The FDA’s neurological devices panel will meet tomorrow to decide the fate of aversive electrical stimulation, devices that generate electrical shocks used by care providers in order to deter unwanted behavior.
The agency will considering banning the use of "noxious" electrical behavior modification over concerns that the practice may pose "a substantial and unreasonable risk of illness or injury." Only one U.S. institution, the Massachusetts-based Judge Rotenberg Center for special needs students, has recently manufactured and is still using electrical stimulation devices (ESDs). Their practices have drawn the ire of public interest groups as well as government watchdogs.
The 1st electrical stimulation devices (ESDs) for aversive conditioning were cleared by the FDA in 1976, based on technologies on the market prior to the FDA’s review authority. Devices currently manufactured by the JRC generate nearly 3 times as much current as the FDA-cleared versions, according to the agency memo.
JRC last won FDA clearance in 1994 for its "Graduated Electronic Decelerator" shock device. The FDA cleared the technology "for the treatment of patients, usually diagnosed as retarded or autistic, who exhibit self-injurious behavior of sufficient intensity and frequency to cause serious damage to themselves."
"The device should be used only on patients where alternate forms of therapy have been attempted and failed," the agency noted. Other ESD devices were cleared for use in helping patients to stop biting their nails or smoking.
JRC has defended its use of aversive shocks, noting that the technology is used only with parent permission and under the watchful eyes of attorneys assigned to the students.
