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FDA Cautions Against Unapproved Tools for Diagnosing Head Injuries

June 20, 2019

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Earlier this month, the U.S. Food and Drug Administration (FDA) warned against using unapproved devices to diagnose concussions and other types of head injuries. In a press release issued on April 10, the FDA cautioned against smartphone and tablet-based applications marketed to coaches, parents, and trainers used to assess changes in brain function. They claim using tools, which are not FDA-approved or cleared, may result in inaccurate diagnosis, leaving many injured individuals to forego appropriate medical care and risk further injury.

The FDA identified several tools and devices that claim to diagnose, treat, or manage head injuries. The agency has not determined these products to be effective in assessing brain injury and have yet to clear or approve them for safe use by the public. In fact, the FDA warns many of these smartphone applications can potentially give injured victims an inaccurate diagnosis, encouraging them to resume their activities as usual and potentially aggravate their injury. To date, the FDA has approved very few tools to detect head injuries. Those that have been approved require the evaluation of a qualified health care provider.

FDA Recommendations

In the press release, the FDA offers several recommendations for anyone caring for children or other individuals who they suspect suffered a head injury:

• Seek immediate medical care for the victim
• Remember that a head injury requires the diagnosis of a qualified health care professional after a thorough evaluation
• Be aware that the FDA has yet to clear or approve any device, tool, or product that claims to diagnose a head injury without an evaluation by a health care provider
• If you or someone in your care has been treated for a concussion or other head injury by such a product with adverse effects, you are encouraged to file a report through MedWatch, the FDA reporting program

Additionally, the FDA reminds clinicians that FDA-cleared and approved devices for diagnosing head injuries have their own limitations. The benefits, risks, and alternatives of their use should always be discussed with patients and their caregivers.

FDA Efforts to Protect Head Injury Victims Moving Forward

The FDA has communicated their concerns about false head injury diagnoses with the companies that create and market these products. The agency continues to evaluate all claims and tools marketed for the detection and evaluation of head injuries and will investigate adverse events reported among health care providers and consumers moving forward. Consumers experiencing adverse events with head injury diagnosis products should report them through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

Philadelphia Defective Medical Device Lawyers at Brookman, Rosenberg, Brown & Sandler Advocate for Patients Injured by Unsafe Products

If you were misdiagnosed or injured by an unsafe medical product, contact the Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler. Because our team of experienced attorneys specialize in medical product liability claims, you can trust you are receiving skilled legal counsel to pursue justice for your injuries. Call us today at 215-569-4000 or contact us online to schedule a free consultation. Located in Philadelphia, we serve clients throughout Pennsylvania and New Jersey, including Delaware County, Chester County, and Philadelphia County.