After years of pressure from patient advocates and mental health experts, U.S. regulators took the unusual step of banning electrical stimulation devices (ESDs) for behavior-control due to the risk of permanent side effects.
The devices are only used at the Judge Rotenberg Educational Center in Canton, Massachusetts, a school where around 45 to 50 children are currently being treated with it, according to the FDA.
The school uses electric-shock devices on children with autism and other intellectual disabilities to stop them from engaging in self-harming and aggressive behaviors, like head-banging or attacking people.
Unfortunately, the devices pose “significant psychological and physical risks,” according to the FDA, including worsening underlying symptoms, depression, anxiety, and post-traumatic stress disorder.
Patients may also suffer pain, burns, and tissue damage, but they may be too disabled to communicate their pain.
The ban on electrical stimulation devices takes effect 30 days after publication, with the exception of some patients who may need up to 180 days to transition to another treatment.
The FDA proposed banning the devices in 2016, but missed its own deadline to issue a final rule by December 2019. Only after Senate Democrats sent a letter did the FDA take action.
The ban only applies to devices for self-injurious or aggressive behavior. It does not include smoking cessation therapies, or other devices like cranial electrotherapy stimulators and transcranial magnetic stimulators.
The ban is an extremely rare move for the FDA. Only two other medical devices have been banned in the agency’s history — fake hair implants in 1983 due to infections, and powdered surgical gloves in 2017 due to allergic reactions.
Source: FDA Takes Rare Step to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior