{"id":619,"date":"2024-09-18T14:02:31","date_gmt":"2024-09-18T14:02:31","guid":{"rendered":"https:\/\/medical-article.com\/?p=619"},"modified":"2024-09-18T14:02:31","modified_gmt":"2024-09-18T14:02:31","slug":"unpacking-the-fdas-non-recall-recalls","status":"publish","type":"post","link":"https:\/\/medical-article.com\/?p=619","title":{"rendered":"Unpacking the FDA\u2019s Non-Recall Recalls"},"content":{"rendered":"

When the Agriculture Department<\/strong> posted a recall of chicken nuggets that might be contaminated, it directed consumers to return them or throw the stuff away<\/a>.<\/p>\n

When the Consumer Product Safety Commission<\/strong> announced that poorly designed baby loungers could suffocate babies, it warned consumers to immediately stop using them<\/a>.<\/p>\n

But when it comes to medical devices, the Food and Drug Administration<\/strong> and manufacturers routinely allow doctors and hospitals to continue using equipment that, as the government sees it, could injure or kill the patients it\u2019s supposed to help. KFF Health News recently highlighted the issue<\/a> of non-recall recalls in an examination of MitraClip<\/strong><\/a>, a cardiac implant.<\/p>\n

In 2016, medical device giant Abbott<\/strong> issued a recall for the device \u2014 \u201ca Class I recall, the most serious type,\u201d the FDA said. \u201cUse of this device may cause serious injuries or death,\u201d an FDA notice<\/a> said.<\/p>\n

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves.<\/p>\n

In a notice<\/a>, Abbott revised instructions for use and required doctors who implant the clips to undergo training.<\/p>\n

The company told KFF Health News that the device has been proved safe and effective \u201cbased on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,\u201d a condition in which blood flows backward through the heart\u2019s mitral valve. The condition can lead to heart failure and death.<\/p>\n

Medical device recalls can include \u201cremovals,\u201d in which the device is pulled from where it is used or sold, and \u201ccorrections,\u201d which address the problem in the field \u2014 for instance, by repairing, adjusting, relabeling or inspecting a device.<\/p>\n

\u201cIt\u2019s very oxymoronic,\u201d said Rita Redberg<\/strong>, a cardiologist at the University of California at San Francisco<\/strong> and former editor in chief of the journal JAMA Internal Medicine<\/strong>. \u201cA recall makes it sound like it\u2019s recalled. But that is not actually what it means.\u201d<\/p>\n

From 2019 through 2023, there were 338<\/strong> Class I medical device recalls, 164 <\/strong>of which were corrections and 174 <\/strong>of which were removals, FDA spokesperson Amanda Hils<\/strong> said.<\/p>\n

Some products undergo multiple recalls while still on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.<\/p>\n

\u201cWhen deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,\u201d FDA spokesperson Audra Harrison<\/strong> said.<\/p>\n

In some cases, a medical device that is the subject of a recall can remain on the market safely with a simple fix, said Sanket Dhruva<\/strong>, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don\u2019t remove devices can provide unwarranted reassurance and leave the public at risk, Dhruva said.<\/p>\n

\u201cDepending on the risks and benefits of the device versus the alternatives, it may be better to actually remove the recalled device from clinical use and the market,\u201d Redberg said.<\/p>\n

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org<\/a>.<\/em><\/p>\n

KFF Health News<\/a> is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF\u2014an independent source of health policy research, polling, and journalism. Learn more about KFF<\/a>.<\/p>\n

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This story can be republished for free (details<\/a>).<\/p>","protected":false},"excerpt":{"rendered":"

When the Agriculture Department posted a recall of chicken nuggets that might be contaminated, it directed consumers to return them or throw the stuff away. When the Consumer Product Safety Commission announced that poorly designed baby loungers could suffocate babies, it warned consumers to immediately stop using them. But when it comes to medical devices,…<\/p>\n","protected":false},"author":0,"featured_media":620,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-619","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles"],"_links":{"self":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts\/619"}],"collection":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=619"}],"version-history":[{"count":0,"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/posts\/619\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=\/wp\/v2\/media\/620"}],"wp:attachment":[{"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=619"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=619"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medical-article.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=619"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}