Abstract
Since the introduction of hand-held x-ray units in dentistry, a few inexpensive devices have emerged that lack the necessary safety measures and failed to meet U.S. Food and Drug Administration (FDA) standards. They are advertised actively and sold online in the United States.
The authors present several safety issues associated with an imported hand-held x-ray device that has not been cleared by the FDA and compare the device with an FDA-cleared unit.
The authors found that the non-FDA-cleared device posed major safety hazards, including high radiation doses to patients and operators, lack of operator shielding, lower-than-acceptable kilovolt (peak) value, inadequate collimation, lack of an audible signal of x-ray generation and absence of a so-called dead-man switch.
Dental professionals must be aware of unsafe x-ray equipment and use only those devices that have been cleared by the FDA to protect themselves and their patients.