measurement devices do not have 'bias' they have 'tolerance'. Give them some credit
Pulse oximeters give biased results for people with darker skin
81–90 of 124 posts
Re: Pulse oximeters give biased results for people with darker skin
#82I'm a student EMT and our instructor told us not to rely on a pulse ox reading if our patient has dark skin, or if they were in a fire, or are a lifelong smoker, or if they have any nail polish or dirt/grease on their fingertips. We just look for the 94-100% range and would only take action if we get a reading around 87% or lower, or see a sudden drop during treatment. There are a few alternatives designs that aim to…
Personally, I've never seen a case where the difference was clinically meaningful. So, meh...
Pulse oximetry is for monitoring change. When a critical value is needed for medical intervention, such as a decision to put in a breathing tube, tests like arterial blood gas has are used.
Re: Pulse oximeters give biased results for people with darker skin
#83Re: Pulse oximeters give biased results for people with darker skin
#84Earlier quoted context omitted.
Getting oxygen at home reimbursed by Medicare also requires diagnoses with certain conditions and specific testing. If oxygen at home is required the testing to satisfy Medicare requirements won't be conducted using the common finger tip pulse ox meter.
Do you have an example of what testing they do actually use?
Re: Pulse oximeters give biased results for people with darker skin
#85I'm a student EMT and our instructor told us not to rely on a pulse ox reading if our patient has dark skin, or if they were in a fire, or are a lifelong smoker, or if they have any nail polish or dirt/grease on their fingertips. We just look for the 94-100% range and would only take action if we get a reading around 87% or lower, or see a sudden drop during treatment. There are a few alternatives designs that aim to…
Re: Pulse oximeters give biased results for people with darker skin
#86I'm a student EMT and our instructor told us not to rely on a pulse ox reading if our patient has dark skin, or if they were in a fire, or are a lifelong smoker, or if they have any nail polish or dirt/grease on their fingertips. We just look for the 94-100% range and would only take action if we get a reading around 87% or lower, or see a sudden drop during treatment. There are a few alternatives designs that aim to…
Re: Pulse oximeters give biased results for people with darker skin
#87The SpO2 measurement performance of a device must be verified before the device is released to the market. The U.S. Food and Drug Administration (FDA) suggests using standards presented in the following:
ISO 80601-2-61:2017 – Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Pulse Oximeters – Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff
According to these regulations, manufacturers need to declare the calibration range, reference, accuracy, methods of calibration and range of displayed saturation level. Furthermore, for the performance assessment, the FDA requires at least 200 data points equally spaced over a saturation range of 70% to 100%. Test subjects should have different ages, gender, and skin tones. For instance, the FDA requires that at least 30% of the volunteers must have dark skin pigmentation. The overall error or the root mean square error (RMSE) must be below 3.0% for transmissive pulse oximetry and below 3.5% for reflective pulse oximetry.
© 26 Mar, 2019, Maxim Integrated Products, Inc. https://www.maximintegrated.com/en/design/technical-document...
Re: Pulse oximeters give biased results for people with darker skin
#88Re: Pulse oximeters give biased results for people with darker skin
#89I'm a student EMT and our instructor told us not to rely on a pulse ox reading if our patient has dark skin, or if they were in a fire, or are a lifelong smoker, or if they have any nail polish or dirt/grease on their fingertips. We just look for the 94-100% range and would only take action if we get a reading around 87% or lower, or see a sudden drop during treatment. There are a few alternatives designs that aim to…
I'm not very familiar, so I'm not sure how to interpret this. Does this describe the normal procedure for when you can rely on a pulse oximeter, or does it describe the modified procedure for when you can't?
Re: Pulse oximeters give biased results for people with darker skin
#90Earlier quoted context omitted.
Noted and thanks for the information, but as far as I can tell my point stands if the feature is completely inaccessible. I don't really understand what the GP comment was referring to regarding Apple Watch pulse oximetry accuracy. Other consumer devices such as my smartphone and watch have working pulse oximeter sensors built-in that are presumably FDA approved (or not FDA banned anyway), so it doesn't bode well for…
I have a lot of confidence in Apple even if they are less than 100% all the time. They put a vast amount of effort into catering for diverse users, their iOS accessibility, for example. So I would bet that the Watch sensors are solid. Or will be, as the feature appears to be coming soon: https://9to5mac.com/2020/03/08/apple-watch-blood-oxygen-satu...