Psychiatric News reports that a US FDA advisory panel will recommend that the agency prohibit the growing use of “electrical stimulation devices” (ESDs) for “aversive therapy” on psychiatric patients. However, the agency “has yet to make a final ruling on whether to ban ESDs from the U.S. market.”
According to Psychiatric News, ESD devices “consist of a battery, an electric-pulse generator, electrodes that are attached to the skin on the trunk or extremities, and either a built-in accelerometer or a radio-controlled actuator to deliver the pulse. The devices are approved to be used at voltage ranges between 150 volts and 200 volts from 0.5 seconds to 12 seconds shock duration; they are typically used in individuals who have severe autism or development disabilities or who have repeatedly injured themselves or others through behaviors such as eye gouging, skin pinching, hair pulling, or banging their head against hard surfaces.”
A majority of the members of the FDA Neurological Devices Panel agreed that ESD devices have little clinical evidence to support their use and pose “an unreasonable and substantial risk of illness or injury” to patients, reports Psychiatric News. Though the FDA has not ordered the devices removed from the US medical market, the panel also suggested new clinical trials involving the use of ESDs would be unethical.
FDA Panel Says No to Aversive-Therapy Devices (Psychiatric News, September 05, 2014. DOI: 10.1176/appi.pn.2014.9a7)