The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning to dentists about the dangers of buying dental medical devices online after a counterfeit product for drilling and cleaning teeth shattered while being used on a patient.
The MHRA is concerned about an apparent rise in the number of counterfeit and non CE-marked dental products that are for sale on the internet and has issued a Medical Device Alert to dentists warning them that these products may not have been tested for safety and could fail during use, with a risk of injury to patient and user.
Since 2012, the MHRA has issued warnings about a dangerous counterfeit dental X-ray machine that emitted harmful levels of radiation, counterfeit dental curing lights that could result in poor-quality fillings, and other fake dental medical devices that could cause serious harm to patients.
It is currently working with auction websites to remove identified counterfeit or non CE-marked products.
John Wilkinson, MHRA’s director of devices, said: “The patient in this latest incident was unhurt, but dentists buying and using counterfeit and non CE-marked dental medical devices are putting the safety of their patients at risk.
“Dentists should only buy dental medical devices from a legitimate manufacturer or supplier.”
Dr Martin Fallowfield, chairman of the British Dental Association's (BDA) Principal Executive Committee, added: ‘The BDA encourages all dentists to source equipment from legitimate, reputable manufacturers and suppliers who can demonstrate that the necessary legal requirements are being met. That will ensure both the quality of equipment purchased, and that you, your colleagues and your patients are protected. A list of many of the companies who manufacture or supply legitimate dental medical devices is published on the British Dental Industry Association’s website.”
