As a global leader in medical technologies, Masimo is committed to providing products that serve all people, regardless of age, sex, race, ethnicity, or skin color. Recent media coverage has called into question the reliability of pulse oximetry in people with darker skin pigmentation.
“Masimo SET® measure-through motion and low perfusion pulse oximetry has been validated using nearly equal numbers of dark and light-skinned people to optimize performance, accuracy, and safety in all demographics. Because this is an important patient safety issue of public concern, Masimo looked internally to evaluate the equality of our pulse oximetry measurements in relation to skin color, and found that Masimo SET® pulse oximetry accurately measures oxygen saturation without any clinically significant bias between dark and light-skinned individuals. Finally, we have committed to initiating additional prospective studies with independent researchers to further validate the performance of Masimo SET® technology across the entire spectrum of skin pigmentation.”
William C. Wilson, MD, MA, Chief Medical Officer, Masimo
Below are answers to some of the most common questions we've received from the public and our customers on this important issue.
Drs. Barker and Wilson presented an abstract at the 2022 Annual Meeting of the Society for Technology in Anesthesia (STA).1 The abstract summarized a retrospective evaluation of Masimo’s internal volunteer desaturation data, collected between October 2015 and July 2021. The study included paired samples obtained from 75 subjects (39 black and 36 white). In total, 7,183 paired samples were compared (3,201 from black subjects and 3,982 from white subjects). The SpO2 values were obtained from each subject using Masimo SET® pulse oximeters with RD SET® sensors, and time-matched with arterial blood gas (ABG) samples from each subject. The ABG samples were obtained within 5 seconds of the SpO2 values.
The average SpO2-SaO2 difference (bias, or mean error) is -0.20% for black subjects and -0.05% for white subjects, and the bias difference between groups is 0.15. The large sample size provided enough power to discern a statistical difference of p < 0.001. However, the bias difference of 0.15% is NOT clinically significant, because SpO2 values are displayed in 1% increments on pulse oximeters.
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. Many other technologies can be challenged by factors like dark skin, movement, and poor circulation.
Since its introduction in 1995, Masimo SET® has been shown in over 100 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 as ranked in the 2021-2022 U.S. News & World Report Best Hospitals Honor Roll.2-4
The FDA has issued some guidance that helps explain this issue and how to choose the right kind of pulse oximeter. We also encourage you to learn more about why Masimo SET® is the choice of leading hospitals and doctors around the world.
Yes. We believe that all manufacturers should validate their pulse oximeters on patients of all skin colors.
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.
Barker SJ, Wilson WC. Accuracy of Masimo SET® Pulse Oximetry in Black and White Volunteer Subjects: A Retrospective Review. Annual Meeting of the Society of Technology in Anesthesiology. Presented Jan 15, 2022.
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.