Read our Founder and CEO Joe Kiani's response the recent reports about pulse oximetry and racial bias.
Below are answers to some of the common questions we've received from the public and our customers on this important issue.
No. As the recent FDA communication explains, there are many different pulse oximeters, some of which are tested in clinical studies and used by doctors in hospitals (like Masimo SET® pulse oximetry). Others do not undergo any testing, do not have verified accuracy claims, and should not be relied on as medical devices. Among medical-grade technologies, Masimo SET® is the leader. Since its introduction in 1995, Masimo SET® has been shown in over one hundred independent and objective studies to outperform other pulse oximetry technologies. Today, Masimo SET® is used to monitor more than 200 million patients around the world annually and is also the primary pulse oximetry technology at 9 of the top 10 hospitals according to the 2020-2021 U.S. News & World Report Best Hospitals Honor Roll.1-3
Masimo SET® uses a variety of advanced algorithms and techniques to analyze light waves that pass through the fingertip and display an accurate measurement of the oxygen saturation of the blood in the fingertip. Many other technologies can be confused by factors like dark skin, patient movement, and poor circulation.
Masimo SET® was tested from the start on patients with a wide range of skin colors, so when we say “pulse oximeters are not racist,” we are referring to our confidence in the fact that our technology doesn’t discriminate. Our internal data (reported to the FDA) supports this statement, as do outside studies like one conducted in 2017 that showed that our technology showed “no significant difference in systematic bias based on skin pigment.”
As part of the development of Masimo SET®, we tested our technology on more than 2000 patients, with more than 1000 of them having darker skin. The difference in bias between lighter-skinned and darker-skinned patients was so small as to be insignificant (less than 1%). Accuracy was measured by comparing pulse oximetry readings to blood glass analysis using blood samples. When we compared results for patients who had self-identified their ethnicity, we found a similar, insignificant, difference in accuracy between Black and Caucasian study subjects.
We encourage you to visit our website to learn more about how pulse oximetry works and why Masimo SET® is the choice of leading hospitals and doctors around the world. You can also learn more by reading a recent article written by our Founder and CEO that explores this issue, including other studies, in more detail. Recently, the FDA also issued some guidance that helps explain this issue and how to choose the right kind of pulse oximeter.
We take the concerns raised by the NEJM letter very seriously. We’ve been in touch with those researchers to better understand how they arrived at their conclusions. We are conducting further internal research and working with other scientists and doctors to continue testing our technology to make sure it is as accurate as possible.
Yes. We believe that all manufacturers should be required to disclose the data they use to develop and test their pulse oximetry so there is transparency about how well each technology works on patients of all skin colors.
The researchers acknowledged that their study had limitations. We are looking forward to working with them and all committed researchers to further examine this important issue.
Pulse oximetry is a standard of care in hospital settings, but for years, traditional pulse oximetry was plagued by unreliability when it was needed most—during patient motion and low perfusion. Clinicians were forced to live with excessive false alarms, inaccurate data, and an inability to obtain readings on the most critical patients.
With Masimo SET® technology, Masimo solved the "unsolvable" and established a new standard in pulse oximetry by introducing the ability to measure through motion and low perfusion.
Clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com/evidence/pulse-oximetry/set/. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
Estimate: Masimo data on file.
For professional use. See instructions for use for full prescribing information including indications, contraindications, warnings and precautions. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.