Dentistry.co.uk and Laboratory examine the work done to clarify the way regulators enforce the illegal dental manufacture or import of dental devices such as dentures and crowns.
In the first part of this article, we discussed the current situation regarding the duty of the General Dental Council (GDC) and the Medicines and Healthcare products Regulatory Agency (MHRA) to regulate the use of illegally manufactured or imported dental devices in the UK dental market.
This article aims to detail the historic work done to change regulatory policy and repeat the call for further change.
There have already been two attempts to get the GDC to adopt the law.
Initial guidance
The first came in 2012, Professional Standards Authority (PSA) (then the Council for Healthcare Regulatory Excellence) responded to concerns. After discussions with the MHRA, GDC and Care Quality Commission (CQC) it released a statement saying:
‘The GDC has instituted the following checks:
- It will monitor the number of complaints about dental devices, received by its Fitness to Practise Department, and whether, in such cases, patients have been offered a statement of manufacture by the dentist
- It will also monitor the number of complaints about dental devices, received by the Dental Complaints Service to make sure those cases which raise an issue of fitness to practise are referred to the GDC’s fitness to practise department or the MHRA
- It will consider, as part of the work being undertaken with the Law Commission to design new legislation, any changes to its powers that may be necessary to fill any regulatory gaps that may be contributing to the dental technicians’ concerns.’
When the GDC’s progress on this was checked a year later, the GDC chief executive at the time said it had been stopped as being ‘too onerous’.
It is unclear as to whether any actual policy was produced for GDC workers to follow or whether the GDC council did not order the changes to be made.
If this guidance from the PSA had been implemented there would not be any doubt that illegal practice would have been stopped.
Further attempts
The second major attempt involved the GDC council itself after a visit from the MHRA to discuss the MDR with the GDC.
A letter from a GDC director (cleared for publication and published by The Dental Technician in 2016) discussed the GDC’s internal project to review policy in relation to MHRA regulations. This project updated the 116-page internal guidance given to GDC caseworkers and the processes for ‘recording information relating to a breach of the MHRA regulations’.
The letter stated: ‘We implemented a new process for recording incidences of MHRA regulation breaches in our cases system. We are also in contact with the MHRA and are in the process of developing a formal Information Sharing agreement, to ensure that an appropriate level of information is being shared between our two organisations so that in situations where there has been a breach of any relevant legislation, public protection can be guaranteed.’
The director also said: ‘I am not aware of a previous policy of intentionally not requesting a statement of manufacture. During an investigation a caseworker would regularly request a complete copy of the patient’s records for review. It would naturally follow that a copy of the statement of manufacture of any custom-made medical device should be contained within those records. If this were not the case, I would expect a caseworker to elicit further contact in order to establish why this document was missing.’
Processes stopped
Extracts from the GDC caseworker guidance document were also provided, which made clear that actual policy existed for GDC workers to follow when they became aware of illegal activity.
The GDC says that there is no information sharing agreement with the MHRA, so these processes appear to have been stopped.
The MHRA and the GDC have both been asked who stopped the policy development and why.
While both organisations said they ’could’ share data, neither organisation would say why the GDC’s attempt to develop a formal information sharing agreement had been stopped or who had stopped it.
At one point, the GDC also published a patient leaflet about the patient’s right to the Statement of Manufacture saying: ‘The person who prescribes your treatment (usually your dentist) must offer you a statement of manufacture with full details of the appliance. The statement is like a certificate or warranty and proves that your device has been made to legal standards especially for you. You don’t have to take a copy of the statement; it will be kept on file and you can ask for a copy at any time during the lifetime of the appliance.’
This patient leaflet also appears to have been withdrawn.
The Kingsholm Group
The Kingsholm Group was formed after an investigation into the regulation of dental devices by the late Larry Browne. This investigation threw up some concerning information – the regulatory gap between the MHRA, which regulates dental device manufacture, and the GDC, which controls both aspects.
It found no formal GDC education policy for dentists and no clear processes when illegal activity was encountered. Browne – who was editor of The Dental Technician journal at the time – passed on concerns (and much of the information in this article) to the Dental Laboratories Association (DLA), the Dental Technologists Association (DTA), the Orthodontic Technicians Association (OTA) and the Dental Appliance Manufacturers Audit Scheme (DAMAS) and the Kingsholm Group was formed.
