The U.S. Food and Drug Administration (FDA) warned consumers last month to be cautious about “certain products intended to aid in the assessment, diagnosis, or management of a head injury, which includes concussion, traumatic brain injury (TBI), and mild traumatic brain injury (mild TBI or mTBI).”
Elaborating, it noted that such products “claim to assess and diagnose any changes in brain function by having an injured person perform tests on a smartphone or tablet-based app to determine a change in mental (cognitive) status including vision, concentration, memory, balance, and speech.”
The FDA is “concerned” that the products “do not have FDA clearance or approval are being marketed to individuals, including parents and caregivers, athletic coaches, and health care providers for the assessment, diagnosis, or management of a head injury, including concussion,” and “serious risks” to those who reply on them.
“The use of unapproved medical devices may lead to an incorrect diagnosis,” according to the communicae. “An incorrect diagnosis of ‘no head injury’ after an injury, for example, could lead a person with a serious head injury to return to their normal activities instead of getting medical care. Not getting needed medical care and returning to normal activities could lead to worsening of the injury.”
Jeffrey Shuren, M.D., J.D., director of the FDA Center for Devices and Radiological Health, issued the following statement: “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.”
The FDA went on to issue the following “Recommendations for Individuals, Parents and Caregivers:
Seek medical attention right away if you, your child, or a person in your care gets a head injury.
Remember, a head injury, including concussion, should only be diagnosed by a health care provider after a thorough evaluation.
Be aware that the FDA has not approved or cleared any devices that can assess, manage or diagnose a concussion without an evaluation by a health care provider.
If a person in your care has been treated for a head injury, such as concussion, with a medical device and experienced a problem, the FDA encourages you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.”
It also added “Recommendations for Athletic Coaches and Athletic Administrators:
If you suspect an athlete or spectator may have a head injury, make sure they seek medical care right away.
Remember, a head injury, including concussion, should only be diagnosed by a health care provider after a thorough evaluation.
Be aware that the FDA has not approved or cleared any devices that can assess, manage, or diagnose a concussion without an evaluation by a health care provider.
If a person in your care has been treated for a head injury, such as concussion, with a medical device and experienced a problem, the FDA encourages you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Recommendations for Health Care Providers:
Be aware that the safety and effectiveness of devices for diagnosis, assessment, or management of head injuries, such as concussion, have been established in only a limited number of devices, which should only be used by a health care provider.
Be aware that there are limitations that should be considered when using cleared and approved devices to aid in diagnosing, treating, or managing concussion, and labeling should be followed closely.
Discuss the benefits and risks of all available options for diagnosing and managing head injuries, including concussion, with your patient and their caregiver.
If any patients experience adverse effects from procedures that involved the use of a medical device intended to diagnose, treat or manage a brain injury, the FDA encourages you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.”
