Attorneys-General representing half of the US and Washington are calling on the FDA to step up its ongoing efforts to eliminate racial biases from pulse oximetry readers.
Last November, the regulator convened a meeting of its medical devices advisory committee to delve into the technological issues that can cause pulse oximeters to deliver inaccurate results for people with darker skin tones, and devise new recommendations for the regulation and usage of the devices for medtech makers, doctors and patients.
A year later, on 1 November, 25 Attorneys-General signed a letter penned by California’s Rob Bonta asking the FDA to put the findings discussed at the meeting into action.
A spate of studies published in recent years describe how many widely used, FDA-cleared pulse oximeters tend to produce inaccurate results for many non-white patients, reports FierceBiotech.
Because fingertip-worn pulse oximeters work by sending light beams through the skin to measure the amount of oxygen in the blood, said the researchers, any devices not developed and tested on a variety of skin tones will inevitably have trouble calculating the amount of light that passes through darker skin and can therefore potentially display oxygen saturation numbers higher than a patient’s actual O2.
Those inaccuracies mean that many BIPOC patients may experience life-threatening delays in receiving necessary care.
One 2020 study, for example, found that black patients were almost three times more likely than white patients to experience “hidden hypoxaemia” that wasn’t spotted by a pulse oximeter.
These inequities were further exacerbated by the Covid-19 pandemic, as pulse oximetry has been a crucial tool in monitoring the health of patients hospitalised with the virus.
In their letter, the Attorneys-General call on the FDA to “act with urgency to address the inaccuracy of pulse oximetry when used on people with darker-toned skin”.
The letter cites new data doubling down on the findings that faulty pulse oximeters contributed to delays in Covid care for non-white patients, while also highlighting growing concerns about the use of the technology elsewhere: pulse oximetry is not only a crucial tool in maternal and newborn care, but it’s also being added into new predictive diagnostics, so failing to rectify the technology’s current issues “could end up reproducing health disparities based on race”.
The state lawyers offered six proposals for the FDA to enact immediately.
They include a requirement for all pulse oximeter makers to include labels on their products about the potential race-based inaccuracies and a suggestion that the FDA send a letter to all healthcare providers describing the technology’s risks and updated usage guidelines.
They also asked the agency to expedite its review and public release of the proposed recommendations from last year’s advisory committee meeting and to finalise new rules that would require clinical trials of medical devices – including but not limited to pulse oximeters – to be “demographically representative”.
In addition to those “urgent actions”, they also asked the FDA to support research and development efforts regarding how both new and existing pulse oximetry devices can be made more racially equitable.
NEJM article – Racial Bias in Pulse Oximetry Measurement (Open access)
See more from MedicalBrief archives:
Race versus skin tone debate in resolving pulse oximeters’ false readings
Pulse oximeters deliver unreliable readings across ethnic groups
Biased oximeter readings skewed Covid treatment – US cohort study
How software bias leads to under-diagnosis in black men’s lung problems