Public Statement by the Disability Law Center on the March 4, 2020 Decision by the FDA to Ban Electrical Stimulation Devices (ESDs) for Self-Injurious or Aggressive Behavior.

March 4, 2020

Today’s announcement by the FDA finally bans painful electric shock of persons with disabilities used for the purposes of behavior modification.  Such measures have been widely discredited in clinical literature and practice and are still regularly used at only one facility in the entire country, regrettably here in Massachusetts.

For over six years, the FDA carefully studied this issue using external and internal experts in range of fields such as medicine, psychiatry, psychology, neurology, special education, biomechanical engineering, statistics and medical ethics.   It also heard testimony from a broad range of stakeholders including former residents from the Judge Rotenberg Center, families, providers, experts and advocates.  This includes more than 1,500 public comments received about the proposed rule, as well as approximately 300 comments submitted to the April 2014 FDA advisory panel meeting.

FDA’s final conclusion is that these devices present an “unreasonable and substantial risk of illness or injury.” We appreciate the agency’s detailed, multi-disciplinary expert analysis, its careful deliberate process, and its commitment to protecting people with disabilities from pain and other physical and emotional injury.

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Decision by the FDA to Ban Electrical Stimulation Devices (ESDs) for Self-Injurious or Aggressive Behavior.

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