Guest editorial

The recent study by van der Eijk and colleagues titled, “‘New-Generation’” Pulse Oximeters in Extremely Low-Birth-Weight Infants: How Do They Perform in Clinical Practice?” evaluates the performance of pulse oximeters in the neonatal intensive care unit by comparing the variances in SpO2 values between 3 brands of pulse oximeters. We were not surprised that the study found little difference in performance between the 3 devices. As the manufacturer of one of the technologies evaluated in the study, we would like to offer some observations based on our experience collecting thousands of hours of pulse oximetry monitoring data in newborns. Almost all pulse oximeters perform adequately in well-perfused, stable patients. The differences between technologies are observed when monitoring during challenging conditions such as motion and low perfusion. In 1997, Masimo received an FDA 510(k) with the indication for use to measure oxygen saturation “during both no motion and motion conditions.” In 1999, Masimo received an FDA 510(k) adding the indication for use in “patients who are well or poorly perfused.” Masimo received this indication by submitting test results showing that Masimo SET pulse oximetry could detect oxygen saturation changes during motion and low perfusion. Without measuring oxygen saturation during changing conditions, some pulse oximeters can appear to accurately measure oxygen saturation by freezing or by dynamic averaging. Both of these approaches mask the limitations of these pulse oximeters. In contrast, Masimo SET measure-through motion pulse oximeters