March 15, 2012
The Food and Drug Administration is warning health professionals not to use certain potentially unsafe hand-held dental x-ray units from outside the United States.
The FDA is aware of hand-held dental x-ray units that have not been reviewed by the agency being sold online by foreign manufacturers for direct shipment to U.S. customers. The FDA stated that these devices might not be safe or effective and could expose the user and patient to unnecessary and potentially harmful radiation.
The Washington State Department of Health alerted the FDA after tests on such a device revealed it did not comply with x-ray performance standards.
As a result, the FDA is investigating the extent of the problem. To date, no adverse events have been reported in connection with the problem.
Hand-held dental x-ray units that have been cleared by the FDA bear a permanent certification label or tag, a warning label, and an identification label or tag. The agency maintains searchable databases of device approvals and clearances at www.fda.gov/MedicalDevices under "Products and Medical Procedures," then "Device Approvals and Clearances."
Health professionals should contact their state radiation control program if they become aware of a hand-held dental x-ray unit that could be hazardous or does not meet FDA requirements. The Conference of Radiation Control Program Directors lists contacts for each state at www.crcpd.org/Map/RCPmap.htm.