Friday I received an Issue Alert from the ADA with this headline!
FDA Investigates Handheld dental x-ray Units
The ADA alert article does not name any products. However it is important to make it clear the Nomad is not the subject of this investigation. Nomad is FDA approved and has proven to be safe in numerous clinical studies. The actual FDA press release is here. The full text of the ADA alert is after the jump as well as the Nomad response.
Personally I am a big fan of the concept of hand held x-ray in general and the Nomad in particular. I have been telling people Nomad is safe for years, I even made a little video about it here. On the other hand there are some hand held devices that have not been proven to be safe. These are not approved for use in the US and it is these off brands that the ADA and the FDA are talking about.
Nomad is FDA Approved
|FDA investigates Handheld dental x-ray UnitsA press release issued by the U.S. Food and Drug Administration (FDA) warns dental and veterinary professionals to not purchase or use certain potentially unsafe hand-held dental X-ray units. According to the FDA, the units were sold online by manufacturers outside the United States and shipped directly to U.S. customers but the units have not been reviewed by the FDA and do not meet FDA radiation safety requirements.The FDA is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays.The FDA is investigating the extent of the problem and notifying state regulatory authorities, dental professional organizations and other health organizations about the safety risks. To date, no adverse events have been reported.A hand-held dental X-ray unit is a small, portable device that is intended for dental X-ray examinations. All units that have been cleared by the FDA bear a permanent certification label/tag, a warning label, and an identification (ID) label/tag on the unit. Use of these devices requires a prescription from a licensed practitioner.The FDA advises that you should verify when purchasing or using these devices that they have been reviewed and tested to meet FDA’s standards by doing the following:
The FDA will continue to monitor this problem and keep the public informed as new information becomes available.
Questions about this alert can be directed to the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
For more information:
This email has been distributed to all members of the American Dental Association.
OREM, UTAH—10 February 2012—Aribex®, Inc., the worldwide leader in handheld x-ray technologies, clarified that their Aribex NOMAD handheld x-ray devices are legal and not the subject of an investigation announced today by the U.S. Food and Drug Administration (FDA).
The FDA investigation involves the illegal online sales of handheld dental and veterinary x-ray units by manufacturers outside the United States. Aribex stressed that the NOMAD, which is manufactured in the United States, is proven safe, FDA-cleared, and approved for use in almost all states. Aribex officials said the company continues to have a positive working relationship with the FDA along with other state and local radiation safety officials.
“Clinician and patient safety has always been our number-one priority in developing and distributing our handheld x-ray device,” said Ken Kaufman, Aribex President and CFO, “and we are disappointed to learn that other manufacturers may not share a similar perspective. Just as the FDA fulfills its responsibilities, Aribex is equally committed to its role as the pioneer of safe and effective, battery-powered, handheld x-ray systems.
“We support the FDA in their efforts to warn and protect, and we follow their message with one of our own: we ask dentists, hygienists, veterinarians and other certified radiation operators to understand that rapidly changing technology has made it possible for handheld x-ray systems to be both safe and effective. Not only is the NOMAD safe, patients and users have found that it improves their imaging experience.”
Aribex affirmed that each of their x-ray products meets FDA requirements, including FDA 510(K) clearance and labeling. Company officials said that numerous studies and evaluations have found the NOMAD to be safe, including the Washington State Department of Health study referenced by the FDA in today’s news release. Aribex maintains that their NOMAD systems are superior in their shielding and cone design characteristics when compared to any other intraoral dental x-ray system.
In response to challenges this may cause for U.S. dental and veterinary practices, Aribex is offering a $200 trade-up rebate on the purchase of a NOMAD to replace an illegal device. For more information on this rebate, affected practitioners should contact Aribex at 866-340-5522 or visit www.aribex.com.