On March 4, 2020, the U.S. Food and Drug Administration (FDA) published a final rule to ban electrical stimulation devices (ESDs). ESDs had previously been used for self-injurious or aggressive behavior, but in a statement accompanying the FDA ESD ban, officials stated that the devices present “an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.”
What Are ESDs?
According to the FDA ESD ban, ESDs are electronic devices that administer electrical shocks through electrodes attached to the skin of individuals. The purpose of these shocks is marketed as a method of immediately interrupting self-injurious or aggressive behavior. Alternatively, these shocks have also been used in attempts to condition the individuals to stop engaging in undesirable behavior.
While these ends are not inherently wrong, the FDA ESD ban discusses the scientific evidence which indicates that a number of significant psychological and physical risks are associated with the use of ESDs and there can be unintentional side-effects. Some of these side-effects include:
- Anxiety
- Burns
- Depression
- Pain
- Posttraumatic stress disorder (PTSD)
- Tissue damage
- Worsening of underlying symptoms
The FDA ESD ban also addresses the difficulty in discovering these complications as many of the individuals receiving this type of shock therapy also possess intellectual or developmental disabilities that make communication of these complications difficult.
Why Is the FDA ESD Ban Being Implemented?
As the FDA ESD ban announcement describes, the evidence espousing the effectiveness of ESD therapy for treating self-harm and aggression is weak. Equally important to note is that evidence of the comparative benefits of alternative treatments is very strong.
It is exceedingly rare for the FDA to outright ban a product from sale or use. Oftentimes the product can be brought back to a safe, reliable state through modification or updated safety warnings. Sometimes, however, as is shown by ESDs for aggression and self-harm, a product meets the FDA’s definition of unreasonable and the devices cannot be corrected through new or updated labeling. The FDA ESD ban has been declared as necessary to protect public health.
The March 4 rule follows a 2016 proposed rule to ban ESDs from the marketplace and takes effect 30 days after publication in the Federal Register. As a point of clarification, the FDA ESD ban is only applying to ESDs used for self-harming or aggressive behavior. This means that ESDs used for purposes like quitting smoking are not affected and neither are FDA-cleared or approved devices like cranial electrotherapy stimulators or transcranial magnetic stimulation, which the FDA has deemed a reasonable assurance of safety and effectiveness.
Additionally, the FDA ESD ban includes a gradual transition period for individuals currently using ESDs to allow time for them to transition to another treatment. This transition period is concluded by two compliance dates. Individuals using ESDs on the day the FDA ESD ban is published in the Federal Registrar will be required to transition to an FDA compliant treatment plan within 180 days. All ESD devices must be removed from circulation and use within 30 days of publication in the Federal Register.
Alternatives to ESDs were explained in the FDA ESD ban announcement. The FDA approves of modern behavioral treatments including positive behavioral support medications for curbing self-injurious or aggressive behaviors in patients.
Ultimately, Director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health, William Maisel, M.D.m M.P.H. presented one of the best arguments for the FDA ESD ban:
“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 behavior, thus avoiding the substantial risk ESDs present.”