Dentistry.co.uk and Laboratory ask where the professions’s regulators stand on the illegal dental manufacture or import of dental devices such as dentures and crowns.
Should illegal activity in dentistry be a ‘never event’?
This series aims to pose some questions about the attitude of dentistry’s regulators towards illegally manufactured or imported dental devices.
Specifically: if a dentist chooses to fit illegally manufactured or imported dental devices, does the regulators’ policy protect the dentist rather than the patient – even if the patient has problems or is harmed? Or does the current policy give those involved with illegal manufacture or import the confidence to continue?
The aim of this article is to give readers enough information to decide for themselves.
Regulating illegal manufacture
There are concerns in the dental technician community that the regulators are not taking illegal manufacture and/or import seriously enough.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the General Dental Council (GDC) have been asked for a clear and detailed account of what action they take when they become aware of illegal manufacturers or illegally manufactured or imported dental devices being fitted to patients.
The GDC was asked if it would develop a statement of fact on how it deals with this aspect of illegal dentistry. To date, it has not, and no detailed policy was received from either regulator. The GDC will say only that it ‘may’ take action.
In the opinion of the authors, the use of ‘may’ is dissembling, and does not represent the transparency and consistency mentioned in the PSA’s principles for good regulation. It is our belief that if the regulator finds evidence of illegally manufactured dental devices being fitted, the regulator either ‘does’ or ‘does not’ take action.
Examples of illegal dentistry
The GDC and MHRA were given two examples of illegal dentistry and asked to give exact details of their policy.
A basic example was of a manufacturer with no training, who was not registered with the MHRA, but made a simple orthodontic retainer – leaving the plastic edges sharp. No statement of manufacture was made. When the retainer was fitted to a child, the sharp edges cut the child’s gums causing them to bleed. Some people may think that legally this may constitute assault.
A more complex example was also provided: an importer who was not registered with the MHRA but was importing counterfeit dental implants. These counterfeits are replicas of a genuine and more expensive implant, machined to look like the real thing.
This importer did not keep records of this. The importer was popular because it was considerably cheaper than the real devices made within a legal framework.
The MHRA has encountered a case of illegally imported implants (and has had at least one suspected illegal importer reported to it), but will not provide details.
No policy processes arriving at a visible sanction were received from either the GDC or MHRA for either example.
What does medical device regulation do for patients?
Dental implants, crowns, bridges, dentures, and any other custom-made dental device for patients are regulated by the MHRA.
Manufacturers must register with the MHRA and comply with manufacturing regulations. Not doing so is a criminal offence. To avoid any doubt over this, the MHRA holds an online database of manufacturers, which can be be found here.
Manufacturing has a number of legal requirements that ensure the device is safe and conforms to a basic set of standards.
These requirements include training and understanding of manufacturing, record keeping for traceability and material safety, and producing information for patients called the Statement of Manufacture (SoM). The patient has a legal right to this document: withholding it is a criminal offence.
This document must contain the name and address of the manufacturer. The MHRA have said that a patient can expect to see this name and address on the MHRA website. The MHRA randomly audits manufacturers registered with it: it is a watertight system of ensuring basic standards.
Which regulators and organisations are involved?
The MHRA regulates dental device manufacturers and importers. The GDC regulates some people who make dental devices (if they are GDC registrants) and all people who fit dental devices to patients.
The GDC has a duty to ensure its registrants are complying with the law. The CQC also regulates those who fit dental devices to patients. It has the remit and opportunity to ensure the legislation is being followed in dental practices. The GDC and CQC are involved in inspecting dental teaching hospitals.
The Professional Standards Authority (PSA) audits the GDC and CQC (amongst others) – but it does not audit the MHRA.
With that said, the PSA can only advise: the GDC council has primacy. If the GDC council has decided to take no action if it learns that a dentist has fitted illegally manufactured devices to dental patients, the PSA cannot compel the GDC to change policy.
The PSA can – and does – point out what it sees as deviation from its guidance for good regulation. So far, it has not done so for this issue since the GDC overrode its original attempt to do so.
The Dental Technologists Association (DTA) represents some dental technicians who are GDC registrants and may be considered GDC stakeholders. The Dental Laboratories Association (DLA) is an organisation that represents some dental device manufacturers, and may be an MHRA stakeholder.
Differences in regulation
The MHRA and GDC regulate differently.
We asked the MHRA a number of very focused questions on this issue, and while gave some broad-brush answers, the way it regulates was clear.
The MHRA only focuses on whole sections of the industry in a general way. By contrast, the GDC is supposed to focus on the outcome for each individual dental patient to see if the treatment meets its published standards.
While the GDC can (and does) seek to sanction an individual, publish fitness to practice findings and set an example to others if it chooses, the MHRA has an openly different focus.
