FDA Update – PULSE OXIMETERS

The FDA has some concerns on the precision on Pulse Oximeters when it is used by people of different skin tones. They recently came out with this update.

Can Skin Tone Affect the Precision of Pulse Oximeters? 

The FDA is Working to Determine the Accuracy As Well As Limitations

The U.S. Food and Drug Administration (FDA) continues to evaluate all available information pertaining to factors that may affect pulse oximeter accuracy and performance. Because of ongoing concerns that these products may be less accurate in individuals with darker skin pigmentations, the FDA is planning to convene a public meeting of the Medical Devices Advisory Committee later this year to discuss the available evidence about the accuracy of pulse oximeters, recommendations for patients and health care providers, the amount and type of data that should be provided by manufacturers to assess pulse oximeter accuracy, and to guide other regulatory actions as needed. Further details concerning the agenda, timing and location of the Advisory Committee meeting will be announced in the coming weeks.

When we get the date and time of this meeting we will update you.

Questions?

For more information on Pulse Oximeters, please email us at: info@mdiconsultants.com and ref: Pulse Oximeters: Accuracy and Limitations.