The U.S. Food and Drug Administration (FDA) has issued new draft guidelines to address inaccuracies in pulse oximeters—critical medical devices used to measure oxygen levels in the blood. The proposal requires manufacturers to improve testing protocols, specifically focusing on patients with darker skin tones.

Key Highlights

• Purpose of Pulse Oximeters:

Pulse oximeters, commonly used in hospitals and clinics, measure oxygen levels in the blood by sending wavelengths of light into the skin. However, studies show that darker skin pigmentation can interfere with the accuracy of readings.

• COVID-19 Spotlight:

The devices became indispensable during the COVID-19 pandemic but drew scrutiny after research revealed that they often overestimate oxygen levels in Black patients, potentially delaying treatment and increasing mortality risks.

• FDA’s New Testing Guidelines:

The FDA has proposed stricter requirements for manufacturers to ensure device accuracy across diverse skin tones.
Key recommendations include:

1. Enrolling at least 150 participants in clinical studies, with a minimum of 25% having darker skin tones (up from 15%).

2. Using two methods to evaluate participants' skin pigmentation: visual assessments and scientific, light-based melanin measurements.

Impact on Medical Devices

• Focus on Professional Use:

The guidelines apply to professional-grade oximeters used in medical settings but exclude over-the-counter models, which are unregulated and categorized as "general wellness" devices.

• Ongoing Use of Existing Devices:

Older oximeters will remain in use, but manufacturers seeking updates or modifications must provide new data on device performance across diverse racial groups.

• Public Consultation Period:

The FDA has opened a 60-day public comment window on the draft recommendations before finalizing the guidelines.

• Broader Implications:

The FDA’s move highlights the growing recognition of racial biases in medical technology. The proposed guidelines aim to improve equitable healthcare outcomes by ensuring medical devices work effectively for all racial groups.With these new measures, the FDA is setting a precedent for tackling systemic biases in medical devices. As public consultations begin, this initiative could mark a significant step toward building a more inclusive healthcare system.