FDA Proposes New Guidance To Address Pulse Oximeter Inaccuracies Due to Skin Tone
Federal regulators are calling for larger pulse oximeter clinical studies, to ensure manufacturers examine the accuracy of the devices on all skin tones.
Federal regulators are calling for larger pulse oximeter clinical studies, to ensure manufacturers examine the accuracy of the devices on all skin tones.
Agency hopes the program will result in cancer treatment clinical trials that represent all patient demographics.
Further improvements to medical device quality, surveillance and the medical device recall program are planned by the FDA throughout 2024.
Concerns about the safety and accuracy of pulse oximeters for people with darker skin will be reviewed by health experts at a panel advisory meeting in February 2024
Pulse Oximeter inaccuracies contributed to deaths among Black Americans during the COVID-19 pandemic, the panel believes.
Pulse oximeter inaccuracies have led to treatment delays for Black, Asian and Latinx patients.
Many Black and Latino patients received delayed care for COVID-19 due to poorly designed pulse oximeters, researchers warn