VIDEO EXCERPT: ECRI Vice President of Device Safety Scott Lucas
presented to the FDA on pulse oximeters’ performance on varying
skin pigmentation.

Pulse oximeters are an important tool to assess whether a patient is in respiratory distress due to low oxygen levels, but these devices are less accurate for patients with darker skin tones. This can result in missed and delayed diagnoses and treatment for a variety of illnesses. The Food and Drug Administration (FDA) published a discussion paper and requested feedback on its proposal to improve evaluation and monitoring of pulse oximeter performance.

In a public meeting held by the FDA Center for Devices and Radiological Health (CDRH) on Feb. 2, ECRI—a leading, non-profit patient safety organization and the nation’s only independent evaluator of medical devices—offered recommendations to ensure the accuracy of this critical technology for all patients. Scott Lucas, vice president of device safety, presented at the virtual public meeting of the Anesthesiology Devices Panel.

ECRI has been evaluating the safety and effectiveness of medical equipment for over 50 years and published its first evaluation of pulse oximeters in 1989. ECRI’s resources on pulse oximeters are used by healthcare providers worldwide in the selection, implementation, and maintenance of this critical technology.

Recommendation Highlights

ECRI outlined three main recommendations on ways to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters.

• Pilot test the proposed Monk Skin Tone (MST) protocol to assess skin tone and skin variations across many patients. Train users on the tool and evaluate if they can use it consistently. Assess if different users can get the same reading on the same patient – then address discrepancies through cognitive interviewing. Update relevant training programs.

• MST is typically performed by looking at the skin pigment on a patient’s forehead. But pulse oximeters are most commonly applied on the finger. For many people, the skin pigment differs between the face and hands. Identify MST at the pulse ox sensor location, the finger (which is consistent with FDAs proposal for quantification of skin tone).

• For calculating Individual Typology Angle (ITA), choose colorimetry devices validated for reliable and consistent use across a diverse group of users. Some device vendors may have completed testing that shows they can produce consistent readings. Without that validation data, conduct a pre-study validation trial to assess if individuals use the colorimeters consistently, such as at the same angle and same pressure against the skin and if different users get the same readings on a single patient.

“This level of rigor in clinical trials is a great start, but it should not stop when the device is cleared. We recommend integrating post-market performance reviews to track incidents with the devices and to capture performance disparities in previously cleared devices. Vendors should continue to submit data about device performance among patients with different skin tones to identify and reduce care disparities.” – Scott Lucas, VP of Device Safety, ECRI

For more information, contact:

Yvonne Rhodes, ECRI Associate Director-Strategic Communications, YRhodes@ECRI.org

About ECRI

ECRI is an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings. With a focus on technology evaluation and safety, ECRI is respected and trusted by healthcare leaders and agencies worldwide. Over the past 55 years, ECRI has built its reputation on integrity and disciplined rigor, with an unwavering commitment to independence and strict conflict-of-interest rules. ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific.