Panel finds pulse oximeters less accurate on darker skin
A Food and Drug Administration (FDA) advisory panel on Tuesday said it was clear that pulse oximeter devices do not provide accurate readings for people with “darker skin pigmentations.”
In an all-day meeting, the panel reviewed published literature, Medical Device Reporting (MDR) data and clinical evidence from studies regarding the accuracy of blood oxygen readings from pulse oximeters in people with darker skin pigmentation.
Concerns over accuracy have been longstanding, but the COVID-19 pandemic pushed the issue into the mainstream
The panel discussed the concerns about the devices and made recommendations for health care providers, labeling for patients and study design and analyses.
- Inaccurate readings pose a clinical risk in hospitals; for instance a patient may not get moved into intensive care units if they need it.
- But the panel was not unanimous in recommendations on how to limit the inaccuracies going forward.
- The panel recommended more studies to understand the issue and that device makers include skin pigmentation as a potential factor affecting accuracy in labeling.
Pulse oximeters, which are meant to detect low blood oxygen levels work by shining a light source through a fingertip and analyzing the light that passes through.
