1＜0？！莫让术中保温设备成为伤害患者的凶器！原创 2016-06-20 SIFIC热点团队 SIFIC官微
“1＜0” 莫让术中保温设备成为伤害患者的凶器
日前，韩国检方重新对五年前不明原因肺病死亡事件展开调查，受害者总数达1528人，这个重大安全案件惊动了整个韩国。根据《美国手术部位感染预防指南（2014版）》，围手术期维持体温在常温（≥35.5℃）属于I级证据，即使是轻度低温也会增加SSI发生率。3T型加热-冷却器在美国广泛用于维持手术患者体温，下面报道中曝光的心胸外科手术患者发生结核分枝杆菌嵌合体感染可能与该设备有关。 我们应该正视医疗设备的使用和清洁消毒，莫让它们成为杀害患者的凶器！
Stockert 3T型加热-冷却器 与分枝杆菌嵌合体感染有关
检索：周密 原作者：Troy Brown·RN 译者：刘明星 古丽米热·阿尔肯 王珍丽 臧金成 编写：陈志锦 审稿：唐文瑞、高珊、陈志锦
警报美国食品药品监督管理局的一份安全警报显示，在美国，心胸外科手术患者发生结核分枝杆菌嵌合体感染可能与曾经暴露于被结核分枝杆菌污染的Stockert 3T型加热-冷却设备（变温水箱）有关，这些索林集团德国分公司生产的设备应用于心胸外科手术中。 这份安全警报进一步说明，近期欧洲的一项研究揭示了从一些感染的心胸外科患者采集到的结核分枝杆菌标本与这些患者手术过程中使用的加热冷却设备采集到的样本，以及德国生产维修这些设备的环境中采集到的样本三者之间的联系。 该研究发现还提示，在欧洲发生的开胸心脏手术患者结核分枝杆菌嵌合体感染与一种型号3T的变温水箱直接相关。目前，美国专家正试图确定美国感染患者和从3T设备中分离到的分枝杆菌嵌合体与从欧洲感染患者中分离到的分枝杆菌嵌合体和以前在德国生产设备和服务设施中发现的分枝杆菌嵌合体是否相关。 2015年10月，FDA发布了一则安全通讯，建议在使用加热-冷却器时，尽量减少患者暴露于微生物制剂。在6月2-3日召开的FDA医疗器械咨询委员会的循环系统设备小组会议，回顾了加热-冷却设备污染的调查数据，且相关专家提出了科学观点和临床建议。加热-冷却设备是通过调节闭合管路中的水温，来调节心胸外科和其他手术患者的体温。患者不会与水直接接触；然而，被污染的水可以进入设备的其他部分或者被雾化，FDA警告：“细菌可通过空气和设备的排气孔而传播到环境和患者。”
推荐规范FDA指出，于2014年9月前购买和使用的从工厂运来的3T型设备，可能被结核分枝杆菌嵌合体污染。除了2015年安全规范有关建议外，FDA还有以下几点建议： 告知从事心胸外科手术的医务人员，其患者可能有感染结核分枝杆菌嵌合体的风险。这样的风险在接受或植入假体产品或材料（如心脏瓣膜、移植物、左室辅助设备），或使用这些设备接受心脏移植手术的患者中更高。 根据美国疾病预防与控制中心的“关于鉴定变温水箱设备相关非结核分支杆菌感染”的临时防控指南，建立一种潜在暴露患者的随访和监测方法，该临时防控指南在网上可以查找到。 2014年9月后购买和使用的3T设备应继续遵循FDA2015年安全通信的建议，以及按照制造商的最新要求进行设备的清洗、消毒和维护，以减少病人感染的风险。 美国FDA鼓励医务人员和病人通过“MedWatch安全信息网络系统”，填写和提交有关使用3T的不良事件或副作用的报告。报告表格可以通过下载或者致电1-800-332-1088获得，也可以发邮件到列表中的地址或通过传真1-800-FDA-0178等途径获得。
英文原版
Stockert 3T Heater-Cooler Device Linked to M chimaera Infection
Cardiothoracic patients who have been infected with Mycobacterium chimaera in the United States may have been exposed to the bacteria from contaminated Stӧckert 3T Heater-Cooler System devices (Sorin Group Deustchland GmbH) used during cardiothoracic procedures, according to a safety alert from the US Food and Drug Administration (FDA).
"A recently published European study describes a link between M chimaera clinical samples from several infected cardiothoracic patients with samples from the heater-cooler devices used during these patients' procedures, and with environmental samples from the device manufacturer's production and servicing facility in Germany," the alert explains.
The study findings suggest that M chimaera infections that occurred in European patients during open-chest cardiac surgery are directly linked to "one specific heater-cooler model ― the 3T."
US experts are currently trying to ascertain whether the infections in the US patients and M chimaera isolated from the 3T are associated with M chimaera isolated in infected European patients and M chimaera previously found at the device's production and servicing facility in Germany.
In October 2015, the FDA issued a safety communication with recommendations for minimizing patient exposure to microbial agents during use of heater-cooler devices.
The Circulatory System Devices Panel of the FDA's Medical Devices Advisory Committee is meeting on June 2-3 to review data and obtain expert scientific and clinical opinion about contaminations from all heater-cooler devices.
Heater-cooler devices are used to regulate body temperature during cardiothoracic and other surgical procedures via temperature-controlled water in closed circuits. Patients are not directly exposed to this water; however, contaminated water can enter other parts of the device or aerosolize, "transmitting bacteria through the air and through the device's exhaust vent into the environment and to the patient," according to the FDA alert.
Recommendations The FDA recommends that facilities that purchased and used the 3T before September 2014 be aware that the devices that were shipped from the factory may have been contaminated with M chimaera. In addition to the steps recommended in its 2015 safety communication, the FDA recommends that facilities and staff do the following:
Inform healthcare providers who have performed cardiothoracic surgeries of the risk for M chimaera infection in their patients. The risk may be higher in patients who have undergone procedures involving the introduction of a prosthetic product or material, such as a heart valve, graft, or left-ventricular assist device, or who underwent heart transplant when the device was being used.
Establish a method for patient follow-up and surveillance in cases of potential exposure, in accordance with the recommendations in the US Centers for Disease Control and Prevention's Interim Guide for the Identification of Possible Cases of Nontuberculous Mycobacterium Infections Associated With Exposure to Heater-Cooler Units, which is available online.
Facilities that purchased and used the 3T after September 2014 should continue following the FDA's recommendations in the 2015 safety communication and the manufacturer's most current instructions for the cleaning, disinfection, and maintenance to reduce patient risk.
The FDA encourages healthcare professionals and patients to report adverse events or side effects related to the use of the 3T to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online. The reporting form can also be downloaded or obtained by calling 1-800-332-1088 and returned by mail to the address listed on the form or by fax at 1-800-FDA-0178.
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