The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning to both the general public and healthcare professionals regarding the increasing availability of unreliable infrared thermometers which are available to buy online in the UK.
Since the start of the pandemic, taking a person’s temperature PRIOR to allowing them entry into a building, as a means of checking for a raised temperature / infection and likely stated as a control measure within the related risk assessment due to it being contactless and therefore regarded as a safe methodology, has become popular and created an increase in demand for these products, despite the MHRA’s previous warning of 3rd July 2020 which stated:
“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”.
The reason the MHRA is involved is because marketed claims that a product can be used for medical purposes makes a product a “medical device” which falls under the MHRA’s auspices as they are the regulatory body responsible for enforcing the law on medical devices in the UK with a range of investigatory and enforcement powers to ensure the safety and quality of said products. Suppliers who fail to comply are likely to attract and be subjected to prosecution. The MHRA recommends that businesses follow government advice (see link below), as well as implementing scientifically reliable methods of testing for COVID-19.
Health Minister Lord Bethell has previously said:
“It is important businesses do not rely on temperature screening tools and other products which do not work. The best way to protect people and minimise the risk of catching the virus is to always follow social distancing guidelines, wear a face mask on public transport and when in enclosed public spaces, and to regularly wash your hands.”
The Director of MHRA Devices Division, Graeme Tunbridge stated:
“People in the UK are unknowingly buying poor quality infrared thermometers which do not meet the required standards of safety and performance. It is important that people know what to look out for when purchasing these products, or any other medical devices, especially online. You should always look for the CE or UKCA mark on any medical device – this will either be on the device or on its packaging, and that includes when you are buying these products online.”
If you, as an employer are using infrared thermometers as a means of trying to ensure safety in your workplace then you should reconsider. Using these devices is not regarded as a safe means of identifying this infection as it is not reliable, mostly due to the fact that not all people with the infection have a temperature, and not all people with a temperature have COVID 19. You should review your risk assessment(s) and instigate the recommended control measures for your industry type government advice on safe working during COVID-19.
As employers, you should ALSO be aware of the legal imperative which stems from the Provision and Use of Work Equipment Regulations to only purchase work equipment which is both suitable for the job and which “conforms with community requirement” and bears the CE mark (valid for devices put on the market up to 30th June 2023) or UKCA (now a valid mark to demonstrate a devices conformity to standards but required for devices put on the market after 1st July 2023).
Before you buy: look for the following information which should be included on the device and packaging. If it is not there or the seller cannot provide it then do not buy the device.
- Name and address of the manufacturer;
- If the manufacturer is not in the EU or UK, the name and address of the European representative or the “UK Responsible Person “;
- The CE or UKCA mark / symbol with a 4-digit number. The CE or UKCA mark itself needs to conform with the correct shape and configuration of the letters and the number identifies the independent third-party organisation (notified body) which has assessed the device;
- Model number and / or name of the device;
- Lot or batch number.
Action to take: if any of this information is missing then the device likely does not meet the legal requirements and you should not purchase it. Instead:
- Inform the supplier of the missing information.
- Report concerns to either the MHRA “Yellow Card Scheme” https://yellowcard.mhra.gov.uk/ or your national reporting authority.
- Healthcare professionals can go through their institutions local reporting procedure.
If this alert has raised questions or you need to discuss any other health & safety related issue do not hesitate to contact your health & safety consultant or the main office for advice / assistance.