Virginia Lifts Restrictions on NOMAD Handheld X-ray
Joins Band of 34 Other States, Approves Full Use of Handheld Device
Orem, Utah — The State of Virginia recently announced that it will drop dosimeter requirements in favor of unrestricted use of the Aribex NOMAD® family of handheld X-ray systems, effective January 1, 2014.
“We applaud the State of Virginia’s judicious decision to band with 34 other states in this ‘stay-with-the-patient’ movement, where more than 13,000 devices are now in use,” said Ken Kaufman, general manager of Aribex. “What we’re seeing is a sophisticated paradigm shift to the new and improved way of taking intra-oral radiographs. We look forward to showing dental professionals throughout the U.S. how the NOMAD Pro 2 enhancements will further evolve intra-oral imaging and provide better access to dental care worldwide.”
After careful investigation, the Virginia Department of Health, Office of Radiological Health has determined that, beginning in 2014, personnel dosimetry will no longer be required for those who operate the NOMAD family of handheld dental X-ray systems. The department’s determination follows an eight-year period during which they established a safe-use baseline of the product.
“When the FDA first cleared the NOMAD in 2005, the regulations governing X-ray systems did not allow handheld operation of an X-ray device,” said Kaufman. “Instead, the rules required that the system be operated from behind a barrier, or at a distance of six feet or more from the Xray head. Recognizing that technology would outpace restrictions, rule-makers allowed for variances to the limitations when alternative methods achieved the same intended result.”
Some states, such as Virginia, California and New Jersey, initially took a cautionary approach in allowing for a variance from these rules by requiring operator personnel to monitor radiation exposure using dosimetry. Such monitoring protocols further confirmed that NOMAD operator dose was as low as reasonably achievable. This year, each of these states have confirmed what dozens of states, studies, and evaluations have found: when used as instructed, the NOMAD is safe and effective. In making this move, Virginia becomes the 35th state with no mandatory personnel dosimetry requirement for operators of the NOMAD.
“As they should be, radiological devices are subject to significant regulation and concern for safety,” said Kaufman. “Safety is our number one priority, and we’re proud that more than 30 independent studies and evaluations have validated our position by attesting to the safety and efficacy of our products.”
While fifteen states currently require operator dosimetry in conjunction with handheld use, many are actively reviewing the data to assess whether to allow for similar policy changes.
“It is no small undertaking to develop a revolutionary technology,” said Kaufman. “Aribex is gratified each time independent data confirms our efforts to design and produce the safest systems possible.”