The government has announced action to tackle potential bias in the design and use of medical devices, as it accepts recommendations from a UK-first independent review into equity in medical devices.
The Department of Health and Social Care commissioned senior health experts to identify potential biases in these devices and recommend how to tackle them.
The government fully accepted the report’s conclusions and has made a series of commitments, including ensuring that pulse oximeter devices used in the NHS can be used safely across a range of skin tones, and removing racial bias from data sets used in clinical studies.
As a result, significant action is already being taken to overcome potential disparities in the performance of medical devices. This includes:
- The Medicines and Healthcare products Regulatory Agency (MHRA) now requests that approval applications for new medical devices describe how they will address bias.
- NHS guidance has been updated to highlight potential limitations of pulse oximeter devices on patients with darker skin tone.
- The National Institute for Health and Care Research (NIHR) is currently accepting funding applications for research into smarter oximeters.
The review followed concerns that pulse oximeters – widely used during the COVID-19 pandemic to monitor blood oxygen levels – were not as accurate for patients with darker skin tones, which could have led to delays in treatment if dangerously low oxygen levels in patients with darker skin tone were missed. However, the review found no evidence from studies in the NHS of this differential performance affecting care.
The medical devices review focused on three areas – optical devices such as pulse oximeters, AI-enabled devices and polygenic risk scores (PRS) in genomics.
Minister of State, Andrew Stephenson, said: “Ministers agree that unless appropriate action is taken, ethnic and other unfair biases can occur throughout the medical device life cycle, from research, development and testing, to approval, deployment and post-market monitoring, as well as in the use of devices once deployed.”