FDA Issues Guidance For Dental Cone-Beam CT Scans

The U.S. Food and Drug Administration (FDA) just issued new guidance for dental cone-beam CT scans.

Cone-beam computed tomography systems (CBCT) are a variation of traditional computed tomography (CT) systems. The CBCT systems are used by dental professionals and rotate around the patient. These systems capture data via a cone-shaped X-ray beam. Data then reconstruct a three-dimensional (3D) image of the patient’s dental area (teeth); oral and maxillofacial region (mouth, jaw, and neck); and ears, nose, and throat (ENT).

CBCT systems have been sold in the U.S. since the early 2000s, and use of these systems is on the rise by radiologists and dental professionals. Used for dental implant planning; visualization of abnormal teeth; evaluation of the jaws and face; cleft palate assessment; and dental caries (cavities), endodontic (root canal), and dental trauma diagnoses, the systems provide a fast, non-invasive method to answer various clinical questions. CBCT images provide 3-D, rather than the traditional 2-D information provided by conventional X-ray.

The new FDA guidance also involves the creation of a new Web page meant to provide clinicians and patients with the most current information on the health and safety of CBCT, explained DrBicuspid.com. According to an FDA spokesman, the “Dental Cone-beam Computed Tomography” web page is new to the Radiation-Emitting Products site. The site will also enable clinicians, patents, and patients to view industry accurate information that will help ensure CBCTs are performed when appropriate and “optimized.” To be optimized means that the exposure settings chosen are based on the “As Low As Reasonably Achievable” (ALARA) principle, said DrBicuspid.com.

“Although the radiation doses from dental CBCT exams are generally lower than other CT exams, dental CBCT exams typically deliver more radiation than conventional dental x-ray exams,” the FDA states on its new web page. “Concerns about radiation exposure are greater for younger patients because they are more sensitive to radiation (i.e., estimates of their lifetime risk for cancer incidence and mortality per unit dose of ionizing radiation are higher) and they have a longer lifetime for ill effects to develop.”

Earlier this year, the FDA released a pediatric x-ray imaging web page and draft guidance so that the manufacturers of x-ray imaging devices would be better able to consider pediatric safety when designing new equipment, Dr.Biscupid.com explained.

Among other things, the FDA states that it and the American Dental Association (ADA) recommend clinicians perform dental X-ray examinations, including dental CBCT, only when necessary for disease diagnosis or treatment. While the clinical benefit of a medically appropriate X-ray imaging exam does outweigh its radiation risk, clinicians should ensure measures are in place to minimize this risk.

The American Academy of Oral and Maxillofacial Radiology, the International Congress of Oral Implantologists, and the American Association of Endodontists all released position statements and professional guidelines for CBCT use in dentistry, said DrBicuspid.com.

Detailed information on FDA guidance is accessible here.

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