{"id":3905,"date":"2025-09-04T13:57:56","date_gmt":"2025-09-04T05:57:56","guid":{"rendered":"https:\/\/rohs.ac.cn\/?p=3905"},"modified":"2025-09-04T13:57:56","modified_gmt":"2025-09-04T05:57:56","slug":"mdr%e6%98%af%e4%bb%80%e4%b9%88","status":"publish","type":"post","link":"https:\/\/rohs.ac.cn\/?p=3905","title":{"rendered":"mdr\u662f\u4ec0\u4e48"},"content":{"rendered":"<p>MDR\u662f\u4ec0\u4e48\uff1f\u8fd9\u662f\u4e00\u4e2a\u5728\u591a\u4e2a\u4e13\u4e1a\u9886\u57df\u4e2d\u51fa\u73b0\u9891\u7387\u6781\u9ad8\u7684\u7f29\u5199\uff0c\u5b83\u53ef\u80fd\u6307\u4ee3\u533b\u5b66\u4e0a\u7684\u591a\u91cd\u8010\u836f\u83cc\uff0c\u4e5f\u53ef\u80fd\u6307\u4ee3\u6b27\u76df\u533b\u7597\u5668\u68b0\u9886\u57df\u7684\u65b0\u6cd5\u89c4<\/p>\n<\/p>\n<p>\u5bf9\u4e8e\u533b\u7597\u4ece\u4e1a\u8005\u3001\u60a3\u8005\u5bb6\u5c5e\u3001\u533b\u7597\u5668\u68b0\u884c\u4e1a\u7684\u4ece\u4e1a\u8005\u4e43\u81f3\u91d1\u878d\u6295\u8d44\u8005\u800c\u8a00\uff0c\u51c6\u786e\u7406\u89e3MDR\u7684\u5728\u4e0d\u540c\u8bed\u5883\u4e0b\u7684\u5177\u4f53\u542b\u4e49\u81f3\u5173\u91cd\u8981<\/p>\n<\/p>\n<p><strong>\u4e00\u3001 MDR\u5728\u533b\u5b66\u9886\u57df\u7684\u542b\u4e49\uff1a\u591a\u91cd\u8010\u836f\u83cc<\/strong><\/p>\n<p>\u5728\u4e34\u5e8a\u533b\u5b66\u548c\u516c\u5171\u536b\u751f\u9886\u57df\uff0cMDR\u662f\u201cMultidrug-Resistant\u201d\u7684\u7f29\u5199\uff0c\u901a\u5e38\u4e0e\u201corganism\u201d\uff08\u5fae\u751f\u7269\uff09\u8fde\u7528\uff0c\u610f\u4e3a\u201c\u591a\u91cd\u8010\u836f\u6027\u5fae\u751f\u7269\u201d\uff0c\u5373\u6211\u4eec\u5e38\u8bf4\u7684\u591a\u91cd\u8010\u836f\u83cc<\/p>\n<\/p>\n<p>\u8fd9\u7c7b\u7ec6\u83cc\u5bf9\u591a\u79cd\u539f\u672c\u6709\u6548\u7684\u6297\u83cc\u836f\u7269\u540c\u65f6\u8868\u73b0\u51fa\u8010\u836f\u6027\uff0c\u7ed9\u611f\u67d3\u6027\u75be\u75c5\u7684\u6cbb\u7597\u5e26\u6765\u4e86\u5de8\u5927\u6311\u6218<\/p>\n<\/p>\n<p><strong>1. MDR\u7684\u5b9a\u4e49\u4e0e\u6807\u51c6<\/strong><\/p>\n<p>\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u548c\u7f8e\u56fd\u75be\u75c5\u63a7\u5236\u4e0e\u9884\u9632\u4e2d\u5fc3\uff08CDC\uff09\u7b49\u6743\u5a01\u673a\u6784\u5bf9MDR\u6709\u8f83\u4e3a\u660e\u786e\u7684\u5b9a\u4e49<\/p>\n<\/p>\n<p>\u901a\u5e38\uff0c\u4e00\u79cd\u7ec6\u83cc\u5982\u679c\u5bf9\u4e09\u7c7b\u6216\u4e09\u7c7b\u4ee5\u4e0a\u4e0d\u540c\u79cd\u7c7b\u7684\u6297\u83cc\u836f\u7269\uff08\u5982\u03b2-\u5185\u9170\u80fa\u7c7b\u3001\u55b9\u8bfa\u916e\u7c7b\u3001\u6c28\u57fa\u7cd6\u82f7\u7c7b\u7b49\uff09\u4ea7\u751f\u8010\u836f\u6027\uff0c\u5373\u53ef\u88ab\u5f52\u7c7b\u4e3aMDR<\/p>\n<\/p>\n<p>\u6bd4MDR\u66f4\u4e25\u91cd\u7684\u662f\u5e7f\u6cdb\u8010