The Agency is telling manufacturers and suppliers of thermal cameras that they should not make claims which directly relate to COVID-19 diagnosis, and is reminding businesses to follow Government advice on safe working during COVID-19.
Graeme Tunbridge, MHRA Director of Devices, said:
Many thermal cameras and temperature screening products were originally designed for non-medical purposes, such as for building or site security. Businesses and organisations need to know that using these products for temperature screening could put people’s health at risk.
These products should only be used in line with the manufacturer’s original intended use, and not to screen people for COVID-19 symptoms. They do not perform to the level required to accurately support a medical diagnosis.
We are reminding anyone selling these products not to make claims which directly relate to COVID-19 diagnosis. If they fail to comply, we will take formal enforcement action.
Products which the manufacturer claims are intended for screening for COVID-19, or fever-like symptoms, would be regarded as medical devices and regulated by the MHRA.
There is little scientific evidence to support temperature screening as a reliable method for detection of COVID-19 or other febrile illness, especially if used as the main method of testing.
Temperature readings from temperature screening systems will measure skin temperature rather than core body temperature. In either case, natural fluctuations in temperature can occur among healthy individuals. These readings are therefore an unreliable measure for detection of COVID-19 or other diseases which may cause fever. Furthermore, infected people who do not develop a fever or who do not show any symptoms would not be detected by a temperature reading and could be more likely to unknowingly spread the virus.
The MHRA recommends that businesses and workplaces follow the government advice on safe working during COVID-19, as well as implementing scientifically reliable methods of testing for COVID-19.
Health Minister Lord Bethell said:
As pubs and restaurants begin to reopen, it’s important businesses do not rely on temperature screening tools and other products which do not work.
The best way to protect customers and minimise the risk of catching the virus is to always follow social distancing guidelines, wearing a face mask on public transport and enclosed public spaces, and regularly washing your hands.
Notes to editor
- The Medicines and Healthcare products Regulatory Agency is responsible for protecting and improving the health of millions of people every day through the effective regulation of all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health and Social Care.
- The Yellow Card scheme is MHRA’s system of monitoring the safety of medicines and medical devices in the UK and it acts as an early warning system to identify new, and strengthen existing, safety information about medicines, medical devices, falsified or defective healthcare products, and e-cigarettes.