FDA Panel Discusses Real-World Evidence Confirming Pulse Oximeters Inaccurate for People with Darker Skin Tones

November 3, 2022

The US Food and Drug Administration held a panel this week discussing “mounting real-world evidence” (RWE) that pulse oximeters do not work as well on people with darker skin tones. The topic, long discussed and highlighted by communities of color and patient advocacy groups, came to a head during the COVID-19 pandemic wherein inaccurate readings caused worse health outcomes among Black patients in the US.

According to Chia-Yi Hou, “The agency had issued a Safety Recommendation in February 2021 warning that the accuracy of pulse oximeters can be affected by poor circulation, skin pigmentation, skin thickness, skin temperature and tobacco use. The FDA also points out in this panel that only about 18 percent of pulse oximeter devices list on their label that dark pigmentation is a factor that may affect accuracy. Other factors included on device labels are intravascular dyes, excessive light in the environment, presence of electromagnetic sources, patient movement, nail polish and extreme moisture.”

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(Source: The Hill, November 2nd, 2022)

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