4 ms·

I can see how a lot of things could go wrong with things like a DIY X-ray machine or CAT scanner. And also simpler things like infusion dosage etc. That stuff

I can see how a lot of things could go wrong with things like a DIY X-ray machine or CAT scanner. And also simpler things like infusion dosage etc. That stuff does go through FDA approval in the US, right? It's not all for nothing.

bayesian_horse 10y ago
I've heard that law enforcement uses X-ray machines to look at vehicles on the road, without even asking or informing the drivers they are dosing with radiation. Funny enough, these devices don't need FDA approval, since they aren't medical devices, and the operators don't need to know anything about radiation effects on Humans...
- ptaipale 10y ago
  Those X-ray machines are not DIY. They are specifically designed for the purpose. And FDA requires reporting from manufacturers. http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/SecuritySystems/ucm227201.htm http://www.fda.gov/Radiation-EmittingProducts/RadiationEmitt...
  - lostlogin 10y ago
    Self reporting. Excuse my scepticism, it doesn't have a great track record. Additionally, the users are not exactly experts on radiation safety or knowledgable about radiation dosage, and I don't see how manufacturer reporting can cover what happens in the field.
  - CamperBob2 10y ago
    Everyone from dental hygienists to radiologists must undergo health physics training before being allowed to use an X-ray machine on human subjects. Everyone, that is, but law enforcement. Thanks, FDA. Good job.
    - gohrt 10y ago
      Because the law enforcement devices emit such a tiny rate of dose that it is impossible to harm someone while using it. "A person would have to be screened more than a thousand times in one year in order to exceed the annual radiation dose limit"
      - AstralStorm 10y ago
        Easily achievable with indiscriminate screening. How many times a year do you pass under the speed meter?
      - bayesian_horse 10y ago
        Or once with the wrong settings or too long of an exposure. Or the operators get the scattering effects wrong...
      - CamperBob2 10y ago
        Oh, well, that's different, then. As long as the cops and TSA goons are qualified to tell when the machine is malfunctioning, miscalibrated, or otherwise going full-Therac 25 on us, we're good.
        TeMPOraL 10y ago
        Those machines should be built to be at least as annoying as new cars - i.e. if anything breaks, any diagnostic fails, the machine should not start. They probably aren't built that way though because - unlike with cars - there isn't a profit motive to do it this way there.
      - stordoff 10y ago
        If you'd said, say, 50000 times, I might be more swayed, but a thousand seems easy to hit if these are widely used. If they're used daily, just passing two on a commute is enough to go over the limit.
a-no-n 10y ago
Double-edged sword of regulation: some aspects of regulation protects monopolies, increases burdens on businesses trying to sell life-saving products, self-justifies bureaucracy and adds cost and delay. Other aspects of regulation prevents unsafe, scam and inferior products from endangering public safety. Both positives and negatives, to varying degrees, are in play simultaneously, given a particular product or issue. We need the FDA to not be lap-dogs of industry, not block dying cancer patients from trying almost any experimental, unapproved protocols and not taking forever to approve revolutionary therapies. To modify James Madison's quote: "If everyone were angels, no government regulation would be needed and libertarianism would be as practical of an utopian system as communism." It's balanced, expedient and effective regulation that is the primary duty of medical regulators.
- ptaipale 10y ago
  In a way, the rest of the world is indebted to the U.S. for its regulation. It's a huge and wealthy market, so manufacturers have an incentive to enter it; the regulation is hard so products often really have to improve to get through. The rest of us can then enjoy greater safety of pharmaceuticals and medical equipment without setting up such an expensive regulatory system.
- BurningFrog 10y ago
  All you need for that to work is angel regulators!

bayesian_horse 10y ago

I've heard that law enforcement uses X-ray machines to look at vehicles on the road, without even asking or informing the drivers they are dosing with radiation. Funny enough, these devices don't need FDA approval, since they aren't medical devices, and the operators don't need to know anything about radiation effects on Humans...

ptaipale 10y ago
Those X-ray machines are not DIY. They are specifically designed for the purpose. And FDA requires reporting from manufacturers. http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/SecuritySystems/ucm227201.htm http://www.fda.gov/Radiation-EmittingProducts/RadiationEmitt...
- lostlogin 10y ago
  Self reporting. Excuse my scepticism, it doesn't have a great track record. Additionally, the users are not exactly experts on radiation safety or knowledgable about radiation dosage, and I don't see how manufacturer reporting can cover what happens in the field.
- CamperBob2 10y ago
  Everyone from dental hygienists to radiologists must undergo health physics training before being allowed to use an X-ray machine on human subjects. Everyone, that is, but law enforcement. Thanks, FDA. Good job.
  - gohrt 10y ago
    Because the law enforcement devices emit such a tiny rate of dose that it is impossible to harm someone while using it. "A person would have to be screened more than a thousand times in one year in order to exceed the annual radiation dose limit"
    - AstralStorm 10y ago
      Easily achievable with indiscriminate screening. How many times a year do you pass under the speed meter?
    - bayesian_horse 10y ago
      Or once with the wrong settings or too long of an exposure. Or the operators get the scattering effects wrong...
    - CamperBob2 10y ago
      Oh, well, that's different, then. As long as the cops and TSA goons are qualified to tell when the machine is malfunctioning, miscalibrated, or otherwise going full-Therac 25 on us, we're good.
      - TeMPOraL 10y ago
        Those machines should be built to be at least as annoying as new cars - i.e. if anything breaks, any diagnostic fails, the machine should not start. They probably aren't built that way though because - unlike with cars - there isn't a profit motive to do it this way there.
    - stordoff 10y ago
      If you'd said, say, 50000 times, I might be more swayed, but a thousand seems easy to hit if these are widely used. If they're used daily, just passing two on a commute is enough to go over the limit.

a-no-n 10y ago

Double-edged sword of regulation: some aspects of regulation protects monopolies, increases burdens on businesses trying to sell life-saving products, self-justifies bureaucracy and adds cost and delay. Other aspects of regulation prevents unsafe, scam and inferior products from endangering public safety. Both positives and negatives, to varying degrees, are in play simultaneously, given a particular product or issue. We need the FDA to not be lap-dogs of industry, not block dying cancer patients from trying almost any experimental, unapproved protocols and not taking forever to approve revolutionary therapies. To modify James Madison's quote: "If everyone were angels, no government regulation would be needed and libertarianism would be as practical of an utopian system as communism." It's balanced, expedient and effective regulation that is the primary duty of medical regulators.

ptaipale 10y ago
In a way, the rest of the world is indebted to the U.S. for its regulation. It's a huge and wealthy market, so manufacturers have an incentive to enter it; the regulation is hard so products often really have to improve to get through. The rest of us can then enjoy greater safety of pharmaceuticals and medical equipment without setting up such an expensive regulatory system.
BurningFrog 10y ago
All you need for that to work is angel regulators!