DT News - UK - Authorities issue warning over buying dental devices online

Dental Tribune International

Mon. 24 February 2014

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LONDON, UK: The Medicines and Healthcare products Regulatory Agency (MHRA), the health authority that regulates all medicines and medical devices in the UK, has warned dentists not to purchase dental devices from the Internet. The alert was published after a counterfeit dental drill shattered while being used on a patient.

According to the MHRA, the number of counterfeit and non-CE-marked dental products sold online has risen significantly in recent years. The medical device CE mark, which is mandatory for certain products sold within the European Economic Area, signifies compliance with the essential safety requirements defined in the European medical device regulations. Devices that do not bear a legitimate CE mark may not have been tested for safety and could fail during use, risking injury to patients and users. However, counterfeit dental medical devices can be difficult to distinguish from genuine devices.

Since 2012, the MHRA has issued a number of warnings about medical devices that could cause serious harm to patients, including alerts about counterfeit dental X-ray machines that emitted harmful levels of radiation and counterfeit dental curing lights that could result in poor quality fillings.

The agency recommended that dentists only buy medical devices from legitimate manufacturers and suppliers, who can demonstrate that the necessary legal requirements are being met.

A list of legitimate sources for dental devices can be found on the British Dental Industry Association’s website.

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