Statement in response to publication of the Equity in Medical Devices Independent Review

Responding to the publication of the Independent Review, Professor Habib Naqvi, chief executive of the NHS Race and Health Observatory, said:

“In 2021, during the height of the Covid pandemic, we published a report highlighting our concerns that the accuracy of pulse oximeter readings from Black and minority ethnic people could be seriously compromised and misleading.

“Our report called for all medical equipment and devices to be assessed for suitability of use with ethnic minority patients, and the wider population. This led to the Rt Hon Sajid Javid MP, the then Secretary of State for Health and Social Care, to announce an independent review into medical devices.

“We are pleased that the independent review, led by Dame Margaret Whitehead, has published its report today. It acknowledges the need for immediate modifications, equity assessments and recognises tighter guidance and regulation for medical devices.

“It’s clear that the lack of diverse representation in health research, the absence of robust equity considerations, and the scarcity of co-production approaches, have led to racial bias in medical devices, clinical assessments and in other healthcare interventions.

“The research sector plays a vital role in achieving the ambition to tackle ethnic inequalities in health. There is an urgent need to understand and address factors that lead to the under-representation of ethnic minorities in research, and to explore ways to support researchers in taking more inclusive approaches to research design and delivery.

“The Observatory continues to work on these areas with research and healthcare bodies to ensure medical devices, such as bilirubinometers used in the assessments of newborn babies, factor equity from concept to manufacture, delivery and take-up.

“We need better quality of ethnicity data recording in the NHS and for a broad range of diverse skin tones to be used in medical imaging databanks and in clinical trials – the Observatory is working to make progress in these areas.”