Radiation warning over dental X-ray machine
Cheap eBay X-ray machine could give patients 10 times normal radiation dose
4th December 2012 - Dentists are being warned to stop using portable X-ray machines that fail to display European conformity marks after one product was found to pose a health risk to patients.
Tests carried out by the Health Protection Agency (HPA) and King's College Hospital found that the Tianjie Dental Falcon device lacks sufficient shielding in the X-ray tube, which could result in patients receiving unacceptable levels of radiation. It would also pose a risk to operators under typical dental surgery workloads.
At least one dental surgery has been found using the device.
The cheap imported machine has been available for sale on eBay.
"We have seized 13 of these X-ray machines from the distributor but we urge anyone who has bought one of these machines to contact us," says Bruce Petrie of the Medicines and Healthcare products Regulatory Agency (MHRA) in a statement.
The MHRA says the machine is not stamped with the mandatory CE mark as a medical device.
The potential dangers from the Tianjie Dental Falcon device came to light after the HPA became aware that the cheap sets were for sale on the internet. Its Dental X-ray Protection Services team bought and tested one.
They found there was insufficient lead shielding to protect dentists and patients from excessive radiation, that the X-ray beam was too wide and there was an unusually long X-ray exposure.
In addition, the device posed an electrical hazard as it came fitted with a European plug and travel adaptor which was not earthed or fused for the UK mains supply and could potentially give a 50,000 volt shock.
The Tianjie Dental Falcon is manufactured by Zhengzhou Tianjie Electronic Equipment Co of China.
An MHRA investigation has found that potentially thousands of unapproved hand-held dental X-ray devices are being sold on internet sites such as eBay for as little as £200-300. Approved dental X-ray equipment - which could be either static or hand-held - usually costs far more, in the range from £3,000 to £5,000.
Some of these unapproved hand-held devices were advertised on eBay as “Kodak” X-ray machines. While they could be used with Kodak film, the actual machines are not made by Kodak.
The MHRA says this description is used to give them credibility and the names of the devices change regularly in a bid by the makers to avoid detection.
Barry Cockcroft, chief dental officer for England says in a statement: "It is vitally important that when buying equipment, dentists make sure it is appropriate and safe for use.
"I would urge all dental professionals to be cautious of seemingly cheap devices which may not be fit for purpose and potentially dangerous."
The British Dental Association sent us a statement which said it had "published guidance to dentists in June, following the HPA’s tests, advising members of the dangers associated with the device and reminding them of official guidance on the safe use of X-ray equipment by dental practitioners".