Mina Mahdian1, Andrew J Pakchoian2, Didem Dagdeviren3, Adel Alzahrani4, Elnaz Jalali5, Aditya Tadinada6, Alan Lurie7. 1. Dr. Mahdian is an oral and maxillofacial radiology resident, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington. 2. Dr. Pakchoian is an oral and maxillofacial radiology resident, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington. 3. Dr. Dagdeviren is an oral and maxillofacial radiology resident, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington. 4. Dr. Alzahrani is an oral and maxillofacial radiology resident, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington. 5. Dr. Jalali is an oral and maxillofacial radiology resident, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington. 6. Dr. Tadinada is an assistant professor, Department of Oral Health and Diagnostic Sciences, University of Connecticut School of Dental Medicine, Farmington. 7. 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.
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 AND PRACTICAL IMPLICATIONS: 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.
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 AND PRACTICAL IMPLICATIONS: 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.
Entities:
Keywords:
U.S. Food and Drug Administration; dental clinics; dental technology; hand-held unit; x-ray
Authors: Dennis Rottke; Lisa Gohlke; Robert Schrödel; Stefan Hassfeld; Dirk Schulze Journal: Dentomaxillofac Radiol Date: 2018-02-07 Impact factor: 2.419