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FDA Bans Certain Electrical Stimulation Devices, the Third Ban in History
March 4, 2020
FDA has officially banned electrical stimulation devices used to treat self-injury or aggressive behavior with publication of a final rule Wednesday. The action comes almost six years after convening an advisory committee to weigh the ban and four years after actually proposing it, as pressure mounted from lawmakers in recent months to follow through on ending a “barbaric” practice affecting people with disabilities.
It’s only the third time in history the agency has exercised its authority to ban a device. Regulators formerly banned prosthetic hair fibers and powdered medical gloves.
The electrical stimulation devices (ESDs) covered in Wednesday’s final rule are designed to immediately try to stop self-injurious or aggressive behavior by administering electrical shocks through electrodes placed on the skin. But FDA said evidence shows the devices have been linked to significant physical and psychological risks, including depression, anxiety, post-traumatic stress disorder, pain, burns and tissue damage.
Worse, the population being exposed to the devices may often have difficulty communicating that pain due to intellectual or developmental disabilities.
Under the Federal Food, Drug and Cosmetic Act, FDA will only ban a device if regulators find it “presents a substantial deception to patients or users about the benefits of the device, or an unreasonable and substantial risk of illness or injury, which cannot be corrected by a change in the labeling.” A ban entails complete prohibition of current and future manufacturing, sales and distribution of a medical device.
See Full Article: FDA bans certain electrical stimulation devices called ‘barbaric’ | MedTech Dive
Written by: Maria Rachal
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