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FDA Bans Electrical Stimulation Devices Used for Self-injurious Behavior or Aggressive Behaviour
The US Food and Drug Administration (FDA) announced to ban electrical stimulation devices (ESDs) used to treat aggressive behaviour or self-injurious, denoting the third time in the agency’s history that it has exercised to ban a medical device.
It found to present an unreasonable and substantial risk of illness or injury, which cannot be corrected or eliminated through new changes in device labeling. The act of banning a device is rare but the FDA has the authority to take this action whenever required to protect the health of the public.
FDA says the ban on the devices will take impact after 30 days, even though the agency is allowing a 180-day compliance window for devices in use on particular patients, subject to a physician-directed transition plan.
The Agency has revealed that only one facility is using these devices in the United States, the Judge Rotenberg Educational Center (JRC) in Canton, Massachusetts. And FDA estimates the devices are being used on 45 to 50 patients at the facility.
Evidence shows significant psychological and physical harm to patients, including worsening underlying symptoms, depression, anxiety, post-traumatic stress disorder, pain, burns and tissue damage.
The FDA believes that advanced treatments, such as positive behavioural support and medications can be used to treat self-injurious or aggressive behaviours without harming patients.
