nobody is likely to bother you. If you try operating a discount medical or dental clinic taking xrays of body parts at home that's going to get you in a mess. Liability aside, if you decide to mess with this stuff you need to take safety VERY seriously. Ionizing radiation is no joke and even a small dental head can kill you or cause serious injury. Think of how painful a bad sunburn is and then think what it would feel like to have a bad sunburn all the way through part of your body.

[amyk]

Also remember that inverse-square law applies too.

[james_s]

Yes that's a good point too, distance is your best shield, they are also heavily attenuated by concrete. Xrays are photons, they behave very much like light, spreading out from the point source of the electron beam striking the anode. Also I've heard of some hobbyists kludging something together with a bare tube, that's just stupid IMHO. Dental heads are inexpensive, very well shielded, easy to use, they're a self contained unit with a HV transformer and filament transformer, newer ones have a high frequency transformer and multiplier in the head. Normally they produce a narrow beam and place the film very close to the tube however if you are imaging inanimate objects you have the luxury of taking a much longer exposure which makes it possible to image much larger objects than would typically be done with a dental machine.