Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia.
Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, Georgia.
Infect Control Hosp Epidemiol. 2022 Oct;43(10):1333-1338. doi: 10.1017/ice.2021.396. Epub 2021 Oct 6.
In 2015, an international outbreak of infections among patients undergoing cardiothoracic surgeries was associated with exposure to contaminated LivaNova 3T heater-cooler devices (HCDs). From June 2017 to October 2020, the Centers for Disease Control and Prevention was notified of 18 patients with infections who had undergone cardiothoracic surgeries at 2 hospitals in Kansas (14 patients) and California (4 patients); 17 had exposure to 3T HCDs. Whole-genome sequencing of the clinical and environmental isolates matched the global outbreak strain identified in 2015.
Investigations were conducted at each hospital to determine the cause of ongoing infections. Investigative methods included query of microbiologic records to identify additional cases, medical chart review, observations of operating room setup, HCD use and maintenance practices, and collection of HCD and environmental samples.
Onsite observations identified deviations in the positioning and maintenance of the 3T HCDs from the US Food and Drug Administration (FDA) recommendations and the manufacturer's updated cleaning and disinfection protocols. Additionally, most 3T HCDs had not undergone the recommended vacuum and sealing upgrades by the manufacturer to decrease the dispersal of -containing aerosols into the operating room, despite hospital requests to the manufacturer.
These findings highlight the need for continued awareness of the risk of infections associated with 3T HCDs, even if the devices are newly manufactured. Hospitals should maintain vigilance in adhering to FDA recommendations and the manufacturer's protocols and in identifying patients with potential infections with exposure to these devices.
2015 年，在接受心胸外科手术的患者中爆发了与接触污染的 LivaNova 3T 热交换器（HCD）有关的感染。从 2017 年 6 月至 2020 年 10 月，美国疾病控制与预防中心接到通知，堪萨斯州（14 例患者）和加利福尼亚州（4 例患者）的 2 家医院的 18 名接受心胸外科手术的患者感染了 ，其中 17 名患者接触过 3T HCD。对临床和环境分离株的全基因组测序与 2015 年确定的全球暴发株相匹配。
在每家医院进行调查以确定正在发生的感染的原因。调查方法包括查询微生物记录以识别其他病例，病历审查，手术室设置观察，HCD 使用和维护实践以及 HCD 和环境样本的收集。
现场观察发现 3T HCD 的定位和维护偏离了美国食品和药物管理局（FDA）的建议以及制造商更新的清洁和消毒方案。此外，尽管医院向制造商提出了要求，但大多数 3T HCD 都没有进行制造商推荐的真空和密封升级，以减少含气溶胶的扩散到手术室中。
这些发现强调了即使设备是新制造的，也需要继续意识到与 3T HCD 相关的感染风险。医院应保持警惕，遵守 FDA 的建议和制造商的方案，并识别出接触这些设备的潜在感染患者。
