From Volume 43, Issue 4, May 2016 | Pages 307-312
The Medicines and Healthcare products Regulatory Agency (MHRA) is dealing with a growing number of counterfeit and non-compliant dental devices and instruments for sale to dental practices in the UK. This paper examines the extent of the issue, the dangers posed by the use of counterfeit and non-compliant products, discusses initiatives to address the problem and how the dental team can identify these products and mitigate the associated risks.
The dental industry has become increasingly concerned with the significant growth in the number of counterfeit and non-compliant dental devices reported to, and seized by, the Medicines and Healthcare products Regulatory Agency (MHRA), a trend that has been gathering momentum in recent years, especially due to the growth of internet sellers.
In this regard, in October 2014 the MHRA released information stating that they had seized ‘over 12,000 different pieces of poor quality dental equipment imported into the UK from China and Pakistan and sold on auction websites such as eBay, Amazon and Alibaba.'1 This included 24 dental x-ray machines that emitted high levels of radiation, 384 handpieces that had the potential to malfunction and disintegrate inside a patient's mouth and 3,242 poor quality root canal files that could easily break in use. These findings are summarized in Table 1.
| Type of Dental Device | Numbers Seized |
|---|---|
| Total devices | 12,122 |
| Handpieces | 384 |
| X-ray machines | 24 |
| Curing lights | 683 |
| Endodontic files and burs | 3,342 |
| Air motors | 37 |
| Air prophy units | 14 |
| Class 1 - including various hand instruments, intra-oral tips, amalgamators, prophy brushes, face masks | 7,638 |
It is particularly concerning that counterfeit dental devices are growing in sophistication, appearing to have the appropriate CE marks, bar codes, serial numbers and holographic labels. In addition, the documentation can be expertly forged to be indistinguishable to the untrained eye. Examples of the extensive range of counterfeit and non-compliant products seized by the MHRA are shown in Figure 1.
Between April 2014 and October 2015, the MHRA closed 138 websites which were selling non-compliant or counterfeit devices destined for dental surgeries advertised at cheap prices, far undercutting those of genuine manufacturers' products. Subsequent testing demonstrated that devices purchased in this manner were unsafe and a danger to patient and practitioner safety.2
In response to this growing problem the British Dental Industry Association (BDIA) launched its Counterfeit and Sub-standard Instruments and Devices Initiative (CSIDI) in 2014. The initiative actively promotes awareness of the dangers of poor quality, counterfeit and illegal dental instruments and devices, particularly through the dental press (Figure 2), provides a quick and simple method of reporting incidents to the relevant bodies through www.bdia.org.uk/devicereporting and recommends purchasing only from reputable manufacturers and suppliers. At the time of the launch of CSIDI, Tony Reed, BDIA Executive Director, advised: ‘By purchasing only from reputable suppliers the end user can be assured of a high quality product that meets all the necessary requirements and that will not endanger the user or the patient, nor risk punitive actions from the courts or regulatory bodies.'3
Counterfeit dental products lack the necessary conformity assessments and fall outside the scrutiny and recognized quality systems relevant to the UK market, posing a risk to the user and patients. To place a medical device on the UK and European market legally, a manufacturer must satisfy the Competent Authority that the relevant device meets the essential requirements of The Medical Devices Directive (MDD).4 This is achieved by:
All this provides the purchaser and end user with the confidence that the device has been put through the essential requirements and is of sufficient quality and safe to use. The General Dental Council (GDC) publication Standards for Dental Professionals states that dental professionals are required to: ‘Find out about laws and regulations which affect your work, premises, equipment and business.'5 Logically, this would extend to the principles of the MDD.
Counterfeit and non-compliant dental devices not only risk the health and wellbeing of patients and users, but the use of such products can put a dentist's registration at risk, as illustrated by the GDC Professional Conduct Hearing of 18.01.20166 which saw an immediate order of conditions imposed on a registrant for the purchasing and the permitting of the use of counterfeit handpieces.
This hearing also highlighted the physical risk to patients arising from the use of counterfeit devices, remarking that these included: ‘penetrating wounds created by high speed particles from the disintegrating handpiece, surface stripping or abrading of tissue and risk of infection from the penetration of small fragments'.
The MHRA issued a safety alert to all dental professionals in January 2014,7 following an incident in November 2013 when a counterfeit product for ‘drilling and cleaning’ teeth shattered while being used on a patient. The patient was unharmed but the MHRA felt the danger to be significant and determined that it should aim to raise awareness among dentistry professionals so that other patients are not put at risk.
Intelligence sources at the MHRA cite the most dangerous dental counterfeit products as fake branded handpieces and curing lights. The dangers here are quite clear: the possibility of a handpiece bearing or structural failure causing harm to patient and user, and risks of unstable and ineffectual curing and electric shock from non-CE marked mains chargers for counterfeit curing lights. Whilst counterfeit goods remain a major concern, non-conforming, non-CE marked curing lights have also been seized, as illustrated in Figure 3.
The MHRA has also seized fake hand-held X-ray machines which emit dangerous levels of radiation, especially to the dental care professional operating them, and are an extreme risk of electric shock. However, counterfeit and non-compliant dental devices range from items such as burs and instruments to endodontic probes, impression materials and trays, amalgamators, air prophy units, intra-oral cameras and syringes. Table 2 categorizes the main risks.
| Device Type | Potential Problem/Faults | Potential Risk |
|---|---|---|
| Handpiece | Excessive vibration |
Ineffective in use Patient injury |
| Curing light | Incorrect light emission |
Electric shock (charger) |
| Bur | Failure in use |
Ineffective in use Patient injury - swallowing or inhaling fragments |
| Endodontic file | Failure in use Ineffective action | Ineffective in use Patient injury |
| X-ray devices | Exposure to radiation |
Ineffective in use Patient injury |
There are two main ways that the dental profession can mitigate the risks of purchasing and using counterfeit and non-compliant devices:
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 also be systems in place to ensure that equipment is genuine, compliant and safe to use.
