Was your dental restoration properly regulated and manufactured in the UK?
An independent report provided to Dental Review throws up some disturbingly grey areas regarding the regulation of imported dental devices, including restorations such as crowns, bridgework and dentures.
UK-based dental technicians are required to understand and abide by the laws that govern the materials and techniques they use in the manufacture of such devices – but how does the complex set of General Dental Council (GDC) requirements imposed on UK technicians relate to those who import dental devices? Importing dental devices is legal and covered by the GDC in their guidance.
Members of the general public may be surprised to discover that some dental devices dentists place in a patient’s mouth is done outside the UK and is not covered by GDC regulation, but on paper looks exactly the same as a registered GDC technician made device.
An importer needs only register with the medical devices regulator, the MHRA, and meet their requirements, and, although they must not call themselves a dental technician, dentists are legally entitled to buy devices from such an importer.
However, the report advises us that the person who actually makes the device does not need any qualifications. What’s more the importer needs no qualifications, need not pay to register with the GDC, understand or follow GDC standards, do CPD, or have indemnity insurance. If the device causes the patient a problem, as a non registrant the importer cannot be held accountable by GDC Fitness to Practice procedures because both the device and the importer is outside the regulator’s jurisdiction.
How do you know where your crown came from?
Two ways, labelling and the Statement of Manufacture (SoM), which is a receipt that by law should be provided to the patient which clearly lays out that the dental device about to be placed in their mouth was prescribed for them, lists the materials used and the manufacturer.
On its website the GDC states: “If the device is made outside the EU the actual manufacturer must be disclosed to the patient.” Both the MHRA and GDC seem confused by this labelling requirement. Both organisations say that when a device is imported into the EU the address on the SoM is that of the importer – which MHRA describes as the authorised representative – not the actual manufacturer.
For all practical purposes the importer becomes the UK face for a dental device made by an unregulated manufacturer working anywhere in the world. It will have a UK address just like any device made under GDC jurisdiction, although it might have been manufactured in Russia, Mexico, Asia or the Far East. The device will not look any different but you will have no surety about the conditions under which it was manufactured or the materials used,
Anyone can sign the SoM. The authors of the report say that both the GDC and MHRA have said that as far as they are concerned there are no requirements about who may sign the SoM, so it can be signed by someone who may be an untrained non registrant. Such a grey area opens the system to abuse by unscrupulous dental professionals who put price before patient safety.
However, the GDC will hold the registered dentist accountable if a problem arises as the result of them using an unregulated dental device. They are told: “You will be held professionally accountable for the safety and quality of the appliance because you have chosen not to sub-contract or issue the prescription to a registered dental technician who would otherwise be accountable him or herself. You take on the dental technician’s responsibilities for the appliance and the GDC will hold you accountable for your decision.”
The “B” Word
And finally – Brexit. If dental devices are classed as “goods” in the EU’s single market the UK must not put up “barriers to trade” and must allow trade even though the devices do not meet the GDC’s strict requirement for UK manufacturers under their jurisdiction.
Anything the GDC did to hinder trade could be seen as a barrier with legal consequences. However, once the UK leaves the single market there arises the strong possibility that the GDC will be able to better regulate where devices used in a dental patient’s are manufactured, and who makes them. If you are struggling to find a positive angle from which to embrace Brexit that’s something to get your teeth into.