It was recently brought to our attention that the FDA is investigating illegal online sales of handheld dental X-ray units by manufacturers outside the U. S. These units, which have not been reviewed by the FDA and don’t meet FDA radiation safety requirements, have been shipped directly to U.S. customers. It’s bad enough that something like this has occurred; however, it’s occurring during National Pet Dental Health Month seems to make matters worse. Dr. Patricia Wohlferth-Bethke, myself, and others here at the AVMA are working to get the word out to the veterinary community about this problem.
To make sure your equipment is safe and not one with which the FDA is concerned, please read the Agency’s press release, “FDA investigating illegal online sale of handheld dental X-ray units,” and alert, “FDA Safety Communication: Illegal Sale of Potentially Unsafe Hand-held Dental X-Ray Units,” both of which were announced Friday, February 10, 2012. The alert provides key information for veterinarians and human health care providers who have purchased or are considering purchasing a hand-held dental X-ray unit. In the alert, the FDA recommends that “if you become aware of a device that you think is hazardous or does not meet FDA’s radiation safety or premarket clearance requirements, contact your state regulatory agency, which will then notify the FDA. The Conference of Radiation Control Program Directors (CRCPD)website has a list of contacts for each state.”