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ASRT Statement on FDA’s Proposed Repeal of Radiologic Health Activities

Apr 09, 2019

The Food and Drug Administration recently published a proposed rule to amend certain parts of its radiologic health regulations, including a recommendation to end the use of gonadal shielding on patients during medical diagnostic x-ray procedures.

The American Society of Radiologic Technologists is in conversations with the American Association of Physicists in Medicine and will meet with the American College of Radiology in May to discuss the FDA’s proposal on gonadal shielding. In addition, ASRT is in discussions with other medical imaging organizations to gather information about their positions on the FDA’s proposed rule.

Gonadal shielding is currently a standard practice for many facilities and radiologic technologists. As such, the radiologic technology community should examine how changing long-standing shielding guidelines will affect patients and procedures.

In addition, changing radiation safety best practices requires significant communication between members of the radiologic technology community. If the community eliminates radiation safety practices, a number of systems will require amendments including many state statutes, facility protocols and educational program curriculums.

Several other organizations are weighing in on the subject of shielding practices. The AAPM released a statement on April 2, 2019, recommending discontinuing gonadal and fetal shielding practices. In addition, the National Council on Radiation Protection is preparing a paper for a fall release that will provide recommendations, based on scientific evidence, on whether gonadal shielding should continue to be used as a routine safety precaution.

ASRT will publish more information on this topic after it meets with stakeholders. Information will be available on the ASRT website and in other communication vehicles.

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