FDA Convening Panel on Pulse Oximeter Accuracy

There are growing concerns that pulse oximeters could take less accurate readings for patients with darker skin pigmentations.

The FDA will convene a public meeting of the Medical Devices Advisory Committee later this year to discuss evidence about the accuracy of pulse oximeters due to ongoing concerns that the devices might be less accurate for individuals with darker skin pigmentations.

The issue first arose due to the Covid-19 PHE causing an increase in the use of pulse oximeters. A recent report, “Racial Bias in Pulse Oximetry Measurement,” suggests that the devices might be less accurate in people with dark skin pigmentation.

The yet-to-be-scheduled meeting of the Medical Devices Advisory Committee will discuss:

  • The available evidence about the accuracy of pulse oximeters.
  • Recommendations for patients and healthcare providers.
  • The amount and type of data that should be provided by manufacturers to assess pulse oximeter accuracy
  • Any regulatory actions as needed.

Further details concerning the agenda, timing, and location of the Advisory Committee meeting will be announced in the coming weeks.

The FDA reported it is evaluating all available information pertaining to factors that might affect pulse oximeter accuracy and performance. In the meantime, it has published a web page that offers the following information:

  • How patients and caregivers should take a reading.
  • How they should interpret a reading.
  • When to contact a healthcare provider.
  • Recommendations for healthcare providers.
  • Interpretation and limitations of pulse oximetry.
  • How to report problems with a pulse oximeter.

 

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