The United States Food and Drug Administration (FDA) has posted a press announcement concerning Electrical Stimulation Devices (ESD) for self-injurious or aggressive behavior. The devices are found to present unreasonable and substantial risk of illness or injury.
ESD administer electrical shocks through electrodes attached to the skin of individuals to immediately interrupt self-injurious or aggressive behavior or attempt to condition the individuals to stop engaging in such behavior. According to the FDA, evidence indicating a number of significant psychological and physical risks are associated with the use of these devices, including worsening of underlying symptoms, depression, anxiety, posttraumatic stress disorder, pain, burns and tissue damage. In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain. Evidence of the device's effectiveness is weak and evidence supporting the benefit-risk profiles of alternatives is strong. As the risks presented by ESD meet the definition of unreasonable and substantial and cannot be corrected or eliminated through new or updated labeling, banning the product is necessary to protect public health.
The FDA has information that indicates only one facility is using these devices in the United States at this time, the Judge Rotenberg Educational Center (JRC) in Canton, Massachusetts, and estimates between 45 and 50 individuals are currently being exposed to the devices. The FDA believes that state-of-the-art behavioral treatments, such as positive behavioral support, and medications can enable health care providers to find alternative approaches for curbing self-injurious or aggressive behaviors in their patients.
In making the determination that these products present an unreasonable and substantial risk of illness or injury to the public and therefore meet the regulatory standard for banning, the FDA considered all available evidence, including clinical and scientific data, input from experts in the field and state agencies, and comments from JRC, individuals and parents of individuals on whom ESD have been used, and disability rights groups, as well as insights from the expert members of the April 2014 FDA advisory panel.
This rule applies only to ESD used for self-injurious or aggressive behavior and does not apply to aversive conditioning devices used for other purposes, such as those used for smoking cessation, which are outside the scope of this rule, or other FDA-cleared or approved devices or technologies such as cranial electrotherapy stimulators or transcranial magnetic stimulation, both of which have been found to have a reasonable assurance of safety and effectiveness for different indications.
For details, please refer to the following links:
https://www.fda.gov/news-events/press-announcements/fda-takes-rare-step-ban-electrical-stimulation-devices-self-injurious-or-aggressive-behavior
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 March 2020