The government has committed to ensuring NHS pulse oximeters work across all skin tones, following an independent review into equity in medical devices.

And it said it will ‘drive forward work’ to remove racial bias from data sets used in clinical studies and improve transparency around the development of medical devices and clinical tools that use artificial intelligence (AI).

‘We wholeheartedly agree with the principles of the report: that medical technology should be unbiased and equitable,’ health minister Andrew Stephenson wrote in the government’s response to the report.

The report recommended that regulators, developers, manufacturers and healthcare professionals take ‘immediate mitigation actions’ to ensure existing pulse oximeter devices in the NHS can be used ‘safely and equitably’ for all patient groups across the range of skin tones.

New pulse oximeter devices should have to prove that they have been tested on a representative sample of the population, and that they are accurate in all groups, including those with darker skin tones, before they can be approved, the report recommended.

‘Innovators, researchers and manufacturers should co-operate with public and patient participants to design better, smarter oximeters using innovative technologies to produce devices that are not biased by skin tone,’ it added.

In response, the Medicines and Healthcare products Regulatory Agency (MHRA) has implemented ‘a new validation process for clinical investigations in the UK that requests applicants demonstrate how they intend to address bias’, the government said.

The MHRA also intends to investigate ‘whether there is evidence of inaccuracy in different skin tones for other optical devices’, and propose ‘relevant regulatory action based on this, working closely with global partners’, the government said.

And it added that the National Institute for Health and Care Research (NIHR) welcomed funding applications for research into smarter oximeters.

Amandeep Doll, head of engagement and professional belonging at the Royal Pharmaceutical Society (RPS), told The Pharmacist that equitable access to medical devices was ‘essential in providing safe and effective patient care’ to patients of all ethnicities.

‘It’s vital that steps are taken to address any disparities that exist in the way devices work, or are used, to ensure that they are safe and effective for all patients, regardless of their ethnicity,’ she said.

Ms Doll added: ‘We look forward to the government driving forward its commitment to promote equity and fairness in the provision of healthcare services, including the use of medical devices.’

And she said the RPS ‘would welcome the opportunity to work with others to help remove these biases in the medical devices that pharmacists supply.’

AI, genomics and clinical trials

The report also recommended that: ‘The NHS should lead by example, drawing on its equity principles, influence and purchasing power, to influence the deployment of equitable AI-enabled medical devices in the health service.’

In response, the government said it agreed that there were opportunities ‘for equity to be considered within NHS procurement and deployment processes’.

But it said that a ‘proportionate approach’ that ‘does not excessively limit the number of devices available in the NHS’ would be required.

‘Implementation of this recommendation, and the related sub-recommendations, would require careful consideration and planning to ensure the best approach is taken to achieve the recommendation’s aim,’ it added.

Preparing regulators for the ‘inevitable disruption’ from new AI technologies was ‘a key priority for government’, the response said.

‘We believe that encouraging cross-sector collaboration is the best approach to achieve the aim of this recommendation,’ the government added.

The report was commissioned by former health and social care secretary Sajid Javid, and was conducted by a panel of clinicians and academics with expertise in health inequalities and equity in diagnostic and artificial intelligence tools. The panel was chaired by Professor Dame Margaret Whitehead and comprised Professor Raghib Ali, Professor Enitan Carrol, Professor Chris Holmes and Professor Frank Kee.

The report’s recommendations, and the government’s response, also highlighted the importance of including under-represented groups in research.

The government added that it will ‘continue to support initiatives to ensure diversity in genomic research, such as Our Future Health and Genomics England’s Diverse Data initiative’.

Pharmacist and academic Dr Mahendra Patel has suggested that involving community pharmacies in clinical trials could help recruit patients from a diverse range of communities throughout the UK.