The Food and Drug Administration (FDA) is reminding clinicians that the safety and effectiveness of devices intended to aid in the assessment of head injury have been established in only a limited number of devices.
In a safety communication, the agency advised healthcare providers to only use FDA-cleared devices in assessing or diagnosing head injury, after the agency discovered some unapproved medical devices were being marketed for diagnosis and management; the FDA has not approved or cleared any device that can assess or diagnose a head injury without an evaluation by a clinician.
In addition to reminding healthcare providers that there are only a limited number of devices that have been deemed safe and effective, the FDA also noted the limitations of these devices for concussion diagnosis and management.
The agency has contacted the manufacturers behind the unapproved medical products to communicate their concerns; they will continue to monitor this area and provide updates when significant information becomes available.
Any adverse effects from procedures that involved the use of a medical device intended to diagnose, treat or manage a brain injury, should be reported through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
For more information visit FDA.gov.