Pulse oximeters that meet current performance standards continue to be a vital component of safe anesthesia care. However, studies in recent years have pointed to potential disparities in pulse oximeter performance that have been linked to patient skin tone. A prominent study from Sjoding et al. in 2020 suggested that pulse oximeters could be less likely to successfully detect occult hypoxemia in patients who self-identified with races associated with darker skin tones (N Engl J Med 2020;383:2477-8). This study built on past research to generate questions about potential disparities in pulse oximeter performance that would negatively impact patient care decisions and draw public attention to this issue (Anesthesiology 2005;102:715-9; Anesth Analg 2007;105:S18-23).
“While the FDA’s forthcoming study is expected to provide some level of closure and consensus on the role of skin tone in pulse oximeter performance, ASA will remain an active voice on this issue as we work through the important steps ahead.”
As the growing trend of research around performance disparities raised concerns among anesthesiologists and the broader health care community, the Food and Drug Administration (FDA) began reaching out to stakeholders and planning further research into pulse oximeter performance errors and their causes. ASA remained engaged every step of the way. In 2022, then-ASA President Randall Clark, MD, FASA, delivered comments to the FDA, requesting that the agency examine and address the effects of skin pigmentation on pulse oximeter accuracy, as well as determine whether there are any other factors that may negatively affect the performance of these devices.
In late 2023, the FDA took action to meet the requests of ASA and other stakeholders, detailing a proposed study to examine the effects of skin tone, race, and ethnicity on pulse oximeters while also asking for feedback on other factors of device performance that the agency should consider in future research (asamonitor.pub/48QrgHJ). The FDA’s proposed research was devised to inform future guidelines on premarket studies for the design and development of new pulse oximeter technology. The clinical study design included use of the Monk Skin Tone scale as a validated method of capturing race and ethnicity diversity in skin pigmentations, as well as individual typology angle, which can identify pigmentation at a specific point on an individual’s skin, such as a finger or other sensor sites.
ASA comments, developed primarily by the Committee on Equipment and Facilities, offered a comprehensive response to the FDA, recommending that the study remain grounded in clinical decision-making and clinical outcomes and suggesting potential device performance factors for future consideration, such as device misapplication, patient blood conditions, and low perfusion states. ASA’s comments stressed the importance of access to current pulse oximeter technology on patient safety and pointed out that clinical decisions using these devices should consider the overall clinical context and not fully rely on a single measurement. ASA’s letter stated definitively that “every patient should have access to effective monitoring technologies and care regardless of race, ethnicity, or any other personal characteristic.”
Building on this encouraging progress toward a better understanding of pulse oximeter performance issues, multiple ASA members participated in the FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee meeting in February 2024. The meeting served to solidify stakeholder response on the FDA’s proposed study, and our members’ input helped the panel reach agreement on increasing the sample size of study participants with differing skin tones to strengthen the research. Previously, the FDA’s guidance for premarket research only recommended that a minimum of two “darkly pigmented subjects or 15% of the study group” be included in clinical device studies.
This panel represented a milestone in advancing research to improve the accuracy of future pulse oximeter technology. It also helped translate years of engagement and advocacy on this issue from organizations like ASA into greater public awareness of this work through prominent media coverage in outlets like CNN and others (asamonitor.pub/3TxURBg).
While the FDA’s forthcoming study is expected to provide some level of closure and consensus on the role of skin tone in pulse oximeter performance, ASA will remain an active voice on this issue as we work through the important steps ahead. ASA will continue advocating for the FDA to examine other factors in pulse oximeter performance and ensure that guidance for pulse oximeter manufacturers derived from the agency’s research meets the clinical needs of anesthesiologists, including preserving widespread access to these devices.