A Framework to Evaluate Feasibility, Safety, and Accuracy of Wireless Sensors in the Neonatal Intensive Care Unit: Oxygen Saturation Monitoring

Monitoring vital signs in the Neonatal Intensive Care Unit (NICU) typically relies on wired skin sensors, which can limit mobility, cause skin issues, and interfere with parent-infant bonding. Wireless sensors offer promising alternatives, but evaluations to date often emphasize accuracy alone, lack NICU-specific validation, and rarely use standardized frameworks. Our objective was to develop and apply a comprehensive framework for evaluating the feasibility, safety, and accuracy of wireless monitoring technologies using a wireless pulse oximeter, the Anne limb (Sibel Health, USA), in real-world NICU conditions. A prospective study was conducted on a diverse NICU population. A custom system enabled synchronized data recordings from both standard and wireless devices. Feasibility was assessed as signal coverage across a variety of daily care activities and during routine procedures. Safety was evaluated through skin assessments after extended wear. Accuracy was examined sample-by-sample and interpreted using the Clarke Error Grid for clinical relevance. The wireless oximeter device showed high feasibility with reliable Bluetooth connection across a range of patients and activities (median wireless PPG coverage = 100%, IQR: 99.85-100%). Skin assessments showed no significant adverse effects. Accuracy was strong overall (median bias 1.34%, 95% LoA -3.63 to 6.41), with most data points within clinically acceptable Clarke error grid zones A and B, though performance declined for infants on supplemental oxygen. This study presents a robust, multidimensional framework for evaluating wireless monitoring devices in NICUs and offers recommendations for future research design and reporting.