与美敦力 Duet 室外引流管有关的感染 - 罗德岛普罗维登斯罗德岛医院,2023 年 1 月至 2024 年 1 月

Kevin M Gibas, Dianne B. Auld, Stephanie Parente, Jean Horoho, Leonard A. Mermel
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引用次数: 1

摘要

脑室外引流管(EVD)是插入脑室的医疗设备,用于引流多余液体、控制颅内高压、监测颅内压和给药。EVD 或相关引流系统部件的意外断开、断裂或骨折(断裂)会导致脑脊液 (CSF) 泄漏,增加 EVD 相关感染的风险。罗德岛医院在 2023 年 9 月中旬将 Integra Life Sciences EVD 系统更换为 Medtronic Duet EVD 系统后,观察到 CSF 培养阳性率增加了三倍,从 2023 年 1 月至 9 月期间每千个 EVD 就位日(EVD 日)2.8 例增加到 11.4 例。2023 年 10 月至 2024 年 1 月期间,每 1,000 个 EVD 日的 CSF 培养阳性率为 4(比率比 [RR] = 5.7;95% CI = 1.5-22.0;p = 0.01),感染率增加了 8 倍,从每 1,000 个 EVD 日 0.7 例增加到 6.5 例(RR = 9.8;95% CI = 1.1-87.3;p = 0.04)。罗德岛医院感染控制部门在 2023 年 12 月至 2024 年 1 月期间进行的一项调查发现,美敦力 Duet EVD 系统经常出现断开连接和破损的报告。通过搜索食品药品管理局制造商和用户设施设备经验数据库,在全国范围内发现了 326 份关于 Duet EVD 系统组件断开和破损的报告,其中包括 2023 年期间的 175 份报告。已提交医疗产品安全网络报告。Duet EVD 产品最终于 2024 年 1 月被召回,原因是 EVD 系统断开连接以及 CSF 泄漏和感染报告。鉴于神经外科中心广泛使用 EVD 系统以及 EVD 相关感染的风险,医院感染预防和控制计划未来可能考虑的一项策略是将 EVD 相关感染纳入医院监控计划,以快速识别此类事件的增加,并确定与此类感染相关的因素,防止出现更多感染。
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Infections Associated with Medtronic Duet External Ventricular Drains — Rhode Island Hospital, Providence, Rhode Island, January 2023–January 2024
External ventricular drains (EVDs) are medical devices that are inserted into the ventricles of the brain to drain excess fluid, manage intracranial hypertension, monitor intracranial pressure, and administer medications. Unintentional disconnections and breaks or fractures (breaks) of EVDs or associated drainage system components can result in cerebrospinal fluid (CSF) leakage and increased risk for EVD-associated infections. After replacement of Integra Life Sciences EVD systems with Medtronic Duet EVD systems at Rhode Island Hospital in mid-September 2023, a threefold increase was observed in the prevalence of positive CSF cultures, from 2.8 per 1,000 days with an EVD in place (EVD days) during January-September 2023 to 11.4 per 1,000 EVD days during October 2023-January 2024 (rate ratio [RR] = 5.7; 95% CI = 1.5-22.0; p = 0.01) and an eightfold increase in the prevalence of infections, from 0.7 to 6.5 per 1,000 EVD days (RR = 9.8; 95% CI = 1.1-87.3; p = 0.04). An investigation by Rhode Island Hospital Infection Control during December 2023-January 2024 identified frequent reports of disconnections and breaks of the Medtronic Duet EVD system. A search of the Food and Drug Administration Manufacturer and User Facility Device Experience database identified 326 reports nationwide of disconnection and breaks of components of the Duet EVD system, including 175 during 2023. A Medical Product Safety Network report was filed. The Duet EVD product was ultimately recalled in January 2024, citing disconnections of the EVD system and reports of CSF leakage and infection. Given the widespread use of EVD systems by neurosurgery centers and the risk for EVD-associated infections, a strategy for future consideration by hospital infection prevention and control programs might be inclusion of EVD-associated infections in hospital surveillance programs to rapidly identify increases in these events and determine factors related to such infections to prevent additional infections.
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