Pulmonary and critical care expert Michael Sjoding presented U-M research on racial bias in pulse oximeters to an FDA advisors committee
On Nov. 1, 2022, a Food and Drug Administration (FDA) advisory committee held a virtual meeting to decide whether pulse oximeters, medical devices used to measure patient’s blood oxygen levels that play a key role in critical care assessment, need to be regulated differently based on research showing the devices are less accurate in people with darker skin.
During the 10-hour meeting, pulmonary experts discussed evidence on the accuracy of pulse oximeters and factors that may affect pulse oximeter accuracy. Among them was Michael Sjoding, M.D., M.S., associate professor of internal medicine within the U-M Division of Pulmonary and Critical Care Medicine, who presented findings from a series of studies by his team that found prescription pulse oximeters missed low blood oxygen levels at a statistically significant higher frequency in hospitalized Black patients than in White patients.
When it comes to pulse oximeter readings, “small differences, at a population level, can have a big impact” on health disparities, Sjoding told the committee.
The FDA advisors ultimately recommended more research on disparities, more testing of devices, and better labeling for pulse oximeters to caution users against flawed readings.
- IHPI Policy Brief: Pulse Oximeters Are Less Accurate in Hospitalized Black Patients
- STAT News: Pulse oximeters and their inaccuracies will get FDA scrutiny. What took so long?
- Bridge Michigan: Michigan doctor helps shine national focus on race bias in pulse oximeters
- STAT News: FDA panel asks for improvements in pulse oximeters