Concussion can be a serious injury for any athlete, and in recent years, many public resources have been introduced to help individuals better understand the injury.

But a new warning to consumers is encouraging a cautious approach.

The U.S. Food and Drug Administration recently issued a warning to the public not to use medical devices marketed to consumers that claim to help assess, diagnose, or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI. 

The FDA warned that these tools — such as apps on a smartphone marketed to coaches or parents for use during sporting events — have not been reviewed by the FDA for safety and efficacy and could result in an incorrect diagnosis, potentially leading to a person with a serious head injury returning to normal activities instead of getting medical care.

Access the FDA’s full communication here

To date, there are a limited number of medical devices that have been cleared or approved by the FDA to aid in the diagnosis, treatment, or management of concussion, and all of them require an evaluation by a health care professional. 

Rather than rely on these products, the FDA recommends that consumers, parents, caregivers and athletic coaches should help individuals to seek treatment right away from a health care professional if any head injury, including concussion, is suspected.

“We want to help share this message that apps on a phone are not a viable replacement for treatment from a medical professional,” said Dr. Bruce Griffin, director of the Center for Sport Science at US Lacrosse. “We expect every lacrosse club and organization to follow our guidelines by seeking the help of a local provider to develop a Concussion Management Plan.”

The FDA provides a full list of safety recommendations online related to concussions and 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, putting individuals at greater danger,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. 

“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.” 

In its recent communication, the FDA explains that the products of concern include those that claim to assess and diagnose changes in brain function by having an injured person perform tests on a smartphone or tablet-based app to determine a change in physical or mental (cognitive) status including vision, concentration, memory, balance and speech. 

Concussion Awareness

US Lacrosse has developed a number of resources to help the lacrosse community learn more about concussions.

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