FDA warns veterinarians about safety concerns with use of unapproved, foreign-labeled dental X-ray devices
The alert was issued after regulators became aware of the sale of some units from foreign sources over the Internet directly to U.S. customers. FDA reports these units may not be safe or effective and could expose both users and patients to unnecessary and potentially harmful X-rays.
FDA was tipped off to the sale of these units by the Washington State Department of Health after agency officials purchased one and subsequent tests revealed the device did not comply with X-ray performance standards.
The agency says it is now investigating the extent of the problem by notifying state regulators, veterinarians and dentists about the health risks involved with the use of the portable devices intended for dental X-ray examinations.
No adverse events have been reported to date.
Units that have been cleared by FDA will bear a permanent certification label/tag, a warning label and an identification (ID) label/tag on the unit, FDA reports. Use of these devices requires a prescription from a licensed practitioner, FDA adds.
When purchasing such equipment, FDA advises healthcare professionals to:
• 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; and
• contact their state regulatory agency if they become aware of a device that may be hazardous or does not meet FDA’s requirements.
Questions about this FDA alert may be directed to the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at firstname.lastname@example.org, or by calling (800) 638-2041 or (301) 796-7100.