The UK Department of Health and Social Care (the Department) has commissioned a “far reaching” rapid independent review into whether there is a “systemic bias” inherent in medical devices in the UK as a result of the existing system of regulation. The review will also consider possible responsive measures, including potentially via regulation (see the press release here).

The review will examine the design and use of medical devices to identify possible discrepancies in the impact on patients from different ethnic groups and gender with the potential to exacerbate existing inequalities in healthcare. The review was precipitated, in particular, by the COVID-19 pandemic, which showed that people from ethnic minority communities were at greater risk of hospitalisation and death.

Writing in the Sunday Times, Health Secretary, Sajid Javid, said that he was determined to “close the chasms that the pandemic has exposed”. In particular, the Department highlighted research relating to oximeters which concluded there was a greater risk of inaccurate results in darker skinned patients, following on from ongoing public discussion of the issue, for example, the call for further assessment of so-called “oximeter bias” by the NHS Race & Health Observatory in April 2021.

The COVID-19 experience is clearly a key driver for this review, with the press release and much of the associated commentary giving special focus to oximeters and ethnicity. However, the review’s scope is broad and covers all approved UK medical devices, and gender is cited as an additional metric for review in the press release. The specific example was given of MRI scanners, which are not currently recommended for pregnant or breastfeeding women.

The specific aims of the review are to:

1. identify where systematic bias and risk exist with existing approved devices;

2. make recommendations on how these issues should be tackled in the creation of a medical device from design to use, including potentially via regulation; and

3. be future-focused and consider the enhanced risk of bias in the emerging range of algorithmic based data / artificial intelligence tools.

The press release points out that existing UK medical device regulations (which still derive from pre-Brexit EU legislation) do not specifically require that medical devices are equally effective regardless of factors such as ethnicity and gender. It goes on to welcome the UK’s new regulatory freedom post-Brexit to forge the UK’s own regulatory agenda, adding that this has enabled the UK to “strengthen the focus on ensuring that devices are appropriately designed and tested so that they can support the full range of our diverse communities.”

Responding to the announcement of the review, the BMA declared its support, adding that there “needs to be a requirement that all research and development of medical devices are based on testing them on people of different ethnicities before production”.

Although this review is UK-led and will focus on the UK regulations, Mr Javid, appearing on the BBC’s Andrew Marr Show and writing in the Sunday Times, described the bias issue as “systemic” and “international”, and confirmed that he intended to work alongside his global counterparts, including Xavier Becerra in the US and other “like-minded nations”, on introducing new international standards to ensure that medical devices have been tested on all races before they are allowed to be sold.

This review and its timing fits into the wider context of the MHRA’s recent consultation into the wider overhaul of UK medical device regulation post-Brexit, which closed on 25 November 2021 (see my previous blog post on the consultation here), and it will be interesting to see how recommendations from this review will be incorporated into the much anticipated reform of UK medical device regulation more broadly.

Initial findings from the review are expected in late January 2022. The identity of the independent chairperson has not yet been revealed.