ST. LOUIS - Aside from microwaving our meals and raising our kids, we use our smartphones for just about everything in our lives. Now, there are even some apps that claim to be able to diagnose concussions. However, the FDA is strongly urging coaches, parents, and trainers to stay away from such apps and to trust an old-fashioned method to diagnose head injuries instead.
In a warning issued on April 10, the U.S. Food and Drug Administration warned the public to not use unapproved or uncleared medical devices to help assess or diagnose a head injury.
“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own. Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in the warning.
“Products being marketed for the assessment, diagnosis, or management of a head injury, including concussion, that have not been approved or cleared by the FDA are in violation of the law," he said.
Dr. Brian Mahaffey is a physician for Mercy Hospital in St. Louis who sees dozens of athlete head injuries each year. He also agrees with the FDA's stance on tech's place in diagnosing concussions.
“We’re following 15 to 20 at a time," said Mahaffey.
The Mercy doctor works with hundreds of athletes each year. And although he’s open to technology that can help educate and assess, he hasn’t seen anything reliable that can help diagnose a head injury.
“The issue is, with a lot of apps, is that they’re not very specific or not very sensitive. So when you look at them through purely a scientific standpoint, they’re just not good enough to be able to make that diagnosis," said Mahaffey.
Both Mahaffey and the FDA highly recommend athlete's see a concussion specialist to diagnose any head injury instead of relying on an application via phone or tablet.
“Do not rely on those applications and don’t rely just on technology. It’s a tool, but can you apply it correctly?" said Mahaffey.
Parkway South High School works with Mercy athletic trainers for every sporting event. They're also relying on human diagnoses for now.
“Relying on an app to make that decision, when talking about a student athlete’s brain, that’s a big step, I think," said Pat Burns, Athletic Director at Parkway South.
“I think right now, dealing with the personal touch and having our people look at our athletes, just is so much better for our kids, and making sure they’re getting the proper care and proper treatment," said Burns.
So if you want to use technology to help judge whether or not medical attention is needed, go ahead. But relying on any tech to diagnose any head injury could result in a misdiagnosis, allowing a serious injury to go untreated, especially because symptoms vary from person to person and may not appear right away.
"Anything that educates people about concussions, we’re all for that. But having someone who is a concussion specialist, if you’re in high school or college, your athletic trainer is your concussion specialist, they’re the best to go to make that diagnosis and to start that treatment process," said Mahaffey.
Symptoms of a concussion can include, headache, fogginess, neck discomfort, numbness, tingling, nausea, not sleeping well, sleeping too much, changes in behavior, and overall simply not feeling well.
Concussion symptoms can vary from person to person and can be hard to diagnose. And sometimes symptoms don’t appear right away.
There are FDA-approved medical devices which can assess head injuries. That list can be found here.
You can read more on the FDA's warning here.