Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.

The FDA continues to evaluate all available information pertaining to factors that may affect pulse oximeter accuracy and performance. Because of ongoing concerns that these products may be less accurate in individuals with darker skin pigmentations, the FDA is planning to convene a public meeting of the Medical Devices Advisory Committee later this year to discuss the available evidence about the accuracy of pulse oximeters, recommendations for patients and health care providers, 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. Further details concerning the agenda, timing, and location of the Advisory Committee meeting will be announced in the coming weeks.

An article in JAMA Internal Medicine titled, "Racial and Ethnic Discrepancy in Pulse Oximetry and Delayed Identification of Treatment Eligibility Among Patients With COVID-19" notest that their study "results suggest that overestimation of arterial oxygen saturation levels by pulse oximetry occurs in patients of racial and ethnic minority groups with COVID-19 and contributes to unrecognized or delayed recognition of eligibility to receive COVID-19 therapies.

Reference

Fawzy A, Wu TD, Wang K, et al. Racial and Ethnic Discrepancy in Pulse Oximetry and Delayed Identification of Treatment Eligibility Among Patients With COVID-19. JAMA Intern Med. 2022;182(7):730–738. doi:10.1001/jamainternmed.2022.1906