Nonin CO-Pilot™ and PalmSAT ® 2500 Series meet FDA standards, delivering accurate readings and outperforming competitors
Summary
In 2024, the Open Oximetry Project conducted an evaluation of handheld pulse oximeters, including the Nonin CO-Pilot™ and the Nonin PalmSAT® 2500 Series. The assessment aimed to determine the accuracy of these devices across patients with varying skin tones, including those with darker pigmentation. This effort addresses longstanding concerns about pulse oximeter performance for individuals with darker skin, as studies have shown that inaccuracies in oxygen saturation readings for patients of color contributed to delayed treatment and adverse outcomes during the COVID-19 pandemic.1
Pulse oximeters have historically shown discrepancies in their readings for individuals with dark skin pigmentation.2 With these issues gaining more attention in recent years, the Open Oximetry Project was established to evaluate pulse oximeter performance across diverse populations. By sharing de-identified data, the project aims to bring visibility to these performance disparities and advocate for more accurate solutions.
The Open Oximetry Project’s data revealed that while many devices from other manufacturers fall short of FDA compliance standards, Nonin handheld pulse oximeters (CO-Pilot and PalmSAT 2500 Series) meet those standards, demonstrating strong performance across tested skin tones within the 85-100% oxygen saturation range and at varying perfusion levels3 (see figure 1).
These devices exhibit low bias and minimal error in oxygen saturation (SpO2) readings, validated through comparison with the gold standard arterial blood gas (SaO2) measurements.3 This evaluation confirms Nonin’s ability to deliver accurate readings for diverse patients.3
As healthcare professionals continue to seek equitable solutions for patient monitoring, these findings are pivotal in guiding providers toward selecting tools that offer accurate, accessible monitoring for all patients, supporting improved clinical outcomes across the healthcare spectrum.
Methods
To evaluate Nonin’s handheld pulse oximeters, the Open Oximetry Project conducted a rigorous assessment using a comprehensive testing protocol. The process compared SpO2 readings from Nonin’s devices to SaO2 measurements.
Participants in the study were selected from a broad demographic, ensuring diversity across skin tones and perfusion levels. Data collected were analyzed for accuracy, including mean bias and Accuracy Root Mean Square error (ARMS). The evaluation focused on how handheld oximeters, including Nonin devices, performed across these varied populations in everyday use cases.
To establish performance expectations, the devices were evaluated on the following metrics:
Bias: This refers to the average difference between SpO2 and SaO2 measurements. It indicates whether a device consistently overestimates or underestimates oxygen saturation. Bias values of a smaller magnitude indicate more accurate readings.
ARMS: This refers to the Accuracy Root Mean Square error, which considers both the average difference and the variation in measurements between SpO2 and SaO2. A lower ARMS indicates greater overall accuracy, with values ≤3% required to meet FDA regulatory standards.
Key Takeaways
The analysis demonstrated that Nonin’s handheld pulse oximeters provide accurate results with minimal bias and error.3 These findings reaffirm the overall accuracy of Nonin devices and their ability to support precise clinical decision-making across a diverse range of patients.
Accuracy Across Patient Populations
The evaluation confirmed that Nonin’s CO-Pilot handheld pulse oximeter delivers accurate performance for all patients, irrespective of skin tone.3 This device exhibited minimal bias and low error rates compared to the reference device. Nonin’s pulse oximeters met FDA accuracy requirements; the CO-Pilot performed with an ARMS value of 1.4%, while the PalmSAT 2500 recorded an ARMS value of 2.2%—both well within the regulatory threshold.3
Combined with the data from the Leeb G, Auchus I, Law T, et al. study, confirming the accuracy of Nonin’s fingertip oximeters4 (Onyx Vantage 9590®), these findings further reinforce the company’s commitment to providing dependable, accurate solutions for patient monitoring across diverse populations.
Manufacturer Claims vs. Clinical Outcomes
In contrast, handheld pulse oximeters from other manufacturers displayed higher bias and error rates, particularly for patients with dark skin pigmentation. For instance, the Masimo Rad-97® and the Masimo Rad-G™ models did not meet FDA regulatory accuracy standards3 (see figure 3). Notably, this performance fell short of manufacturer claims in both models.
These findings underscore the need for careful evaluation when selecting pulse oximeters, ensuring that devices meet FDA standards and perform accurately across all patient populations.
Reinforcing Equitable Patient Monitoring
The data released by the Open Oximetry Project highlights the critical need for medical devices that deliver accurate performance across all patient populations, including those with darker pigmentation and low perfusion. While many manufacturers claim regulatory adherence, these findings emphasize the importance of ensuring pulse oximeter performance meets FDA regulatory standards. This is key in addressing clinical disparities and ensuring healthcare professionals have the tools needed to provide high-quality care and optimize patient monitoring.
Nonin’s handheld pulse oximeters (CO-Pilot and PalmSAT 2500 Series) meet FDA regulatory standards, offering devices with accurate performance3 and supporting informed clinical decision-making to help improve patient outcomes.