The GDC’s hidden policy on illegal dental devices
The Medicines and Healthcare Products Regulation Agency (MHRA) does not believe that the General Dental Council (GDC) should give registrants who break medical devices safety legislation or use illegal suppliers a warning, rather than being reported to the appropriate regulator.
When asked how it responds to irregularity over the Statement of Manufacture – to registrants who have been sourcing illegal devices from illegal suppliers – or are illegal manufacturers, the GDC replied that, ‘On first notification we remind the registrant of our standards about complying with all relevant legislation and signpost them to the MHRA website containing information on becoming registered. On the second notification we would refer the matter straight to the fitness to practise process’.
However, this two-strike policy creates an unwarranted safety net for the use of illegal dental devices, and this safety net must be removed in the interests of patient safety and the fairness of its own registrants.
The MHRA has responded to concerns regarding these policies by saying that the transparency and regulatory co-operation recommendations of the Francis Report relate to service provision and professional fitness to practise regulation, neither of which are directly relevant to MHRA responsibilities for regulating the safety and performance of medical devices put on the market by manufacturers.
The MHRA went on to say that the registration requirement in the Medical Devices Directive (MDD) related to manufacturers and dental laboratories placing custom made devices on the market rather than necessarily giving them to individual technicians, unless they were placing custom-made devices on the market in their own name. The registration requirement also did not require dental technicians to be registered with the GDC, which was a separately regulated issue.
As the GDC and the MRHA are not overlapping authoritative bodies, the few areas of mutual interest do not merit a formal agreement between the regulatory regimes, as any issues can be easily dealt with by contact between the organizations.
Whilst the illegal practise of dentistry is a matter for the GDC, in relation to breaches of medical devices legislation, the MHRA does not consider dental devices to be zero risk, and stated that it would take appropriate action to resolve any non-compliances which are brought to its attention.
