ECRI made recommendations to the FDA for improving the accuracy of pulse oximeters on patients with darker skin tones.

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, according to ECRI. 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 offered recommendations to ensure the accuracy of this critical technology for all patients. Scott Lucas, vice president of device safety at ECRI, 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.

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,” said Lucas. “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.”