BBC News: MHRA raise concerns over unsafe thermometers
The UK’s medical device regulator, The Medicines and Healthcare products Regulatory Agency (MHRA) have today raised concerns around the volume of inaccurate thermometers that have flooded the UK market.
The MHRA is warning the public and healthcare professionals to take care when buying infrared thermometers and to know what to look for when purchasing online.
The MHRA has seen a significant rise in the number of inaccurate infrared thermometers making their way onto the UK market –this is believed to be caused by the COVID-19 pandemic creating a massive increase in demand for these products.
Graeme Tunbridge, Director of MHRA Devices division said:
‘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 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’
Andy Mahoney, Chief Executive Officer of Celsium said:
‘People have been diligent in wanting to measure temperature at home but due to high demand, stocks have run low in high street stores meaning many purchases are made online.
It is challenging to determine whether a product meets the strict regulatory standards – and this has inadvertently led to purchases of inaccurate, sub-standard and unregulated products which are effectively unsafe.
The lack of accuracy offered by many thermometers was in fact one of the main reasons we developed Celsium as we believe really strongly that providing people with an inaccurate reading (false negative/positive) is actually more dangerous than not taking a temperature at all. Unfortunately, innovation has been stifled for many years in this field with most devices, simply being modern iterations of the first thermometer invented over 300 years ago!
We are very proud of the fact that Celsium is CE marked as a Medical Device and has undergone significant testing and validation to achieve this regulatory compliance. This improved accuracy and medical device approvals has provided the foundation for our development into the NHS and Life Science clinical research where we are now undertaking several evaluations.
What is Celsium?
Celsium combines a wearable sensor with a software platform to create for the first time, an accurate and reliable method for the measurement of body temperature.
BBC News article HERE
The full MHRA statement can be found HERE