Autism: FDA Announces Proposal to Ban Electric Stimulation Devices

The FDA announced today a proposal to ban electrical stimulation devices (ESDs) which are known to be used on autistic people who are “self-injurious or aggressive.” The FDA stated the devices “present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes in labeling.” Evidence of adverse effects caused by ESDs included “significant psychological and physical risks …including depression, anxiety, worsening of self-injury behaviors and symptoms of post-traumatic stress disorder, pain, burns, tissue damage and errant shocks from a device malfunction.” Note this is a proposed ban. Once this proposal is published in the Federal Register, Monday, April 25, 2016, there is a 30 day comment period for the general public.

The FDA has known about this shock device for years. The FDA had previously warned the Judge Rotenberg Center in 2011 and 2012 that their ESD was out of compliance with FDA regulations as the device had been modified to allow increases in voltage. Originally, the ESD had been approved in 1994 at a set voltage. This Judge Rotenberg Center is the only known location in the United States that uses the device; the Center was previously known as the Behavioral Research Institute and has moved over the years from California to Rhode Island to its present location in Massachusetts.

Additionally, even the UN has advocated the ESD be banned. Back in 2013, the UN’s special rapporteur on torture, Juan Mendez, called out the Judge Rotenberg Center for using this electrical stimulation device on those with autism and said the device amounted to torture. Mr. Mendez advocated at that time that action be taken at the federal level.

Sources: FDA.gov http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm497194.htm

Office of the Federal Register: https://www.federalregister.gov/articles/2016/04/25/2016-09433/banned-devices-electrical-stimulation-devices-used-to-treat-self-injurious-or-aggressive-behavior

Forbes.com http://www.forbes.com/sites/emilywillingham/2016/04/22/fda-seeks-to-ban-electric-shock-devices/#4856b7237ead   AND

http://www.forbes.com/sites/emilywillingham/2013/03/08/autism-shock-therapy-is-torture-says-un-official/#75fe3e4b4fc2

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