FDA panel recommends banning “aversive” shock devicesBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3035 (Published 30 April 2014) Cite this as: BMJ 2014;348:g3035
- Michael McCarthy
A US Food and Drug Administration advisory panel has recommended that the FDA ban an aversive therapy device that administers electric shocks to developmentally disabled patients who engage in aggressive or self injurious behavior.
A majority of the panel concluded that the device, called an electrical stimulus device, “presented a substantial and unreasonable risk of illness or injury,” said an FDA summary of the panel’s deliberations, which were held 24 April.1
The devices are worn on the waist or as a back pack with electrodes attached to the patient’s skin. The shock can be triggered either remotely or by certain actions, such as head banging.
The sensation caused by the shocks has been described as mild as a “prick” to as severe as “sharp pain,” and the treatment can induce emotions that have been characterized as ranging from “unpleasant” to “horrible” and “agonizing,” said an FDA staff briefing document provided …