Understanding, common sense and diligence
NewsPosted by: Dental Design 21st June 2019
Edmund Proffitt, Chief Executive of the BDIA, on why there really shouldn’t be any sales of counterfeit and non-compliant dental equipment.
The British Dental Industry Association (BDIA) has been running its Counterfeit and Substandard Instruments and Devices Initiative (CSIDI) awareness campaign highlighting the dangers of fake and non-complaint dental equipment for five years now. In that time, over 40,000 illegal dental items have been seized by the authorities, two related GDC fitness to practise investigations have taken place and, thankfully, the awareness of the issue and dangers have become much more ‘mainstream’. However, the government regulator for medicines and dental and medical devices, the Medicines and Healthcare products Regulatory Agency (MHRA), reported 230 ‘incidents’ relating to counterfeit and non-compliant dental products last year, and dental equipment remains high-up on the official government ‘watch list’ of potentially dangerous fake medical devices.
In conversation with dental colleagues there now appears to now be a far greater general awareness of the dangers of purchasing counterfeit and non-compliant dental equipment and a recognition that the GDC will not hesitate to take action against those found to be using such equipment. One would hope that with greater recognition comes greater vigilance and a greater realisation that ‘too good to be true’ deals for dental equipment on the internet are just that, and the purchase and use of such devices is potentially going to end badly.
There is a very broad range of legitimate and bona fide suppliers of dental equipment in the UK, including 125 BDIA members, and common sense alone should play a great part in avoiding purchasing dental devices to be used on patients from unknown, unproven and untrusted sources and websites. The dental press, company websites and trade shows are full of plenty of legitimate suppliers offering equipment at price points suiting all professionals. There really is no reason to move into the territory of unfamiliar and potentially dangerous purchasing decisions, and in the eyes of the regulator, no excuse. Common sense and due diligence must be shown, and the GDC, BDA and BDIA recommend that all equipment should be sourced from reputable suppliers.
Counterfeit medicines, and, to a lesser extent, medical devices, are rife on the internet and targeted at vulnerable, ill and concerned members of the public. STI and HIV self-test kits, slimming pills, erectile dysfunction medicines and dermal fillers all top the MHRA’s watch list, and it is possible to understand why. However, there is no justification why counterfeit and fake dental handpieces, curing lights, x-ray machines and endodontic files should also be near the top of the MHRA watch list. These are not being illegally imported for anxious members of the public who are suffering pain to buy online to perform DIY dentistry on themselves – they are being imported, and seized, because GDC registered professionals are continuing to purchase them for use on unsuspecting patients!
Whilst there is evidence that there is a far greater recognition of the dangers of this equipment, significant time and effort from the MHRA, UK Border Force, HMRC and police forces is expended on searching for and seizing these goods destined for the hands of professionals, who are willing to take the risk and buy dangerous and fake products on line. At this point it is worth reminding ourselves that the GDC advises that: “Registrants should be mindful that counterfeit equipment can look like a genuine product and even carry ‘CE approval’ markings, but can be potentially dangerous to patients and dental staff using them and that they should carry out appropriate checks to ensure the products they are purchasing or commissioning are legitimate”.
There are two main ways that dental professionals can mitigate the risks of purchasing and using counterfeit and non-compliant devices. These are in the purchasing process, and later, by identifying suspect products that may be encountered in practice.
When considering the purchase of dental equipment, the person responsible for purchasing should be aware of risks of counterfeit and non-compliant devices and exercise not only common sense and care, but there should be systems in place to ensure that equipment is genuine, compliant and safe to use. This is where there is no substitute for ‘understanding, common sense and diligence’.
When purchasing or handling new dental equipment it is always worth considering a few simple points. Did you or the purchaser pay a price that was drastically out of line with the normal price for the product? Was it purchased from an internet dealer or supplier that you didn’t know? Can you compare it with a similar product you know to be genuine – check the weight – copies made with cheap alloy are often much lighter. Check the ‘finish’ – there may be rough edges or poor-quality laser etching. Check the company and product name and logo – are they exactly as they should be? Copies may have small but important differences, or even mistakes.
If appropriate, check the charging/power plug – it must be supplied with a UK plug, not a Chinese or European plug with adapter – otherwise it is non-compliant. Always look for and at the CE mark – there usually is one, but can you be sure it is genuine, or even the correct one? The Notified Body who issues the CE mark can be contacted to confirm compliance and if there is any doubt a list of legitimate Notified Bodies is available on the BDIA counterfeits website (www.bdia.org.uk). Check the paperwork – if it is in a huge number of languages, including Chinese, this can be a clue that it is a copy, as devices will also generally need instructions in English. If there is any doubt over the equipment you can always contact the manufacturer and genuine products can be tracked back through the supply chain to confirm authenticity.
Five years into the industry’s CSIDI programme we are pleased that the awareness of the dangers of counterfeit and non-compliant products has dramatically increased in the practice. If, going forwards, the whole dental team can work with suppliers and apply ‘understanding, common sense and diligence’ there is no reason why there shouldn’t be any purchasing of counterfeit and non-compliant dental equipment at all in the future.
About the author
Edmund Proffitt, Chief Executive of the BDIA.
