What is a medical
device according to the FDA? For this discussion I will limit their definition to the applicable points of their description. A medical
device is an apparatus which is- intended for use in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf
Since there is a growing body of evidence that concussions may lead to disease, specifically ALS (Lou Gehrigs Disease).
Does Concussion Cause Motor Neuron Disease?: The Question St... : Neurology Today
A team of Boston scientists has published a study suggesting that patients with chronic traumatic encephalopathy (CTE) may be at greater risk of motor neuron disease (MND). The report, published online Aug. 11 in the Journal of Neuropathology and Experimental Neurology, is now being hotly debated as neurologists field calls from worried head injury patients and patients with amyotrophic lateral sclerosis (ALS) who wonder whether their motor neuron disease was triggered by repeated injuries to the head.
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This may require the FDA to step in and demand that all football helmets are taken off the market until the manufacturers can prove they are safe and effective.
If the good researchers from the University of California were given the grant by Helmet Control (a division of TC) to study these devices and Prue Talbot, director of UC Riverside's Stem Cell Center, was assigned the task, this article would probably read like this-
Two days ago, on December 3, researchers at the University of California, Riverside released information suggesting that helmets are not safe and may pose dangerous health risks. Complete study results will appear online in the December 7 issue of Helmet Control.
Researchers evaluated five helmet brands and found design flaws, inadequate labeling, quality control concerns, and health issues. They warn that helmets are potentially harmful and should be removed from the market until their safety can be assessed. The study examined the following helmets: Amads, Scuut, Rydel, Nitekey and All Scar Sports.
What are helmets?
Helmets are essentially head protection systems and are widely available at sporting goods stores, athletic supply companies and on the internet. However, we know little about their health effects.
Helmets are designed to protect the head from injury in the case of collision with other players arms, shoulders, feet and heads.
Why are they popular?
People believe that helmets are a safe substitute for conservative play," said Prue Talbot, director of UC Riverside's Stem Cell Center, whose lab led the research. "However, there are virtually no scientific studies on helmets and their safety. Our studyone of the first studies to evaluate helmetsshows that this product has many flaws, which could cause serious public health problems in the future if the flaws go uncorrected."
More information about helmets:
Helmets have a molded polycarbonate shell, a chin strap, padding, face masks and air systems. Each component is designed to protect the football player from serious injury.
Now P. Elizabeth, do you have any idea why these helmet should be taken off the market? Why they are dangerous? Why the comments are so negative about your article? Its not a personal attack, its a journalistic attack. You didnt even give a link to the research or any clue on specific reasons why the researcher came to the conclusion drawn. That in itself is another story.