TY - JOUR
T1 - The impact of continuous wireless monitoring on adverse device effects in medical and surgical wards
T2 - a review of current evidence
AU - Aagaard, Nikolaj
AU - Larsen, Arendse Tange
AU - Aasvang, Eske K
AU - Meyhoff, Christian S
N1 - © 2022. The Author(s), under exclusive licence to Springer Nature B.V.
PY - 2023/2
Y1 - 2023/2
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85135323794&partnerID=8YFLogxK
U2 - 10.1007/s10877-022-00899-x
DO - 10.1007/s10877-022-00899-x
M3 - Review
C2 - 35917046
SN - 1387-1307
VL - 37
SP - 7
EP - 17
JO - Journal of Clinical Monitoring and Computing
JF - Journal of Clinical Monitoring and Computing
IS - 1
ER -