DT News - UK - Interview: "Any non-compliant or counterfeit medical device is a risk to public safety"

Dental Tribune International

Tue. 20 October 2015

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In response to an increase in counterfeit and unapproved dental products seized in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) launched an initiative in partnership with the British Dental Industry Association (BDIA) last year to make dental professionals aware of the dangers these products can pose to their own and their patient’s safety. Dental Tribune had the opportunity to speak with investigator Maxine Marshall, who will discuss the dangers of buying dental equipment online during her mini-lecture programm this week at the Dental Showcase in Birmingham, about the outcome and what needs to be done to ensure the removal of these products from the market.

Dental Tribune: Last year saw a worrying number of counterfeit or unapproved dental goods being seized in the UK. Were the majority of these products purchased online?
Maxine Marshall: Most of them were. In 2013/2014, we seized about 12,000 individual pieces of dental equipment, with the majority being curing lights, dental handpieces, files, pliers and other equipment that dentists use. That was quite a large seizure for that year.

What is the estimated number of unknown cases?
Unfortunately, we do not know and this is one of reasons that we are continuing our work with the BDIA. This year, our main focus is to communicate to health professionals that they need to come to us. If there is an incident with the equipment purchased or if they think it is not what they had bought, instead of disposing of it, they should submit a report.

Any non-compliant or counterfeit medical device is a risk to public safety or patient safety. Our main objective is to try to stop such products coming into the UK at the port of entry, but we can only do that if we can trace the product back to the source from which it was purchased.

Purchases of critical devices can be made through various channels nowadays. What are the ones to be the most cautious of and what product categories are the most sought after?
Online purchases are made mainly through eBay or Google. There, one can simply search for handpieces or curing lights, for example, and from there be taken to the respective websites. The majority of the devices that we seize in the UK come from China via the ports and quite often through fulfilment houses. Of most concern are dental handpieces, especially those that run at very high speeds. If something happens in the patient’s mouth when using such a device, it can be quite nasty.

Together with the BDIA, you launched the Counterfeit and substandard Instruments and Devices Initiative last year to heighten awareness of these products among dental professionals. Have these efforts paid off in your opinion?
From 2014 to 2015, we have actually seen a reduction in the number of investigations we conducted. Our latest figures are from four weeks ago. We hope that much of it has to do with the work that we are doing with the BDIA.

On top of that, the MHRA, General Dental Council and NHS England have formed a working group over the last 12 months and they regularly discuss the issue of dental equipment. All these organisations have also sent out messages to all health professionals through publications and general lines of communication to raise dentists’ awareness of the importance of buying from reputable sources.

Would you say that awareness among dental professionals has generally improved?
We hope it has, considering the amount of work we have put into this. This matter is something we want to focus on at the BDIA Dental Showcase. One of the things we need to do is to talk to dentists at our stand and ask them if they have seen anything we put out on this issue. Hopefully from that, we will receive positive feedback. I do believe the message is getting out there, if not initially to everyone, but we are getting there.

Thank you very much for the interview.

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