Across the healthcare landscape, more and more conversations are focusing on health inequity. Specific to pulse oximetry, recent research, media, and regulatory discussions have been raising awareness around disparities in care.
Red flags following COVID-19
In the wake of the COVID-19 pandemic, research showed a disparity in oxygen reading levels for people with darker skin tones, which may have impacted care and outcomes.1 This research encouraged clinicians and manufacturers to come together and discuss ways to make this technology, which had been in use for decades, more equitable.
The potential for technology to create – and close – gaps in health equity
Pulse oximetry – a global standard of care in patient monitoring – plays a critical role in care decisions. The test uses calibrated light and algorithms to help determine oxygen saturation, which is one part of a diagnostic set of tools to determine patient care and affect outcomes. Each pulse oximetry system processes data in a unique way, which affects performance. For example, research demonstrates that pulse oximetry results can be impacted by dark skin pigmentation, which absorbs some of the light from the emitter. This absorption prevents the light from penetrating through the tissue and blood to be accurately read by the pulse oximeter. 2
Medtronic Nellcor™ SpO2 device vs. Masimo SET™* SpO2 device
In 2022, a leading hypoxemia research laboratory team evaluated device performance and accuracy of the Medtronic Nellcor™ SpO2 and Masimo SET™* SpO2 devices. Results showed the Masimo device missed 30% of hypoxemic events in people with dark skin pigmentation and low perfusion. In the Medtronic device, that same rate was 8%. That means the Medtronic Nellcor™ SpO2 device missed 74% fewer hypoxemic events in patients with dark skin pigmentation and low perfusion during the most challenging situations.2†
Designing an ecosystem for greater equity
Although the Medtronic device has achieved a high level of performance, there is still more work to be done. To ensure that its clinical evidence realistically mirrors patient populations, Medtronic is investing in additional clinical research. The new Medtronic Clinical Physiology Lab in Denver, Colorado is one example. Dedicated to conducting research and clinical studies on pulse oximeters with a diverse patient population, the lab uses the Monk Skin Tone (MST) scale — a more inclusive 10-tone scale designed to represent a broader range of communities than the previously used Fitzpatrick scale.
Sharing this research will be critical. Although pulse oximeter technology has been the global standard of care across multiple clinical settings for decades, an internal Medtronic marketing survey has shown has shown that a majority of nurses were unaware of the disparities in outcomes for patients with dark skin tones between pulse oximeter devices. 3 To help ensure that every bedside clinician and nurse has the knowledge they need to treat patients confidently and effectively, Medtronic will continue to raise awareness of disparities in care and provide educational resources.
Part of a deeper commitment
For Medtronic, efforts to help reduce health inequities in pulse oximetry are linked to a larger story. As a global leader in healthcare technology, Medtronic has always seen the potential of technology to be a profound equalizer. In early 2023, Medtronic signed<https://news.medtronic.com/medtronic-signs-zero-health-gaps-pledge-advance-health-equity-newsroom> the Zero Health Gaps Pledge to advance health equity, joining the World Economic Forum’s Global Health Equity Network with the goal of protecting all patients from disparities in care. By combining the right healthcare technology, building lasting partnerships, and sharing learnings, Medtronic believes it is possible to help reduce disparities in outcomes for everyone, everywhere.
References
†The study (not funded by Medtronic) enrolled 146 healthy subjects in the 92-96% saturation range and examined paired readings from Nellcor™ N-595 and Masimo Radical 7™* pulse oximeters generated simultaneously. This study was not designed for head-to-head comparison of the respective devices.
- 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 Jul 1;182(7):730-738. Erratum in: JAMA Intern Med. 2022 Oct 1;182(10):1108.
- Gudelunas MK, Lipnick M, Hendrickson C, et al. Low perfusion and missed diagnosis of hypoxemia by pulse oximetry in darkly pigmented skin: a prospective study. Anesth Analg. 2024;138(3):552-561.
- Based on internal report REF-24483 Health Equity Market Research Results. March 2024.