An assistant professor in the University of Michigan’s Division of Pulmonary and Critical Care, realized first-hand that the small device may yield less accurate oxygen readings in patients with dark skin
On a person of color, the pulse oximeter could indicate a patient’s oxygen levels are normal, suggesting they could be discharged home — but then their blood samples might show low oxygen levels, suggesting they not only needed additional care but also oxygen support.
The FDA issued new draft guidance that recommends companies making medical products should develop and submit a “race and ethnicity diversity plan” to the agency early in their development of products, and that plan should include enrolling diverse groups of people into their clinical trials.
