Dental News - Handheld dental x-ray devices under investigation by FDA

Daniel Zimmermann, DTI

Thu. 16 February 2012

save

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.

To post a reply please login or register

Retainer usage under investigation

CLEVELAND, OH, USA: Little has been written about retainer usage and subsequent patient compliance. For this reason, Prof. Manish Valiathan, Assistant ...

Handheld X-ray device frees dentists to expand work with underserved patients

Anaheim, Calif., USA: An untended benefit seen by dental professionals across the world after they bring the Aribex NOMAD handheld X-ray device into their ...

NOMAD handheld X-ray verified safe for user, study shows

An independent study presented at the 41st Annual Conference on Radiation Control, held 18–21 May 2009, concluded that the NOMAD handheld dental X-ray...

Aribex CEO receives Utah Governor’s Medal for NOMAD Pro handheld X-ray

Recognitions continue to accumulate for the advances in radiography brought about by the NOMAD handheld X-ray system. On Jan. 19, D. Clark Turner, PhD, ...

CDA meeting offers products by the bay

SAN FRANCISCO, Calif, USA: As thousands of dentists, hygienists, assistants and technicians descend on the “City by the Bay” this week to attend...

2013 Greater New York Dental Meeting gets under way

NEW YORK, N.Y., USA: Every year right after Thanksgiving, dental professionals flock to the Big Apple from across the country and around the world to attend...

AAP comes to ‘City by the Bay’

NEW YORK, N.Y., USA: The American Academy of Periodontology will host its 100th anniversary annual meeting in San Francisco from Sept. 19 to 22. The ...

Midwinter Meeting gets under way in Chicago

CHICAGO, Ill., USA: As more than 30,000 dentists and dental professionals begin exploring all that the Chicago Dental Society’s 149th Midwinter ...

Yankee meeting in Boston gets under way

BOSTON, Mass., USA: More than 300 continuing education courses are being offered here at the 39th Yankee Dental Congress. According to meeting organizers, ...