When (If) to Worry? Evaluating the Accuracy of Home-Grade Pulse Oximeter Devices

Respiratory complaints, and concern for the presence and/or development of hypoxemia, compose one of the most common reasons for pediatric patients to present for health care provider evaluation, and disposition decisions for these providers are strongly influenced by S_pO2 measured by pulse oximetry.^1,2 Whereas in the acute care setting S_pO2 monitoring with medical-grade devices is standard practice, pulse oximetry monitoring in the home setting is increasingly common either for children with chronic cardiorespiratory disease or by individuals who are simply curious about their oxygen status. There is wide variability in provider decisions to prescribe home pulse oximetry.³ However, feasibility and efficacy of this practice have been described in several adult and pediatric conditions including obstructive sleep apnea,⁴ acute COVID-19,⁵ bronchopulmonary dysplasia,⁶ and congenital cardiac disease.^7,8 Whereas monitoring in these scenarios is typically performed using medical-grade devices, patients and/or their parents are increasingly able to obtain non–medical-grade (home grade) devices designed for out-of-hospital use, which can be inexpensively purchased in person or online. Whereas medical-grade pulse oximeters are approved by regulatory bodies such as the United States FDA and must be accurate within 3% of a measured oxyhemoglobin saturation, these home-grade pulse oximeters are not subject to the same approval rigor.⁹ Because of the ease with which caregivers or patients can purchase these devices, it behooves the medical community to understand their accuracy and limitations.^9,10 Whereas some studies¹¹ have been performed to assess the accuracy of home-grade devices in adults, pediatric data are scarce and limited by either small sample sizes or lack of enrolled subjects with overt hypoxemia.^{12,13 …}

Correspondence: John W Berkenbosch MD, Pediatrics/Pediatric Critical Care University of Louisville, Norton Children’s Hospital 571 S. Floyd, Suite 332, Louisville, KY 40202. E-mail: john.berkenbosch{at}louisville.edu