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.