Up to date, expert answers to frequently asked questions (FAQ) about oxygen supply systems, respiratory care and pulse oximetry written by OCC & collaborators.
The effect of skin pigmentation on pulse oximeter accuracy remains poorly characterized. Pulse oximeters may be less accurate in patients with darker skin, especially at lower oxygen saturations. Of note, this inaccuracy can tend to overestimate oxygen saturation, which may lead to false reassurance during clinically real hypoxemia. The amount of inaccuracy varies significantly between different devices, manufacturers, and probes. The OpenOximetry.org Project is actively working to better understand the impact of pigment on oximeter accuracy and to develop new strategies to eliminate this source of error.
References: Okunlola et al, Resp Care, Nov 2021, Bickler et al, Anesthesiology 2005; Feiner et al, Anesth Analg 2007; Adler et al, Acad Emerg Med 1998; Bothma et al, S Afr Med J 1996; Zeballos et al, Am Rev Respir Dis 1991; Ries et al, Chest 1989; Emery J Perinatol 1987; Sjoding et al, N Engl J Med 2020
Keywords: skin, pigment, skin tone, accuracy
For oximeters that have been approved by the US FDA, accuracy over the SpO2 range of 70-100% is within a few SpO2 percent of the actual value when tested under laboratory validation conditions (for some oximeters, performance may be different when used in various clinical conditions). Most oximeters tend to be more accurate with higher SpO2 values than lower SpO2 values.
The FDA has published guidelines for the recommended standards for pulse oximeter performance, which includes device accuracy. These guidelines require the devices to be tested with a minimum of 200 data points over an SaO2 range of 70% to 100%, and to be tested on people with different skin tones. Studies have shown that many low-cost pulse oximeters demonstrate highly inaccurate readings. However, some low-cost pulse oximeters have performed with similar accuracy to more expensive units when used in healthy subjects. However, it is important to recognize that many additional variables can make even good pulse oximeters have less accurate readings.
Keywords: accuracy, low-cost, guidelines, FDA
For FDA or ISO clearance, pulse oximeters must undergo testing in healthy human study subjects.
ISO 80601-2-61 defines the test requirements, and the FDA has published guidance that refers to this standard. The standard requires the devices to be tested with a minimum of 200 data points (paired observations: pulse oximeter, co-oximeter) evenly distributed over an SaO2 range of 70% to 100%. The standard requires that devices be tested on “10 or more healthy subjects that vary in age and gender” and that the study has subjects with “a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.”
Briefly, study subjects are semi-supine (30° head up) with a nose clip (to prevent breathing through the nose), breathing controlled mixtures of air-nitrogen-carbon dioxide via a mouthpiece from a partial rebreathing circuit with a voluntarily increased minute ventilation (sometimes coached with a metronome) and 10 to 20 L/min total fresh gas flow into the circuit. A 22-g radial artery catheter is placed to sample arterial blood for the measurement of SaO2.
The gas mixture (e.g. nitrogen) of the circuit is manually adjusted to achieve a series of 10 to 12 stable SaO2 plateaus between 70% and 100% (approximately 70%, 73%, 76%, 80%, 83%, 86%, 89%, 92%, 95%, 98%, and 100%). Carbon dioxide is manually increased into the circuit to prevent hypocapnia. At each plateau (after 30-60 seconds of stability) an arterial sample is drawn and immediately “functional” arterial Sao2 (HbO2/[Hb+HbO2]) is determined by multi-wavelength oximetry (e.g. an ABL-90, OSM3 or similar device). After an additional 30 seconds of stability another sample is drawn. These SaO2 values are recorded and used to compare with recorded simultaneous SpO2 values from the device being tested. During the tests, subjects’ extremities may be placed under a warmer to promote good perfusion.
References: FDA Guidelines
Keywords: FDA, guideline, clinical, accuracy, 510k, approval, ISO
According to FDA regulations, manufacturers of pulse oximeters should validate device performance on “a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.” While ‘darkly pigmented’ is not formally defined, it is routinely defined by testing labs as Fitzpatrick skin phototype groups V-VI. The Fitzpatrick scale is a widely used method for classifying skin pigment, from I (pale white) to VI (darkest brown). However, it was originally developed for skin photosensitivity typing, which is not the same as skin color, and should not be conflated with race or ethnicity. Studies have shown inaccuracies in self-reported values, especially in darker skin types. There are other similar visual skin color classification systems, but as with the Fitzpatrick scale, they are all subjective.
