FDA makes rare move to ban a type of medical device

The FDA March 4 published a final rule to ban electrical stimulation devices, or ESDs, that are used to prevent self-injurious or aggressive behavior. 

The agency called the ban "necessary to protect public health" since many people that the devices have been used on have intellectual or developmental disabilities that make it difficult for them to communicate their pain.

This is only the third time the FDA has banned a type of medical device, but the agency said they "present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling."

The devices work by delivering electric shocks through electrodes attached to a patient's skin and are supposed to immediately interrupt self-injurious or aggressive behavior or to condition the patient to stop engaging in such behavior. 

The FDA said evidence has indicated a number of significant risks, both psychological and physical, are associated with the use of the devices, including depression, anxiety, post-traumatic stress disorder, pain, burns and tissue damage.

"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," the agency wrote. 

The FDA said it is only aware of one facility in the U.S. that still uses the devices, the Judge Rotenberg Educational Center, a special education center in Canton, Mass. The devices are used on 45 to 50 people at the center, the agency said. 

The FDA clarified that this final rule only applies to devices being used for self-injurious or aggressive behavior and doesn't apply to similar devices used for other purposes, such as for helping people to quit smoking.

Read the full news release here

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