The U.S. FDA announced a virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to discuss ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations.
The committee will also discuss factors that may affect pulse oximeter 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 oximeter accuracy and to guide other regulatory actions as needed.
The committee will meet on Nov. 1, 2022. For additional meeting details, see the meeting announcement in the Federal Register.
The FDA continues to evaluate all available information pertaining to factors that may affect pulse oximeter accuracy and performance. FDA recommendations initially provided have not changed. The FDA says it will continue to keep the public informed as significant new information or recommendations become available.
The COVID pandemic caused an increase in the use of pulse oximeters, and a late 2020 report published in The New England Journal of Medicine suggested that the devices may be less accurate in people with dark skin pigmentation.
The U.S. FDA subsequently informed patients and healthcare providers that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy under certain circumstances that should be considered. The FDA suggested that patients with conditions such as COVID who monitor their condition at home should pay attention to all signs and symptoms of their condition and communicate any concerns to their healthcare provider.
