FDA mulls banning electro stim devices for treating self-injury aggressive behavior

The FDA today proposed a ban on electrical stimulation devices used to treat self-injurious or aggressive behavior over concerns about the safety of the devices.

ESDs are designed to deliver electrical shocks through electrodes attached to the skin of individuals in an attempt to reduce self-injurious or aggressive behavior, the FDA said.  However evidence indicates a number of psychological and physical risks associated with the devices.

Among the possible psychological effects are depression, anxiety, worsening of self-injury behaviors and symptoms of post-traumatic stress disorders. On the physical end, burns, pain, tissue damage and errant shocks can occur.

The FDA said that individuals exposed to the devices often have intellectual or developmental disabilities that make it “difficult to communicate their pain or consent.”

The federal watchdog said it takes the act of banning devices seriously, and only seeks to ban devices on “rare occasions when it is necessary to protect public health.” The agency said it is seeking a ban because the risk the devices pose cannot be corrected or eliminated through changes to the labeling.

“Our primary concern is the safety and well-being of the individuals who are exposed to these devices. These devices are dangerous and a risk to public health–and we believe they should not be used,” FDA Center for Devices and Radiological Health acting director Dr. William Maisel said in a press release.

Currently, only 1 center in the U.S. is using the devices, and the FDA estimates that between 45 and 50 individuals are currently being exposed to the device.

The FDA said it took into account all available scientific and clinical data, as well as input from experts in the field and state agencies in making its decision.

The agency will be accepting comments on the proposed ban over the next 30 days.

The post FDA mulls banning electro stim devices for treating self-injury, aggressive behavior appeared first on MassDevice.

from MassDevice http://ift.tt/1r4fyoi