FDA Cautions Against Unapproved Tools for Diagnosing Head Injuries - Drug and Medical Device Litigation Legal Blogs Posted by Cary L. Sandler - Lawyers.com

FDA Cautions Against Unapproved Tools for Diagnosing Head Injuries

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 RecommendationsIn 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 victimRemember that a head injury requires the diagnosis of a qualified health care professional after a thorough evaluationBe 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 providerIf 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 programAdditionally, 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 ForwardThe 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.

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Cary L. Sandler

Licensed since 1979

Member at firm Brookman, Rosenberg, Brown & Sandler

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Cary L. Sandler

Licensed since 1979

Member at firm Brookman, Rosenberg, Brown & Sandler

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AV Preeminent

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