In early 2021, in response to Sjoding et al’s findings of racial (note, not necessarily skin color) bias in pulse oximetry measurement, the FDA issued a statement encouraging further investigation on pulse oximeter accuracy in darker skin types. Given the limitations of the Fitzpatrick scale, there is a need to adopt a standardized objective method for measuring skin color that provides reliable, quantitative, and easily interpretable results. For more discussion on new ways to address racial inequity in oximetry, check out this paper (November 2021).
There are several commonly used skin colorimeters on the market, including Mexameter, Colorimeter, and DermaCatch as listed below.
The Fitzpatrick skin type (FST) was developed in 1975 as a tool to assess the likelihood to burn during phototherapy treatments and is commonly used. The original scale was I-IV and it was only later that more diverse skin types were included.
References: Image: CC BY 3.0 – D’Orazio et al, Int J Mol Sci, 2013; Eilers et al, Accuracy of Self-Report in assessing Fitzpatrick skin phototypes, JAMA Derm, 2013 ; Ware et al, Racial Limitations of Fitzpatrick skin type, Cutis, 2020 ; Wong et al, Analysis of discrepancies between pulse oximetry and arterial oxygen saturation measurements by race and ethnicity and association with organ dysfunction and mortality, JAMA, 2021
Von Luschan’s Chromatic Scale
The Von Luschan’s Scale was developed as a tool to assess racial classifications according to skin color. It consists of 36 colored tiles which are compared to a person’s skin color.
References: Image: Von Luschan’s Scale
Other ways to quantify skin pigment
Below we describe a few (of the many) products on the market to quantify skin pigmentation.
- Narrow-band reflectance colorimeter (only targets melanin and hemoglobin)
- Output: melanin index and erythema index (arbitrary units 0-999)
- Melanin index can be falsely affected by erythema
- Requires base to be plugged in to display results (no computer needed)
- The CM-700d Spectrophotometer is portable, wireless, and lightweight
- Allows for evaluation, reproduction, and control of pigment colors
- Aperture switches between 3mm and 8mm sizes to evaluate small to large samples
- Color spaces: L*a*b*, L*C*h, Hunter Lab, Yxy, XYZ, Munsell
- Full visible spectrum reflectance colorimeter
- Output: skin color RGB, L*a*b, xyz, ITA
- Requires USB connection to Windows PC to display results
- Full visible spectrum reflectance colorimeter
- Output: skin color L*a*b, ITA, L*c*h, RGB, melanin and erythema indices
- Melanin and erythema indices insensitive to each other
- Portable and battery operated
Interpreting quantitative results
Correlating quantitative measures to a visual color spectrum
- Skin color comprises of melanin content, oxy/deoxy-hemoglobin content, and endogenous/exogenous pigments such as bilirubin and carotene
- The CIE L*a*b color space is a device-independent reference for all the colors visible to the human eye and the most commonly used metric to quantify skin color
- Individual Typology Angle (ITA) is calculated from L and b and objectively categorizes skin color into 6 different groups, from very light to dark
- Explanation of CIE L*a*b color space
- Explanation of how skin colorimeters and spectrophotometers work
- Correlates Fitzpatrick, ITA, Melanin Index
- Correlates Fitzpatrick, ITA, Melanin index
Keywords: skin pigment, Fitzpatrick, melanin, skin color, Colorimeter
Additional References: Okunlola et al, Pulse oximeter performance, racial inequity, and the work ahead, Resp Care, Nov 2021; FDA guidance on pulse oximeters; February 19, 2021 FDA statement “Pulse Oximeter Accuracy and Limitations”: addresses Sjoding’s findings, research limitations, and the need for further study; Sjoding et al, Racial Bias in Pulse Oximetry Measurement, NEJM, Dec 2020