A far-reaching review is being launched into the impact of
potential bias in the design and use of medical devices.
There are concerns that the way medical devices and technologies
are designed and used could mean a patient’s diagnosis and
treatment is affected by their gender or ethnic background,
exacerbating existing inequalities in healthcare.
The coronavirus (COVID-19) pandemic has exposed health
disparities across the country as the virus had a greater impact
on those whose underlying health was poorer and death rates have
been higher among people from ethnic minority communities.
While current UK regulations set out clear expectations, they do
not currently include provisions to ensure that medical devices
are equally effective regardless of demographic factors, such as
ethnicity.
The independent review will look at devices such as oximeters –
used to measure oxygen levels – to identify potential
discrepancies in how they work for different ethnic groups. As
part of this, the review will consider whether existing
regulations mean there is a systemic bias inherent in medical
devices.
For example, some research has concluded darker skinned patients
who might need to be hospitalised are at greater risk of
inaccurate results from oximeters due to a tendency for this
group to present higher levels of oxygen in their blood.
Existing research on this has highlighted the need for this issue
to be further examined, as these devices are critical for
monitoring and deciding if treatment is needed for diseases such
as COVID-19, where every minute counts and accurate data is
vital.
All devices will be covered by the review. Another specific
example includes MRI scanners, which are today still not
recommended for use for pregnant or breastfeeding women, and
further research is needed on how to expand the scope of the
equipment’s use, which this review seeks to do.
Patients can be reassured that the NHS are experts in providing
the best possible care with the devices currently available, and
the review is intended to accelerate the process of improving the
quality and availability of devices to diverse communities.
Details of who will be leading the review will be set out in due
course.
Current UK regulations offer a clear set of expectations,
although there is a growing risk of inequalities as devices are
developed at pace and focus on large patient groups.
Not being confined to EU regulations allows 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.
The review will examine medical devices currently on the market
to identify areas of concerns in these products, and aims to:
-
take forward work on identifying where systematic bias and
risk exist with existing approved devices
-
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
-
be future-focused and consider the enhanced risk of bias in
the emerging range of algorithmic based data / artificial
intelligence tools
It is hoped initial findings can be completed and presented by
the end of January 2022.
