Medicines and Healthcare products Regulatory Agency issues alert following seizure of 12,000 unapproved dental devices
Dentists are being warned about the potential dangers of buying and using counterfeit and unapproved dental equipment following the seizure of 12,000 poor-quality devices imported to the UK from China and Pakistan.
The equipment has been sold on auction websites such as eBay, Amazon and Alibaba over the past six months and has provoked a warning from the Medicines and Healthcare products Regulatory Agency (MHRA).
The UK regulator for medical devices and medicines has six ongoing investigations involving the purchase of counterfeit equipment such as high-speed hand-piece drills from auction websites by UK dentists. The seized items include 24 dental X-ray machines that emit high levels of radiation; 384 hand-piece drills that could malfunction and disintegrate inside patient’s mouths; and 3,242 poor-quality root canal files that could break. About 40% are counterfeit and 60% are non-compliant with European medical device regulations.
While there is no evidence to suggest that buying equipment from auction websites is a widespread or deliberate practice among dentists, the MHRA is concerned about the growing range of dental equipment that is being advertised at cheap prices, both online and at dental trade fairs in China.
The MHRA issued a safety alert to all dentistry professionals in January this year 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 aims to raise awareness among dentistry professionals so that other patients are not put at risk.
Purchasing from auction websites and being unable to verify the integrity of the seller has the potential to increase risks to patients and cause reputational damage to the dental profession
Alastair Jeffrey, the MHRA's head of enforcement, said: "Dentists must source their dental equipment from reputable suppliers. Purchasing from auction websites and being unable to verify the integrity of the seller has the potential to increase risks to patients and cause reputational damage to the dental profession.
“The MHRA has seized large amounts of cheaply-priced, counterfeit and unapproved dental equipment. This equipment looks like the genuine product, and often has false CE approval markings, but it is potentially dangerous to patients and the dental staff using it.
“We are working with the British Dental Industry Association, the British Dental Association, eBay, Amazon, and other auction websites to tackle this problem and remove advertisements for this equipment. Dentists or members of the public can contact the MHRA if they suspect that they may have information about counterfeit or unapproved dental equipment through our Adverse Incident Centre by emailing firstname.lastname@example.org or 020 3080 7080.”
Dr Barry Cockcroft, NHS England’s chief dental officer, added: “This is important work by the MHRA. It is imperative for patient safety that dentists do not purchase equipment, from any source where they cannot be confident of the origin or quality.”