No one’s quite sure how to fix pulse oximeters. The FDA asked this lab to find answers
SAN FRANCISCO — The discovery that fingertip oxygen-measuring devices might contribute to health disparities because they appear to work less well on patients with darker skin has roiled the world of pulse oximetry, a $2 billion industry that now faces stricter regulations and pressure to address bias in the development and testing of its devices.
In the search for solutions, regulators from the Food and Drug Administration have turned to a single small lab in San Francisco whose visionary founder helped develop modern blood monitoring tools. For decades, the Hypoxia Lab at the University of California, San Francisco, has quietly worked to assess and improve the precision of this low-cost device that revolutionized health care by allowing fast, cheap, and non-invasive monitoring of blood oxygen levels. These instruments are critical for many aspects of medical care, from the treatment of Covid and pneumonia to neonatal monitoring, and the lab tests more than 60 each year for manufacturers and others in a small room packed with monitors, oxygen tanks, ultrasound machines, breathing tubes, and an operating room gurney.
