University contributes to government review of medical devices

Professor Daniel Martin is among the experts to work on the independent review published by the Department of Health and Social Care
Woman checking blood oxygen levels with finger pulse oximeter
Researchers from the University of Plymouth have contributed to an independent review for the UK Government into the equity of medical devices.
The review, commissioned by the Department of Health and Social Care, sought to identify potential biases in a variety of devices and recommend how to tackle them.
Published on 11 March 2024, the report – Equity in medical devices: independent review – has resulted in a series of government commitments, including ensuring that pulse oximeter devices used in the NHS can be used safely across a range of skin tones.
Among the experts to contribute to the report are Professor Daniel Martin, Professor of Perioperative and Intensive Care Medicine in the University of Plymouth and a consultant at the University Hospitals Plymouth NHS Trust (UHP).
He has led a number of studies into pulse oximeters, including the most comprehensive study ever to explore the issue which was published in February 2024.
Based on a systematic review which assessed more than 733,000 oxygen saturation readings taken from over 222,000 people, it revealed evidence of the devices being inclined to overestimate readings in participants with darker skin tones.
Professor Martin provided a comprehensive summary of evidence for the independent review’s panel and contributed to the development of recommendations in the review. In addition, he acted as expert advisor to the Medicines and Healthcare products Regulatory Agency (MHRA) during their evaluation of pulse oximeter inaccuracy. 

It is clear that pulse oximeters can be inaccurate in patients with darker skin tones, which could have a significant impact on their clinical care. In the independent review our recommendations include education of the public and healthcare providers, influencing regulators and policy makers and encouraging innovation by manufacturers. This is not a problem that can be solved overnight but there needs to be immediate action at multiple levels to make the environment in which we treat patients safer for all of them.

Daniel MartinDaniel Martin
Professor of Perioperative and Intensive Care Medicine

The findings revealed through this work are already being explored in much greater detail through the EXAKT study, funded by the National Institute for Health and Care Research (NIHR) and also being led by Professor Martin.
It is currently in the process of recruiting around 900 critically ill patients with different skin tones from 24 sites around the UK to investigate the accuracy of specific pulse oximeters used in hospitals across the UK today.

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