The agency said that the ESDs are causing unreasonable risk of illness or injury, which cannot be corrected or prevented through a new or updated device labelling
FDA Centre for Devices and Radiological Health. (Credit: Wikipedia/The U.S. Food and Drug Administration)
The US Food and Drug Administration (FDA), a federal agency of the US Department of Health and Human Services, has banned the electrical stimulation devices (ESDs) used for self-injurious or aggressive behaviour.
The regulatory agency said that the ESDs would cause unreasonable risk of illness or injury, which cannot be corrected or prevented through a new or updated device labelling.
FDA Centre for Devices and Radiological Health Product Evaluation and Quality Office 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 behavior, thus avoiding the substantial risk ESDs present.”
FDA has banned the electrical stimulation products to protect the public health
Through electrodes attached to the skin of individuals, ESDs are used to administer electrical shocks to immediately interrupt self-injurious or aggressive behaviour in individuals.
Evidence has shown that various psychological and physical risks, including worsening of underlying symptoms, depression, anxiety, posttraumatic stress disorder, pain, burns and tissue damage are associated with the use of ESDs.
People who are exposed to the devices are found to be facing intellectual or developmental disabilities that make it difficult to communicate their pain.
The agency said that the effectiveness of the devices is poor and the benefit-risk profile of alternative devices is better than ESDs.
In addition, the risks posed by ESDs have reached the agency’s definition of unreasonable and cannot be corrected through new or updated labelling.
FDA said that it rarely bans any device, but holds the authority to take action under severe circumstances, where protecting the public health is necessary. The agency has banned only two other medical devices since it received the authority to ban any medical device.
In addition, the agency has offered two compliance dates, to provide a gradual transition period for a subgroup of individuals currently exposed to the devices, allowing them to shift to another treatment.