美国CDC和FDA再次警告—开放心脏手术使用的变温水箱系统可引起病人分支杆菌感染风险

本帖最后由 doublly 于 2016-10-18 08:47 编辑


被污染的变温水箱系统（L[size=14.3999996185303px]ivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices）引起开放性心脏手术病人奇美拉分支杆菌感染基于前期一项调查和现场实验的基础上（链接http://wwwnc.cdc.gov/eid/article/22/6/16-0045_article，全文见附件），美国CDC和FDA均向医务人员和患者提出警示，建议采取相应应对措施。之前美国FDA于6月份曾在初步调查基础上针对此类医疗器械发布警告（见附件）。

美国CDC建议：

接受开放性心脏手术的患者如出现如下感染症状，请及时就医：夜间盗汗、肌肉痛、体重减轻、乏力或不明原因发热。该建议基于广泛用于开放性心脏手术的（[size=14.3999996185303px]LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T）的变温水箱系统在生产过程中可能已被污染的最新调查证据，被污染的变温水箱系统可能引起患者严重感染。


[size=14.3999996185303px]美国每年有超过250,000例开展心脏手术的患者使用了变温水箱系统，约60%开展了心脏手术患者使用了可能引起奇美拉分枝杆菌感染的变温水箱系统。


美国CDC和FDA于2015年曾就这些可能被污染的变温水箱系统提出警告，近期美国CDC在MMWR杂志上发表公布了由美国CDC和其他机构共同开展的一项实验研究，发现从（LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T）变温水箱系统上分离的细菌与来自美国数个州的患者身上分离的细菌相匹配。这也进一步验证了之前欧洲的相关证据，即这批产自德国的医疗器械在生产过程中即被奇美拉分枝杆菌（Mycobacterium chimaera）所污染。


FDA链接：http://www.fda.gov/MedicalDevice ... tices/ucm520191.htm美国CDC链接：https://www.cdc.gov/media/releas ... nated-devices-.html


Background：The bacteria, Mycobacterium chimaera, is a species of nontuberculous mycobacterium (NTM) often found in soil and water. In the environment, M. chimaera rarely makes healthy people sick. Patients who have been exposed to the bacteria through open-heart surgery can develop general and nonspecific symptoms that can often take months to develop. As a result, diagnosis of these infections can be missed or delayed, sometimes for years, making these infections more difficult to treat. There is no test to determine whether a person has been exposed to the bacteria. Infections can be diagnosed by detecting the bacteria by laboratory culture; the slow growing nature of the bacteria can require up to two months to rule out infection.
D.B.L
2016-10-18