title: Using hand-held dental x-ray devices: ensuring safety for patients and operators.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Dr. Mahdian is an oral and maxillofacial radiology resident, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington.
authors.forename: Mina
authors.initials: M
authors.lastname: Mahdian
authors.affiliation: Dr. Pakchoian is an oral and maxillofacial radiology resident, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Pakchoian
authors.affiliation: Dr. Dagdeviren is an oral and maxillofacial radiology resident, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington.
authors.forename: Didem
authors.initials: D
authors.lastname: Dagdeviren
authors.affiliation: Dr. Alzahrani is an oral and maxillofacial radiology resident, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington.
authors.forename: Adel
authors.initials: A
authors.lastname: Alzahrani
authors.affiliation: Dr. Jalali is an oral and maxillofacial radiology resident, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington.
authors.forename: Elnaz
authors.initials: E
authors.lastname: Jalali
authors.affiliation: Dr. Tadinada is an assistant professor, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington.
authors.forename: Aditya
authors.initials: A
authors.lastname: Tadinada
authors.affiliation: Dr. Lurie is a professor, Department of Oral Health and Diagnostic Sciences, the chair, Division of Oral and Maxillofacial Diagnostic Sciences, and the chair, Section of Oral and Maxillofacial Radiology, University of Connecticut School of Dental Medicine, 263 Farmington Ave., Farmington, Conn. 06030, e-mail lurie@nso.uchc.edu. Address correspondence to Dr. Lurie.
authors.forename: Alan
authors.initials: A
authors.lastname: Lurie
mesh_terms: D018795:Device Approval; D004867:Equipment Design; D006801:Humans; D016273:Occupational Exposure / Q000032:analysis*; D061214:Patient Safety; D011829:Radiation Dosage; D011834:Radiation Monitoring; D011861:Radiography, Dental / Q000295:instrumentation*; D012542:Scattering, Radiation; D014481:United States; D014486:United States Food and Drug Administration
keywords: U.S. Food and Drug Administration; dental clinics; dental technology; hand-held unit; x-ray