At the first meeting, 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, but that he was unable to get details of GDC policy in such cases from the GDC executive.
The existence of an advanced training manual for dental nurses was also discussed: dental nurses can manufacture dental devices under GDC rules and while the reported manual was extremely comprehensive it contained no guidance on the patient’s right to the Statement of Manufacture or how nurses should make devices within the law.
Concerns raised
The GDC did confirm to the group that it does 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.
While the group failed to find consensus on an education policy, the majority did agree to seek more more detail on exactly how regulators regulate.
The group was told that concerns had been raised with the PSA, and that these issues would be explored. (The PSA has now audited the concerns.)
A DLA editorial about the Kingsholm Group told DLA members about the push for education and that the group would ‘unite and work together for the common goal of making the climate for UK technology better’.
While it offered to host the next Kingsholm Group meeting, COVID-19 stalled discussion – but Laboratory magazine and Dentistry.co.uk will follow up on the status of the group in future.
Reporting of illegal manufacturers
The PSA’s Standards of good regulation set out the outcomes that it expects from the GDC (and CQC). These standards prioritise the core role of regulators in protecting patients and reducing harms, promoting professional standards and maintaining public confidence in the professions.
All of these three are compatible with the standards required by the MHRA’s Medical Device Regulations (MDR). The standards are informed by the PSA’s principles of good regulation which states that regulators should act in a way which is proportionate, consistent, targeted, transparent, accountable and agile. These extend to how the GDC deal with illegal devices in dentistry when they become aware of them: hidden policy is not compatible with these requirements.
Concerns over policy, education, insurance and the suspected illegal manufacturers reported to the GDC have all been discussed with the PSA. However, the focus of the published audit (Performance Review 2020/21: General Dental Council) is suprising.
The PSA told The Dental Technician that its audit did not obtain a clear account of GDC policy when it becomes aware of its registrants engaged with this form of illegal activity or looked to see if, in the cases that were reported, it had been followed. It focused instead on whether ‘stakeholders’ find the GDC’s policy acceptable.
The report states: ‘[The GDC] told us that concerns relating to devices do not routinely appear in fitness to practise or illegal practice cases, or cases brought to the Dental Complaints Service.
‘The GDC said that it has limited evidence of risk in this area, and as such this has not been a focus for the Regulation of Dental Services Programme Board’s Risk and Oversight Group. The GDC has worked with stakeholders including the MHRA, registrants and the dental sector about dental devices.’
No clear policy
This is clearly true. However, as previously stated, the GDC had at one point developed a policy expecting caseworkers to gather the Statement of Manufacture in any serious case involving a dental device. Stopping this policy would by definition ‘limit the evidence’ – as would stopping the GDC project involving the ‘new process for recording incidences of MHRA regulation breaches in our cases system’.
The ‘limited evidence’ is therefore hardly surprising, and certainly should not be to the GDC or PSA.
The report also states that ‘the GDC has given us reassurance that it is engaging with stakeholders about this issue, and that it is taking appropriate action when concerns are raised with it about compliance with the legislation’.
The stakeholders in question are the MHRA and the BDA. There is no mention of the Patients Association, the DTA and the DLA as stakeholders. How does this fit in with the PSA’s requirements?
If the MHRA has no clear policy on working with the GDC and is happy that the GDC doesn’t have any clear policy either, that seems to constitute a successful audit.
Exemptions and illegal practice
The Dental Technician claims to have asked the MHRA some very focused questions on whether manufacturers and dentists in dental teaching hospitals were exempt from complying with the MDR when making and fitting devices to patients in teaching hospitals.
The MHRA pointed to an ‘in-house exemption’, which some believe could offer a loophole for failing to comply with the MDR. The details of an exemption must be extremely clear: if one is claimed without following legal requirements, the potential for teaching illegal practice by omission is obvious.
The MHRA was asked for more details as follows:
- Can a dentist in a dental hospital choose not to make the statement of manufacture available to their patients and make the patient ‘aware’ of their right to have their statement, offer it to them or give it to them?
- If manufacturers and dentists in dental hospitals can choose not to implement the MDR, would this be legal for their students not to comply when they leave the dental hospital?
