Avoiding the dangers of counterfeit and non-compliant dental products

Dental professionals are in a distinct position within the wider healthcare sector in that purchasing and procurement is typically carried out at a much more local, independent level than what might be found within, for example, a typical hospital setting.

While this arrangement has many benefits, such as allowing a great degree of freedom regarding the specific products being used in any given practice, it also introduces particular challenges. Individual practices and clinicians will be faced with navigating a huge range of products and suppliers, and with this comes the risk of counterfeit or non-compliant products being supplied. 

The extent of the problem

Having worked closely with the Medicines and Healthcare products Regulatory Agency (MHRA) for many years, the British Dental Industry Association (BDIA) has seen an alarming number of uncertified or fake products making their way into dental practices and being used to treat patients.

We have seen MHRA seizures of a wide range of medical devices, from handpieces to curing lights, endodontic files, surgical instruments and ultrasonic scalers. Potentially dangerous non-compliant products continue to be available through online marketplaces despite not meeting the legal requirements for Great Britain, including restorative materials and even X-ray units.  

What are the risks?

The risk to patient safety should always be the primary concern when considering the dangers of illegally supplied devices. On top of this, purchasing and using non-compliant products can put your professional registration at risk.

The GDC’s own Standards for the Dental Team highlights the importance of regulation in a professional context – Standard 1.9.1 – You must find out about, and follow, laws and regulations affecting your work. This obligation places the onus on those purchasing items for their practice to be vigilant and to ensure that the products are compliant.

Non-compliant products, often supplied from sellers outside of the UK that have not been registered with the MHRA, haven’t followed UK regulations, which means that they may fail basic requirements for quality, safety and performance.

What can be done?

Before purchasing a device, make sure that you are undertaking appropriate checks and precautions:

• Only purchase from reputable suppliers, such as BDIA members
• Consider the price – if it looks too good to be true, it probably is
• Is the manufacturer registered with the MHRA? Try checking the MHRA’s registration database. If the manufacturer isn’t registered, the device is being supplied illegally
• Ask the manufacturer or supplier whether they can provide details of the device’s certification. 

If you encounter a device that you suspect could be counterfeit or non-compliant:

• Do not use the device – doing so could put your patients and your professional registration at risk
• Report the device to the MHRA using the Yellow Card reporting scheme.

The BDIA has developed a series of FAQ explainer documents aimed at the dental team looking at the dangers of counterfeit and non-compliant devices, importation requirements for medical devices and chairside manufacturing requirements, as well as a short video addressing key topics which can be accessed here.