Pulse Oximeter Performance, Racial Inequity, and the Work Ahead

Area of Science:

• Biomedical Engineering
• Clinical Medicine
• Health Equity

Background:

• Pulse oximeters demonstrate reduced accuracy in patients with darker skin tones.
• The underlying reasons for this discrepancy are not fully understood and may be linked to regulatory oversight limitations.

Purpose of the Study:

• To propose research areas and regulatory modifications to enhance pulse oximeter accuracy in individuals with darker skin.
• To address the under-characterization of factors affecting oximeter performance in diverse populations.

Main Methods:

• Review of existing data and expert experience regarding pulse oximeter performance.
• Identification of key factors contributing to inaccurate readings in darker skin pigmentation.
• Formulation of recommendations for regulatory agencies.

Main Results:

• Identification of 5 priority research areas for characterizing oximeter performance variations.
• Proposal of specific regulatory changes including modified accuracy standards, outlier analysis, diverse subject pools, defined skin pigmentation metrics, transparent data reporting, and consideration of low-perfusion states.

Conclusions:

• Implementing proposed research and regulatory changes can improve pulse oximeter accuracy across all skin tones.
• Addressing these issues will reduce bias and enhance access to safe and reliable medical devices for all patients.