\u836f\u83cc\uff08XDR\uff09\u548c\u5168\u8010\u836f\u83cc\uff08PDR\uff09\uff0c\u540e\u8005\u51e0\u4e4e\u5bf9\u6240\u6709\u5e38\u89c4\u6297\u751f\u7d20\u8010\u836f<\/p>\n<\/p>\n<p><strong>2. \u5e38\u89c1\u7684MDR\u7ec6\u83cc\u53ca\u5176\u5371\u5bb3<\/strong><\/p>\n<p>\u4e34\u5e8a\u4e0a\u4ee4\u4eba\u95fb\u4e4b\u8272\u53d8\u7684\u201c\u8d85\u7ea7\u7ec6\u83cc\u201d\u5927\u591a\u5c5e\u4e8eMDR\u8303\u7574<\/p>\n<\/p>\n<p>\u4f8b\u5982\u8010\u7532\u6c27\u897f\u6797\u91d1\u9ec4\u8272\u8461\u8404\u7403\u83cc\uff08MRSA\uff09\u3001\u8010\u4e07\u53e4\u9709\u7d20\u80a0\u7403\u83cc\uff08VRE\uff09\u3001\u4ea7\u8d85\u5e7f\u8c31\u03b2-\u5185\u9170\u80fa\u9176\uff08ESBLs\uff09\u7684\u80a0\u6746\u83cc\u79d1\u7ec6\u83cc\uff08\u5982\u5927\u80a0\u57c3\u5e0c\u83cc\u3001\u80ba\u708e\u514b\u96f7\u4f2f\u83cc\uff09\u3001\u4ee5\u53ca\u591a\u91cd\u8010\u836f\u94dc\u7eff\u5047\u5355\u80de\u83cc\u548c\u9c8d\u66fc\u4e0d\u52a8\u6746\u83cc\u7b49<\/p>\n<\/p>\n<p>\u8fd9\u4e9b\u7ec6\u83cc\u5f15\u8d77\u7684\u611f\u67d3\u5f80\u5f80\u5bfc\u81f4\u60a3\u8005\u6cbb\u7597\u65f6\u95f4\u5ef6\u957f\u3001\u533b\u7597\u8d39\u7528\u5927\u5e45\u589e\u52a0\uff0c\u751a\u81f3\u6b7b\u4ea1\u7387\u663e\u8457\u5347\u9ad8\uff0c\u5df2\u6210\u4e3a\u5168\u7403\u6027\u7684\u516c\u5171\u536b\u751f\u5371\u673a<\/p>\n<\/p>\n<p><strong>3. MDR\u7684\u4ea7\u751f\u539f\u56e0\u4e0e\u9632\u63a7<\/strong><\/p>\n<p>MDR\u7684\u4ea7\u751f\u4e3b\u8981\u662f\u7531\u4e8e\u6297\u751f\u7d20\u7684\u6ee5\u7528\u548c\u8bef\u7528\uff0c\u8fd9\u8feb\u4f7f\u7ec6\u83cc\u5728\u5f3a\u5927\u7684\u9009\u62e9\u538b\u529b\u4e0b\u8fdb\u5316\u51fa\u8010\u836f\u673a\u5236<\/p>\n<\/p>\n<p>\u9632\u63a7MDR\u9700\u8981\u591a\u7ba1\u9f50\u4e0b\uff0c\u5305\u62ec\u5728\u533b\u7597\u7cfb\u7edf\u4e2d\u4e25\u683c\u6267\u884c\u6297\u751f\u7d20\u7ba1\u7406\u8ba1\u5212\uff08ASP\uff09\uff0c\u52a0\u5f3a\u533b\u9662\u611f\u67d3\u63a7\u5236\u63aa\u65bd\uff08\u5982\u624b\u536b\u751f\u3001\u9694\u79bb\u611f\u67d3\u8005\uff09\uff0c\u4ee5\u53ca\u5728\u5168\u7403\u8303\u56f4\u5185\u51cf\u5c11\u519c\u4e1a\u548c\u755c\u7267\u4e1a\u4e2d\u975e\u6cbb\u7597\u6027\u6297\u751f\u7d20\u7684\u4f7f\u7528<\/p>\n<\/p>\n<p>\u5bf9\u516c\u4f17\u800c\u8a00\uff0c\u4e0d\u81ea\u884c\u8d2d\u4e70\u548c\u4f7f\u7528\u6297\u751f\u7d20\u3001\u4e25\u683c\u9075\u5b88\u533b\u5631\u5b8c\u6210\u6574\u4e2a\u7597\u7a0b\u662f\u6bcf\u4e2a\u4eba\u90fd\u80fd\u505a\u5230\u7684\u8d21\u732e<\/p>\n<\/p>\n<p><strong>\u4e8c\u3001 MDR\u5728\u533b\u7597\u5668\u68b0\u9886\u57df\u7684\u542b\u4e49\uff1a\u6b27\u76df\u65b0\u6cd5\u89c4<\/strong><\/p>\n<p>\u5728\u5b8c\u5168\u4e0d\u540c\u7684\u53e6\u4e00\u4e2a\u9886\u57df\u2014\u2014\u533b\u7597\u5668\u68b0\u884c\u4e1a\uff0cMDR\u5219\u4ee3\u8868\u7740\u6b27\u76df\u300a\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u300b\uff08Medical