Up to date, expert answers to frequently asked questions (FAQ) about oxygen supply systems, respiratory care and pulse oximetry written by OCC & collaborators.
Pulse ox validation & certification
The short answer is no.
These devices work by detecting LED pulses from an oximeter, then fabricating their own output signal to the oximeter sensor. The Fluke preserves any noise in the LED light signal while the others simply trigger from it and in doing so eliminate all potential errors due to LED noise (a very common problem with implications for oximeter performance). Some of these devices also have a limited range of simulated conditions (ie perfusion) and require prior calibration to the specific oximeter being tested. Thus, for oximeters already calibrated into the in vitro simulator, the simulator can help confirm that a device is working (or at least is sensing signal) as it was designed to do in the factory. For devices not previously calibrated, conclusions about performance are uncertain.
Multiple studies report to have used these devices to ‘validate’ oximeter performance, yet performance of an uncalibrated oximeter on an in vitro simulator does not ensure good oximeter performance in reality.
Simulators of this type are useful for determining the operating range of an oximeter. For example the limits in terms of dark skin and low perfusion can be found. One can determine if the device reads an erroneous value when pushed beyond its effective range or if it reports nothing.
The OpenOximetry.org Project is working to develop novel in vitro testing devices and protocols that overcome the limitations of prior devices. The hope is that newer techniques can better augment human study subject testing and predict device performance.
Most pulse oximeters do not need to be calibrated by the user before they will work properly. During device development, the microprocessors of pulse oximeters are calibrated using reference SaO2 measurement data that are compiled from healthy volunteers. Volunteers are typically exposed to different levels of inspired oxygen to yield SaO2 ranging from around 75 to 100%.
There are devices such as the Fluke ProSim 8 that are designed to check if select manufacturers’ oximeters are functioning, but are not designed to validate accuracy.
References: Lifebox Pulse Oximetry Learning Module
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
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
The CE marking is a mark that manufacturers must obtain in order for their devices or products to be sold within the European Union (EU). Each company has a notified body that is paid by the company to ensure ISO compliance. The company must demonstrate to the notified body that the device meets the ISO standard. This marking signifies that the product is in compliance with European health, safety, and environmental protection standards. The CE marking may also be found on products sold outside of the EU that have been manufactured to these standards.
The CE marking is required for medical devices, and having it confirms that the device meets essential requirements of the European General Medical Devices Directive and that it is safe. Of note, the CE marking is not a quality indicator or a certification mark, but it does indicate that the device complies with EU regulations and can legally be sold.
Additionally, falsification of CE marking is commonly encountered.
References: European Commission CE Marking
Keywords: CE, marking, european general medical devices directive, EEA
An IP rating, also known as the ingress protection rating, is the rating of a product’s ability to withstand liquid and dust. IP ratings were defined and developed by the International Electrotechnical Commission (IEC), and are recognized all over the world.
The IP code is composed of two numbers:
- The first number rates the device’s protection against solid particles (i.e. dust). It is rated from 0 (no protection) to 6 (full protection).
- The second number rates the device’s protection against liquids. It is rated from 0 (no protection) to 9 (protection from high-pressure, high-temperature liquid).
References: IEC: IP Ratings
Keywords: IP, ingress protection, dust, liquid, IEC
The International Organization for Standardization (ISO) is a worldwide standard-setting body. It is composed of representatives from several national standards organizations and aims to provide common standards for technology, agriculture, healthcare, and other manufactured products. These standards are meant to ensure that products and services are safe and of good quality.
ISO has standards for various healthcare-related devices and products, including pulse oximeters. ISO 80601-2-61:2017 describes the requirements for basic safety and essential performance of pulse oximeter equipment. This also includes standards for the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
References: ISO: Pulse Oximeter
Keywords: ISO, international organization for standardization
To receive FDA approval on a new device intended for human use, a premarket submission called a 510k must be made to the FDA. This must demonstrate that the device is substantially equivalent to a legally marketed device, meaning that it is just as safe and effective.
According to the FDA, a device is considered “substantially equivalent” if the following criteria are met:
- Has the same intended use as the predicate device; and
- Has the same technological characteristics as the predicate;
- Has the same intended use as the predicate; and
- Has different technological characteristics and does not raise different questions of safety and effectiveness; and
- The device is demonstrated to be as safe and effective as the legally marketed device
Once this information has been submitted to the FDA, the FDA will determine whether the device is safe and effective through a thorough review process, including evaluation of performance data and technological characteristics. In the US, a device may not be marketed until the FDA determines that substantial equivalence is present.
References: FDA Premarket Notification 510(k)
Keywords: substantially equivalent, SE, FDA, 510k
The Average Root Mean Square error or root mean square deviation (known as ARMS) is an established measure of SpO2 performance and is used by regulatory agencies to determine how accurately a pulse oximeter performs. Sometimes referred to as “Accuracy Root Mean Square error, ARMS is the square root of the mean of the squared deviations between the pulse oximeter SpO2 measurement and the SaO2 measurement. ARMS approximates the mean absolute deviation (MAD) between SpO2 and SaO2. It is always a positive value, so it cannot indicate whether SpO2 is negatively or positively biased for SaO2.
ARMS is calculated by combining both the bias and the standard deviation into one value. The FDA recommends an acceptable limit of ARMS ≤3% for transmittance devices and ARMS ≤3.5% for reflectance devices. If either component (bias or SD) is very large (i.e. inaccurate), the ARMS will be greater than the acceptable limit and will not be considered a well performing pulse oximeter. If a pulse oximeter device has an ARMS ≤3%, this means that it did not have a large scatter or large outliers in the data, and therefore can accurately measure SpO2. It is important to recognize that even a small difference in ARMS between devices can reflect a large difference in their performance.
ARMS is best referred to as a measure of performance (rather than accuracy).
Keywords: bias, standard deviation, Arms, ARMS