Nonin leads the way in new study
Fingertip pulse oximeters, commonly relied upon in clinical settings, are facing new scrutiny following a comprehensive study revealing their variable performance, particularly in individuals with darker skin pigmentation. The study, conducted by Gregory Leeb and Isabella Auchus, published in eBioMedicine, a part of The Lancet, sheds light on significant discrepancies in Pulse Oximetry device accuracy and highlights the urgent need for improved regulatory standards.
Despite their widespread availability and frequent use, fingertip pulse oximeters have largely evaded stringent regulation, leaving their performance poorly characterised. This study, utilizing the US Food and Drug Administration (FDA) Guidance and International Organization for Standardization Standards, evaluated eleven popular fingertip pulse oximeters across a diverse sample of 34 healthy individuals with varying skin pigmentation.
During the study, the Nonin Onyx Vantage 9590 demonstrated superior accuracy than its counterparts, being the ONLY device to demonstrate an ARMS of less than 3% for all skin types within the study – this being the acceptable performance range outlined by the FDA.
The study shows that even with Oxygen Saturation Levels of only 70% - 80%, and on the darkest skin pigmentation, the Nonin Onyx Vantage 9590 still stayed well within the acceptable 3% ARMS performance range. The Nonin product also showed the smallest range of Bias of all the Pulse Oximeters that were tested. (see Figure)
Five out of the eleven other devices exhibited a root mean square error (ARMS) exceeding 3%, falling outside the acceptable performance range outlined by the FDA. Moreover, nine devices demonstrated notably inferior performance in participants with darker skin pigmentation compared to their counterparts with lighter skin tones.
These findings also underscore the critical need for improved regulatory standards that adequately account for the impact of skin pigmentation on device performance.
It is also evident that current standards and purchasing policies fall short in ensuring equitable performance across diverse populations.
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