Photo Credit: AndreyPopov

The FDA has released draft guidelines proposing larger, more inclusive studies to ensure pulse oximeters work for people with darker skin, according to a press release from the agency. The new recommendations call for enrolling at least 150 patients with diverse skin tones in studies, increasing the representation of patients with darker skin to at least 25% in each study, up from 15%, and using multiple methods to evaluate skin pigmentation. The proposal applies only to pulse oximeters used in medical settings, not over-the-counter oximeters. The FDA recommendations come after studies found pulse oximeters often overestimate oxygen levels in Black patients, potentially delaying treatment and increasing risk. Existing devices will not need to meet these new standards unless manufacturers request updates or modifications. “Our draft recommendations are based on the best available science to help address concerns of disparate performance of pulse oximeters based on an individual’s skin pigmentation,” Michelle Tarver, MD, PhD, said in the release.