FDA Endorses Ban on Shock Devices
Abstract:Six US senators push FDA for a ban on medical devices that are used to administer electric shocks to patients with developmental disabilities. With the view to help modify their behavior, the senators wrote to FDA petitioning Commissioner Robert Califf to cement a ban that would outlaw the use of electrical stimulation devices employed for treating aggressive behavior.
A few months earlier, the FDA proposed a similar ban on devices that use electrodes attached to the skin to deliver electric shocks to prevent individuals/patients from engaging in certain behavior. In addressing these proposals to bar the devices, the FDA said it “determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.”
Currently, the FDA is in the process of reviewing public comments submitted in response to the proposal.
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