The UK Government seems to be taking evidence of racial biases in blood oxygen sensors seriously, after it announced a review of devices in healthcare settings.
It's an issue that's been in the spotlight, as the the FDA is currently investigating claims that optical SpO2 sensors – used in approved medical devices sold over the counter or even used in hospital settings – have been showing incorrect readings for those with darker skin tones.
The issue is called “occult hypoxia” — a situation when a patient’s pulse oximeter reads in the healthy range, but their actual blood oxygen levels are dangerously low.
And it’s been costing lives.
There has been a raft of litigation in the US – and a new report claims that people with dark skin are 32% more likely to have pulse oximeter readings overestimated.
Back in the UK, a review has since been carried out by Professor Dame Margaret Whitehead.
The UK Government has accepted the findings of that report and has now announced that it’s asked authorities to ensure that devices used in NHS hospitals can be used safely across skin tones and to recommend action going forward.
|The government will also work with the Medicines and Healthcare Products Regulatory Agency (MHRA) to ensure regulations for medical devices are safe for patients, regardless of their background, while allowing more innovative products to be placed on the UK market," it said.
Most consumer wearables escape scrutiny by using “not intended for medical purposes” in their small print – but it won’t be long until these also come under the spotlight.
If the result of the FDA investigation follows that of the UK, it seems unlikely that wearables, such as the Apple Watch, would escape regulation.
If it's deemed consumers are using wearables to check their blood oxygen levels, regardless of the small print, then it should be argued that they also need to be accurate across skin tones.
Neil Friedman, CEO of BodiMetrics, which makes the Circul+ smart ring, which has been cleared by the FDA across skin tones, believes that more needs to be done to bring wearables up to standard:
"We are presently in a period where there are many wearables that have pigmentationiIssues There are concerns 100,000s of people died and were misdiagnosed due to pulse oximeters during Covid and the problem continues today," he told PULSE by Wareable..
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James is the co-founder of Wareable, and he has been a technology journalist for 15 years.
He started his career at Future Publishing, James became the features editor of T3 Magazine and T3.com and was a regular contributor to TechRadar – before leaving Future Publishing to found Wareable in 2014.
James has been at the helm of Wareable since 2014 and has become one of the leading experts in wearable technologies globally. He has reviewed, tested, and covered pretty much every wearable on the market, and is passionate about the evolving industry, and wearables helping people achieve healthier and happier lives.