Independent Review of Medical Device Equity: Overview and Key Recommendations

This article was co-authored by Chloe Jaffer, trainee solicitor.

On 11 March 2024, the Department of Health and Social Care published an independent report entitled ‘Equality in Medical Devices: An Independent Review’ (the Report) setting out the findings and recommendations of the review.

The independent review (the 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 this may result in some ethnic groups receiving sub-optimal treatment”.

Background

The report states that “the initial impetus for the review was growing concerns about a specific medical device – the pulse oximeter.” During the pandemic, it was found that “pulse oximeters may not be as accurate for patients with darker skin tones than for those with lighter skin tones.”

The report added that the scope of the review was expanded to “recognize potential errors in other medical devices, not just pulse oximeters, and to look beyond racial and ethnic biases to the increased inequitable errors in performance, including those based on gender and socioeconomic status.”

Devices tested

The review considered “evidence of differential performance of medical devices across socio-demographic groups, which could potentially lead to poorer healthcare for the population group disadvantaged by the bias.” To help inform its recommendations, the review sought to identify the causes of bias. It focused on the following issues:

Optical Devices – use light to detect problems and may react differently to different skin tones.
AI-enabled apps – used to detect skin cancer and interpret X-rays. These may be unintentionally biased against women, non-white ethnic groups, or poorer social groups.
Devices using 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 ancestry. They were developed primarily using genetic data from people of European ancestry.

Recommendations

In summary, we present the following recommendations contained in the Report:

Recommendations 8–14 address the goal of developing safe and fair AI-based medical devices.

AI-enabled device developers and stakeholders are to engage with and support diverse groups of people to contribute to “an AI-enabled device co-design process that incorporates the goals of equity, fairness, and transparency throughout the product lifecycle.”

To ensure “best practice guidelines, quality assurance processes, and governance are aligned and adhered to to provide a clear focus on reducing bias while maintaining full accountability,” stakeholders should collaborate throughout the device lifecycle.

Research committees should prioritize diversity and inclusion.

Recommendations 16–18 address equity issues and societal challenges related to PRS in genomics.

The need for regulation is highlighted in response to the rise in the number of commercially available PRS tests in the UK (which have not yet been adopted by the NHS). PRS provide a way of estimating “a person’s risk of developing a particular disease” by analysing “thousands of genetic variants in the many genes that make up a person’s genome”.

The review recommends that the scope of PRS research “should be expanded beyond genetic diversity to consider the impact of social determinants of health – including lifestyle, living and working conditions, and environmental factors such as air pollution – on overall disease risk, and how these affect the predictive power of PRS across different ethnic and socioeconomic groups.”

Public understanding of the nature of genetic risk and the importance of PRS needs to be improved.

Comment

Diversity and inclusion are important for both patients and healthcare professionals. Overall, the Review’s recommendations were welcomed – particularly in relation to the need to increase diversity – but there is still much work to be done to ensure a more inclusive approach when it comes to research.

Professional bodies in the UK, such as Royal Colleges and health education bodies, should continue to be supported to provide guidance to healthcare professionals on the challenges of equality and ethics.

A broader understanding of the structural determinants of health inequalities is to be welcomed. This should lead to greater trust in medical devices among healthcare professionals and better and safer patient care.

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