The Medicines and Healthcare products Regulatory Agency (MHRA) has warned people and dental staff to be wary when buying dental equipment from the Internet after its enforcement investigators seized a number of potentially dangerous fake dental instruments including a non-approved portable dental x-ray unit that could emit harmful radiation.
Following an MHRA raid at a business address in the West Midlands, a total of 100 fake dental instruments were seized which consisted of scaler tips, light curer composite, gutta percha points, dental cleaning/scraping tools and detail high speed handpieces that are not CE marked and do not carry the appropriate warnings or instructions for use as approved medical equipment does.
The MHRA launched the raid after an anonymous complaint was received with regards to a non-CE marked portable dental x-ray unit that was bought over the Internet on eBay. Following a purchase via eBay, tests revealed that one of the machines available for sale had a lack of sufficient shielding in the X -ray tube, which could mean that the machines emit harmful radiation levels to the operator of the machines and patient.
People can find out if they have bought fake medical equipment by looking out for the following:
- The dental instruments have no recognised brand name and can be recognised by missing information on the packaging
- No instructions for use leaflet is with the product
- No lot or batch identification number is listed
- No CE mark affixed
- No manufacturer or European representative details are listed
- No four digit unique identification number to show that the device has been through the appropriate Notified Body assessment
These products are being sold cheaply on eBay and the MHRA is working with eBay to prevent any further unapproved devices being sold.
John Wilkinson, the MHRA’s Director of Devices, said:
“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 we are 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.”
