At a recent public meeting, attendees testified that the FDA should do more to ensure that pulse oximeters work well in patients with darker skin, better inform clinicians about shortcomings, and recall problematic versions. This follows studies showing that the devices don’t work as well for Black patients, which has led to inaccurate or delayed treatment. Physicians and patients also expressed concern about the devices’ accuracy and the lack of information given to clinicians. The FDA has suggested using the Monk skin tone scale to improve skin tone measurement in studies, but panelists and speakers alike emphasized the need for testing and performance standards that address the devices’ shortcomings in patients with darker skin.
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Quicker fix for pulse oximeters urged during FDA public meeting
