Be careful out there. Hopefully you aren't self treating using these for brain enhancement.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm497194.htm
The U.S. Food and Drug Administration today announced a proposal to
ban electrical stimulation devices (ESDs) used for self-injurious or
aggressive behavior because they present an unreasonable and substantial
risk to public health that cannot be corrected or eliminated through
changes to the labeling.
The FDA takes the act of banning a device
only on rare occasions when it is necessary to protect public health.
ESDs administer electrical shocks through electrodes attached to the
skin of individuals to attempt to condition them to stop engaging in
self-injurious or aggressive behavior. Evidence indicates a number of
significant psychological and physical risks are associated with the use
of these devices, including depression, anxiety, worsening of
self-injury behaviors and symptoms of posttraumatic stress disorder,
pain, burns, tissue damage and errant shocks from a device malfunction.
In addition, many people who are exposed to these devices have
intellectual or developmental disabilities that make it difficult to
communicate their pain or consent. As these risks cannot be eliminated
through new or updated labeling, banning the product is necessary to
protect public health.
“Our primary concern is the safety and
well-being of the individuals who are exposed to these devices,” said
William Maisel, M.D., M.P.H., acting director of the Office of Device
Evaluation in the FDA’s Center for Devices and Radiological Health.
“These devices are dangerous and a risk to public health--and we believe
they should not be used.”
At this time, the FDA has
information that indicates only one facility is using these devices in
the United States, the Judge Rotenberg Educational Center (JRC) in
Canton, Massachusetts, and estimates between 45 and 50 individuals are
currently being exposed to the device. 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. A small subgroup of those exposed to these
devices may need time to gradually transition away from this device to
another treatment. The FDA stands ready to work with health care
providers to help facilitate a safe transition to alternate care for all
of those in need since the proposed rule, if finalized, would
ultimately remove these devices from the marketplace completely.
In
making the determination that these products present an unreasonable
and substantial risk of illness or injury to the public, the FDA
considered all available evidence, including clinical and scientific
data, input from experts in the field and state agencies, comments from
JRC, individuals and parents of individuals on whom ESDs have been used,
and disability rights groups, as well as insights from an April 2014
FDA advisory panel.
The proposed rule is available online at www.regulations.gov for public comment for 30 days.
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation's food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.
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