Electrical Stimulation Devices Banned
06 March 2020
The Food and Drug Administration has issued a final rule banning electrical stimulation devices for self-injurious or aggressive behaviour following a determination that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labelling. The ban includes both new devices (effective from 6 April) and devices currently in use and subject to a physician-directed transition plan (effective from 2 September).
ESDs are aversive conditioning devices that apply a noxious electrical stimulus (a shock) to a person’s skin to reduce or cease self-injurious behaviour or aggressive behaviour, which frequently manifest in the same individual. People with intellectual or developmental disabilities exhibit these behaviours at disproportionately high rates. ESDs intended for other purposes, such as smoking cessation, are not subject to this ban.
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