Evaluating pulse oximeters in ICU according to the new FDA guidances: skin tone and LED spectra assessment

Key Points

• The study aims to assess the performance of pulse oximeters in ICU settings based on new FDA guidelines.
• Evaluated pulse oximeter performance criteria according to updated FDA standards
• Compared device performance on different skin tones and LED spectra
• Some oximeters cleared under older standards exhibit lower accuracy in ICU patients
• Importance of updating device evaluations is underscored by newer guidance standards