Concussion Expert Advises Healthcare Consumers Not to Use Unapproved Medical Apps and Devices to Diagnose Head Injury
Shepherd Center’s Russell Gore, M.D., concurs with FDA warning, offers advice.
According to a new warning issued last week by the U.S. Food and Drug Administration, coaches, parents and other healthcare consumers should not rely on unapproved medical devices, including smartphone apps, to assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI. Russell Gore, M.D., a Shepherd Center concussion expert, agrees with that advisory and offers advice on the use of technology to diagnose concussion.
The FDA’s warning said the use of these unapproved medical devices and apps – which are often marketed to consumers – could result in an incorrect diagnosis, potentially leading to a person with a serious head injury returning to their normal activities instead of getting medical care. Typically, medical devices must be reviewed by the FDA for both safety and efficacy.
To date, there are a limited number of medical devices that have been approved or cleared by the FDA to aid in the diagnosis, treatment, or management of concussion, and all of them require an evaluation by a healthcare professional.
“Even among the current FDA approved medical devices, there is no single, reliable standalone concussion diagnostic test,” said Russell Gore, M.D., director of the Complex Concussion Clinic at Shepherd Center in Atlanta. “There is currently no concussion test, but research is ongoing to better understand this injury and develop innovative diagnostic tests.”
He explained: “Concussion is a complex injury resulting in slowing of brain networks. Every concussion is different, and every individual with head trauma should be assessed by a medical professional experienced in concussion evaluation. There are no individual tests that can reliably diagnose concussion so a concussion evaluation should include multiple assessments evaluating different brain functions, such as thinking, balance and vision. Every concussion test, with or without FDA approval, should be interpreted by an experienced clinician.”
The FDA’s warning about unapproved medical devices to diagnosis head injury says the products of concern include those that claim to assess and diagnose any changes in brain function by having an injured person perform tests on a smartphone or tablet-based app to determine a change in physical or mental (cognitive) status, including vision, concentration, memory, balance and speech.
The FDA’s recommendations for consumers, parents, caregivers, and athletic coaches and trainers note that individuals should seek treatment right away from a healthcare professional if any head injury, including concussion, is suspected.
“There are currently no devices to aid in assessing concussion that should be used by consumers on their own,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Products being marketed for the assessment, diagnosis, or management of a head injury, including concussion, that have not been approved or cleared by the FDA are in violation of the law,” Dr. Shuren said. “The FDA routinely monitors the medical device market and became aware of violative products being marketed to consumers. The FDA has alerted companies to our concerns and asked them to remove such claims.”
The FDA will continue to monitor promotional materials and claims about uses of these and similar products and contact companies when it sees violative practices. If the agency’s concerns are not addressed, the FDA said it will consider what additional actions, including potential enforcement actions, are appropriate. The FDA will continue to monitor complaints and adverse event reports from patients, caregivers, healthcare providers and industry, its advisory said.
At Shepherd Center’s Complex Concussion Clinic in Atlanta, patients receive comprehensive assessment and treatment by a team of specialists in neurology, vestibular and balance disorders, athletic training, rehabilitation medicine, neuropsychology and neurosurgery. The Complex Concussion Clinic streamlines care by providing interdisciplinary resources at a single site. The patient evaluation includes cognitive, ocular-motor, vestibular and balance testing, and, when needed, assessments with other diagnostic technologies including advanced imaging. Patients ages 12 and up can be seen at the Complex Concussion Clinic.
Patients can access the Complex Concussion Clinic through a referral by their frontline provider, which could be a sports medicine, emergency room or primary care physician or athletic trainer. Referral is appropriate for patients who:
- Have dizziness, balance problems and nausea lasting more than a few days after the injury.
- Have protracted difficulty with concentration, memory, dizziness and difficulty sleeping two to three weeks after injury.
- Had a prior concussion that required an extended recovery.
- Have a history of migraine, attention deficits, or other learning challenges.
Shepherd Center, located in Atlanta, Georgia, is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury, brain injury, multiple sclerosis, spine and chronic pain, and other neuromuscular conditions. Founded in 1975, Shepherd Center is ranked by U.S. News & World Report among the top 10 rehabilitation hospitals in the nation. In its more than four decades, Shepherd Center has grown from a six-bed rehabilitation unit to a world-renowned, 152-bed hospital that treats more than 743 inpatients, 277 day program patients and more than 7,161 outpatients each year in more than 46,000 visits.