Ukeru Systems Submit Comments to the FDA on the Need to Immediately Ban the Use of Electrical Stimulation Devices

Friday, May 6, 2016 Medical Gadgets J E 4

WINCHESTER, Va., May 6, 2016 /PRNewswire/ -- Ukeru Systems, a division of Grafton Integrated Health Network, today submitted comments to The Food and Drug Administration (FDA) supporting the agency's proposed ban on the use of electrical stimulation devices (ESDs) as an acceptable behavioral modification technique.

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Ukeru President, Kim Sanders, likened the current use of ESDs on those with mental and physical challenges to other outdated and unethical attempts to control behavior. 

"From lobotomies to forced sterilization, to restraints and seclusion, men, women and children have suffered the traumatic effects of these types of painful mind and body-control techniques for far too long," stated Sanders. 

After extensive study and investigation of ESDs by the FDA, the proposed rule entitled Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior concludes that "these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. FDA is proposing to include in this ban both new devices and devices already in distribution and use."Sanders supported the clear case for elimination of ESDs in her comments by pointing to the success of the Grafton model of care, which focuses on the conceptual and technical elements of trauma informed care, physical restraint-free crisis management approaches, and conflict resolution.  Grafton created Ukeru Systems as the first and only restraint-free training module for those working with adults and children with autism and co-occurring psychiatric diagnoses.

"Behavioral modification techniques such as ESDs and restraints are ineffective and rarely justified," continued Sanders in her statement. "Our staff understands that when a child or adult experiences these types of adverse, violent treatment methods, the current trauma is compounded by past experiences, leading to even more aggression and fueling a psychologically destructive cycle."

FDA's proposal illustrates the real-life trauma induced and exacerbated by ESD exposure presenting often as depression, fear, panic, and aggression. Sanders urged that the ban be passed immediately so that no other American is exposed to this degrading and dangerous practice.

"As a nation, I'm proud that our knowledge and understanding of mental health has substantially evolved," concluded Sanders. "Therefore it is only right that the way we help those suffering from these conditions also evolves from violent control methods to compassionate care."

Sanders encourages other organizations and individuals to offer their support for the ban by commenting on the proposal by May 25.  Those interested can submit comments via the FDA website at 

About Ukeru Systems:

Ukeru Systems is a division of Grafton Integrated Health Network. Over the past 10 years, Grafton developed unique and award winning care management tools and techniques. Ukeru Systems now provides Grafton's behavioral management tools and care trainings to other behavioral health providers. Learn more at

Contact:  Amber McCracken703-599-0134



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SOURCE Ukeru Systems



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