{"id":3649,"date":"2021-05-13T11:59:57","date_gmt":"2021-05-13T03:59:57","guid":{"rendered":"https:\/\/www.cosmomed.com.tw\/?p=3649"},"modified":"2024-07-22T12:51:15","modified_gmt":"2024-07-22T04:51:15","slug":"fda-recall-fluid-warmer","status":"publish","type":"post","link":"https:\/\/www.cosmomed.com.tw\/en\/fda-recall-fluid-warmer\/","title":{"rendered":"Another fluid warmer recall due to aluminum exposure"},"content":{"rendered":"\n
\"\"<\/figure><\/div>\n\n\n\n

FDA\u8fd1\u671f\u767c\u5e03\u4e00\u5247\u5e02\u552e\u8f38\u6db2\u52a0\u6eab\u5668\u7684\u8017\u6750\u53ec\u56de\u8b66\u544a[1]\uff0c\u539f\u56e0\u5728\u65bc\u8a72\u52a0\u6eab\u5668\u8017\u6750\u4f7f\u7528\u92c1\u677f\u76f4\u63a5\u52a0\u6eab\u6db2\u9ad4\uff0c\u9019\u53ef\u80fd\u5c0e\u81f4\u52a0\u6eab\u904e\u7a0b\u4e2d\u904e\u91cf\u7684\u92c1\u6d29\u6f0f\u5230\u8f38\u6ce8\u6db2\u4e2d\uff0c\u4f7f\u75c5\u4eba\u66b4\u9732\u65bc\u9ad8\u542b\u91cf\u7684\u92c1\u96e2\u5b50\uff0c\u5c0d\u65bc\u65b0\u751f\u5152\u3001\u5b30\u5152\u3001\u5b55\u5a66\u3001\u8001\u5e74\u4eba\u3001\u814e\u529f\u80fd\u4e0d\u4f73\u8005\u6216\u662f\u63a5\u53d7\u900f\u6790\u7684\u75c5\u4eba\u4f86\u8aaa\u9019\u9805\u98a8\u96aa\u5c07\u66f4\u9ad8\u3002<\/p>\n\n\n\n

\u5118\u7ba1\u76ee\u524d\u5c1a\u672a\u50b3\u51fa\u75c5\u4eba\u53d7\u50b7\u6216\u6b7b\u4ea1\u7684\u901a\u5831\uff0cFDA\u5df2\u5c07\u5176\u6b78\u985e\u70ba\u7b2c\u4e00\u7d1a\u53ec\u56de(Class I)\uff0c\u9019\u662f\u6700\u56b4\u91cd\u7684\u53ec\u56de\u7b49\u7d1a\uff0c\u610f\u5473\u8457\u4f7f\u7528\u8a72\u8a2d\u5099\u53ef\u80fd\u6703\u5c0e\u81f4\u56b4\u91cd\u7684\u4eba\u8eab\u50b7\u5bb3\u751a\u81f3\u6b7b\u4ea1\u3002<\/p>\n\n\n\n

\u81ea2019\u5e74\u9019\u5df2\u662f\u7b2c\u4e8c\u8d77\u8f38\u6db2\u52a0\u6eab\u5668\u56e0\u53ef\u80fd\u91cb\u653e\u904e\u91cf\u92c1\u96e2\u5b50\u800c\u906d\u5230FDA\u53ec\u56de\u3002\u4e8b\u5be6\u4e0a\uff0c\u92c1\u7684\u6bd2\u6027\u4f5c\u7528\u88ab\u8a8d\u70ba\u662f\u9577\u671f\u6027\u7684[3]\uff0c\u8fd1\u671f\u4ea6\u6709\u7814\u7a76\u5df2\u8b49\u5be6\u92c1\u8207\u963f\u8332\u6d77\u9ed8\u75c7\u7684\u95dc\u806f\u6027[4]\uff0c\u542b\u92c1\u6750\u8cea\u7684\u8f38\u6db2\u52a0\u6eab\u8017\u6750\u53ef\u80fd\u9700\u8981\u88ab\u5be9\u614e\u7684\u8a55\u4f30\u4f7f\u7528\uff0c\u5c24\u5176\u662f\u7576\u5b83\u5011\u904e\u53bb\u5e38\u7528\u65bc\u91cd\u75c7\u60a3\u8005\u3002<\/p>\n\n\n\n

\u201cI do not agree that less toxic is a sufficient reason to continue their use and especially so when they are being used in individuals who are already critically ill.\u201d[2]

\u6211\u4e0d\u540c\u610f\u5c07\u6bd2\u6027\u8f03\u4f4e\u4f5c\u70ba\u7e7c\u7e8c\u4f7f\u7528\u5b83\u5011\u7684\u85c9\u53e3\uff0c\u5c24\u5176\u662f\u7528\u5728\u91cd\u75c7\u60a3\u8005\u8eab\u4e0a\u3002[2]<\/p>Christopher Exley, The Birchall Centre, Lennard-Jones Laboratories, Keele University<\/cite><\/blockquote>\n\n\n\n

