NCRP commentary no. 33-recommendations for stratification of equipment use and radiation safety training for fluoroscopy.

National Council on Radiation Protection and Measurements Commentary No. 33 'Recommendations for Stratification of Equipment Use and Radiation Safety Training for Fluoroscopy' defines an evidence-based, radiation risk classification for fluoroscopically guided procedures (FGPs), provides radiation-related recommendations for the types of fluoroscopes suitable for each class of procedure, and indicates the extent and content of training that ought to be provided to different categories of facility staff who might enter a room where fluoroscopy is or may be performed. For FGP, radiation risk is defined by the type and likelihood of radiation hazards that could be incurred by a patient undergoing a FGP. The Commentary also defines six training groups of facility staff based on their role in the fluoroscopy room. The training groups are based on a combination of job descriptions and the procedures in which these individuals might be involved. The Commentary recommends the extent and content of training that should be provided to each of these training groups. It also provides recommendations on training formats, training frequency, and methods for demonstrating that the learner has acquired the necessary knowledge.

Cause-Specific Mortality in Patients With Advanced Chronic Kidney Disease in the ISCHEMIA-CKD Trial.

BACKGROUND: In ISCHEMIA-CKD, 777 patients with advanced chronic kidney disease and chronic coronary disease had similar all-cause mortality with either an initial invasive or conservative strategy (27.2% vs 27.8%, respectively). OBJECTIVES: This prespecified secondary analysis from ISCHEMIA-CKD (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Chronic Kidney Disease) was conducted to determine whether an initial invasive strategy compared with a conservative strategy decreased the incidence of cardiovascular (CV) vs non-CV causes of death. METHODS: Three-year cumulative incidences were calculated for the adjudicated cause of death. Overall and cause-specific death by treatment strategy were analyzed using Cox models adjusted for baseline covariates. The association between cause of death, risk factors, and treatment strategy were identified. RESULTS: A total of 192 of the 777 participants died during follow-up, including 94 (12.1%) of a CV cause, 59 (7.6%) of a non-CV cause, and 39 (5.0%) of an undetermined cause. The 3-year cumulative rates of CV death were similar between the invasive and conservative strategies (14.6% vs 12.6%, respectively; HR: 1.13, 95% CI: 0.75-1.70). Non-CV death rates were also similar between the invasive and conservative arms (8.4% and 8.2%, respectively; HR: 1.25; 95% CI: 0.75-2.09). Sudden cardiac death (46.8% of CV deaths) and infection (54.2% of non-CV deaths) were the most common cause-specific deaths and did not vary by treatment strategy. CONCLUSIONS: In ISCHEMIA-CKD, CV death was more common than non-CV or undetermined death during the 3-year follow-up. The randomized treatment assignment did not affect the cause-specific incidences of death in participants with advanced CKD and moderate or severe myocardial ischemia. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Chronic Kidney Disease [ISCHEMIA-CKD]; NCT01985360).

Causes of cardiovascular and noncardiovascular death in the ISCHEMIA trial.

BACKGROUND: The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches trial demonstrated no overall difference in the composite primary endpoint and the secondary endpoints of cardiovascular (CV) death/myocardial infarction or all-cause mortality between an initial invasive or conservative strategy among participants with chronic coronary disease and moderate or severe myocardial ischemia. Detailed cause-specific death analyses have not been reported. METHODS: We compared overall and cause-specific death rates by treatment group using Cox models with adjustment for pre-specified baseline covariates. Cause of death was adjudicated by an independent Clinical Events Committee as CV, non-CV, and undetermined. We evaluated the association of risk factors and treatment strategy with cause of death. RESULTS: Four-year cumulative incidence rates for CV death were similar between invasive and conservative strategies (2.6% vs 3.0%; hazard ratio [HR] 0.98; 95% CI [0.70-1.38]), but non-CV death rates were higher in the invasive strategy (3.3% vs 2.1%; HR 1.45 [1.00-2.09]). Overall, 13% of deaths were attributed to undetermined causes (38/289). Fewer undetermined deaths (0.6% vs 1.3%; HR 0.48 [0.24-0.95]) and more malignancy deaths (2.0% vs 0.8%; HR 2.11 [1.23-3.60]) occurred in the invasive strategy than in the conservative strategy. CONCLUSIONS: In International Study of Comparative Health Effectiveness with Medical and Invasive Approaches, all-cause and CV death rates were similar between treatment strategies. The observation of fewer undetermined deaths and more malignancy deaths in the invasive strategy remains unexplained. These findings should be interpreted with caution in the context of prior studies and the overall trial results.

