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FDA Cracking Down On X-ray Exposure For Kids
ericjones12398 writes "The Food and Drug Administration is proposing that manufacturers of X-ray machines and CT scanners do more to protect children from radiation exposure. If companies don't take steps to limit X-ray doses, the agency may require a label on their new equipment recommending it not be used on children. X-rays and CT scans can provide doctors with lots of useful information. But the radiation that creates the helpful images also increases a person's risk for cancer. There's been an explosion in the use of imaging tests. And rising radiation doses, particularly from CT scans, have drawn concern. The cancer risk increases with the dose of X-rays received during a person's lifetime, so kids' exposure is particularly important. It's also the case that children are more sensitive to X-ray damage. The FDA is also telling parents to speak up. If a doctor orders a test or procedure that uses X-rays, parents shouldn't be afraid to ask if it's really necessary. Also, it doesn't hurt to ask if there's an acceptable alternative, such as ultrasound or MRI, that doesn't rely on X-rays."
Radiation will be especially bad for children, since any mutation their cells acquire will be passed on to all daughter cells. For a growing child that will be a lot more cells than for adults who are only replacing their cells.
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...insist on these rules also applying to the TSA?
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I realize this may not be possible because they'd be costing Chertoff ^W^W sympathizing with terrorists, but the FDA should work on TSA body scanners too while they're at it. In medicine, doctors are at least remotely concerned about how much radiation people are exposed to. The TSA is only concerned with keeping people in line, maintaining a security theater, and spending/receiving lots of public money. Limiting children's exposure to X-rays is a respectable, important cause, and not all children will travel by air, but it will all be wasted if the kids run through too many body scanners with traveling parents. Plus, parents will probably not know anything about body scanners, and will believe the TSA agents when they say the scanners are "perfectly safe".
Also, it doesn't hurt to ask if there's an acceptable alternative, such as ultrasound or MRI, that doesn't rely on X-rays.
"There is, but it is not covered by your health insurance."
The "ideal" would be to add a stipulation that no provider (be they medical or otherwise) is permitted to cause the person to exceed the stipulated yearly dose without informed consent, with total dosage accumulated to that point being recorded by the provider before and after a scan.
What I do not see is any way you could possibly achieve this, without being incredibly invasive and/or potentially causing worse side-effects.
Nonetheless, the goal should be to not merely ensure individual scans are given responsibly but that the cumulation of scans is also being done responsibly. That's much harder to do, since human memory isn't reliable and patients can't possibly know what they've been exposed to up to that point (especially in the case of TSA scans). It doesn't matter if individual scans are relatively harmless, it's the dosage per unit time that matters.
It's a small world and it smells funny; I'd buy another if it wasn't for the money; Take back what I paid (SoM)
It's worth noting that the Society for Pediatric Radiology has had a campaign (http://www.pedrad.org/associations/5364/ig/) called Image Gently for a couple years now to raise awareness of this in the radiology community, and in general the trend us towards doing more with MRIs, especially with children.
see your monthly premiums go up in response. There are always trade offs and safety is a frequent one in pretty much every aspect of people's lives. If this is the type of thing where 1 in a million kids might get cancer because of x-rays over more expensive alternatives then it may not be worth switching. Money spent treating the 999,999 kids that are unaffected with the more expensive option could possibly be put to better uses. I am not saying whether or not it is worth it in this case because I have absolutely no idea. I don't know what the chances of problems arising are or the comparative costs of the safer alternatives. What I am saying is that it isn't just a matter of "always use the safer method."
In addition to drugs, the FDA is also responsible for clearing medical products and devices.
Here's this year's list of newly-approved devices so far. If you're going to stick it in your coronary artery, your cardiologist probably wants to know that people smarter than him have spent a lot of time asking a lot of hard questions about it.
Not every device gets the full treatment. But even if you're coming up with a minor tweak to something that's comparatively low risk, it must be cleared under section 510(k): last month's cleared devices. The paperwork's simple compared to a new device approval, but even the 510(k) clearance process means that something as simple as "STERILE LUBRICATING JELLY" is sterile, biocompatible, made in a factory that follows good manufacturing processes, etc.
If it sounds like a horrendous amount of paperwork, well, it is. But the alternative - random uncleared devices without even the practicioner knowing what's in them - is far, far worse. There's a reason that both prescription and over-the-counter medications have standard packaging and labeling requirements, undergo multiyear-long clinical studies, and take the better part of a billion dollars and a decade to bring to market, and why quack 'supplements' advertised on TV and in your email's spam filter have a big disclaimer that "this product is not intended for the diagnosis and treatment of any disease".
If it sounds like TSA used the loophole of "these backscatter X-ray machines aren't intended for the diagnosis and treatment of any disease" in order to circumvent FDA scrutiny, well, I'd have to agree with you there, too. But what's more important: the health of the traveling public, or securing cushy careers for HomeSec bureaucrats?
If the doctor doesn't need to do an x-ray, then performing one is negligent.
