FDA Proposes Stricter Testing for Pulse Oximeters on Diverse Skin Tones

The FDA has proposed new guidelines requiring manufacturers of pulse oximeters to gather comprehensive data on device performance across various racial groups. This move aims to improve accuracy for patients with darker skin tones, following studies highlighting racial discrepancies in the devices' oxygen level readings.

The Food and Drug Administration (FDA) unveiled a proposal on Monday, mandating that manufacturers of medical devices like pulse oximeters gather additional data to verify their effectiveness across racial groups. This action is in response to concerns about the devices' accuracy in patients with darker skin tones.

Pulse oximeters, commonly used in medical settings, operate by clipping onto a patient's finger and using light wavelengths to gauge oxygen levels in the blood. The FDA's draft guidelines call for expanded clinical trials, demanding participation from various racial backgrounds, with a focus on individuals with darker skin pigmentation.

This move follows findings that such devices may overestimate oxygen saturation in Black patients, leading to potential treatment delays. The proposal, which will undergo a 60-day public comment period, aims to rectify racial bias in medical technology, spotlighting the necessity for diversified testing in the healthcare industry.

(With inputs from agencies.)