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A solution for global hygienic challenges regarding the application of heater-cooler systems in cardiac surgery
Perfusion ( IF 1.2 ) Pub Date : 2021-07-13 , DOI: 10.1177/02676591211033483
Maik Foltan 1 , André Nikisch 1 , Jan Dembianny 1 , Anna-Lena Miano 1 , Johannes Heinze 1 , Dennis Klar 2 , Laszlo Göbölös 3 , Karla Lehle 1 , Christof Schmid 1
Affiliation  

71.759 surgical procedures were performed in 2019 with the aid of cardiopulmonary bypass in Germany. To adjust the patient’s body temperature on extracorporeal circulation, the application of a heater-cooler unit (HCU) is mandatory. However, in case of insufficient sanitisation of HCU, life-threatening infections can be transmitted by the device to the patients, including Legionella bacteria, Mycobacterium chimaera, Pseudomonas aeruginosa. To avoid disease transmission, as a requirement for safe medical practice established by regulatory authorities, HCUs must be regularly disinfected by hazardous chemicals posing a danger for both handling humans and the environment. Therefore, to comply with regulations, HCU manufacturers have introduced both timely and financially extensive sanitisation procedures. Our paper describes a novel, effective and easy to handle disinfection method for the above problematics without utilising hazardous chemicals. The method’s technical principle is electrolysis, resulting in drinking water quality regarding the analysed germs in the worldwide most commonly utilised heater-cooler device. The main aim of the study was to prove the efficacy and reliability of the device cleansing process. Furthermore, the economic impact of the novel method was evaluated. Therefore, we have undertaken 60 microbiological sampling series between December 2019 and November 2020 from a conventional HCU (3T LivaNova, Germany). During the total investigational period, no contamination with Pseudomonas aeruginosa or Legionellae could have been demonstrated in the HCU. The extreme slow-growing nontuberculous M. chimaera was detected only in one sample obtained from diamond electrode cleansed HCU water, and source of contamination was promptly eliminated by a simple technical modification of the device test-site. Additionally, the diamond electrode application is beneficial for eliminating potentially hazardous cleansing material from the process, which may affect otherwise both patients operated on cardiopulmonary bypass and the perfusionists.



中文翻译:

关于在心脏手术中应用加热器-冷却器系统的全球卫生挑战的解决方案

2019 年,德国在体外循环的帮助下进行了 71,759 例外科手术。为了在体外循环中调节患者的体温,必须使用加热冷却装置 (HCU)。但是,如果 HCU 消毒不充分,则该设备可能会将危及生命的感染传播给患者,包括军团菌、嵌合分枝杆菌、铜绿假单胞菌。为避免疾病传播,作为监管机构制定的安全医疗实践要求,HCU 必须定期使用对处理人类和环境都构成危险的危险化学品进行消毒。因此,为遵守法规,HCU 制造商引入了及时且耗费大量资金的消毒程序。我们的论文描述了一部小说,针对上述问题提供有效且易于处理的消毒方法,无需使用危险化学品。该方法的技术原理是电解,在世界上最常用的加热-冷却装置中产生与分析细菌有关的饮用水质量。该研究的主要目的是证明设备清洁过程的有效性和可靠性。此外,还评估了新方法的经济影响。因此,我们在 2019 年 12 月至 2020 年 11 月期间从传统 HCU(3T LivaNova,德国)进行了 60 个微生物采样系列。在整个研究期间,HCU 中未发现铜绿假单胞菌或军团菌污染。极端缓慢生长的非结核性 M. chimaera 仅在从金刚石电极清洁 HCU 水中获得的一个样本中检测到,并且通过对设备测试现场进行简单的技术修改迅速消除了污染源。此外,金刚石电极的应用有利于从过程中消除潜在危险的清洁材料,否则可能会影响接受体外循环手术的患者和灌注师。

更新日期:2021-07-14
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