Device Regulation, EU 2017\/745\uff09<\/p>\n<\/p>\n<p>\u5b83\u53d6\u4ee3\u4e86\u539f\u6709\u7684\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08MDD 93\/42\/EEC\uff09\u548c\u6709\u6e90\u690d\u5165\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff08AIMDD 90\/385\/EEC\uff09\uff0c\u5e76\u4e8e2021\u5e745\u670826\u65e5\u6b63\u5f0f\u751f\u6548<\/p>\n<\/p>\n<p><strong>1. MDR\u51fa\u53f0\u7684\u80cc\u666f\u4e0e\u76ee\u7684<\/strong><\/p>\n<p>\u6b27\u76df\u63a8\u51faMDR\u4e3b\u8981\u662f\u4e3a\u4e86\u5e94\u5bf9\u8fc7\u53bb\u51e0\u5341\u5e74\u91cc\u53d1\u751f\u7684\u4e00\u7cfb\u5217\u91cd\u5927\u533b\u7597\u5668\u68b0\u5b89\u5168\u4e8b\u4ef6\uff08\u5982PIP\u52a3\u8d28\u7845\u80f6\u4e73\u623f\u5047\u4f53\u4e8b\u4ef6\uff09\uff0c\u65e8\u5728\u5efa\u7acb\u4e00\u4e2a\u66f4\u900f\u660e\u3001\u66f4\u5b89\u5168\u3001\u66f4\u53ef\u9760\u7684\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u6846\u67b6<\/p>\n<\/p>\n<p>\u65b0\u6cd5\u89c4\u663e\u8457\u52a0\u5f3a\u4e86\u5bf9\u533b\u7597\u5668\u68b0\u4ece\u8bbe\u8ba1\u3001\u751f\u4ea7\u5230\u4e34\u5e8a\u8bc4\u4ef7\u3001\u4e0a\u5e02\u540e\u76d1\u7763\u7684\u5168\u751f\u547d\u5468\u671f\u76d1\u7ba1\u8981\u6c42<\/p>\n<\/p>\n<p><strong>2. MDR\u7684\u4e3b\u8981\u53d8\u5316\u4e0e\u6838\u5fc3\u8981\u6c42<\/strong><\/p>\n<p>\u4e0e\u4e4b\u524d\u7684\u6307\u4ee4\u76f8\u6bd4\uff0cMDR\u7684\u8981\u6c42\u66f4\u4e3a\u4e25\u683c\u548c\u590d\u6742<\/p>\n<\/p>\n<p>\u5176\u6838\u5fc3\u53d8\u5316\u5305\u62ec\uff1a\u66f4\u4e25\u683c\u7684\u4e34\u5e8a\u8bc1\u636e\u8981\u6c42\uff0c\u5f3a\u8c03\u5bf9\u690d\u5165\u7c7b\u548cIII\u7c7b\u5668\u68b0\u8fdb\u884c\u4e34\u5e8a\u8c03\u67e5\u7684\u5fc5\u8981\u6027\uff1b\u52a0\u5f3a\u5668\u68b0\u7684\u53ef\u8ffd\u6eaf\u6027\uff0c\u5f15\u5165\u552f\u4e00\u5668\u68b0\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\uff1b\u6269\u5927\u4ea7\u54c1\u8303\u56f4\uff0c\u5c06\u8bb8\u591a\u6ca1\u6709\u533b\u7597\u76ee\u7684\u4f46\u7c7b\u4f3c\u5668\u68b0\u7684\u4ea7\u54c1\uff08\u5982\u7f8e\u5bb9\u9690\u5f62\u773c\u955c\u3001\u62bd\u8102\u8bbe\u5907\u7b49\uff09\u7eb3\u5165\u76d1\u7ba1\uff1b\u5927\u5e45\u63d0\u9ad8\u5bf9\u6280\u672f\u6587\u4ef6\u7684\u8981\u6c42\u548c\u516c\u544a\u673a\u6784\u7684\u5ba1\u6838\u529b\u5ea6\uff1b\u4ee5\u53ca\u5f3a\u5316\u5236\u9020\u5546\u7684\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\u548c\u8b66\u6212\u7cfb\u7edf\u8d23\u4efb<\/p>\n<\/p>\n<p><strong>3. 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