Regulator steps up battle against online sale of faulty and counterfeit medical devices
Medical device regulators have seized more than 400 fake digital thermometers after raids in Harrow and Oxford as part of a UK-wide blitz on unapproved clinical equipment being sold over the internet.
Some of the fake thermometers were being sold cheaply online for 99p and do not have appropriate CE safety markings, warnings or instructions for use to prevent them endangering people’s health. They are also likely to give inaccurate readings, posing a serious threat to the health of adults and small children who have potentially-lethal illnesses such as meningitis.
High temperatures in children can be a sign of serious illness and these raids by the MHRA show why it is so important that people are aware that fake thermometers and other fake medical equipment are being sold cheaply on the internet
The Medicines and Healthcare products Regulatory Agency (MHRA) launched the raids after the parents of a young child with leukaemia used a fake thermometer bought online and realised it was giving a misleading temperature reading. Their child had a high temperature and was rushed to hospital to receive urgent medical care despite the device showing no abnormality.
The thermometers have no known brand name and can be recognised by information missing on the packaging that would be there had the device gone through the proper regulatory channels. This includes no instruction leaflet, no lot or batch number, no CE Mark confirmation, no manufacturer details, and no four-digit identification number to prove they had gone through an appropriate safety assessment.
During the UK-wide operation, the MHRA also seized a number of other fake medical devices from other locations including seven Kiddicare cool pads that should help reduce to children’s temperatures, and three counterfeit Slendertone devices, which are used to tone people’s stomach muscles.
These products had been sold on Ebay and the MHRA is now working with the internet auction site to prevent unapproved equipment being sold in the future. It is also investigating how the products were supplied to the UK market in the first place.
In association with the UK government and with other regulatory and health bodies, we are working to ensure there is proper guidance to support the safe purchase of medicines over the internet
Dr Nicola Lennard, the MHRA’s deputy clinical director, said: “Inaccurate readings from cheap, fake thermometers could result in a delay to a child getting the medical treatment they need and it is vital that people do not buy or use cheap, unapproved medical devices.
“The MHRA is working with internet sites to ensure that fake medical devices are not sold to people and we urge the public to report faulty medical devices via our Adverse Incident Hotline on 020 3080 7080 or via our website.”
Questioned about the difficulty of policing equipment sold over the internet, a spokesman for the MHRA added: “The MHRA enforcement team continually monitors internet sites, especially those known to be selling prescription-only medicines. Spot checks are made to see if the sites are based in the UK and, if so, we are then able to take action and a number of prosecutions have taken place. We refer overseas sites to the appropriate regulatory body in that country.
“In association with the UK government and with other regulatory and health bodies, we are working to ensure there is proper guidance to support the safe purchase of medicines over the internet and we are playing a key role in a Department of Health working party on the sale and supply of medicines in the UK that will determine the legal and proper way to buy medicines online.
"These moves are intended to reconcile the increasing trend towards electronic commerce, including the growth of e-Pharmacies supplying prescription-only medicines, with the protection of patient safety and public health.”
The crackdown has been welcomed by TV medic, Dr Hilary Jones, who told BBH : “High temperatures in children can be a sign of serious illness and these raids by the MHRA show why it is so important that people are aware that fake thermometers and other fake medical equipment are being sold cheaply on the internet.
“I support the MHRA’s efforts to ensure that people are using safe and effective medical equipment.”