Gregory Leeb, Isabella Auchus, Tyler Law, Philip Bickler, John Feiner, Shamsudini Hashi, Ellis Monk, Elizabeth Igaga, Michael Bernstein, Yu Celine Chou, Caroline Hughes, Deleree Schornack, Jenna Lester, Kelvin Moore, Olubunmi Okunlola, Jana Fernandez, Leonid Shmuylovich, Michael Lipnick
BACKGROUND: Fingertip pulse oximeters are widely available, inexpensive, and commonly used to make clinical decisions in many settings. Device performance is largely unregulated and poorly characterised, especially in people with dark skin pigmentation. METHODS: Eleven popular fingertip pulse oximeters were evaluated using the US Food and Drug Administration (FDA) Guidance (2013) and International Organization for Standardization Standards (ISO, 2017) in 34 healthy humans with diverse skin pigmentation utilising a controlled desaturation study with arterial oxygen saturation (SaO 2) plateaus between 70% and 100%...
March 7, 2024: EBioMedicine