- Robert Preidt
- Posted March 4, 2020
FDA Bans Shock Devices Used on the Mentally Disabled
Electrical shock devices used to reduce aggression and self-harm in patients with autism and other developmental disabilities will be banned, the U.S. Food and Drug Administration said Wednesday.
The devices deliver shocks through electrodes attached to the skin of patients, but there is evidence that they pose significant mental and physical risks to patients, including worsening of underlying symptoms, depression, anxiety, post-traumatic stress disorder, pain, burns and tissue damage, the FDA said.
It also noted that patients' intellectual or developmental disabilities make it difficult for them to communicate their pain, and that there is little evidence that electrical shock devices (ESDs) are an effective treatment.
"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 at 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," Maisel said in an FDA news release.
The ban takes effect 30 days after publication in the Federal Register. The agency first announced its intention to ban the devices in 2016.
Patient groups and mental health experts have long condemned the devices as outdated, ineffective and unethical, the Associated Press reported.
For years, the only place in the United States that has used shock devices is the Judge Rotenberg Educational Center in Canton, Mass., a residential school for people with autism and other psychiatric, developmental or mental disabilities.
Between 45 and 50 people at the center are currently being treated with the devices, the FDA said Wednesday.
School officials have claimed the treatment is a last resort to prevent dangerous behaviors such as head-banging, throwing furniture or attacking teachers or classmates, according to the AP.
Several lawsuits against the school have been launched by families who said their children were traumatized by the shocks, while other parents have said the shocks were the only thing that prevented violent behavior.
The U.S. Centers for Disease Control and Prevention has more on autism.
SOURCES: U.S. Food and Drug Administration, news release, March 4, 2020; Associated Press