The U.S. Food and Drug Administration published a rule Wednesday that bans the use of electrical stimulation devices that are only used at one school in the country – the Judge Rotenberg Educational Center, in Canton.
The JRC uses the devices on people with disabilities who exhibit aggressive behavior that can injure them or others.
5 Investigates has reported extensively on the controversy over the devices and obtained video from inside the center.
One video shows student Andre McCollins being shocked after refusing to take off his coat. He continued to be shocked and restrained for hours.
That video helped push the FDA to first propose banning the devices in 2016. However, no final action was taken until now.
“Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, including worsening of underlying symptoms, depression, anxiety, posttraumatic stress disorder, pain, burns and tissue damage,” the FDA said in a press release.
“Since ESDs were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health,” said Dr. 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 ESDs present.”
While critics of the devices have called them torture, parents of students who attend the Rotenberg Center believe that they are lifesaving devices.
“We will fight any attempt to remove this treatment from their available care and treatment plan,” the Judge Rotenberg Educational Center Parents Association told 5 Investigates in a statement.
“A government agency offering no effective alternative treatments for our loved ones is moving to take away the only treatment that has successfully allowed them to stop maiming themselves, spend time with their family and to learn and engage in the community instead of being in a locked room while physically, mechanically or chemically restrained by drugs. It is a matter of life and death.”
“FDA made a decision based on politics, not facts, to deny this life saving, court-approved treatment,” said the JRC.
“FDA would not even meet with the parents of the loved ones who are at JRC who will be extremely impacted by this poor decision. JRC has provided countless hours of testimony, volumes of information and made clinicians, other staff and family members of our clients, or clients themselves, available to the FDA over the past several years.”
The JRC noted that a Massachusetts court allowed the continued use of the devices in 2018 and “found that the treatment is humane, safe and highly effective.”
The ban is a rare move for the FDA, which has only banned two other medical devices.
The JRC now has 180 days to stop the use of the devices on students who are currently receiving the electrical shocks as a form of treatment.