Last Updated on January 9, 2025 by The Health Master
Pulse Oximeters
The U. S. Food and Drug Administration (USFDA) has issued a draft proposal regarding the upgrading and improving the accuracy of reading pulse oximeters, a medical device.
These devices are very important and crucial for monitoring blood oxygen levels in the patients.
This move of USFDA is based on the growing concerns about potential racial biases in these pulse oximeters, which sometimes show inaccurate reading in individuals with darker skin tones.
The issue with Pulse Oximeters:
Pulse oximeters are medical devices which work on the principle of absorption of light that is by shining light on a finger and measuring how much light is absorbed which gives estimate of blood oxygen levels.
However, studies have shown that darker skin pigmentation can cause a hurdle with these readings which may lead to misreading, wrong diagnoses and delay in the treatment of the patient.
This can be a cause of serious issues and these issues happened during the COVID-19 pandemic, where inaccurate readings could have cause of adverse results for some patients.
USFDA’s Proposal
The USFDA’s draft recommendations has proposed some key amendments for to the testing and approval process for the professional-grade pulse oximeters:
Clinical Trials:
- Clinical studies must be done on minimum 150 patients with having different skin tones.
- At least 25% of participants must have darker skin tones.
Skin Pigmentation Assessment:
There should be at least two methods for evaluation of skin pigmentations of the participants:
- Researcher can do a visual assessment.
- A light-based, scientific measurement of melanin levels.
Impact on the Medical Field:
These proposed changes has been made for updating the pulse oximeters to provide accurate readings for all patients, regardless of their skin color.
The USFDA hopes to minimize the risk of racial bias in these critical medical devices and the same will require manufacturers to conduct more detailed clinical trials and following stricter testing protocols,
Important Considerations:
- Focus on Professional Devices: The USFDA’s recommendations primarily apply for professional-grade Pulse Oximeters used in hospitals and clinics.
- Impact on Existing Devices: There will be no immediate effect on these existing medical devices. However, manufacturers will have to provide new detailed data while seeking changes or updating on the existing models.
- Public Comment: The USFDA is seeking public comments and input on its draft recommendations for 60 days before finalizing the guidelines.
What is the use of pulse oximeters ?
Pulse oximeters are medical devices that measure the oxygen level in a patient’s blood. They are widely used in hospitals, clinics and home settings to monitor oxygen level and respiratory conditions at the time of surgeries and in emergency situations.
What is the importance of pulse oximeters ?
Accurate reading of blood oxygen levels is important and are crucial for patient care. Low blood oxygen levels can lead to serious health issues, including organ damage and even death.
Where can I find information about the USFDA’s proposal?
You can find more information on the USFDA’s website.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: This article is for informational purposes only and should not be considered medical advice.
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