A new federal proposal released by the Food and Drug Administration (FDA) on Monday targets the accuracy of pulse oximeters, devices used to measure oxygen levels in the blood. The FDA is calling for makers of these medical devices to gather additional data to ensure their effectiveness for patients of color.
Pulse oximeters are clip-on devices commonly used in hospitals and medical clinics to monitor oxygen levels in patients. By emitting two wavelengths of light into the skin when clipped onto a finger, these devices estimate the amount of oxygen flowing through the blood based on the light absorption.
During the COVID-19 pandemic, oximeters played a crucial role in emergency care for patients. However, studies have indicated that the accuracy of oximeter readings can be affected by darker skin pigmentation. In response to these findings, the FDA issued a warning in 2021 after a study revealed that oximeters tended to overestimate oxygen levels in Black patients, potentially leading to delays in treatment and increased risks of death.
The FDA's draft recommendations include changes in how companies test their devices, such as enrolling a diverse group of patients in clinical studies, including individuals with darker skin complexion, and evaluating pigmentation using multiple methods.
It is important to note that the FDA guidelines apply specifically to professional oximeters used in medical settings and do not cover over-the-counter devices classified as 'general wellness' products. While the proposed recommendations would not render older devices obsolete, manufacturers seeking approval for updates or new products are expected to provide diversity data as per the FDA's expectations.
As the announcement is in the draft stage, the FDA will be accepting public comments on the proposal for 60 days before finalizing the guidelines. The move reflects ongoing efforts to address potential racial biases in medical technology and improve healthcare outcomes for all patients.
