People should be cautious when buying any dental or medical equipment from the internet because unapproved medical devices can be dangerous or ineffective
The seizure of a number of potentially-dangerous dental instruments, including a portable X-ray unit that could emit harmful radiation, has led to a warning being issued by regulators.
The Medicines and Healthcare products Regulatory Agency (MHRA) today issued an alert to dental staff and individuals to be wary when buying dental equipment over the internet after enforcement officers raided a business address in the West Midlands.
At the property, they found 100 fake dental instruments including scaler tips, light curer composite, gutta percha points, dental cleaning and scraping tools and detail high-speed handpieces that were not CE marked and did not carry the appropriate warnings or instructions for use as approved medical equipment does.
The MHRA carried out the raid after an anonymous complaint was received with regards to a non-CE marked portable dental X-ray unit that was purchased on eBay. Tests later revealed one of the machines available for sale had a lack of sufficient shielding in the X-ray tube, which could put patients and operators at risk of harmful radiation levels.
The MHRA is warning potential purchasers to be on the lookout for the following indications that equipment may be counterfeit or faulty.
- Instruments that have no recognised brand name and have missing information on the packaging
- No instruction leaflet included detailing how to use the device
- No lot or batch identification number listed
- No CE mark affixed
- No manufacturer or European representative details listed
- No four-digit unique identification number to show the device has been through the appropriate Notified Body assessment
John Wilkinson, the MHRA’s director of devices, said the regulator was now working with eBay to prevent any further unapproved devices being sold. He added: “People should be cautious when buying any dental or medical equipment from the internet because unapproved medical devices can be dangerous or ineffective.
The MHRA is committed to protecting the public and is working with internet sites to ensure that fake medical devices are not sold
“The MHRA is committed to protecting the public and is working with internet sites to ensure that fake medical devices are not sold. We urge the public to report faulty medical devices via our adverse incident hotline on 020 3080 7080 or via our website at www.mhra.gov.uk.”
The warning over dental instruments follows a similar alert in June after MHRA teams raided addresses in Harrow and Oxford and uncovered more than 400 fake thermometers, which were also being sold over the internet.
In that case they were tipped off after the parents of a young child with leukaemia used a thermometer they had bought online and realised it was giving a misleading reading. Their child had a high temperature and was rushed to hospital to receive urgent medical care, despite the device showing no abnormality.