- If the MHRA and GDC allow dental hospitals to act in a way that would be illegal outside in regard to making and fitting of dental devices, how would the MHRA respond to a suggestion that allowing dental hospitals to claim health institution exemption from the MDR for custom made dental devices conflicts with the GDC’s duty to educate and could be considered to be ‘teaching illegal practice’?
- Is the MHRA aware of any impediment that would stop manufacturers and dentists in dental teaching hospitals from following the same legal requirements as outside the dental hospital?
- Does the dental hospital claiming exemption have to notify the MHRA?
MHRA statement
The MHRA told The Dental Technician: ‘As stated in the regulations, any custom made medical device that is manufactured and placed onto the UK market has a number of requirements that must be met. The manufacturer must be registered with MHRA, or have a UK Responsible Person registered with MHRA on their behalf (if the manufacturer is based outside of the UK).
‘The manufacturer must also inform the patient of the device’s statement of manufacture and produce and provide if requested a statement of manufacture to the patient.
‘If a device is manufactured and used on a patient within the UK then MHRA will expect the previous action to be undertaken, and if they are not the manufacturer and/or the UK Responsible Person would be in breach of the Medical Device Regulations (MDR) 2002 and could face compliance or enforcement action.
‘MHRA does not require a formal notification or application to manufacture under the in-house exemption in Great Britain and therefore does not hold this information for GB-based institutions applying the exemption.’
The authors would argue that this does not answer all the questions or provide any clarity and guidance. The dental team should have clear guidance.
The response seems to indicate three contradictory principles:
-
- The manufacturer must be registered with MHRA
- The dental team should be clear on how they should behave when trained
- Hospitals may claim an ‘in house exemption’ without notifying the GDC or MHRA.
Legal duty
The GDC has said: ‘While in education, all dental students and trainees are expected to be appropriately supervised by GDC registrants who are then expected to comply with, and support a student or trainee to comply with, all legislation.’
This would indicate a formal expected educational outcome in dental schools – but the GDC has also said there is no formal requirement for dentists and nurses to be taught their legal duty under the MDR as part of their training syllabus.
While GDC says it requires registrants to inform the GDC of any breaches of the law they encounter, it also seemingly allows dental schools to decide not to adopt and teach these legal requirements with a formal expected learning outcome.
Is this a GDC council decision? If it is, where is the explanation of why a basic understanding of the law should be omitted from dentists’ and nurses’ education?
Stopping illegal dentistry….. or giving it confidence to continue?
It is understandable for the MHRA not to want to micromanage dentistry: that is the GDC’s remit. However, the GDC says that it does not want to regulate dental devices and points to the remit of the MHRA.
It would seem difficult for the GDC to argue that having basic standards, patient protection and information for dental devices is not in the dental patient’s interest or that it does not have a duty to ensure that their registrants understand and comply with the law.
Avoiding the regulation of these issues is the cheapest option for both regulators. The GDC’s past problems with large backlogs has been well documented, and this may be behind a reluctance to investigate illegal activity in this area, or why policy development has always been stopped.
Does the MHRA’s point that it ‘cannot disclose commercially sensitive information where we do not consider it necessary’ mean that it puts more importance on avoiding reputational damage to dentists than safe and acceptable dentistry for patients?
Both regulators have said that they ‘could’ work together, so why is this not happening? The failure to do so only leaves illegal dentistry of this nature unchallenged, and gives illegal manufacturers confidence to continue.
With both regulators seemingly unwilling to be open, it is very difficult to get a clear answer. Arguably, only the Health Select Committee of Parliament has the power to find out.
If no action is taken when regulators become aware of illegal activity, then this aspect of regulation offers a false assurance for patients. The many manufacturers practising legally face unfair competition in an unregulated market, with their efforts to comply being a waste of time, money and resources.
Credits
This article has been developed by a number of committed colleagues over the course of several years, who have worked hard to get to the truth behind regulating the manufacture of dental devices in the UK.
The information herein comes from a variety of organisations, including a number of dental editors at a range of different publications (including those in the Dentistry.co.uk stable and beyond). While every effort has been made to get the information right, providing clear information becomes very difficult when faced with a lack of transparency from the organisations involved.
We thank our esteemed colleagues for their work in putting this article together.
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