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.
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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.
This article originally appeared on MPR
