The US Food and Drug Administration has published new draft guidance aimed at improving the accuracy and performance of pulse oximeters — important devices for patient care that estimate the amount of oxygen carried in the blood — across the range of skin pigmentation.

Scientific evidence suggests variations in pulse oximeter readings for individuals with lighter and darker skin pigmentation. The FDA had previously informed patients and healthcare providers that although pulse oximetry is useful in estimating blood oxygen levels, the devices have limitations, including risk of inaccuracy, under certain conditions.

To address these concerns, the FDA has proposed new draft recommendations for manufacturers on ways to gather clinical data, among other details, to help improve the clinical study design and validation efforts for pulse oximeters to evaluate their performance across the range of skin pigmentation. The FDA is committed to working with manufacturers to help ensure the public has access, at the earliest possible, to pulse oximeters that perform accurately across the range of skin pigmentations. 

Key elements of the FDA’s draft recommendations include gathering clinical data (for example, controlled desaturation laboratory study or, in certain cases, real-world data) to evaluate device performance accuracy across the range of skin pigmentations increasing the number of clinical study participants, and so on.

The FDA expects that some of the pulse oximeters currently marketed may meet the updated performance criteria without the need for significant hardware or software modifications. In these instances, if a sponsor submits updated labelling to reflect the collection of clinical data that demonstrates comparable performance across skin pigmentations without device modifications, then the FDA intends to review the submission expeditiously (within 30 days).

(Source: FDA)