Drug & Device News

First Head Trauma Cognitive Deficit Assessment Devices Approved for Marketing

Each year, more than 2 million people sustain head injuries that require a trip to the Emergency Room, according to the U.S. Centers for Disease Control and Prevention. Of these, around 50,000 die, and many more suffer short- and long-term cognitive deficits. In August, the FDA approved two devices that will allow medical practitioners to assess the presence and extent of traumatic brain injury in head trauma victims. These products ' the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric ' are the first devices the FDA has permitted to be marketed for this purpose. They run on desktop or laptop computers and test cognitive skills like reaction time and word recognition. Results are compared to the head injury victim's pre-injury baseline scores, or to an age-matched control database if no patient-specific results are available.

Carlos Pe'a, the director of the division of neurological and physical medicine devices at the FDA's Center for Devices and Radiological Health, cautions, however that while these devices provide “a useful new tool to aid in the evaluation of patients experiencing possible signs of a concussion, but clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to a game.”

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All Blood Should Be Tested for Zika Virus, Agency Says

The FDA is recommending that all donated whole blood and blood products be tested for the Zika virus. “There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research in an Aug. 26 FDA release. See http://bit.ly/2cCL9KQ. Marks continued, “At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.” The Zika outbreak, which at first was mostly limited to countries in South America or to people who had traveled there, showed up late last year in Puerto Rico, and has now been documented in people in South Florida who have not recently traveled. Zika is most often contracted through the bite of the Aedes mosquito, but can also be transmitted through sexual contact. The virus causes uncomfortable symptoms, such as fever and joint pain, but its worst effect is on unborn children, who can develop serious birth defects when their mothers are infected during pregnancy.

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