FDA Bans Electrical Stimulation Devices Used At Controversial School

Federal regulators have issued a ban on the use of electrical stimulation devices to stop aversive behavior among individuals with mental disabilities, which was a practice at the Judge Rotenberg Educational Center in Canton, Massachusetts.

In a final rule issued on Wednesday, the FDA announced the ban on electrical stimulation devices used for prevention of self-injury or aggressive behavior, after facing years of pressure from patient groups and mental health experts who called the treatment outdated, unethical and ineffective.

Electrical stimulation devices were once widely used in this way around the country, but now only one school uses the devices to prevent patients with intellectual or development disabilities from engaging in aggressive or self-harming behavior.

The Judge Rotenberg Educational Center is a residential school for people with autism and other psychiatric, developmental, or mental disabilities. The school uses electrical stimulation devices to deliver shocks to patients as a last resort to behaviors like head-banging, throwing furniture, or attacking teachers or classmates.

The FDA warns there is evidence of psychological and physical risks linked with the use of the devices. Electrical stimulation devices can worsen underlying symptoms, depression, anxiety, post traumatic stress disorder, pain, burns and tissue damage, the agency warns.

The patients the devices are being used on at the school have intellectual or developmental disabilities and are often unable to communicate if they feel pain or other side effects during use, the FDA determined.

Aversive conditioning was widely accepted as a treatment decades ago, but psychiatry now focuses on behavioral modification, prescription drugs, and other therapies which have been proven to be more effective to treat aggressive or self-injurious behavior.

The FDA warned the devices present a substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.

Instead, the agency says doctors should offer treatments that focus on eliminating trigger factors for aggressive behavior or teach patients coping skills. Additionally, medications to help with mood, impulsiveness, and other behavioral issues can also be prescribed when necessary.

It is rare for the FDA to completely ban a device. The agency has only banned two other medical devices since gaining the authority to do so, including powdered surgical gloves, due to allergic reactions, and fake hair implants, which lead to infections.

The electrical stimulation device ban comes following a 2016 proposed rule to ban the devices and takes effect 30 days after publication, with the exception of some patients who may need a gradual transition period of 180 days as directed by their doctor.

“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,” Dr. William Maisel, director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health, said in the press release. “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.”