More than 12,000 pieces of counterfeit dental equipment have been seized in the U.K. in the past six months, and the Medicines and Healthcare Products Regulatory Agency is warning dentists about the danger of buying and using counterfeit and unapproved dental equipment.
The illegal products, ranging from drills to radiography systems, were counterfeit copies of major brands or substandard with fake documentation, according to the MHRA. Among the items seized were handpiece drills that could malfunction and disintegrate in patients' mouths, dental x-ray systems that emit high levels of radiation, and root canal files that could break. Other equipment included curing lights, air motors, air syringes, scalers, prophy powder and brushes, autoclaves, mixing tips, and amalgamators.
The equipment was imported into the U.K. from China and Pakistan, and sold on auction websites such as eBay, Amazon, and Alibaba in the past six months, the agency noted.
There was a real risk to patients from equipment that does not meet European safety standards, according to equipment safety officials.
Some products appeared to have official safety CE marks, but officials said it meant "Chinese export." The items were discovered during an investigation by the government agency that is responsible for ensuring that dental equipment meets safety standards.
"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 to dentists at cheap prices, both online and at dental trade fairs in China," the agency stated in a press release.
Alastair Jeffrey, the MHRA's head of enforcement, said in the release that there are risks associated in purchasing equipment from auction websites.
"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," Jeffrey said.
"The MHRA has seized large amounts of cheaply priced, counterfeit, and unapproved dental equipment," he continued. "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."
Tony Reed, the executive director of the British Dental Industry Association, said his organization will work closely with the MHRA.
"We are delighted to be working closely with the MHRA to raise awareness of counterfeit and noncompliant products through our Counterfeit and Substandard Instruments and Devices Initiative (CSIDI)."
Dentists risk prosecution if they knowingly buy equipment that put patients at risk, officials said.
The British Dental Trade Association is encouraging dentists to report suspect equipment.