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 they should carry out appropriate checks to ensure the products they are purchasing or commissioning are legitimate.'8
To mitigate the risk of counterfeit and non-compliant devices at the purchasing stage, the British Dental Industry Association (BDIA) recommends that all purchases, however small, are made from a reputable supplier. This advice is echoed by the British Dental Association (BDA) with Dr Mick Armstrong, Chair of the BDA Principal Executive Committee, advising that, ‘The BDA encourages all dentists to source equipment from legitimate, reputable manufacturers and suppliers who can demonstrate that the necessary legal requirements are being met. That will ensure both the quality of equipment purchased, and that dentists, their colleagues and patients are protected.'9
The price of a product advertised for sale is a strong indication as to its authenticity or otherwise. Reputable manufacturers invest heavily in research and development, training, and high quality materials, an outlay which is reflected in the price. A deal which vastly undercuts the usual retail price should be treated with caution, at the very least. When considering purchasing any dental product through an unproven web supplier, the onus is on the buyer to make the necessary checks. Products from reputable suppliers have serial numbers and can be tracked, so a call to the manufacturer before purchase, to check out whether they do, indeed, sell their products through a certain channel, or whether an offer is genuine, is strongly recommended. Alex Breitenbach, Managing Director of NSK United Kingdom Ltd, advises: ‘Where you buy from, and the price that is charged, should be your first clue as to a fake. Once the product is in your hand it's already too late to wonder whether it's not what it seems.'
Bruce Petrie, Investigation Team Leader at the MHRA, advised the authors that, ‘Recognizing a fake just by looking at it is very hard. The time to suspect that an item is counterfeit or substandard is before you even purchase it. Check the chain of supply and look where the product has come from. Websites can look very convincing but major manufacturers do not sell their products on eBay. Caveat emptor is entirely applicable here.'
Once a product has been purchased, however, recognizing non-compliant or counterfeit goods is not always straightforward. Counterfeiters are growing increasingly sophisticated, expertly forging not only packaging and documentation, but also CE marks, holographic labels and barcodes. It may only be when the product fails in use that the deception becomes apparent.
Bruce Petrie, Investigation Team Leader at the MHRA, has seen some shocking examples of items which not only break down almost immediately, but are liable to fail in the patient's mouth. One batch of X-ray equipment seized by the MHRA was found to use cheap kitchen foil instead of lead in order to block radiation. The advertisement for this product is shown in Figure 4. Electric devices may also have faulty connections or wiring, which risk causing electric shock. Curing lights bought ‘on the cheap’ have been found to contain simply a blue bulb, generally harmless, but certainly ineffective. Cheap alloys used in handpieces or other equipment bend or break after a few uses, or fail to withstand the sterilizing process, and counterfeit or non-compliant burs have been known to shatter at high speeds, putting the patient at risk of either swallowing or inhaling fragments and the dentist at risk of adverse medicolegal circumstances. Not only patients but also operators are endangered, which is particularly so for members of the dental team using radiographic equipment which does not meet the necessary standards.
However, there are a number of possible questions the dentist can consider to help identify equipment which is suspected as fake or substandard:
A growing number of products are returned to dental manufacturers with complaints about their performance or quality, yet turn out to be copies. Items such as handpieces, which are especially widely counterfeited, are high quality instruments developed by specialist manufacturers for professionals to use. The power and speed of such a device makes it critical that it is produced using high quality materials and to a consistently high standard for durability and longevity, otherwise the safety of the dental team and the patient is compromised.
Sonia Tracey, Managing Director of the handpiece manufacturer W & H UK Ltd (St Albans, UK) comments on the counterfeit issue to the authors, stating: ‘We use serial numbers and unique data matrix coding on each item, so can trace our products; dentists knowingly using illegal, non-compliant products risk both their patients' safety and their own professional registration.' Richard Muller, Managing Director of Prima Dental Group, (Gloucester, UK) specialist dental bur manufacturer, explained some of the steps his company was taking to combat the counterfeiting trade. The branding now features layers of different colours in geometric shapes, which is more difficult to forge than a single colour, and the CE marking and details of the Notified Body are displayed prominently, so that they can be verified immediately.
The MHRA is working not only with the BDIA and its members but also with websites such as Amazon and eBay to clamp down on these imports. A spokesman for eBay said that its sellers must comply with the law and the company's own policies, adding: ‘eBay has made significant investment in technology, people and systems to improve both our own investigations and our responsiveness to concerns raised by regulators in line with our commitment to ensuring we are the most trusted way to shop.'10
The counterfeit trade is continually coming up with new ways to copy dental products and their authentication, and the ultimate responsibility is on the practitioner and/or those who order dental materials and devices to be vigilant. Knowingly purchasing and using counterfeit or substandard equipment violates the GDC Standards for Dental Professionals and risks loss of registration or, as in the recent case heard by the GDC, could result in the imposition of conditions placed on a registrant.
The key message must be to buy only from reputable suppliers and know where the product is coming from. A bargain may turn out to be very costly, either in terms of staff and patient safety, or the dental professional's reputation. If you find a product that is substandard or counterfeit, it should be reported promptly. This can be done through the MHRA Yellow Card Scheme (Figure 7) which can be accessed via the CSIDI section on the BDIA website: www.bdia.org.uk. The old adage applies: ‘If the price is too good to be true – it probably is.'
