UPDATED (4/24/14, 20:36 ET): The Neurological Devices Panel of the FDA has recommended banning electrical stimulation devices (ESDs). FDA is not obliged to follow the advice of its advisory panels, but often does.
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The Neurological Devices Panel (NDP) of the Medical Devices Advisory Committee to the FDA is meeting today to discuss a possible ban on electrical stimulation devices (ESDs) for aversive conditioning. According to the Food, Drug, and Cosmetic Act, FDA has the authority to ban medical devices that present "an unreasonable and substantial risk of illness or injury." The NDP will review the efficacy and safety of ESDs as compared with other therapies such as pharmaceuticals, surgery, and behavior modification therapy in order to make its recommendation.
ESDs have been in use for decades in the United States. When the Medical Device Amendments were passed in 1976, some ESDs were already on the market. FDA recommended classifying them as Class II, based on the belief the electrical hazards they posed, such as accidental leakage of current, could be "managed with performance standards." FDA received no public comment on this proposed rule, which became final in 1979. Like all Class II devices, ESDs are subject to the 510(k) process, which means that new devices may be introduced without submitting full clinical trial data, provided the manufacturer can demonstrate that they are "substantially equivalent" to devices already on the market. As Brent Ardaugh and his colleagues documented in a 2013 New England Journal of Medicine article, the 510(k) submission process has the potential for allowing devices with little similarity to existing devices to enter the marketplace without appropriate testing.
Despite the fairly long existence of ESDs, many Americans did not become aware of them until the advocacy group Mental Disability Rights International (MDRI) submitted a report to the United Nations documenting abuse involving ESDs and restraint devices at the Judge Rotenberg Educational Center (JRC) in Massachusetts. The JRC, which is still in operation, has what its staff call a "near-zero rejection policy," which means that nearly all individuals who apply to the school are accepted and permitted to stay, regardless of the severity of their behavior problems. According to MDRI, however, the treatment for many JRC students involves painful, damaging shocks delivered by a Graduated Electronic Decelerator (GED) as often as dozens or even hundreds of times per day. A psychologist from the New York State Department of Education who visited the JRC is quoted in the MDRI report as saying, "No other class of citizen in the United States could be subjected to this." In 2011, Governor Deval Patrick banned the use of GEDs for any new student at the JRC, but the legality of ESDs nationwide is still an open question.
At the present time, FDA acknowledges risks of ESDs other than accidental electrical current leakage. In preparation for today's meeting, FDA prepared a list of questions for the NDP, including an item about the risks of ESDs. Risks identified by FDA include acute stress and post-traumatic stress disorder (PTSD); anxiety and other negative emotional reactions; depression, including the potential for suicidality; neurological injury; pain; psychosis; substitution of negative behaviors other than the target behavior; and tissue damage, including burns. FDA has asked its panelists to weigh in on whether this list is accurate and complete as part of making a recommendation for or against a ban on ESDs.
If the panel recommends against a ban, one reason might be the possibility of risk-mitigation strategies such as alterations to existing devices (and guidelines for future devices) that would limit their ability to cause harm. Other strategies to reduce the risk posed by ESDs include label changes, such as restricting the use of ESDs for aversive therapy to only those individuals whose self-injurious behaviors pose a threat to their own lives. If the panel recommends banning ESDs, panelists must also consider whether such a ban would affect individuals currently receiving aversive therapy via ESDs.
Finally, the panel has been asked to consider the separate question of whether a clinical trial for ESDs could ever be conducted ethically, and if so, how. An update will be provided on this site after the Neurological Device Panel makes its recommendations.