The U.S. Food and Drug Administration's role in improving radiation dose management for medical X-ray imaging devices.

The U.S. Food and Drug Administration (FDA) has been concerned with minimizing the unnecessary radiation exposure of people for half a century. Manufacturers of medical X-ray imaging devices are important partners in this effort. Medical X-ray imaging devices are regulated by FDA under both its electronic product regulations andits medical device regulations. FDA also publishes guidance documents that represent FDA's current thinking on a topic and provide a suggested or recommended approach to meet the requirements of a regulation or statute. FDA encourages manufacturers to develop medical devices that conform to voluntary consensus standards. Use of these standards is a central element of FDA's system to ensure that all medical devices marketed in the U.S. meet safety and effectiveness requirements. FDA staff participate actively in the development and maintenance of these standards, often advancing or introducing new safety and dose management requirements. Use of voluntary consensus standards reduces the amount of time necessary to evaluate a premarket submission and reduces the burden on manufacturers. FDA interacts with industry and other stakeholders through meetings with industry groups, public meetings, public communications, and through the development of voluntary consensus standards. In these interactions, FDA staff introduce new concepts for improving the safety of these devices and provide support for similar initiatives from professional organizations. FDA works with all stakeholders to achieve its mission of protecting and promoting the public health.

Patient Exposure from Radiologic and Nuclear Medicine Procedures in the United States: Procedure Volume and Effective Dose for the Period 2006-2016.

Background Comprehensive assessments of the frequency and associated doses from radiologic and nuclear medicine procedures are rarely conducted. The use of these procedures and the population-based radiation dose increased remarkably from 1980 to 2006. Purpose To determine the change in per capita radiation exposure in the United States from 2006 to 2016. Materials and Methods The U.S. National Council on Radiation Protection and Measurements conducted a retrospective assessment for 2016 and compared the results to previously published data for the year 2006. Effective dose values for procedures were obtained from the literature, and frequency data were obtained from commercial, governmental, and professional society data. Results In the United States in 2006, an estimated 377 million diagnostic and interventional radiologic examinations were performed. This value remained essentially the same for 2016 even though the U.S. population had increased by about 24 million people. The number of CT scans performed increased from 67 million to 84 million, but the number of other procedures (eg, diagnostic fluoroscopy) and nuclear medicine procedures decreased from 17 million to 13.5 million. The number of dental radiographic and dental CT examinations performed was estimated to be about 320 million in 2016. Using the tissue-weighting factors from Publication 60 of the International Commission on Radiological Protection, the U.S. annual individual (per capita) effective dose from diagnostic and interventional medical procedures was estimated to have been 2.9 mSv in 2006 and 2.3 mSv in 2016, with the collective doses being 885 000 and 755 000 person-sievert, respectively. Conclusion The trend from 1980 to 2006 of increasing dose from medical radiation has reversed. Estimated 2016 total collective effective dose and radiation dose per capita dose are lower than in 2006. © RSNA, 2020 See also the editorial by Einstein in this issue.

Patient radiation doses in interventional cardiology in the U.S.: advisory data sets and possible initial values for U.S. reference levels.

PURPOSE: To determine patient radiation doses from interventional cardiology procedures in the U.S and to suggest possible initial values for U.S. benchmarks for patient radiation dose from selected interventional cardiology procedures [fluoroscopically guided diagnostic cardiac catheterization and percutaneous coronary intervention (PCI)]. METHODS: Patient radiation dose metrics were derived from analysis of data from the 2008 to 2009 Nationwide Evaluation of X-ray Trends (NEXT) survey of cardiac catheterization. This analysis used identified data and did not require review by an IRB. Data from 171 facilities in 30 states were analyzed. The distributions (percentiles) of radiation dose metrics were determined for diagnostic cardiac catheterizations, PCI, and combined diagnostic and PCI procedures. Confidence intervals for these dose distributions were determined using bootstrap resampling. RESULTS: Percentile distributions (advisory data sets) and possible preliminary U.S. reference levels (based on the 75th percentile of the dose distributions) are provided for cumulative air kerma at the reference point (K(a,r)), cumulative air kerma-area product (P(KA)), fluoroscopy time, and number of cine runs. Dose distributions are sufficiently detailed to permit dose audits as described in National Council on Radiation Protection and Measurements Report No. 168. Fluoroscopy times are consistent with those observed in European studies, but P(KA) is higher in the U.S. CONCLUSIONS: Sufficient data exist to suggest possible initial benchmarks for patient radiation dose for certain interventional cardiology procedures in the U.S. Our data suggest that patient radiation dose in these procedures is not optimized in U.S. practice.

