MHRA warning on bogus dental equipment

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 have been seized by the Medicines and Healthcare products Regulatory Agency (MHRA) in the past six months.

The regulatory agency is warning dentists about the potential danger of buying and using counterfeit and unapproved dental equipment. It has six ongoing investigations involving the purchase of dental 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 on use. About 40 per cent of the equipment is counterfeit and 60 per cent non-compliant with European medical device regulations.

The MHRA is concerned about the growing range of dental equipment being advertised to dentists at cheap prices, both online and at dental trade fairs in China but there is no evidence to suggest that buying equipment from auction websites is a widespread or deliberate practice among UK dentists.

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 the 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."

Contact the MHRA Adverse Incident Centre at aic@mhra.gsi.gov.uk or on 020 3080 7080.

Link

Medical Device Alert: Counterfeit or non-CE marked dental medical devices