Electrical stimulation devices (ESDs) are designed to deliver electric shocks to a patient via electrodes attached to their skin. In certain care settings they have been deployed to interrupt self-injurious or aggressive behaviour in patients with intellectual or developmental disabilities, which in turn is hoped to condition them to stop engaging in said behaviour in the future. The ethics of ESDs were under fire for quite some time before their outright US ban in March 2020.
Conditions such as autism can make it difficult for those affected to process and express distressing emotions like pain or fear, which can lead them to lash out and attempt to harm themselves or others. While this kind of behaviour needs to be effectively managed to prevent injury, the effectiveness of ESD-centric aversive therapy is questionable on both ethical and efficacy fronts. The medical consensus is now that these behaviours should instead be managed through positive reinforcement, such as rewards and teaching appropriate skills.
The outright ban of medical devices in the US is rare. Historically, the US Food and Drug Administration (FDA) has only banned prosthetic hair fibres and powdered surgeons’ gloves, making ESDs the third type of device banned in the agency’s history.
The Judge Rotenberg Educational Center (JRC) in Massachusetts was understood to be the only facility in the US still using the treatment at the time of the ban, with only 45 to 50 residents thought to have been subject to it on a regular basis. Both the JRC and the JRC Parents Association strongly opposed the FDA’s ruling.
In a statement issued to multiple media outlets, the JRC Parents Association said: “[The] FDA’s actions today can only be interpreted one way: FDA is saying that our children’s lives do not matter.
“A government agency offering no effective alternative treatments for our loved ones is moving to take away the only treatment that has successfully allowed them to stop maiming themselves, spend time with their family and to learn and engage in the community instead of being in a locked room while physically, mechanically or chemically restrained by drugs. It is a matter of life and death.”
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Disability rights advocates and the FDA itself have rejected these claims across the board.
FDA director of product evaluation and quality Dr William Maisel said: “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.”
The JRC has faced several civil lawsuits alleging mistreatment of former residents.
1971: Matthew Israel founds the Behavior Research Institute
Matthew Israel founded the Behavior Research Institute in Rhode Island, a facility which would later move to Massachusetts and in 1994 become known as the JRC. The centre opened itself up to patients with severe behavioural issues beyond the reach of other institutions, relying on aversive therapy to condition their violent outbursts. This involved making them smell ammonia, smacking them with a spatula and forcing them to wear a helmet, which would play white noise into their ears. These practises would later become the basis for an ESD known as the Graduated Electronic Decelerator (GED).
1984: SIBIS becomes commercially available in the US
The Self-Injurious Behavior Inhibiting System (SIBIS) was released onto the US market by Human Technologies. The device was designed to reduce self-injurious behaviour directed at the head, such as punching, and delivered an electric shock to the wearer when triggered. The shock was mild, and lasted for 0.2 seconds.
1988 – 1990: Israel invents his own ESD
Israel used SIBIS on 29 students between 1988 and 1990. During this period, there was a day where he administered 5,000 shocks to a 12-year-old patient named Brandon. Seeing no positive change in his behaviour, Israel came to the conclusion that the shocks administered by the device were not painful enough to be truly aversive. When Human Technologies refused to build a stronger SIBIS at his request, Israel decided to build his own ESD, the GED.
The GED is placed inside a backpack from which electrodes placed over the body are strung. The original GED delivers a 15 to 30 milliamp shock, which lasts for two seconds. Later, the GED-4 was invented, delivering three times the charge of the original GED. The shocks are known to be extremely painful, and can leave burns, scabs and scars on the skin.
2006: JRC condemned by the state of New York
The New York State Education Department released a report saying the Judge Rotenberg Center was shocking patients “without a clear history of self-injurious behaviours.” The report found that residents were shocked with the GED for nagging, swearing or failing to maintain a neat appearance.
2007: Prank calls made instructing staff to shock students
Staff at one of JRC’s residential homes received a call they believed to be from a senior manager, instructing them to administer shocks to two male students aged 16 and 19. Over the following three hours, one of the boys was given 77 shocks, while the other received 29. It was later revealed that the phone call had been made by a prankster.
As a result of this incident, Israel was forced to resign as head of the school and was sentenced to five years’ probation. Prosecutors at the time said Israel had ordered his employees to destroy surveillance videos taken during the night in question.
2012: Footage of restrained student subject to ESD goes viral
A video from JRC showing 18-year-old Andre McCollins being shocked by an ESD was released to the public. In the video, he is restrained face-down, and is given repeated shocks, which cause him to cry out in pain. His mother, Cheryl McCollins, goes on to file a lawsuit against the centre.
2013: JRC condemned by the UN
The UN released a report concluding that the “rights of students of the JRC subjects to electric shocks and physical means of restraint have been violated under the UN convention against torture.”
2014: FDA takes first step to ban ESDs
The FDA held a public meeting of its Neurological Devices Panel to weigh up whether or not to ban the use of ESDs for self-injurious behaviour. The public comment period that followed drew more than 1,500 responses, with feedback overwhelmingly supporting a ban.
2016: FDA issues formal proposal to ban ESDs
Two years on from its first meeting into the matter, the FDA announced a formal proposal to ban ESDs like GEDs that are used to try and treat self-injurious behaviour and aggression.
2020: ESDs officially banned
The FDA officially banned ESDs to treat self-injury or aggressive behaviour on 4 March 2020, saying the devices “present an unreasonable and substantial risk of illness or injury.” It accepted that evidence showed that ESDs were linked to significant physical and psychological risks, including depression, anxiety, post-traumatic stress disorder, physical pain, burns and tissue damage, with weak evidence to support their effectiveness as a treatment for self-injury or aggression against this risk profile.
The ban took effect following its publication in the federal register on 6 April 2020, with compliance required within 30 days. For these patients, compliance was required within 180 days, to allow them time to transition to another treatment to manage their behaviour.