AAPM Task Group Report 272: Comprehensive acceptance testing and evaluation of fluoroscopy imaging systems.

Modern fluoroscopes used for image guidance have become quite complex. Adding to this complexity are the many regulatory and accreditation requirements that must be fulfilled during acceptance testing of a new unit. Further, some of these acceptance tests have pass/fail criteria, whereas others do not, making acceptance testing a subjective and time-consuming task. The AAPM Task Group 272 Report spells out the details of tests that are required and gives visibility to some of the tests that while not yet required are recommended as good practice. The organization of the report begins with the most complicated fluoroscopes used in interventional radiology or cardiology and continues with general fluoroscopy and mobile C-arms. Finally, the appendices of the report provide useful information, an example report form and topics that needed their own section due to the level of detail.

Dosimetry for the study of medical radiation workers with a focus on the mean absorbed dose to the lung, brain and other organs.

BACKGROUND: The reconstruction of lifetime radiation doses for medical workers presents special challenges not commonly encountered for the other worker cohorts comprising the Million Worker Study. METHODS: The selection of approximately 175,000 medical radiation workers relies on using estimates of lifetime and annual personal monitoring results collected since 1977. Approaches have been created to adjust the monitoring results so that mean organ absorbed doses can be estimated. RESULTS: Changes in medical technology and practices have altered the radiation exposure environments to which a worker may have been exposed during their career. Other temporal factors include shifts in regulatory requirements that influenced the conduct of radiation monitoring and the changes in the measured dose quantities. CONCLUSIONS: The use of leaded aprons during exposure to lower energy X rays encountered in fluoroscopically based radiology adds complexity to account for the shielding of the organs located in the torso when dosimeters were worn over leaded aprons. Estimating doses to unshielded tissues such as the brain and lens of the eye become less challenging when dosimeters are worn at the collar above the apron. The absence of leaded aprons in the higher energy photon settings lead to a more straightforward process of relating dosimeter results to mean organ doses.

Collar Badge Lens Dose Equivalent Values among United States Physicians Performing Fluoroscopically Guided Interventional Procedures.

PURPOSE: To describe the range of occupational badge dose readings and annualized dose records among physicians performing fluoroscopically guided interventional (FGI) procedures using job title information provided by the same 3 major medical institutions in 2009, 2012, and 2015. MATERIALS AND METHODS: The Radiation Safety Office of selected hospitals was contacted to request assistance with identifying physicians in a large commercial dosimetry database. All entries judged to be uninformative of occupational doses to FGI procedure staff were excluded. Monthly and annualized doses were described with univariate statistics and box-and-whisker plots. RESULTS: The dosimetry data set of interventional radiology staff contained 169 annual dose records from 77 different physicians and 698 annual dose records from 455 nonphysicians. The median annualized lens dose equivalent values among physicians (11.9 mSv; interquartile range [IQR], 6.9-20.0 mSv) was nearly 3-fold higher than those among nonphysician medical staff assisting with FGI procedures (4.0 mSv; IQR, 1.8-6.7 mSv) (P < .001). During the study period, without eye protection, 25% (23 of 93) of the physician annualized lens dose equivalent values may have exceeded 20 mSv; for nonphysician medical staff, this value may have been exceeded 3.5% (6 of 173) of the time. However, these values did not account for eye protection. CONCLUSIONS: The findings from this study highlight the importance of mitigating occupational dose to the eyes of medical staff, particularly physicians, performing or assisting with FGI procedures. Training on radiation protection principles, the use of personal protective equipment, and patient radiation dose management can all help ensure that the occupational radiation dose is adequately controlled.

Microbial Contamination Risk and Disinfection of Radiation Protective Garments.

ABSTRACT: Healthcare-associated infections are a major public health concern for both patients and medical personnel. This has taken on greater urgency during the current COVID-19 pandemic. Radiation Personal Protective Equipment (RPPE) may contribute to risks of microbial contamination. This possibility was tested in 61 personal or shared-use lead aprons and thyroid collars at Columbia Presbyterian Irving Medical Center. Fifty percent tested positive for either bacterial or fungal contamination, mostly around the neckline of lead vests and thyroid collars. Repeated testing of garments some weeks to months later confirmed continued presence of microbial contamination. The possibility that hospital-approved disinfection agents could degrade the radio-protective features of these garments was also examined. Samples of identical construction to garments in regular use were subjected to either daily or weekly wipes with hypochlorite or alcohol-based hospital-approved cleaning agents for 6 mo. A third group of samples was maintained in contact with the cleaning agents for 6 mo. All samples were fluoroscoped four times during the study. None demonstrated any degradation in radioprotection. All samples were photographed monthly. Physical degradation of the outer plastic covering by concentrated hypochlorite and limited mechanical damage around stitched seams of the samples cleaned daily with alcohol was noted. Based on the high prevalence of microbial contamination, regular cleaning and disinfection protocols should be implemented. Regular cleaning with medical-facility-approved cleaning and disinfecting agents is likely to be effective at reducing the microbial load and unlikely to result in significant reduction in radioprotective properties of these garments.

