FDA to discuss pulse oximetry concerns
By HME News Staff
Updated 10:42 AM CDT, Thu September 22, 2022
WASHINGTON – The U.S. Food and Drug Administration will hold a virtual meeting on Nov. 1 to discuss ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigments. The CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee will also discuss factors that may affect pulse oximetry accuracy and performance, the available evidence about the accuracy of pulse oximeters, recommendations for patients and health care providers, and the amount and type of data that should be provided by manufacturers to assess pulse oximetry accuracy and guide other regulatory actions as needed.
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