To ask the Secretary of State for Health and Social Care, what assessment he has made of the accuracy of oxygen blood level tests such as pulse oximeters in patients with darker skins.
This answer is the replacement for a previous holding answer.
Answered on
29 January 2021
Pulse oximeters are regulated as medical devices and fall within the remit of the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA is aware of the potential impact of skin colour on pulse oximeter readings, although no reports of incorrect results due to this factor have been received. Clinicians do not depend entirely upon these readings, instead using them in combination with other diagnostic indicators.
The MHRA will continue to monitor the safety and performance of pulse oximeters. If concerning evidence arises over results interpreted in a clinical setting for patients with darker skin pigments, the MHRA will undertake any necessary investigation, reviewing compliance in line with regulations and international standards.