Department of Anaesthesia and Intensive Care, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark.
VIVE - Danish Center for Social Science Research, Copenhagen, Denmark.
J Clin Monit Comput. 2023 Feb;37(1):7-17. doi: 10.1007/s10877-022-00899-x. Epub 2022 Aug 2.
Novel technologies allow continuous wireless monitoring systems (CWMS) to measure vital signs and these systems might be favorable compared to intermittent monitoring regarding improving outcomes. However, device safety needs to be validated because uncertain evidence challenges the clinical implementation of CWMS. This review investigates the frequency of device-related adverse events in patients monitored with CWMS in general hospital wards. Systematic literature searches were conducted in PubMed and Embase. We included trials of adult patients in general hospital wards monitored with CWMS. Our primary outcome was the frequency of unanticipated serious adverse device effects (USADEs). Secondary outcomes were adverse device effects (ADEs) and serious adverse device effects (SADE). Data were extracted from eligible studies and descriptive statistics were applied to analyze the data. Seven studies were eligible for inclusion with a total of 1485 patients monitored by CWMS. Of these patients, 54 patients experienced ADEs (3.6%, 95% CI 2.8-4.7%) and no USADEs or SADEs were reported (0%, 95% CI 0-0.31%). The studies of the SensiumVitals® patch, the iThermonitor, and the ViSi Mobile® device reported 28 (9%), 25 (5%), and 1 (3%) ADEs, respectively. No ADEs were reported using the HealthPatch, WARD 24/7 system, or Coviden Alarm Management. Current evidence suggests that CWMS are safe to use but systematic reporting of all adverse device effects is warranted.
新技术使连续无线监测系统(CWMS)能够测量生命体征,与间歇性监测相比,这些系统在改善结果方面可能更有优势。然而,需要验证设备的安全性,因为不确定的证据对 CWMS 的临床实施提出了挑战。本次综述调查了在综合医院病房中使用 CWMS 监测的患者中与设备相关的不良事件的频率。在 PubMed 和 Embase 中进行了系统的文献检索。我们纳入了在综合医院病房中使用 CWMS 监测的成年患者的试验。我们的主要结局是未预料到的严重不良设备效应(USADE)的频率。次要结局是不良设备效应(ADE)和严重不良设备效应(SADE)。从合格研究中提取数据,并应用描述性统计分析数据。有 7 项研究符合纳入标准,共纳入 1485 例接受 CWMS 监测的患者。这些患者中有 54 例出现 ADE(3.6%,95%CI 2.8-4.7%),未报告 USADE 或 SADE(0%,95%CI 0-0.31%)。SensiumVitals®贴片、iThermonitor 和 ViSi Mobile®设备的研究分别报告了 28 例(9%)、25 例(5%)和 1 例(3%)ADE。HealthPatch、WARD 24/7 系统或 Coviden Alarm Management 未报告 ADE。目前的证据表明,CWMS 可以安全使用,但有必要系统报告所有不良设备效应。