The impact of continuous wireless monitoring on adverse device effects in medical and surgical wards: a review of current evidence

Nikolaj Aagaard*, Arendse Tange Larsen, Eske K. Aasvang, Christian S. Meyhoff

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftReviewForskningpeer review

2 Citationer (Scopus)

Abstract

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.

OriginalsprogEngelsk
TidsskriftJournal of Clinical Monitoring and Computing
Vol/bind37
Sider (fra-til)7–17
ISSN1387-1307
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
CSM and EKA have founded a start-up company, WARD247 ApS, with the aim of pursuing the regulatory and commercial activities of the WARD-project. WARD247 ApS has obtained license agreement for any WARD-project software and patents. One patent has been filed: “Wireless Assessment of Respiratory and circulatory Distress (WARD)—Clinical Support System (CSS)—an automated clinical support system to improve patient safety and outcomes”. None of the above entities have influence on the study design, conduct, analysis, or reporting. CSM also reports direct and indirect research funding from Merck, Sharp & Dohme Corp. and Boehringer Ingelheim outside the submitted work as well as lecture fees from Radiometer. EKA reports institutional research funding from Norpharma, and advisory board work with GenEdit and Concentric Analgesics outside the submitted work and lecture fees from Radiometer. ATL has received research funding from Innovation Fund Denmark as part of a PhD program under the WARD-project.

Publisher Copyright:
© 2022, The Author(s), under exclusive licence to Springer Nature B.V.

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