A recent Reuters Health article http://www.reuters.com * noted “Children are not simply ‘small adults,’ and a device found to be safe and effective in adults may have a very different safety and effectiveness profile when used in a pediatric population….” “Without this data, it is difficult for clinicians and parents to make informed treatment decisions that weigh the risks and benefits of a particular treatment…,” The new study examined what kind of testing has been done on medical devices meant for kids since an act of Congress incentivized their development seven years ago.
“Most of the devices had been approved with a stipulation that the device makers conduct postmarket trials once the product was being used commercially to make sure it was safe and effective. But only three required that kids be included in the trials, and none of those was actually complete, according to results published in Pediatrics.”
“Designing devices for children is more complex because they are still growing and may need to have the device for many decades, in contrast to older adults…” “Without testing the device in children, it’s impossible to say how the device will perform long term, but it can be difficult to enroll children with rare diseases in clinical trials for both practical and ethical reasons.
* to read the full Reuters article “Medical devices for kids are often only tested on adults” by Kathryn Doyle highlight and click on open hyperlink http://www.reuters.com/article/2014/04/14/us-medical-devices-kids-testing-idUSBREA3D0U920140414
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