3 June 2016
Ban on Electrical Stimulation Devices Used to Treat Aggressive Behaviour Under Consideration
The Food and Drug Administration is giving interested parties until 25 July to comment on a proposal to ban electrical stimulation devices used to treat aggressive or self-injurious behaviour. The agency has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labelling and is therefore proposing to include in this ban both new devices and devices already in distribution and use.
ESDs are devices that apply a noxious electrical stimulus to a person’s skin upon the occurrence of a target behaviour in an attempt to condition the individual over time to reduce or cease that behaviour. Self-injurious and aggressive behaviours frequently manifest in the same individual and people with intellectual or developmental disabilities exhibit these behaviours at disproportionately high rates. Notably, many such individuals have difficulty communicating and cannot make their own treatment decisions because of such disabilities. SIB commonly include head-banging, hand-biting, excessive scratching and picking of the skin, although more extreme SIB may result in bleeding, protruding and broken bones, blindness from eye-gouging or poking, other permanent tissue damage, or injuries from swallowing dangerous objects or substances. AB involve repeated physical assaults and can be a danger to the individual, others or property.
ESDs are intended to reduce SIB and AB according to the principle of aversive conditioning. Aversive conditioning pairs a noxious stimulus with a target behaviour such that the individual begins to associate the noxious stimulus with the behaviour, with the intended result being that the individual ceases engaging in the behaviour and, over time, becomes conditioned not to manifest the target behaviour. The noxious stimulus delivered by an ESD is an electric shock to the skin. Some ESDs are intended for other purposes, such as smoking cessation, although the proposed ban includes only those devices intended to reduce or eliminate SIB or AB. ESDs are not used in electroconvulsive therapy, sometimes called electroshock therapy or ECT, which is unrelated to the proposal at hand.
Whenever the FDA finds, on the basis of all available data and information, that a device presents substantial deception or an unreasonable and substantial risk of illness or injury, and that such deception or risk cannot be or has not been corrected or eliminated by labelling or by a change in labelling, it may initiate a proceeding to ban the device. In making such a finding, the FDA weighs the benefits against the risks posed by the device and considers the risks relative to the state of the art. With respect to ESDs for SIB and AB, the FDA has weighed these factors based on consideration of information from a variety of sources, including the scientific literature, opinions from experts, information from and actions of state agencies, information from the affected manufacturer, information from patients and their family members, and information from other stakeholders.