Government to take new action tackling ethnic and other biases in medical devices

The action follows the publication of an independent report, put together by senior health experts commissioned by the Department of Health and Social Care, identifying the impact of ethnic and other biases in the design and use of medical devices.

The report came after concerns that pulse oximeters – devices that were used widely during the Covid-19 pandemic to monitor oxygen levels in blood – were not as accurate for patients with darker skin tones, which could have led to delays in treatment.

While the report found no evidence from studies in the NHS that this affected care, evidence of harm stemming from poor performance in pulse oximeters has been found in the US healthcare system.

Conclusions from the report have seen the government make numerous commitments, with ministers agreeing that appropriate action is needed to address unfair biases that can occur throughout the life cycle of a medical device.

These include ensuring that NHS pulse oximeter devices can be safely used across a range of skin tones, and removing racial bias from data sets used in clinical studies.

The commitments will be part of ongoing work to tackle disparity in the healthcare system, with the government looking to address bias issues from design stages and provide extra funding for new devices that work without bias.

Following the news, Leigh Day product safety partner Jill Paterson said:

“It is positive to see the government take a proactive step towards addressing the biases highlighted in the report. After concerns during the Covid-19 pandemic about the ability of some devices to perform properly for patients with darker skin, it is important that the government makes sure to tackle these issues and minimise any potential risk.”