February 13, 2012
Silver Spring, Md.—A Food and Drug Administration safety communication advises dental and veterinary professionals to avoid buying or using certain hand-held dental X-ray units.
“The FDA is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays,” says the notice posted Feb. 10 at the FDA Website. “The units, sold online by manufacturers outside the United States and directly shipped to U.S. customers, have not been reviewed by the FDA and do not meet FDA radiation safety requirements.”
The FDA is notifying state regulatory agencies and dental and other health professional organizations about the safety risks but says that no adverse events have been reported to the FDA as of the posting date.
A hand-held dental X-ray unit is a small, portable device intended for dental X-ray examinations, the notice said. All units that have been cleared by the FDA for marketing bear a permanent certification label/tag, a warning label and an identification label/tag on the unit. Use of these devices requires a prescription from a licensed practitioner.
“Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA's standards,” said Steve Silverman, director of the Office of Compliance in FDA's Center for Devices and Radiological Health. To ensure this, the FDA advises that users:
- Verify the presence of required labels on the device.
- Ask vendors whether the device has been reviewed and cleared by the FDA.
- Access the FDA Medical Device Approvals and Clearances searchable database to verify that the X-ray unit has been cleared by the FDA.
- Contact their state regulatory agency if they become aware of a device that may be hazardous or does not meet the FDA's requirements.
The Washington State Department of Health alerted the FDA after tests on a device purchased online revealed it did not comply with X-ray performance standards. FDA is investigating and will continue to monitor the problem.
Questions can be directed to the Division of Small Manufacturers, International and Consumer Assistance at DSMICA@FDA.HHS.GOV, 1-800-638-2041 or 1-301-796-7100.