Electrical Stimulation Devices (ESDs)
ESDs Are Intended to Treat Self-injurious or Aggressive Behavior
The United States Food and Drug Administration (FDA) is proposing ban on ESDs because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.
Aversive conditioning devices were on the market prior to passage of the Medical Device Amendments on May 28, 1976. As such, these devices were included in FDA’s original device classification efforts.
Aversive conditioning devices were identified in the classification regulation (21 CFR part 882.5235) as “an instrument used to administer an electrical shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics” [Class II (performance standards)].
the FDA has cleared four ESDs for aversive conditioning for the treatment of SIB.
The main components of these devices are an electrical stimulus (“shock”) generation module, cutaneous electrodes, and either a remote monitor module or an automatic mechanism to trigger a stimulus to be applied to the patient. The stimulus generation module is carried by the patient via a waist or back pack, and the electrodes are attached to the patient’s skin. The remote monitor emits a radio signal that is uniquely coded to a specific generator module and is controlled by a trained practitioner who determines when it is appropriate to deliver an electrical shock to the patient. An example of a device with an automatic trigger is the SIBIS (Self-Injurious Behavior Inhibiting System) device (K853178) in which an acceleration sensor module is placed in a headband worn by the patient. When the sensor detects a blow to the head that is sufficient enough, it triggers an electrical stimulus to be applied to electrodes placed on the patient’s body.
FDA Authority to Ban Devices
Section 516 of the Federal Food, Drug, and Cosmetic Act (the Act) authorizes FDA to ban, by regulation, any device intended for human use that “presents substantial deception or an unreasonable and substantial risk of illness or injury.”
According to 21 U.S.C. § 360f(a); 21 CFR § 895.21(a)(3), the FDA is required to consider “all available data and information” in making a banning determination. This information can include data obtained under other provisions of the Act, information supplied by manufacturers, and any other information submitted voluntarily as required by 21 CFR § 895.21(a)(3)
21 U.S.C. § 360f(a) states:
(a) General rule. Whenever the Secretary finds, on the basis of all available data and information, that
- device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury; and
- in the case of substantial deception or an unreasonable and substantial risk of illness or injury which the Secretary determined could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period;
he may initiate a proceeding to promulgate a regulation to make such device a banned device.
Before banning a device, FDA must make a specific determination that the substantial deception or unreasonable and substantial risk cannot be eliminated by a change in the labeling for the device. According to the statute, if FDA finds that the deception or risk can be corrected or eliminated through labeling, FDA must notify the manufacturer of the need for revised labeling and provide a specified period for the manufacturer to implement the revision. 21 U.S.C. § 360f(a)(2); see also 21 C.F.R. § 895.21(c). For instance, FDA can require labeling to include a specific statement, notice, or warning presented in a specific manner and form. 21 C.F.R. § 895.25(b). If the manufacturer fails to implement the change within the period specified by FDA, the agency may initiate the banning process.
ESDs administer electrical shocks through electrodes attached to the skin of individuals to attempt to condition them to stop engaging in self-injurious or aggressive behavior. Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, including depression, anxiety, worsening of self-injury behaviors and symptoms of posttraumatic stress disorder, pain, burns, tissue damage and errant shocks from a device malfunction. In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain or consent. As these risks cannot be eliminated through new or updated labeling, banning the product is necessary to protect public health.
The FDA considered all available evidence, including clinical and scientific data, input from experts in the field and state agencies, comments from JRC, individuals and parents of individuals on whom ESDs have been used, and disability rights groups, as well as insights from an April 2014 FDA advisory panel.
“Our primary concern is the safety and well-being of the individuals who are exposed to these devices,” said Acting Director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “These devices are dangerous and a risk to public health–and we believe they should not be used.”
According to FDA, at this time, the FDA has information that indicates only one facility is using these devices in the United States, the Judge Rotenberg Educational Center (JRC) in Canton, Massachusetts, and estimates between 45 and 50 individuals are currently being exposed to the device. The FDA believes that state-of-the-art behavioral treatments, such as positive behavioral support, and medications can enable health care providers to find alternative approaches for curbing self-injurious or aggressive behaviors in their patients.
- FDA’s proposed rule is available here >
Publication Date:Monday, April 25, 2016
- Agency: Food and Drug Administration
- Type: Proposed Rule
- Pages: 124
- Document Number:2016-09433
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Last Updated: 2016-04-22
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