Wearable biosensors for pediatric hospitals: a scoping review.

As wearable biosensors are increasingly used in healthcare settings, this review aimed to identify the types of wearable biosensors used for neonate and pediatric patients and how these biosensors were clinically evaluated. A literature search was conducted using PubMed, CINAHL, Embase, Web of Science, and Cochrane. The studies published between January 2010 and February 2024 were included. Descriptive statistics were used to present counts and percentages of types, locations, clinical evaluation methods, and their results. Seventy-nine studies were included. 104 wearable sensors and 40 devices were identified. The most common type of biosensor was optoelectrical sensors (n = 40, 38.5%), and used to measure heart rate (n = 22, 19.0%). The clinical evaluation was tested by a combination of validity (n = 68, 86.1%) and reliability (n = 14, 17.7%). Only two-thirds of the wearable devices were validated or reported acceptable reliability. The majority of the biosensor studies (n = 51, 64.5%) did not report any complications related to wearable biosensors. The current literature has gaps regarding clinical evaluation and safety of wearable biosensor devices with interchangeable use of validity and reliability terms. There is a lack of comprehensive reporting on complications, highlighting the need for standardized guidelines in the clinical evaluation of biosensor medical devices. IMPACT: The most common types of biosensors in pediatric settings were optoelectrical sensors and electrical sensors. Only two-thirds of the wearable devices were validated or reported acceptable reliability, and more than half of the biosensor studies did not report whether they assessed any complications related to wearable biosensors. This review discovered significant gaps in safety and clinical validation reporting, emphasizing the need for standardized guidelines. The findings advocate for improved reporting clinical validation processes to enhance the safety of wearable biosensors in pediatric care.