{"id":670,"date":"2024-03-27T12:04:50","date_gmt":"2024-03-27T12:04:50","guid":{"rendered":"https:\/\/retirednurseblog.com\/index.php\/2024\/03\/27\/fda-renews-proposed-ban-on-electrical-stimulation-devices\/"},"modified":"2024-03-27T12:04:50","modified_gmt":"2024-03-27T12:04:50","slug":"fda-renews-proposed-ban-on-electrical-stimulation-devices","status":"publish","type":"post","link":"https:\/\/retirednurseblog.com\/index.php\/2024\/03\/27\/fda-renews-proposed-ban-on-electrical-stimulation-devices\/","title":{"rendered":"FDA renews proposed ban on electrical stimulation devices"},"content":{"rendered":"<div>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/clu78gsqk000g3b6h3ubh6ja1@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The US Food and Drug Administration is again proposing a ban on electrical stimulation devices used to reduce or stop self-injurious or aggressive behavior, the agency said in a statement Monday.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/clu7afnya00023b6h3hepz5it@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Electrical stimulation devices deliver electrical shocks through electrodes attached to a person\u2019s skin to attempt to reduce or stop harmful behaviors. The only facility currently using these devices in the US is the Judge Rotenberg Education Center in Canton, Massachusetts, where an estimated 50 people have a treatment plan that includes the potential use of such a device, according to the statement.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/clu7afm1g00003b6hta3d4jr4@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The FDA says it has taken this rare step of banning a previously approved device because electrical stimulation devices \u201cpresent an unreasonable and substantial risk of illness or injury.\u201d    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/clu78chua00033b6hqfntc0cr@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            This is the second time the FDA has proposed a ban on these devices. In 2020, the agency issued a final rule that banned the devices from the marketplace, but that rule was annulled after a federal appeals court ruled that the FDA did not have the authority to ban the devices under the Federal Food, Drug, and Cosmetic Act.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/clu78chua00043b6h30z01zgm@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Since that decision, changes to the act have made it clear that the FDA does have the authority to issue such a ban, according to Monday\u2019s statement.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/clu78chua00053b6hapyxynn3@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The FDA said the devices \u201cpresent\u00a0a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.\u201d    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/clu78chua00063b6hian28nlb@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            \u201cNotably, some people who exhibit self-injurious or aggressive behavior have intellectual or developmental disabilities that make it difficult for them to communicate or make their own treatment decisions,\u201d the agency said.    <\/p>\n<div data-uri=\"cms.cnn.com\/_components\/factbox\/instances\/clu78ib0a000s3b6h9wgdfshv@published\" class=\"factbox_inline-small         factbox_inline-small__standard  \" data-article-gutter=\"true\">\n<ul class=\"factbox_inline-small__items factbox_inline-small__items--ul\">  <\/ul>\n<\/div>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/clu78chua00073b6hw6ki457n@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The proposed ban would apply only to electrical stimulation devices intended to be used for self-injurious or aggressive behavior, not to aversive conditioning devices used for other purposes, such as smoking cessation, the agency said.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/clu78chua00093b6hk30a2d4y@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            \u201cThose exposed to these devices may need time to gradually transition away from this device and adjust treatment plans.\u00a0The FDA intends to consider the needs of these patients should we finalize the proposed ban,\u201d it said.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/clu78chua000a3b6h6sbe4ft6@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Other behavioral treatments, such as positive behavioral support and medications, are alternative approaches for self-injurious or aggressive behaviors, the FDA said in 2020.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/clu78chua000b3b6h7fsff2th@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The new proposal will be open for comment until May 28, after which the FDA will review and consider comments before determining whether to issue a final rule.    <\/p>\n<\/p>\n<div>This post appeared first on cnn.com<\/div>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"<p>The US Food and Drug Administration is again proposing a ban on electrical stimulation devices used to reduce or stop self-injurious or aggressive behavior, the agency said in a statement Monday. Electrical stimulation devices deliver electrical shocks through electrodes attached to a person\u2019s skin to attempt to reduce or stop harmful behaviors. The only facility &#8230;<\/p>\n","protected":false},"author":1,"featured_media":671,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"loftocean_post_primary_category":0,"loftocean_post_format_gallery":"","loftocean_post_format_gallery_ids":"","loftocean_post_format_gallery_urls":"","loftocean_post_format_video_id":0,"loftocean_post_format_video_url":"","loftocean_post_format_video_type":"","loftocean_post_format_video":"","loftocean_post_format_audio_type":"","loftocean_post_format_audio_url":"","loftocean_post_format_audio_id":0,"loftocean_post_format_audio":"","loftocean-featured-post":"","loftocean-like-count":0,"loftocean-view-count":520,"tinysalt_single_post_intro_label":"","tinysalt_single_post_intro_description":"","tinysalt_hide_post_featured_image":"","tinysalt_post_featured_media_position":"","tinysalt_single_site_header_source":"","tinysalt_single_custom_site_header":"0","tinysalt_single_custom_sticky_site_header":"0","tinysalt_single_custom_sticky_site_header_style":"sticky-scroll-up","tinysalt_single_site_footer_source":"","tinysalt_single_custom_site_footer":"0","footnotes":""},"categories":[35],"tags":[],"class_list":["post-670","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-news"],"_links":{"self":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts\/670","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/comments?post=670"}],"version-history":[{"count":0,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts\/670\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/media\/671"}],"wp:attachment":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/media?parent=670"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/categories?post=670"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/tags?post=670"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}