Counterfeit and non-compliant dental devices: the dangers and how to mitigate them

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.

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.