Last reviewed 23 November 2021

The Department of Health and Social Care (DHSC) has announced a rapid review to assess “potential” race and gender bias in the design and use of all medical devices, including pulse oximeters.

The review will look at whether potential bias in medical devices and the impact on patients from different ethnic groups.

The UK-led review aims to drive forward new international standards to improve healthcare and tackle disparities. And, while current UK regulations set out expectations, they do not currently include provisions to ensure that medical devices are equally effective regardless of demographic factors like ethnicity.

The DHSC announced: “The independent review will look at devices such as oximeters, used to measure oxygen levels, to identify potential discrepancies in how they work for different ethnic groups. As part of this, the review will consider whether existing regulations mean there is a systemic bias inherent in medical devices.”

All 16- to 64-year-olds testing positive for Covid-19 who are not double jabbed became eligible for NHS England’s GP Covid Oximetry@home scheme in September.

Under this scheme, those with symptoms measure their oxygen saturation levels with a pulse oximeter three times and day and record this digitally or on paper for GP practice monitoring. But research recently found that darker-skinned patients are at greater risk of inaccurate results from oximeters due to a tendency to present higher levels of oxygen in their blood.

Another example includes MRI scanners, which are not currently recommended for use for pregnant or breastfeeding women, so further research is needed on how to expand the scope of the use of this equipment.

The DHSC confirmed that the rapid review will launch shortly, and initial findings are expected by the end of January. An independent Chair to lead the review will be announced in due course.