HQ Team
March 26, 2024: The US regulator, the Food and Drug Administration plans to ban electrical stimulation devices due to “unreasonable and substantial risk” of illness or injury.
The devices are intended to reduce or stop self-injurious or aggressive behaviour and are administered to the skin through electric shocks by electrodes.
This is the second time the FDA has proposed a ban on these particular devices — the first being in 2020 and challenged in the courts, according to a statement from the regulator.
“The agency has determined that these devices present an unreasonable and substantial risk of illness or injury.”
Psychological risks
Some people who exhibit self-injurious or aggressive behaviour have intellectual or developmental disabilities that make it difficult for them to communicate or make their own treatment decisions.
These devices present several psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.
The proposed rule, if finalised, will remove ESDs from the market, and the devices will no longer be considered legally marketed, the FDA stated.
The FDA stated that it had information to indicate that only one facility is currently using these devices in the United States, which is the Judge Rotenberg Education Center in Canton, Massachusetts.
“We estimate around 50 individuals currently have a treatment plan that includes the use, or potential use, of an ESD,” said Owen Faris, Ph.D., acting director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health.
‘Gradual transition’
“Those exposed to these devices may need time to gradually transition away from this device and adjust treatment plans.”
New evidence considered by the FDA includes clinical and scientific data, input from experts in the field and state agencies and comments received from the previously proposed rule to ban ESDs.
They further incorporated input from patients and parents of individuals who have been treated with ESDs, and disability rights groups, as well as insights from FDA advisory panels.
The new proposed rule “does not apply to aversive conditioning devices intended to be used for other purposes, such as those used for smoking cessation.”
The planned rule is open for comment until May 28, 2024. The FDA will then review and consider comments before determining whether to issue a final rule.
