Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

3 July 2022
Author: Nathan E Botts
Number of views: 904

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

More links

Pulse oximeters’ inaccuracies in darker-skinned people require urgent action, AGs tell FDAMore than two dozen attorneys general are urging Food and Drug Administration officials to take urgent action to address disparities in how well pulse oximeters, the fingertip devices used to monitor a person’s oxygen levels, work on people with darker skin.
Pulse Oximeter Accuracy and Limitations: FDA Safety CommunicationThe 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
Racial and Ethnic Discrepancy in Pulse Oximetry and Delayed Identification of Treatment Eligibility Among Patients With COVID-19Are there systematic racial and ethnic biases in pulse oximetry among patients with COVID-19, and is there an association between such biases and unrecognized or delayed recognition of eligibility for oxygen threshold–specific therapy?

Categories: Medical Devices

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