Independent review on equity in medical devices: overview and key recommendations

This article was co-authored by Chloe Jaffer, Solicitor Apprentice.

On 11 March 2024, the Department for Health and Social Care published an independent report - 'Equity in Medical Devices: Independent Review’ (the Report) setting out the findings and recommendations of the Review.

The independent review (Review) was commissioned in response to evidence “about the potential for racial and ethnic bias in the design and use of some medical devices commonly used in the NHS, and that some ethnic groups may receive sub-optimal treatment as a result”.

Background

The Report provides that the “initial stimulus for the review was growing concern about a specific medical device – the pulse oximeter”. During the pandemic, it was identified that “the pulse oximeter may not be as accurate for patients with darker skin tone than those with lighter skin”.

The Report adds that the scope of the Review was extended to “recognise the potential for bias in other medical devices, not just pulse oximeters, and beyond racial and ethnic bias to further unfair biases in performance, including by sex and socio-economic status”.

Devices reviewed

The Review considered “the evidence for differential performance of medical devices by socio-demographic groups that had the potential to lead to poorer healthcare for the population group disadvantaged by the bias”. To help inform the recommendations the Review sought to identify the causes of the bias. The focus was on the following:

1. Optical devices - These use light to detect problems and may react differently to different skin tones.
2. AI-enabled applications - Used to detect skin cancer and interpret x-rays. These can be unintentionally biased against women, non-white ethnicities or poorer social groups.
3. Devices that utilise polygenic risk scores (PRS) in genomics - These calculate genetic risk factors for common diseases and do not predict risk as accurately for people of non-European backgrounds. They were mainly developed using genetic data from people of European descent.

Recommendations

By way of a summary, we highlight the following Recommendations from the Report:

• Recommendations 8-14 relate to the aim of developing safe and equitable AI medical devices.

AI-enabled device developers and stakeholders are to engage with diverse groups of people and ensure they are supported so as to contribute “to a co-design process for AI-enabled devices that takes account of the goals of equity, fairness and transparency throughout the product’s lifecycle”.

To ensure “best practice guidance, assurance and governance processes are co-ordinated and followed in support of a clear focus on reducing bias, with end-to-end accountability” stakeholders should work together across the device lifecycle.

Diversity and inclusion should be prioritised by research commissioners.

• Recommendations 16-18 address equity and societal challenges relating to PRS in genomics.

There is an emphasis on the need for regulation in response to an increase in commercially available PRS tests in the UK (which have not yet been adopted by the NHS).  PRS provide a means of estimating “an individual’s risk of developing a particular disease” by looking “at thousands of genetic variants across many genes that make up a person’s genome”.  

The Review recommends that the focus on the PRS studies “should be widened beyond genetic diversity to include the contribution of the social determinants of health - including lifestyle, living and working conditions and environmental factors such as air pollution – to overall disease risk, and how these affect the predictive potential of PRS among different ethnicities and socio-economic groups”.

Public understanding of the nature of genetic risk and meaning of the PRS, is to be improved. 

Comment

Diversity and inclusion matter to both patient and healthcare professional.  Broadly speaking the Review’s recommendations have been welcomed - particularly, with regard to the need to increase diversity -  however, there remains work to be done on ensuring a more inclusive approach, when it comes to research.   

Professional bodies in the UK, such as Royal Colleges and the health education bodies across the UK, should be further supported to provide guidance for healthcare professionals on the equity and ethical challenges.

A wider understanding of structural determinants of health inequities is to be welcomed.  It should yield greater confidence in medical devices by healthcare professionals and better, and safer, patient care.  

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