FDA Proposes Ban on Electrical Stimulation Devices for Self-Injurious and Aggressive Behaviors: Implications, Risks, and Alternatives
The United States Food and Drug Administration (FDA) has announced its intention to ban electrical stimulation devices intended for reducing or stopping self-injurious or aggressive behaviors. This decision, which aims to protect individuals from potential harm associated with these devices, marks the second attempt by the FDA to restrict their usage following a legal challenge in 2021.
Background and Context:
Electrical stimulation devices deliver electrical shocks through electrodes attached to an individual’s skin in an attempt to curb harmful behaviors. To date, only one facility in the US – the Judge Rotenberg Education Center (JRC) in Canton, Massachusetts – employs this method for approximately 50 people as part of their treatment plans.
Psychological and Physical Risks:
The FDA asserts that these devices present significant risks to the individuals undergoing treatment, including psychological risks such as depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks like pain, burns, and tissue damage.
Previous Attempts and Legal Challenges:
The FDA’s rationale for the proposed ban stems from its belief that these devices pose an unreasonable and substantial risk of harm. This stance is based on a previous attempt in 2020 to ban the devices, which was overturned following a court decision that questioned the FDA’s authority under the Federal Food, Drug, and Cosmetic Act. However, recent legislative changes have granted the FDA the necessary power to issue such a ban.
Alternative Treatments:
The FDA maintains that individuals with self-injurious or aggressive behaviors can benefit from alternative treatment methods, including positive behavioral support and medications. These approaches are not only more humane but have also proven effective in managing such behaviors.
Public Comment Period and Implications:
The proposed ban on electrical stimulation devices for self-injurious or aggressive behaviors is currently open for public comment until May 28, 2023. Once the comments have been reviewed and considered, the FDA will make a final determination on whether to issue a rule banning these devices.
It is essential to note that this proposed ban applies only to electrical stimulation devices intended for self-injurious or aggressive behaviors and not to aversive conditioning devices used for other purposes, such as smoking cessation.
Transitioning from Electrical Stimulation Devices:
Individuals who have been exposed to these devices may require assistance in transitioning away from them and adjusting their treatment plans. The FDA intends to consider the needs of these patients should they finalize the proposed ban.
In conclusion, the FDA’s proposal to ban electrical stimulation devices used for self-injurious or aggressive behaviors is a significant step towards prioritizing the protection and wellbeing of those at risk. The public comment period provides an opportunity for individuals and organizations to voice their opinions on this matter, ultimately influencing the final decision on whether these devices will remain in use.
