Handheld dental x-ray devices under investigation by FDA

SILVER SPRING, Md., USA: The Food and Drug Administration is advising dental professionals and veterinarians in the U.S. to stay away from handheld x-ray devices that are being offered by online sellers and shipped from abroad. At least one of these devices was recently found not to comply with safety standards and therefore to be potentially hazardous for dentists and patients, the organisation said.

FDA officials told Dental Tribune ONLINE that they are currently monitoring handheld dental x-ray units throughout the United States. Information about the device in question were recently send to the organisation by the Washington State Department of Health in Tumwater, Washington, which found during an inspection that a device purchased from a seller outside the country did not fulfill the FDA's x-ray performance standards.

The organisation said to have notified state regulators as well as dental and other health organisations about the potential health risks. Dentists will be also advised to verify whether the devices they are using have the required labelling and to contact state officials in case they are unsure if their device is safe.

The organisation refused to disclose further information about the extend of the problem or when and where these devices could have entered the country. However, Dental Tribune found that several devices produced in China and other countries are directly offered via internet to customers in the West including those in North America.

FDA-approved devices are currently available from a dozen manufacturers including Sigma, Digimed or Aribex. It's president and CFO Ken Kaufman welcomed the investigation while emphasising that these systems including the company's NOMAD unit have generally proven safe and effective.

"Clinician and patients safety have always been our number-one priority in developing and distributing our handheld x-ray device," he said. "We are dispappointed to learn that other manufacturers may not share a similiar perspective."

Aribex received FDA clearance for NOMAD in 2005. Since then, the company has been able to sell 8,000 pieces of its handheld system worldwide.

Research has found that radiation from handheld dental x-ray devices is below recommended levels and pose no greater risk that standard dental radiography like CT's.