Occupational Doses to Medical Staff Performing or Assisting with Fluoroscopically Guided Interventional Procedures.

Background Staff who perform fluoroscopically guided interventional (FGI) procedures are among the most highly radiation-exposed groups in medicine. However, there are limited data on monthly or annual doses (or dose trends over time) for these workers. Purpose To summarize occupational badge doses (lens dose equivalent and effective dose equivalent values) for medical staff performing or assisting with FGI procedures in 3 recent years after accounting for uninformative values and one- versus two-badge monitoring protocol. Materials and Methods Badge dose entries of medical workers believed to have performed or assisted with FGI procedures were retrospectively collected from the largest dosimetry provider in the United States for 49 991, 81 561, and 125 669 medical staff corresponding to years 2009, 2012, and 2015, respectively. Entries judged to be uninformative of occupational doses to FGI procedures staff were excluded. Monthly and annual occupational doses were described using summary statistics. Results After exclusions, 22.2% (153 033 of 687 912) of the two- and 32.9% (450 173 of 1 366 736) of the one-badge entries were judged to be informative. There were 335 225 and 916 563 of the two- and one-badge entries excluded, respectively, with minimal readings in the above-apron badge. Among the two-badge entries, 123 595 were incomplete and 76 059 had readings indicating incorrect wear of the badges. From 2009 to 2015 there was no change in lens dose equivalent values among workers who wore one badge (P = .96) or those who wore two badges (P = .23). Annual lens dose equivalents for workers wearing one badge (median, 6.9 mSv; interquartile range, 3.8213.8 mSv; n = 6218) were similar to those of staff wearing two badges (median, 7.1 mSv; interquartile range, 4.6-11.2 mSv; n = 1449) (P = .18), suggesting a similar radiation environment. Conclusion These workers are among the highest exposed to elevated levels of ionizing radiation, although their occupational doses are within U.S. regulatory limits. This is a population that requires consistent and accurate dose monitoring; however, failure to return one or both badges, reversal of badges, and improper badge placement are a major hindrance to this goal. © RSNA, 2019 Online supplemental material is available for this article. See also the editorial by Karellas in this issue.

Preventing Harm From Fluoroscopically Guided Interventional Procedures With a Risk-Based Analysis Approach.

PURPOSE: Fluoroscopically guided interventional (FGI) procedures often have lower complication rates compared with alternative surgical procedures, providing an option for patients with a high risk of perioperative mortality. Although severe radiation injuries are rare, patients receiving peak skin doses exceeding 3 Gy can suffer from radiation-induced tissue injuries, ranging from transient erythema to nonhealing wounds. As these iatrogenic injuries may manifest weeks to months postprocedure, proper diagnosis and timely medical intervention are less likely. Clinically, the lack of situational awareness for monitoring air kerma continues to be a challenge despite the recommendations of numerous organizations on ways to achieve fluoroscopy safety. For patient safety efforts, this study aimed to identify and mitigate systematic gaps associated with potentially high-radiation dose fluoroscopic procedures in US Department of Veterans Affairs (VA) and non-VA medical institutions. METHODS: In this study, a multi-institutional team utilized Healthcare Failure Mode and Effect Analysis (HFMEA) on an example implantable cardioverter defibrillator lead extraction procedure. RESULTS: With this approach, 29 interventions were devised and prioritized by feasibility, cost-effectiveness, and expected clinical impact. Five of the 29 interventions were recommended for immediate implementation or piloting. CONCLUSIONS: This work demonstrates the application of formal risk-based analysis techniques in FGI procedures. These high priority interventions may be valuable for other facilities to consider when performing potentially high-radiation dose procedures and conducting risk-benefit analyses. Formal risk analysis techniques such as the HFMEA process are recommended for other facilities to use to improve safety for their high-risk procedures.

