ASA Comments on FDA's Planned Research of Links Between Pulse Oximeter Performance and Skin Pigmentation, Race, and Ethnicity

This week, the American Society of Anesthesiologists (ASA) submitted comments to the Food and Drug Administration (FDA) on the agency’s Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity discussion paper. ASA’s comments provided recommendations on FDA’s plans to conduct a clinical study examining the role of skin pigmentation, race, and ethnicity in the performance of pulse oximeters.

In the comment letter, ASA acknowledged the previous studies linking pulse oximeter performance errors to darker skin tones and supported the need for further research on this topic. ASA recommended that FDA’s research on pulse oximeter performance contemplate how the effective use of that technology affects clinical decision-making as well as clinical outcomes. In response to FDA’s request for other considerations that may require further examination, ASA provided several potential factors, including device misapplication, patient blood conditions, and low perfusion states.

FDA’s planned study is intended to guide the future development and approval of pulse oximeters. ASA’s comments emphasized the importance of maintaining access to legacy pulse oximeter devices, as pulse oximeters are a central feature of patient safety.

Click here to read ASA’s full comment letter.

Please contact the ASA Department of Quality and Regulatory Affairs at [email protected] with any questions.