- Habib Naqvi, chief executive, NHS Race and Health Observatory,
- Veline L’Esperance, senior clinical adviser, NHS Race and Health Observatory
“All medical equipment and devices should be assessed for suitability of use with ethnic minority patients, as well as with the majority population. This should be sufficiently evidenced by manufacturers before devices receive market approval.” This was the key recommendation in the NHS Race and Health Observatory’s report “Pulse Oximetry and Racial Bias,” published in March 20211 that led Sajid Javid, then secretary of state for health and social care, to announce an independent review into medical devices.
The announcement of the independent review, in February 2022, formed part of wider plans to level up the country and reduce existing inequalities through the Health Disparities White Paper.2 The paper was eventually dropped and replaced by the Major Conditions Strategy,3 which included review of medical devices, although the focus shifted from “racial bias” to “equity ” in medical devices.
There has long been evidence of the stark health inequalities faced by ethnic minority communities in the UK. By drawing together the evidence, and filling gaps where we find them, the NHS Race and Health Observatory makes overwhelmingly clear the case for meaningful action on race inequity in our health service. Put another way, we exist to remove excuses.
The Equity in Medical Devices review has just been published.4 The review panel’s reflection that: “the biggest driver of health inequity in the UK by far is socioeconomic disadvantage,” should be read with some caution. Data show that health inequalities between ethnic groups are not fully explained by socioeconomic differences.5 Furthermore, ethnic minority groups are disproportionately affected by socioeconomic deprivation, which is a key determinant of health.6 Indeed, factors such as economic deprivation are themselves the result of longstanding structural inequalities and racial bias—what we call the “causes of the causes” of the inequalities.
The review report found unfair bias in relation to medical devices (eg, pulse oximeters, x ray machines, and bilirubinometers), but that the bias was “largely unintentional.” Bias in the physical aspects of device design usually stems from unrepresentative data and lack of inclusion during the development process. Manufacturers and regulators must ensure that these design shortcomings are identified and eliminated so that they do not exacerbate ethnic health inequalities.
The review’s recommendations are therefore largely to be welcomed, especially the focus on increasing diversity in research participation and in co-production approaches to design of devices. This should help reduce potential computational biases often perpetuated through the use of homogeneous research participants and databases. But we should also not forget the importance of working towards increasing representation among those leading on research and design. Additionally, the recommendations could have gone further in outlining the important role of education and training in ethnic health inequality.
The NHS Race and Health Observatory has a partnership with the National Institute for Health and Care Research which is underpinned by acknowledgement that the research sector plays a vital role in helping to reduce racial and ethnic inequalities in health and care. Understanding and tackling factors that have led to the under-representation of ethnic minorities in research, and exploring ways to support researchers to take more inclusive approaches to research design and delivery, are critical areas of focus for us.
However, robust, inclusive research is not the only enabler for equity. As we saw during the covid-19 pandemic, building trust and confidence in our healthcare system and medical interventions needs to be a critical focus for us all. Trust has fast become a new determinant of health—influencing people’s decisions on whether to take up a health intervention. You can have the most inclusively designed healthcare intervention that will meet the needs of our diverse populations—but if there is little trust in the intervention, uptake will be affected. Building and re-building levels of trust with local communities is therefore an important factor that must underpin any recommendation in this area.
Bias in the design of medical devices can be introduced at any point in the development process, therefore a wider understanding of structural determinants of health inequities, and a cross-government approach to anti-racism, are imperative. In order to ensure the equitable provision of inclusive medical devices, and to tackle potential avoidable harm, it is key to embed a structural view of health inequity across the wider healthcare system.
Footnotes
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Competing interests: We have read and understood the BMJ policy on declaration of interests and declare the authors are the chief executive and senior clinical adviser to the NHS Race and Health Observatory.
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Provenance and peer review: not commissioned, not externally peer reviewed.