Pulse Oximetry FAQ

This FAQ has been compiled by our team of experts. Please submit your questions at the bottom of this page!

Pulse Oximetry FAQ Common pulse ox myths

Is it true that oximeters are not reliable below 70% SpO2?

Not necessarily. This commonly recited myth stems from the fact that oximeters are only tested in clinical validation studies down to 70% SpO2 due to the stated requirement by the FDA and also because of limitations by institutional review boards. So, while oximeters are not usually validated clinically below SpO2 70%, and oximeter performance becomes less accurate at lower SpO2, oximeter readings below 70% should not be disregarded. Widely inaccurate SpO2 values below ~SpO2 70% are more often due to poor signal in the context of a critically ill patient with poor perfusion, rather than an inherent limitation in inherent oximeter technology.

Keywords: accuracy, inaccurate

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Healthy Human Performance Tests

To meet 2017 ISO standards (80601-2-61) or 2013 FDA guideline adherence for clinical use, pulse oximeter performance must be tested in healthy humans in a laboratory setting. Independent device testing for the Open Oximetry Project follows our protocol consistent with ISO and FDA. Only devices labeled as ‘verified’ or ‘failed’ have been independently tested by the Open Oximetry Project.
All other devices listed show data from manufacturers or published literature and have not been confirmed by the Open Oximetry team. Scoring criteria will be modified based on evolving data on this topic. See the table below for scoring criteria for this category:

No Data

1 (red)

>4%

2 (red)

<4%

AND/OR Data suggesting Arms for dark skin color of >4%

AND/OR Data suggesting Arms for PI<1 in dark or light skin color of >4%

3 (yellow)

<4%

AND/OR Data suggesting Arms for dark skin color of 3-4%

AND/OR Data suggesting Arms for PI<1 in dark or light skin color of 3-4%

4 (green)

<3%

AND No data for or against performance problems in darker skin colors

AND No data for or against performance problems in low perfusion

5 (green)

<3%

AND Extended testing beyond ISO/FDA recommendations Criteria TBD April 2023

* only independently tested devices by OpenOximetry (Hypoxia Lab and Clinimark Lab) get labeled as ‘verified’