The issue of pulse oximeters performing poorly on people with darker skin tones has been a longstanding problem in the healthcare system. Despite the Food and Drug Administration’s suggestion in 2013 for manufacturers to test the devices on more diverse skin tones, little progress has been made in improving their performance. A recent study published in JAMA analyzed FDA approval documents for 767 oximeters and found that references to skin tone, pigmentation, or race were mentioned in only 25% of submissions after the FDA guidance was released.
The lack of improvement in addressing this issue has been frustrating for healthcare professionals and researchers alike. The inconsistency and confusion in how terms related to skin tone, race, and ethnicity were defined and used in the documents further highlight the need for clearer guidance and enforcement to ensure that pulse oximeters work effectively on all skin tones.
Pulse oximeters, which are used to measure oxygen levels non-invasively, have been known to overestimate oxygen levels in patients with darker skin due to the interference of melanin in the skin. This issue gained more attention during the Covid-19 pandemic when it was found that Black patients were more likely to have low oxygen levels go undetected, leading to delays in treatment and higher mortality rates for patients with darker skin.
The FDA has taken steps to address the issue by issuing warnings about the devices and working on new guidance for manufacturers to create more equitable devices. However, delays in the publication of this guidance have raised concerns among health equity leaders and healthcare professionals who rely on these devices for clinical decision-making.
Some manufacturers have argued that their devices work well on a range of skin tones based on their internal studies. Research is ongoing to develop more equitable devices and improve testing protocols. However, challenges such as the costs to manufacturers and their reluctance to admit bias in their devices have hindered progress in addressing the issue.
Legal action, such as lawsuits brought against device manufacturers, may be necessary to push for change. Federal purchasing power could also incentivize the adoption of more equitable devices by providing pre-purchase agreements for newer devices or higher reimbursements for devices proven to be more equitable.
In conclusion, addressing the bias in pulse oximeters is a complex issue that requires collaboration among stakeholders to ensure that all patients receive accurate and reliable readings. More research, clearer guidance, and potentially legal action may be needed to drive the development and adoption of more equitable devices in healthcare settings.