It said: ‘We cannot disclose commercially sensitive information where we do not consider it necessary to do so and where the disclosure may not be proportionate to what is sought to be achieved by it. Therefore, we are not able to disclose details of investigations or outcomes unless we are satisfied that the disclosure is necessary and proportionate.’
Regulatory gap
It added: ‘We acknowledge that even with the most stringent regulatory processes and oversight, there will always be allegations and incidences of non-compliant medical devices.
‘It would not be possible for MHRA to fully investigate every referral it receives, therefore, we operate a risk-based system to assess allegations and balance the volume of referrals against available resources. This system takes into consideration the potential hazards associated with the alleged non-compliance and the degree of perceived potential harm as well as the severity and probability that the alleged non-compliance will result in harm. This gives us an overall risk rating for each allegation (“low risk”, “significant risk”, “high risk” and “serious risk”).’
This seems to indicate that if the MHRA discovers illegally manufactured devices being fitted to dental patients, its default policy is not to take any visible action to enforce its own regulation with regard to dentistry.
There is a regulatory gap between the GDC and MHRA, but attempts by the GDC and PSA to close it have seemingly stopped. The GDC council has been unwilling to say why.
What is the role of regulation?
If we say hypothetically that the rate of illegal manufacture and import in the UK dental market is 12%, then it would be reasonable to assume the regulator’s role is to try and reduce this to zero.
Let’s say a dental nurse knows that their dentist is fitting devices from an illegal manufacturer and reports it to the GDC (as the GDC says they should). In theory, this should go through the GDC processes and result in a fitness to practice hearing. If proven, that finding would become public, providing ‘moral hazard’ to the profession – and hopefully reducing the hypothetical 12% figure.
We would argue that the case of illegally imported dental implants the MHRA mentions would have been the ideal opportunity to work together with the GDC as it did with counterfeit equipment, but the outcome of this case never became published and public.
It is clear that the MHRA is not in the business of creating moral hazard for illegal practice in dentistry and the illegal dental device market.
A failure of education?
We do not believe that the GDC has investigated any cases like the examples cited above. But what would happen if the GDC were to do so, and ask a dentist or nurse why they acted illegally? It’s easy to imagine the potential answers: ‘I did not understand the legal requirements.’ Or: ‘I have not been taught.’
In this case it would be a failure of education: a problem which is the GDC’s remit and could be argued is a result of their education policy. The registrant may say that they thought that as the GDC and MHRA don’t have a policy to take action and give visible sanctions, the law was not being enforced, so why comply?
This issue is being discussed here on Dentistry.co.uk and in Laboratory magazine but it is a question that has been raised by other outlets too.
In the GDC’s earlier responses, it has talked of proportionality. If the GDC became aware of the cases like the examples here but took no action, would the failure to set an example be ‘proportional’ – or enabling to illegal practice?
Would patients expect a dentist to fit illegally manufactured devices, or the GDC and MHRA not to have clear policy and not to act in the way they did over a dentist’s use of counterfeit handpieces?
More effective collaboration
The MHRA and GDC have shown they can work together if they choose.
Some time ago, a dentist using counterfeit drills and equipment that had been bought online was suspended for three months following an fitness to practice hearing. The case was discussed for months, and there can be few dentists who do not know what will happen if they are tempted to buy counterfeit equipment from online auction sites.
This was a clear case of medical regulation being ‘seen’ to be done: readers may wonder why the GDC and MHRA have chosen not to do this for dentists who fit illegally manufactured or imported devices.
When the MHRA became aware of the illegal implant case, if it had inspected the importer and given the GDC the names of the dentists using and fitting the illegally imported implants, the GDC could have taken proportionate action.
By choosing not to do this it could be argued that the MHRA has given the illegal market the confidence to continue.
Are dentists invalidating their insurance?
It is believed that you cannot insure against the consequences of a dental registrant deliberately fitting illegal manufactured or imported devices to a patient, as by doing this the dentist would invalidate their dental indemnity. This seems to have been a problem in the illegally manufactured breast implant fiasco.
Having indemnity insurance is a GDC requirement for registration. It can (and will) remove people from the register who do not have it.
The regulators and PSA have been asked whether a dentist would continue to be insured if a dentist fits an illegally manufactured or imported device to a patient. None of them have been inclined to comment with one regulator saying it ‘amounted to giving insurance advice’.
One reason why they may be unwilling to give an assurance is if neither the GDC or MHRA will explain how they make a regulatory finding and a patient (or their legal advisor) cannot find out if they have been involved in illegal practice, then the concept of illegal dentistry regarding insurance and legal action is a moot point.
Work is ongoing to change the regulators’ approach to this serious issue, which is discussed in the second part of this article
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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