Magazine uncovers disturbing evidence about illegal dental devices
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- Published: Tuesday, 02 November 2021 07:40
- Written by Tony Jacobs
- Hits: 1718
A project to understand how the Medical Device Regulation (MDR) is implemented in dentistry started by The Dental Technician (DT) has arrived at the truth: “Regulators take no action if illegally manufactured or imported dental devices are fitted to dental patients”.
DT say their investigation into how dental devices are regulated threw up some concerning information. They claim that there is 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. They found no formal GDC education policy for dentists and no clear processes when illegal activity is encountered.
They gave GDC two examples of illegal practice, one simple and one complex and requested the regulator to provide a ‘Statement of Fact’ on policy and process regarding the examples. This, they say, 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, to stop illegally manufactured devices being fitted to patients.
The basic example of illegal activity given to the GDC was of a manufacturer, who has had no training and is not registered with the MHRA and 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 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 GDC Executive responded to the Dental Technician’s request by confirming the regulatory gap with other regulators and that the GDC does not ensure that the regulation 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. Previously the GDC had said that it was developing caseworker policy and a ‘formal information sharing agreement’ with the MHRA. This seems to have been stopped.
The Dental Technician says 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? They promise to keep their readers updated.
Meanwhile the General Medical Council has reacted strongly to reports of doctors prescribing Botox to patients they never see.
The Sunday Times has reported that doctors and nurses are running a lucrative sideline prescribing Botox remotely despite medical guidelines requiring them to see patients face to face.
An undercover reporter posing as a beautician found doctors and nurses willing to bend rules on prescribing. For £20 a time, online medics offered to prescribe the cosmetic anti-wrinkle drug to patients hundreds of miles away without ever seeing them in person.
Three told an undercover reporter they would sign off prescriptions without speaking to the person receiving the treatment, relying instead on consultations carried out by beauticians with no medical training. The practice leaves the system open to abuse and puts patients at risk, experts have warned.
The General Medical Council and Nursing and Midwifery Council said they were investigating cases, with the nursing regulator describing the findings as “deeply worrying”.
*MHRA – the Medicines and Healthcare products Regulatory Agency, which regulates medicines and medical/dental devices.
Original article can be found at:
https://dentaltechnician.org.uk/2021/10/18/gdcs-policy-on-illegal-manufacturing-revealed/
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