As a prospective or current radiologic technologist, it is important to be apprised of events that have shaped the legislation and regulations that standardize the radiology field. Myriad federal legislations directly pertain to radiological treatments. Whether you manage an imaging center, operate radiological equipment, or are involved in ordering or analyzing imaging procedures, the health and safety of your patients and the integrity of your institution depend on your understanding of radiology regulations.
The Electronic Product Radiation Control Program
Regulation of electronic radiation-emitting products falls under the jurisdiction of the U.S. Food and Drug Administration (FDA). This includes any product that, whether as part of its normal operation or due to improper shielding, emits or has the potential to emit radiation. This definition includes large categories of items outside the boundaries of medical devices, such as microwaves, televisions and television receivers, various types of video equipment, and lasers.
However, this program also oversees the development of medical devices including radiological imaging equipment. The current provisions included in the Electronic Product Radiation Control Program stem from legislature originally enacted in 1968, affording a large amount of precedent and history to the FDA’s oversight of electronic radioactive equipment. Manufacturers of these types of technologies are held in check through performance standards. Notices of noncompliance may be sent to manufacturers at any time and require immediate action.
Consumer-Patient Radiation Health and Safety Act of 1981
The Consumer-Patient Radiation Health and Safety Act written in 1981 was passed to elicit standards from the Secretary of Health and Human Services. This important piece of legislation exerted regulations over several key elements of the field of radiology in the United States. It created requirements for the accreditation of any education program that trains radiologic technologists, enacted standards for individuals who administer radioactive technologies and treatments, and constructed federal guidelines to regulate radiology technology and its applications. It also rendered unlawful any radiologic procedures performed by an uncertified individual.
ALARA
ALARA, or “As Low As Reasonably Achievable,” is a guideline for radiologic treatment that urges using only as large a radiation dose as is necessary for the desired result. This principle is particularly touted in pediatric environments, since children can be up to 10 times more sensitive to radiation than adults. The concept is strongly promoted by the Society for Pediatric Radiology, which has hosted conferences to facilitate cross-specialty and industry communication, and has established the Image Gently Alliance, whose goal is to change practice by raising awareness of the opportunities to lower radiation dose in the imaging of children. ALARA is a vital conceptual cog in the wheelhouse of radiological safety and requires large amounts of collaboration on the parts of radiology professionals across all subindustries and specialties to help achieve it.
Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
Launched by the FDA in 2010, the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging works to protect patients from the dangers of radiation technology. It focuses on two levels of decision-making involved in the radiologic imaging process: “justification” and “dose optimization.” The principle of justification-based safety mandates that before performing a radiology procedure on a given patient, it should be confirmed whether the procedure would cause more good than harm. This decision is made by the attending physician or lead radiologist. Dose optimization refers to the philosophy behind ALARA – the amount of radiation applied in any given treatment should be the minimum amount necessary to achieve the desired result. The initiative works to improve procedures, enforce regulations, and improve health and safety measures in radiology settings.
Mammography Quality Standards Act
Originally enacted in 1992 and since reauthorized with amendments in 1998 and 2004, the Mammography Quality Standards Act (MQSA) granted to the FDA the authority to inspect and regulate all mammography facilities and hold them to stringent quality standards. The regulations were put in place to protect any woman that requires mammography procedures from receiving subpar treatment or results. These regulations are enforced through facility visits made by FDA inspectors to ensure that all quality standards are met.
As with all medical treatments and procedures, radiologic imaging exams expose patients (and practicing technologists) to a certain amount of risk. Thus, radiology and its technologies, facilities, and services are highly regulated by the FDA and through legislative ordinances. These regulations and standards ensure that both radiologists and their patients can proceed with confidence and can remain well informed about both the benefits and risks of engaging in radiological procedures. As a future or practicing radiologic technologist, keeping abreast of legislative regulation will become (or must remain) an important part of your role.
Learn More
The AdventHealth University Bachelor of Science in Radiologic Sciences online degree offers working imaging professionals an expanded opportunity to learn the technical, medical and people skills to help them continue their professional growth. Whether your goal is to provide a higher level of patient care or to advance your career by moving into management, education, consulting, or industry, the place to begin is with an Online Bachelor of Science in Imaging Sciences.
Sources:
http://www.fda.gov/radiation-emittingproducts/electronicproductradiationcontrolprogram/
http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/LawsandRegulations/ucm118156.htm
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm193950.htm
https://www.congress.gov/bill/97th-congress/house-bill/2457
http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm2007191.htm
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2663649/
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094441.pdf
https://www.ncbi.nlm.nih.gov/pubmed/10943276
http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/AbouttheMammographyProgram/
http://www.imagegently.org/About-Us/Campaign-Overview
