{"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 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