General > General Technical Chat
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:
--- Quote from: amyk on April 09, 2020, 01:19:55 pm ---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.
--- End quote ---
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
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