It's nowhere near that simple. Like most medical procedures, imaging has costs (in a medical sense) and benefits. The medical "cost" of performing a few radiographs of a potentially broken limb are very low, but the diagnostic benefit is very high. The medical "cost" of doing a thoracic CT is significant enough that every radiologist thinks it over in some detail before ordering one - the radiation dose is several orders of magnitude higher than a single peripheral radiograph. However, the diagnostic benefit in many circumstances is so thoroughly outweighed by the tiny risk of cancer that the CT is often worthwhile. There are many borderline circumstances though, where it's simply a judgment call as to whether the radiation dose is worthwhile to obtain the image. What about a person who loses consciousness and falls, doesn't remember whether he hit is head, but shows no signs of brain injury? Is a head CT worthwhile? Most ER docs say yes, but some would wait and see if any neurological symptoms appear. The increased cancer risk from radio-imaging in children has to be balanced against the increased sensitivity of children to injury, the difficulty of using other (more subjective) non-imaging diagnostic approaches with children, and the increased impact on quality of life of a missed diagnosis in a child. Bottom line: There is no clear answer as to whether radiological imaging is worth the risk in some cases. I tend to believe that radiation exposure is less harmful than most people make it out to be, and that the established limits for exposure are already extremely cautious, and there's little reason to avoid most imaging procedures. At the same time, I am reluctant to get repeated abdominal CT's for my kidney stones because I know that if the procedure is repeated every time I have a problem my cumulative exposure will eventually be very substantial.
I am a geek attorney, but not your geek attorney unless you've already retained me. This is not legal advice.
(Doesn't change my opinion that all full-body airport scanners are a waste of money, and xray backscatter scanners in particular should be banned.)
But the FDA is right to focus on over-prescribed medical xray procedures.
The FDA can regulate medical equipment, but it can't regulate the practice of medicine. So if these rules are too onerous, medical equipment manufactures will just label the machines as not for use on children (and likely take out any canned child-specific protocols), and doctors will continue to use the machines on children. In the middle ground, if the rules aren't too hard for the manufacturers to follow, but they cause the images to be poor, doctors and technologists will modify the protocols or use adult protocols on children. And if they're no different than what is done now, what's the point?
If there's really a problem with the protocols being such that the dose to children is higher than necessary to make good images, both manufacturers AND radiologists have to be involved in the solution.
And that what TSA is all about
It's not about terrorism, it's not about security, it's about numbing the public through excessive harassment
Muchas Gracias, Señor Edward Snowden !
Here is a classic problem: Right lower quadrant pain and fever in a child or adolescent. The diagnosis that comes to mind is appendicitis, but not every case of right lower quadrant pain and fever is appendicitis. You don't want to miss this diagnosis - if the appendix ruptures it spills bacteria all throughout the abdomen causing a significant amount of morbidity and possibly mortality.
The classic diagnostic method was history, physical examination and a couple of lab tests. In most cases, this worked out pretty well. The missed appendicitis rate was pretty low but the false positive rate - the number of times you operated on somebody who didn't have appendicitis was about 10%. Not the end of the world - it's a simple surgery and the vast majority of times it is uncomplicated but in the best possible world, you would not operate on somebody unless you really needed to.
A CT scan decreases the false positive rate to something like 1 - 2 % and the false negative rate to about the same. Significantly better than before, BUT with the caveat of additional radiation and in the case of women, radiation to the gonadal structures. Ultrasound (no radiation) is another way to do the test but it's results are often quite variable, depending on the skill of the operator and the size of the patient.
And, experience in Europe seems to indicate that a significant number of patients can be treated successfully with just antibiotics and no surgery.
So, the decision on how to proceed in a patient whom you suspect has appendicitis is not simple indeed. What the FDA is doing is waving the radiation flag around and saying 'look at me - look at me carefully'.
Faster! Faster! Faster would be better!
As a trauma ER nurse who just last night treated a 3 year-old who fell 35 feet out of her apartment window, I agree with the sentiment of the effort without agreeing with the implementation.
Sometimes, the extended waiting and confusion caused by more red tape can destroy a child's life sooner and with more pain than the possibility of radiation exposure.
If we had to produce written statements, warnings, and consents instead of a verbal okay from the parents last night before that girl's CT and head to toe X-rays, the case may have turned out with a funeral this weekend.
You know what can cause lifelong problems in the development of a child? An undiagnosed femur or C-spine fracture with a delay in assessment of an abdominal bleed.
Because we all know that all the agencies of the US Government work together seamlessly to develop and implement policy:
FDA: Protect the children from radiation
TSA: Protecting the public from terrorists requires us to irradiate the public
FDA: Radiation is bad
TSA: Radiation is good
FDA: Too much radiation for kids is bad
TSA: Radiation is harmless
FDA: Think of the children!
TSA: The children might be terrorists
Anyone else surprised?
Laws affecting technology will always be bad until enough techies become lawyers.