February 10, 2012
FDA probes illegal sale of handheld dental X-ray devices
By: Jennifer Fiala
For The VIN News Service
Handheld dental X-ray units that do not bear the U.S. Food and Drug Administration’s (FDA) seal of approval could be emitting dangerous levels of radiation, especially if they are purchased online from overseas manufacturers or distributors.
Photo courtesy of Dr. Jan Bellows
Handheld dental X-ray equipment approved by the FDA must bear a seal of approval. The label featured above appears on a handheld unit owned by Dr. Jan Bellows, a veterinary dentist in Weston, Fla. The FDA did not immediately confirm that this is the type of label required to denote the agency's approval, nor did it provide an example of one to the VIN News Service.
The FDA issued that warning today to veterinarians and dentists — medical professionals most likely to purchase and use the small, portable devices intended for dental X-ray examinations.
The FDA is investigating problems with handheld X-ray devices after the Washington State Department of Health alerted the agency that tests on a device purchased online did not meet the FDA’s performance standards. FDA officials did not name manufacturers or distributors implicated in its investigation but shared concerns that unregulated devices could expose patients to potentially harmful X-rays.
“The units, sold online by manufacturers outside the United States and directly shipped to U.S. customers, have not been reviewed by the FDA and do not meet FDA radiation safety requirements,” the FDA said in a news release. “… To date, no adverse events have been reported.”
All units that have been cleared by the FDA bear a permanent certification label, warning label and identification tag, the agency said. “Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet the FDA’s standards,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health, in the FDA news release.
The FDA recommends that users:
- 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 FDA has cleared an X-ray unit.
- Contact their state regulatory agency if they become aware of a device that may be hazardous or does not meet the FDA’s requirements.
Dr. Jan Bellows is one of 114 board-certified veterinary dentists and practices in Weston, Fla. He estimates that 20 to 30 percent of veterinary practices do intraoral radiology, the vast majority using stationary units.
Of those with handheld devices, he puts the number at 1 percent. “It’s not very common,” Bellows asserted, noting that he has three handheld units in his practice.
Just one bears the FDA logo on its label, he said. The two units without the FDA logo are Nomads, a brand of handheld X-ray equipment that widely is used in human dentistry and manufactured by Utah-based Aribex, Inc., Bellows said.
Photo courtesy of Aribex, Inc.
Labels on the Nomad Pro, a popular handheld X-ray device manufactured by Aribex, Inc., do not include the FDA's logo. According to Abexis officials, regulatory approval is outlined at the bottom of the label where it states that the Nomad Pro is "designed and manufactured" in conformance with International Electrotechnical Commission (IEC) standards.
According to FDA documents, regulators deemed Nomad portable X-ray systems to be "safe and effective." The agency did not provide the VIN News Service with an example of how its approval should appear on labels affixed to X-ray equipment.
Ken Kaufman, president of Aribex, said that the company's equipment comes with the appropriate label, which states in fine print that each unit is compliant with federal regulations. "When devices leave our facility they are labeled according to FDA requirements," he said. "It is part of our inspection process."
When asked what veterinarians should do in cases where the devices they use do not bear labels, the FDA relayed that it is the responsibility of each manufacturer to include FDA labels on their units if they're approved by the agency.
For veterinarians, “the bottom line is to follow the suggestions laid out in the (news release) to make sure the device purchased and used is FDA-cleared,” a FDA media official said.
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