Nationwide surveys of chest, abdomen, lumbosacral spine radiography, and upper gastrointestinal fluoroscopy: a summary of findings.

This paper reports findings from Nationwide Evaluation of X-ray Trends surveys conducted in 2001, 2002, and 2003 of clinical facilities that perform routine radiographic examinations of the adult chest, abdomen, lumbosacral spine, and upper gastrointestinal fluoroscopic examinations. Randomly identified clinical facilities were surveyed in approximately 40 participating states. For the surveyed radiographic exams, additional facilities that use computed radiography or digital radiography were surveyed to ensure adequate sample sizes for determining comparative statistics. State radiation control personnel performed site visits and collected data on patient exposure, radiographic/fluoroscopic technique factors, image quality, and quality-control and quality-assurance practices. Results of the NEXT surveys are compared with those of previous surveys conducted in 1964 and 1970 by the U.S. Public Health Service and the Food and Drug Administration. An estimated 155 million routine adult chest exams were performed in 2001. Average patient entrance skin air kerma from chest radiography at facilities using digital-based imaging modalities was found to be significantly higher (p < 0.001), but not so for routine abdomen or lumbosacral spine radiography. Digital-based imaging showed a substantial reduction in patient exposure for the radiographic portion of the routine upper gastrointestinal fluoroscopy exam. Long-term trends in surveyed diagnostic examinations show that average patient exposures are at their lowest levels. Of concern is the observation that a substantial fraction of surveyed non-hospital sites indicated they do not regularly have a medical physics survey conducted on their radiographic equipment. These facilities are likely unaware of the radiation doses they administer to their patients.

Entrance surface dose and image quality: comparison of adult chest and abdominal X-ray examinations in general practitioner clinics, public and private hospitals in Malaysia.

This study was undertaken to compare the entrance surface dose (ESD) and image quality of adult chest and abdominal X-ray examinations conducted at general practitioner (GP) clinics, and public and private hospitals in Malaysia. The surveyed facilities were randomly selected within a given category (28 GP clinics, 20 public hospitals and 15 private hospitals). Only departmental X-ray units were involved in the survey. Chest examinations were done at all facilities, while only hospitals performed abdominal examinations. This study used the x-ray attenuation phantoms and protocols developed for the Nationwide Evaluation of X-ray Trends (NEXT) survey program in the United States. The ESD was calculated from measurements of exposure and clinical geometry. An image quality test tool was used to evaluate the low-contrast detectability and high-contrast detail performance under typical clinical conditions. The median ESD value for the adult chest X-ray examination was the highest (0.25 mGy) at GP clinics, followed by private hospitals (0.22 mGy) and public hospitals (0.17 mGy). The median ESD for the adult abdominal X-ray examination at public hospitals (3.35 mGy) was higher than that for private hospitals (2.81 mGy). Results of image quality assessment for the chest X-ray examination show that all facility types have a similar median spatial resolution and low-contrast detectability. For the abdominal X-ray examination, public hospitals have a similar median spatial resolution but larger low-contrast detectability compared with private hospitals. The results of this survey clearly show that there is room for further improvement in performing chest and abdominal X-ray examinations in Malaysia.

Nationwide Evaluation of X-ray Trends survey of abdomen and lumbosacral spine radiography.

Results of the 1995 Nationwide Evaluation of X-ray Trends (NEXT) survey of facilities that perform diagnostic radiographic examinations of the abdomen and lumbosacral spine were compared with those of previous NEXT surveys conducted in 1987 and 1989. A clinically validated radiographic phantom was used in the 1995 survey to capture data about radiation exposure and image quality. Additional data were obtained regarding clinical techniques, facility workloads, x-ray beam quality, film processing quality, and darkroom fog. Mean skin-entrance air kerma for the abdomen examination dropped from 3.2 mGy (in 1987) to 2.8 mGy at hospitals and from 3.4 mGy (in 1989) to 3.0 mGy at nonhospital facilities. Mean skin-entrance air kerma also decreased for the lumbosacral spine examination from 3.7 mGy (in 1987) to 3.3 mGy at hospitals and from 3.8 mGy (in 1989) to 3.2 mGy at nonhospital facilities. The quality of film processing improved, although 58 (18.3%) of 317 surveyed facilities did not meet the Mammography Quality Standards Act standard for film processing quality, compared with 185 (5.9%) of 3,120 mammography facilities inspected in 1995. Finally, 181 (58.0%) of 312 surveyed facilities had darkroom fog levels greater than the Mammography Quality Standards Act standard, compared with 1,426 (16.6%) of 8,605 mammography facilities inspected in 1995.