The U.S. Food and Drug Administration (FDA) is calling on manufacturers of pulse oximeters to make crucial updates to their devices, aiming to improve accuracy and save lives. Pulse oximeters, which measure the oxygen saturation in the blood, have been found to perform less accurately on individuals with darker skin tones, posing a significant health risk.
Recent scientific studies have revealed that pulse oximeters tend to give inaccurate readings for people with darker skin, potentially leading to undetected health issues. A 2020 report from the New England Journal of Medicine highlighted that Black patients, in particular, were nearly three times more likely to experience “occult hypoxemia” — a dangerous condition where low blood oxygen levels go undetected by pulse oximeters.
In response, the FDA issued a formal warning in February 2021 about the limitations of pulse oximeters. The new draft guidance calls for manufacturers to improve clinical study designs, ensuring that pulse oximeters are validated across diverse skin tones, particularly for medical use. These changes are essential to ensure pulse oximeters provide accurate, reliable results for all patients, regardless of their skin color.
It’s important to note that the FDA’s updated guidance applies only to medical-grade pulse oximeters used in healthcare settings. Devices used for wellness or fitness purposes, such as those built into fitness tracking watches from companies like Garmin and Coros, are not impacted by these changes.
Pulse oximeters, which work by sending light through the finger to measure oxygen levels and pulse rate, have long been a staple in medical assessments. However, their potential inaccuracies, especially for people with darker skin, have raised concerns that the FDA is now addressing through its new recommendations.
With these changes, the FDA hopes to ensure that all patients receive the most accurate readings possible, regardless of their skin tone, ultimately enhancing patient care and safety.
Read more:
- The Timing Of Your Coffee Could Impact Heart Health, Study Reveals
- America’s Health Care System: When Profits And Wall Street Take Priority
- U.S. Overdose Deaths Surge, Outpacing Global Rates: Time For Action
