New FDA Guidelines Aim to Improve Pulse Oximeter Accuracy
Recent guidelines from the U.S. Food and Drug Administration (FDA) seek to enhance the accuracy of pulse oximeters, particularly in the context of racial health disparities that became pronounced during the COVID-19 pandemic. While the guidelines are a step forward, many readily available consumer devices remain unregulated.
The Issue at Hand
Pulse oximeters, which measure blood oxygen levels, have been criticized for their performance disparities among individuals with darker skin tones. During the pandemic, the inaccuracies in these devices contributed to unequal medical care for Black patients, who suffered much higher mortality rates from COVID-19 compared to their white counterparts.
According to a report by the Minnesota Star Tribune, many pulse oximeters available at pharmacies and online lack the rigorous testing required for medical devices. For instance, the CVS Health Pulse Oximeter is a frequently purchased device that has not been subject to extensive regulatory oversight.
FDA Recommendations
On January 11, 2025, the FDA released comprehensive draft guidance specifying that clinical oximeter tests should include a more diverse participant pool. Specifically, the agency is increasing the number of trial participants from 10 to 150, with a requirement that at least 25% of them have darker skin tones.
This change aims to ensure that pulse oximeters are equitable in their accuracy across different skin types. However, products sold over the counter may still evade these specifications.
Raising Concerns About Accessibility
Experts like Dr. Frank Chan of Medtronic emphasize that reliance on pulse oximetry for clinical decisions can lead to significant outcomes in patient care. Additionally, concerns have arisen that the new FDA guidelines do not sufficiently regulate the health-and-wellness devices primarily accessible to consumers.
Even though the FDA’s updated recommendations have garnered attention, many feel they fall short of adequately addressing widespread issues related to the performance of pulse oximeters in real-world conditions. The potential bureaucratic challenge of testing these devices has also raised concerns among makers of lower-cost health devices.
Conclusion and Future Implications
The FDA’s new guidelines mark an important effort towards reducing health disparities associated with pulse oximeter use. Nevertheless, the limitations in regulation for over-the-counter devices remain a critical hurdle that must be addressed. In the ongoing fight to ensure equitable healthcare, understanding the ramifications of these medical technologies will be essential.
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