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ASPartOfMe
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17 Jul 2017, 5:25 am

Why hasn't FDA passed ban on medical device used at Massachusetts facility to shock students with disabilities?

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A special needs day and residential school in Canton, is the only school in the country using an electrical shocking device that the U.S. Food and Drug Administration (FDA) has proposed banning.

Judge Rotenberg Educational Center (JRC), uses electrical stimulation devices (ESDs), which send electrical shocks through electrodes attached to the skin.

In April 2016, the FDA proposed a rule banning the devices due to its "unreasonable and substantial risk to public health." Since then, nothing has changed.

Last April -- it seemed -- that after decades of similar complaints of students and complaints by those in the industry, the FDA was on the side of disability advocates.

On April 22, 2016 the FDA proposed the rule banning the devices. There was then a comment period until May 25, which got extended until July 25.

So why is the FDA taking so long to decide what course to take?

One reason is that this would only be the third time the FDA has passed a ban on a medical device. The first time was in 1983 for prosthetic hair fibers, which were scalp implantation devices to simulate natural hair. The FDA, however, found the devices did not work and could cause serious injury or illness.

They have also recently placed a ban on Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove. This rule was proposed April 1, 2016 and was banned January 18, 2017.

A standard drug approval process it takes the FDA about 10 months. But according to Stephanie Caccomo, FDA press officer, this doesn't follow the same guidelines and is unable to give a timeline on when it will be decided.

Another reason might be the topic's complex nature.

Depending on the number of comments and information brought in during that time, it could take the FDA some time to sort through all of it.

No matter the reason, the ball in now in the court of the Trump Administration.

Advocates had pushed the Obama Administration to finalize the ban but were unsuccessful, which means it is transferred to the next administration.

"There are a couple of possibliities for this rule going forward," said Samantha Crane, Legal Director at Autistic Self Advocacy Network. "One is the FDA could theoretically could just finalize the rule."

The other is much more complicated.

Typically, Crane said, when there's an administration change, the head of the FDA looks overs the pending rules and decides what moves forward. At this time, it's not uncommon to rewrite the rule, issue a new notice and allow for another comment period.

"It could easily take another year," Crane said.

Crane points out that the panel the FDA used to make this decision was academic, not political and is urging the administration to finalize the proposed rule, rather than going through these additional steps.

If the ban doesn't pass, however, advocates say they aren't giving up.



Bureaucracy can move fast if they want to - see travel ban.

There is nothing complicated about this. If hardened terrorists at Guantanamo were treated the way autistic teens are at the Rotenberg center there this would be massive international scandal. For over 30 years advocates have been trying to close this prison to no avail. I am usually the last person to talk this way but if the Trump admistratration keeps dragging thier feet some vigilantes need to go in and forcefully liberate the victims.


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Recovering from tongue cancer and suspected Ramsey Hunt Syndrome (Ear Shingles), somewhat verbal.
Identified and joined WP August 26, 2013
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CharityGoodyGrace
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17 Jul 2017, 6:47 pm

I agree... it had BETTER move fast. Get Trump to sign an executive order... thing is, I doubt he would about this.

It is never okay to make a person's life hell with shock devices or otherwise, to help them... because the whole point of helping them is making their life NOT hell.