The FDA is close to enacting a ban on electrical stimulation devices sometimes used to treat self-harm and aggression used in people with intellectual or developmental disabilities.
The agency, which rarely bans medical devices, proposed the ban on the devices in 2016 because they present “an unreasonable and substantial risk of illness or injury to the public.” Some people’s intellectual or developmental disabilities make it difficult to communicate their pain or consent, the agency said.
The devices’ use has been linked to depression, anxiety, worsening of self-injury behaviors and symptoms of post-traumatic stress disorder, pain, burns, and tissue damage, according to the FDA. Additional risks include errant shocks from a device malfunction. Disabilities-rights organizations have been pressuring the FDA to enact the ban, including protesting last year at the home of then-FDA commissioner Scott Gottlieb.
The proposed ban does not apply to electrical stimulation devices used to create aversions to other conditions or habits, such as smoking.
A medical device ban covers the total prohibition on the current and future sales, distribution and manufacturing of a device. This ban is scheduled to take effect sometime in December. The final rule may be found here.