FDA Bans Devices Used To Shock Those With Developmental Disabilities
After nearly four years, federal officials are banning devices used to administer electric shocks on people with developmental disabilities citing an “unreasonable and substantial risk of illness or injury.”
The Food and Drug Administration said Wednesday it will finalize a ban on what are known as electrical stimulation devices. The devices deliver electrical shocks via electrodes attached to the skin in an effort to condition individuals not to engage in self-injurious or aggressive behaviors.
The FDA cited evidence of psychological and physical risks from the devices including burns, tissue damage, worsening underlying symptoms, depression, anxiety and post-traumatic stress disorder. The agency noted that many people receiving the electric shocks have disabilities that make it difficult for them to communicate their pain.
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Since the risks posed by the devices cannot be addressed through a change in labeling, the FDA said “banning the product is necessary to protect public health.”
“Since (electrical stimulation devices) were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health,” said William Maisel, director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health. “Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behavior, thus avoiding the substantial risk (electrical stimulation devices) present.”
Federal regulators pointed to positive behavioral support and medications as examples of other ways to address self-injurious or aggressive behaviors.
There is only one place in the country that is known to use the electrical stimulation devices — the Judge Rotenberg Educational Center in Canton, Mass., which serves children and adults with developmental disabilities as well as those with behavioral and emotional problems. Currently, 45 to 50 individuals at the center are believed to be using the devices, the FDA said.
The Rotenberg Center said that FDA officials refused to visit and would not meet with the parents of individuals who will be affected by the ban.
“The Judge Rotenberg Educational Center (JRC) will continue to advocate for and will litigate to preserve this court-approved life-saving treatment,” the center said in a statement. “FDA made a decision based on politics, not facts, to deny this life saving, court-approved treatment.”
The FDA first proposed the ban in 2016 and said it received more than 1,500 comments in response, the “overwhelming majority” of which supported barring the devices. Nonetheless, the agency stalled on finalizing the regulation, missing a self-imposed deadline at the end of last year and drawing condemnation from disability advocates and lawmakers alike.
With Wednesday’s announcement, the FDA described the move to ban a device as a “rare step,” saying that the agency has only ever banned two other medical devices before.
The ban, which applies to both new and existing devices, will take effect 30 days after the rule is published in the Federal Register. However, the FDA is allowing 180 days for individuals who are currently using electrical stimulation devices to transition off of them under the supervision of a physician.
Julia Bascom, executive director of the Autistic Self Advocacy Network, called the FDA’s action “long overdue,” but she noted that “the fight is not over yet.”
“There is a six-month phaseout for people who are currently on the device, and we anticipate the JRC will fight the implementation of the ban,” Bascom said. “But this is a huge step, and we are glad to see it.”
(Updated: March 4, 2020 at 5:40 p.m. ET)
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