GDC uncertainty over who can sign the Statement of Manufacture

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GDC guidance has said that a registered dental technician should oversee process workers.

DENTISTS are told, “If you prescribe a dental appliance to be made by a person in the UK who is not a registered dental technician, you may put your registration at risk. Equally, you may put your registration at risk if you receive a dental appliance made in the UK by a person who is not a registered dental technician.”

 

This may be why many people believe that the General Dental Council has a requirement that a registrant must complete the initial and final inspections of a dental device before it is given to a patient. The GDC does not regulate outside the UK so similarly if unregistered process workers outside the UK who are trained to an unknown level and are not doing CPD, etc., want to supply a UK dentist then the device would have to be inspected by a GDC registrant who would then sign the Statement of Manufacture (SoM).

The belief that there is a link to GDC registration and taking responsibility by signing the SoM is reasonable but in fact it appears that there is no restriction and anyone can sign the SoM.

A dental technician has asked the GDC and MHRA if there are any restrictions as to who can sign the SoM.

The MHRA said: “In terms of the Medical Devices Directives (93/42/EEC), there’s no specific stipulation that the statement of manufacture must be signed off by someone suitably qualified or by a GDC registrant.”

The GDC was asked “if there is any legal bar that the GDC is aware of that prevents anyone from signing the SoM?” The GDC replied: “This is a legal matter on which the GDC cannot advise. You may wish to seek legal advice on this matter.”

Editors Comment

The expected standard for a dental device being given to a patient is that it will be made to the same standards that could be expected from a degree-trained dental technician who is maintaining their competence by doing CPD.

Anything less and the GDC would be failing patients.

As there are over 6,000 registered technicians in the UK, this would not be an unreasonable expectation. Many people will be surprised that there is not a requirement by the GDC that the SoM is signed by a registrant as this would provide a logical link with the GDC’s standards and its commitments to education and treating all registrants equally by ensuring that other supply models are to the same standard.

The suggestion by the GDC that technicians should seek legal advice themselves could be looked at in two ways. Firstly the GDC does not know the answer. In this case the question arises: is it not the GDC’s job to understand the law and find out if they don’t?

The other more likely explanation is that this question has further serious legal consequences as to how dental technicians and dental devices are regulated and the GDC does not feel inclined to share what it knows. If this is the case, so much for the new commitment to transparency that it has signed up to!