Cataract risk in US radiologic technologists assisting with fluoroscopically guided interventional procedures: a retrospective cohort study.

OBJECTIVES: To assess radiation exposure-related work history and risk of cataract and cataract surgery among radiologic technologists assisting with fluoroscopically guided interventional procedures (FGIP). METHODS: This retrospective study included 35 751 radiologic technologists who reported being cataract-free at baseline (1994-1998) and completed a follow-up questionnaire (2013-2014). Frequencies of assisting with 21 types of FGIP and use of radiation protection equipment during five time periods (before 1970, 1970-1979, 1980-1989, 1990-1999, 2000-2009) were derived from an additional self-administered questionnaire in 2013-2014. Multivariable-adjusted relative risks (RRs) for self-reported cataract diagnosis and cataract surgery were estimated according to FGIP work history. RESULTS: During follow-up, 9372 technologists reported incident physician-diagnosed cataract; 4278 of incident cases reported undergoing cataract surgery. Technologists who ever assisted with FGIP had increased risk for cataract compared with those who never assisted with FGIP (RR: 1.18, 95% CI 1.11 to 1.25). Risk increased with increasing cumulative number of FGIP; the RR for technologists who assisted with >5000 FGIP compared with those who never assisted was 1.38 (95% CI 1.24 to 1.53; p trend <0.001). These associations were more pronounced for FGIP when technologists were located ≤3 feet (≤0.9 m) from the patient compared with >3 feet (>0.9 m) (RRs for >5000 at ≤3 feet vs never FGIP were 1.48, 95% CI 1.27 to 1.74 and 1.15, 95% CI 0.98 to 1.35, respectively; pdifference=0.04). Similar risks, although not statistically significant, were observed for cataract surgery. CONCLUSION: Technologists who reported assisting with FGIP, particularly high-volume FGIP within 3 feet of the patient, had increased risk of incident cataract. Additional investigation should evaluate estimated dose response and medically validated cataract type.

Caution: Predictors ahead.

Radiation dose data can be used as a starting point to establish local TAVR reference levels. Cancer risk is of concern but is very low in the context of TAVR patients. Improvements in clinical radiation management will reduce both patient and staff risk for all procedures.

Occupational health hazards in the interventional laboratory: Time for a safer environment.

Over the past 30 years, the advent of fluoroscopically guided interventional procedures has resulted in dramatic increments in both X-ray exposure and physical demands that predispose interventionists to distinct occupational health hazards. The hazards of accumulated radiation exposure have been known for years, but until recently the other potential risks have been ill-defined and under-appreciated. The physical stresses inherent in this career choice appear to be associated with a predilection to orthopedic injuries, attributable in great part to the cumulative adverse effects of bearing the weight and design of personal protective apparel worn to reduce radiation risk and to the poor ergonomic design of interventional suites. These occupational health concerns pertain to cardiologists, radiologists and surgeons working with fluoroscopy, pain management specialists performing nonvascular fluoroscopic procedures, and the many support personnel working in these environments. This position paper is the work of representatives of the major societies of physicians who work in the interventional laboratory environment, and has been formally endorsed by all. In this paper, the available data delineating the prevalence of these occupational health risks is reviewed and ongoing epidemiological studies designed to further elucidate these risks are summarized. The main purpose is to publicly state speaking with a single voice that the interventional laboratory poses workplace hazards that must be acknowledged, better understood and mitigated to the greatest extent possible, and to advocate vigorously on behalf of efforts to reduce these hazards. Interventional physicians and their professional societies, working together with industry, should strive toward the ultimate zero radiation exposure work environment that would eliminate the need for personal protective apparel and prevent its orthopedic and ergonomic consequences. © 2008 Wiley-Liss, Inc.

Always on My Mind.

This article is focused on occupational radiogenic brain tumors and some radioprotective techniques used to manage this risk. Published case reports have stimulated concern among operators. The anatomical pattern of tumor locations is not consistent with measured radiation dose distributions at operators' heads. In addition, the lack of statistically positive findings in these reports, and a recently published survey on radiologist's mortality both indicate that the current level of fluoroscopists' radiation safety practices is likely to be adequate. This presumes that the rules of dose-management, time, distance, and shielding continue to be followed. These are briefly reviewed in this article. The use of radioprotective surgical caps is a current fashion. In clinical practice, these caps provide minimal reductions in brain dose and might induce operators to neglect applying the practical rules mentioned above. Appropriate management of personal, staff, and patient risk should always be on the radiologists' mind.