\u7121\u92c1\u6bd2\u7591\u616e \u300e\u8c9d\u723e\u66fc\u7279\u8f38\u6db2\u7ba1\u7406\u7cfb\u7d71<\/strong>\u300f
\u8c9d\u723e\u66fc\u7279\u8f38\u6db2\u7ba1\u7406\u7cfb\u7d71<\/a>\u4f7f\u7528\u5c08\u5229\u96fb\u78c1\u52a0\u6eab\u6280\u8853\u3001\u91ab\u7642\u7b49\u7d1a\u4e0d\u93fd\u92fc\u71b1\u4ea4\u63db\u5668\uff0c\u5168\u54c1\u9805\u8017\u6750\u4e0d\u542b\u92c1<\/strong>\u3001\u7121\u92c1\u6bd2\u7591\u616e\u3002\u9ede\u64ca\u6309\u9375\uff0c\u5373\u523b\u70ba\u60a8\u57f7\u884c\u5feb\u901f\u3001\u53ef\u9760\u3001\u9664\u6c23\u7684\u8f38\u6db2\u3001\u8f38\u8840\u6cbb\u7642\u3002<\/p>\n\n\n\n

\"\"<\/figure><\/div>\n\n\n\n

\u53c3\u8003\u8cc7\u6599\uff1a<\/strong>
[1].Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum<\/a>
[2].Exley C. Aluminium-based fluid warmers are not proven to be safe. Anaesthesia. 2020 Jun;75(6):833. doi: 10.1111\/anae.15013. PMID: 32383512.<\/a>
[3].Perl T, Kunze-Szikszay N, Br\u00e4uer A, Roy T. Quantified aluminium levels released into blood and fluids using the Level 1 Fast Flow Fluid Warmer. Anaesthesia. 2020 Jun;75(6):834. doi: 10.1111\/anae.15020. PMID: 32383510.<\/a>
[4].Mold M, Linhart C, G\u00f3mez-Ram\u00edrez J, Villegas-Lanau A, Exley C. Aluminum and Amyloid-\u03b2 in Familial Alzheimer’s Disease. J Alzheimers Dis. 2020;73(4):1627-1635. doi: 10.3233\/JAD-191140. PMID: 31958088.<\/a>
<\/p>\n","protected":false},"excerpt":{"rendered":"

The FDA declared that the recall of an emergency infusion device kit which warms fluids directly with an aluminum plate, may leak aluminum into the fluids and expose patients to high levels of the metal.<\/p>","protected":false},"author":1,"featured_media":3669,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","jetpack_post_was_ever_published":false},"categories":[65],"tags":[383,352,66,127,222,94,91,384,102,354,71,96],"class_list":["post-3649","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-info","tag-aluminum-free","tag-belmont-medical","tag-belmont-rapid-infuser","tag-cosmo-medical","tag-fms2000","tag-ri-2","tag-91","tag-384","tag-102","tag-354","tag-71","tag-96"],"jetpack_featured_media_url":"https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3.jpg","jetpack_shortlink":"https:\/\/wp.me\/paJTt6-WR","rttpg_featured_image_url":{"full":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3.jpg",658,466,false],"landscape":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3.jpg",658,466,false],"portraits":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3.jpg",658,466,false],"thumbnail":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3-300x212.jpg",300,212,true],"medium":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3-400x283.jpg",400,283,true],"large":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3.jpg",658,466,false],"1536x1536":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3.jpg",658,466,false],"2048x2048":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3.jpg",658,466,false],"trp-custom-language-flag":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3-18x12.jpg",18,12,true],"hestia-blog":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3-360x240.jpg",360,240,true],"woocommerce_thumbnail_2x":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3-460x460.jpg",460,460,true],"woocommerce_thumbnail":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3-230x230.jpg",230,230,true],"woocommerce_single":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3-600x425.jpg",600,425,true],"woocommerce_gallery_thumbnail":["https:\/\/www.cosmomed.com.tw\/wp-content\/uploads\/2021\/05\/fluid-warmer-recall-3-160x160.jpg",160,160,true]},"rttpg_author":{"display_name":"pohsun","author_link":"https:\/\/www.cosmomed.com.tw\/en\/author\/pohsun\/"},"rttpg_comment":0,"rttpg_category":"\u8cc7\u8a0a<\/a>","rttpg_excerpt":"\u4f60\u4f7f\u7528\u7684\u8f38\u6db2\u52a0\u6eab\u5668\u542b\u92c1\u55ce\uff1f\u518d\u6b21\u6709\u5e02\u552e\u8f38\u6db2\u52a0\u6eab\u7cfb\u7d71\u7684\u542b\u92c1\u8017\u6750\u88abFDA\u53ec\u56de\uff0c\u8a72\u8017\u6750\u53ef\u80fd\u5728\u52a0\u6eab\u904e\u7a0b\u4e2d\u6703\u6d29\u6f0f\u904e\u91cf\u7684\u92c1\u5230…","_links":{"self":[{"href":"https:\/\/www.cosmomed.com.tw\/en\/wp-json\/wp\/v2\/posts\/3649","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cosmomed.com.tw\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cosmomed.com.tw\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cosmomed.com.tw\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cosmomed.com.tw\/en\/wp-json\/wp\/v2\/comments?post=3649"}],"version-history":[{"count":1,"href":"https:\/\/www.cosmomed.com.tw\/en\/wp-json\/wp\/v2\/posts\/3649\/revisions"}],"predecessor-version":[{"id":6493,"href":"https:\/\/www.cosmomed.com.tw\/en\/wp-json\/wp\/v2\/posts\/3649\/revisions\/6493"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.cosmomed.com.tw\/en\/wp-json\/wp\/v2\/media\/3669"}],"wp:attachment":[{"href":"https:\/\/www.cosmomed.com.tw\/en\/wp-json\/wp\/v2\/media?parent=3649"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cosmomed.com.tw\/en\/wp-json\/wp\/v2\/categories?post=3649"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cosmomed.com.tw\/en\/wp-json\/wp\/v2\/tags?post=3649"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}