Stop The Shock! – A Follow Up

I continue to be appalled at the fact that “electrical stimulation devices”, as they are clinically referred to by the U.S. Food and Drug Administration, are still to date not banned for use against people with self-injurious or aggressive behaviors. As we mentioned last month, it has been 2 years since the FDA submitted a proposed rule to ban the use of these devices. They state the following reason for the proposed ban in their summary:

“The Food and Drug Administration (FDA or we) is proposing to ban electrical stimulation devices used to treat aggressive or self-injurious behavior. FDA has determined 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.”

In the Executive Summary of the proposed rule the FDA writes:

“The effects of the shock are both psychological (including suffering) and physical (including pain), each having a complex relationship with the electrical parameters of the shock. As a result, the subjective experience of the person receiving the shock can be difficult to predict.” In addition, the findings included a determination by the FDA that “ESDs for SIB or AB present a number of psychological and physical risks: Depression, fear, escape and avoidance behaviors, panic, aggression, substitution of other behaviors (e.g., freezing and catatonic sit-down), worsening of underlying symptoms (e.g., increased frequency or bursts of self-injury), pain, burns, tissue damage, and errant shocks from device misapplication or failure. Based on literature for implantable cardioverter defibrillators, FDA has determined that ESDs present the risks of posttraumatic stress or acute stress disorders, shock stress reaction, and learned helplessness.”

Let’s just take a quick review of the timeline so far…

• April 25, 2016 the proposed rule banning the use of ESDs was published in the Federal Register
• May 25, 2016 was the deadline to receive public comment
• The total number of public comments received was 1209
• April 13, 2018 the FDA is still reviewing the public comments, according to the spokesperson for the FDA

I have to ask the FDA this question(s)…If you know, and you do because you published it, that shocking people causes pain and suffering how long do you propose it will take to issue this ban and stop the pain and suffering? How much longer will it take to review the 1209 comments that basically reinforce that fact that this is inhumane treatment and a violation of the basic human right to live free and safe from harm? What else do you need from the advocacy community to convince you to publish a final rule?

The fact that this is not already banned is more than frightening because it means that we, society as a whole, have not come to the point where we respect the rights and human dignity of people who happen to have challenging behaviors.

Teresa Anderson, Policy Director, The Arc of California