US dental authorities are reacting swiftly to reports of lead found in dental work imported from China and India.
The American Dental Association (ADA) and National Association of Dental Laboratories (NADL) are now calling for more stringent regulation of imported dental material following a TV report citing two cases of patients being sick after lead was found in their dental restorations.
It’s prompted Florida lawmakers to push for full disclosure and the ADA to issue guidelines to its members regarding outsourcing work abroad.
The new legislation will require all dental laboratories to disclose to dentists where a product was manufactured and what materials were used, and provide certificates of authenticity.
In the UK, the General Dental Council (GDC) recently warned dentists of the risk of legal comeback if laboratory work carried out overseas went wrong.
The GDC maintain that dentists who commission technical work from laboratories outside the UK – and which do not meet the standards set by the Medical Devices Directive (MDD) – are in danger of being solely culpable if mistakes are made.
From August, registration of dental care professionals becomes mandatory and all technical work in the UK must be undertaken in a laboratory that employs technicians registered with the GDC.
Additionally, all labs must be registered with the Medicines and Healthcare Products Regulatory Agency.
Currently, the only guarantee is via a third party, the laboratory’s ‘authorised representative’ in the UK, who is supposed to be responsible for ensuring that the manufacturer complies with the MDD.
But the GDC feels this fails to deliver enough reassurance for dental patients here.
GDC Chief Executive, Duncan Rudkin, said that if a dentist had not taken the appropriate steps to ensure that work coming in from overseas was of appropriate quality, there would be no-one else to take responsibility.
In its guidelines to newly registering dental technicians, the GDC states:
‘The GDC does not have the power to protect the UK technology industry from foreign competition, any more than we have the power to stop patients seeking dental care abroad.
‘We make it very clear to GDC registrants, including dentists, clinical dental technicians and dental technicians that they need to understand and comply with their responsibilities under the laws and regulations governing their business, which in this case include the medical devices regulations.’
‘Individual dentists and technicians are accountable to the GDC for fulfilling these responsibilities, regardless of whether they are ‘GDC rules’ or simply part of the law of the land.’
Currently only 2,883 technicians out of a possible 10,000 in the UK have registered with the GDC and there are worries about bringing so many on board by the end of July.
Richard Daniels, Chief Executive of the Dental Laboratories Association (DLA), believes that clearer communications policy being pursued by the GDC may encourage more technicians to register.