The US Food and Drug Administration has issued a final rule to ban the use of electrical stimulation devices (ESDs) for the treatment of self-injurious or aggressive behaviour in neuroatypical patients.
ESDs administer shocks through electrodes attached to a patient’s skin to interrupt self-injury or aggression, and attempt to condition them to stop engaging in this behaviour in the future. The majority of patients exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate when they are in pain, which can result in self-harm or aggression.
Evidence of the effectiveness of ESDs is weak and activists have been campaigning to have their use suspended for years. The FDA first announced its intent to ban ESDs in 2016, and now accepts that ESDs present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labelling.
Mounting evidence indicates a number of significant psychological and physical risks associated with the use of these devices, including worsening of underlying symptoms, depression, anxiety, post-traumatic stress disorder, pain, burns and tissue damage.
FDA Office of Product Evaluation and Quality director William Maisel said: “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.
“Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behaviour, thus avoiding the substantial risk ESDs present.”
The FDA ESDs ban takes effect following its publication in the federal register on 6 April 2020, with compliance required within 30 days.
The Judge Rotenberg Educational Center in Massachusetts is thought to be the only facility in the US using ESDs for the treatment of self-injurious behaviour and aggression, with 45 to 50 individuals estimated to be exposed to the devices currently. For these patients, compliance is required within 180 days to allow time for them to transition to another treatment.
The outright ban of a medical device is rare – historically, the FDA has only otherwise banned prosthetic hair fibres and powdered surgeon’s gloves.