FDA Warns Judge Rotenberg Center

See this story from ABC News.  It begins:

A Boston area school for severely disabled children has received a warning letter from the U.S. Food and Drug Administration over its use of devices that administer shocks to its students when they misbehave, a form of restraint that is at the extreme end of a practice that has lawmakers calling for nationwide reform.

The devices "violate the Federal Food, Drug, and Cosmetic Act because your facility has failed to obtain FDA clearance or approval," the Dec. 6 letter to the Judge Rotenberg Educational Center says. An earlier version had FDA approval.

Disturbing video showing staff at the school administering 31 shocks in 2002 to a teenager with autistic characteristics, Andre McCollins, was part of a recent ABC News report about children who have been injured or killed while being restrained in school. The school's use of what it called "skin shocks" represents an extreme example, but is not the only measure that has brought objections from critics. Other schools have faced criticism for using handcuffs, stuffing children into so-called therapy bags, or placing them in small padded chambers known as seclusion rooms.