5 minute read
GDC’s Policy on Illegal manufacturing revealed
GDC’S POLICY ON ILLEGAL MANUFACTURING
REVEALED
lA project to understand how the Medical Device Regulation (MDR) is implemented in dentistry started by The Dental Technician has arrived at the truth:
Regulators take no action if illegally manufactured or imported dental devices are fitted to dental patients. This information has been shared with the Kingsholm group.
Larry Browne’s (who is very sadly no longer with us) investigation into how dental devices are regulated threw up some concerning information. A regulatory gap between the MHRA who regulate dental device manufacture, the CQC who regulate those who fit devices to patients and the GDC who control both aspects. It found no formal GDC education policy for dentists and no clear processes when illegal activity is encountered. The Dental Technician passed on concerns to the DLA, the DTA, the OTA and DAMAS and the Kingsholm group was formed.
At the first meeting Larry Browne told the group that The Dental Technician would follow the DTA’s advice to its members and report suspected illegal dental device manufacturers advertising on the internet but not appearing to be on the MHRA database, to the GDC. One reader reported to Larry that they had reported a suspected illegal dental device importer to the MHRA. Larry told the group that he was unable to get details of GDC policy in such cases from the GDC executive. There was discussion that dentists are exempt from manufacturing legislation, however another member gave the group a document from the EU Commission explaining in detail why (just like the rest of us) dentists are not exempt from the legislation when they manufacture dental devices. The GDC confirmed to the group that they do not require dentists and nurses to receive formal training on the MDR when making and fitting dental devices but it may happen in the future.
There was a vote on whether the group should get more detail on exactly how regulators regulate. The majority agreed to get the information. The group has recently received more detailed information. The GDC was given two examples of illegal practice, one simple and one complex and requested to provide a ‘Statement of Fact’ on policy and process regarding the examples. (A Statement of Fact is a useful document that lets all people, be they technicians, lab owners or patients, understand the truth about regulation. It is comprehensive, covering the GDC’s caseworker guidance and indicative sanctions, working with other regulators and the Statement of Manufacture which provides a legal framework to stop illegally manufactured devices being fitted to patients.)
Examples of illegal activity
The basic example given to the GDC was of a manufacturer who has had no training and is not registered with the MHRA who makes a simple orthodontic retainer. They leave the plastic edges sharp. When it is fitted to a child the sharp edges cut the child’s gums and they bleed. The manufacturer has received no training; the manufacturer is not registered with the MHRA. No statement of manufacture was made.
The more complex example was of an importer who is not registered with the MHRA but is importing devices with counterfeit dental implants, they do not keep records of this. They are popular because they are considerably cheaper than the real devices made within a legal framework. (The MHRA have had just such a case but will not provide details, and readers may also remember that a reader has reported a suspected illegal importer to the MHRA).
The GDC Executive responded confirming the regulatory gap with other regulators and that the GDC does not ensure that the MDR is being implemented and followed in dental schools. They did not provide any detail on policy or sanctions when a registrant chooses to fit illegally manufactured devices to patients. Readers may remember an article with the GDC saying that it was developing caseworker policy and a ‘formal information sharing agreement’ with the MHRA. This seems to have been stopped.
The group was also given information from the MHRA. They were asked “if dental hospital labs are exempt?” (from medical device regulation). They said “Any manufacturers of custom-made devices are legally required to register with MHRA. This was also the case prior to 1 January 2021.” If this is the case, then it may mean that manufacturers and clinicians in dental hospitals not complying with the legislation may be breaking the law and teaching illegal practice by example.
The group was told that concerns have now been raised with the Professional Standards Authority (PSA) who audit the GDC and CQC and the group was told that the issues will be explored during the next GDC audit. The next meeting of the Kingsholm group (reported in a previous issue of the DT) has been cancelled.
Where next…. strengthen patient protection or loosen regulation?
The Dental Technician will continue Larry’s work and report on the PSA audit which should happen this winter and compare it to the Statement of Fact and report on developments. (The Dental Technician will not publish the Statement of Fact yet while the PSA consider it and new policy has yet to be formalised.) Readers may be aware that the MHRA is holding a consultation on possible future changes to medical device regulation. Readers should not be surprised if manufacturing regulation on devices made by dentists and nurses is loosened. Let us hope any changes are fair to patients and all registrants.
These developments raise very many serious questions – How big is the black market? How many complaints made by patients to the GDC and Dental Complaints Service about dental devices involve illegal activity? Will the regulators raise standards and focus on the patient or lower standards to a more unregulated market?
The Dental Technician will keep its readers updated.
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