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Quality assurance in screening mammography. 1990

This evaluation was a cooperative effort between ECRI and the Swedish Testing Institute for Medical Supplies (Sprima AB), Stockholm. As noted in our last mammography evaluation, we are initially focusing on mammography units in our series of radiology and imaging studies because (1) improvements in technology (e.g., lower radiation doses) now make routine screening feasible; (2) third-party payers are supporting screening programs, and (3) breast cancer is a major threat to women's health. Again ECRI will provide physicists and radiologists with our raw test data on request. In our previous evaluation, we discussed the role of mammography in reducing breast cancer mortality rates and tested the units for screen-film mammography and xeromammography capability, basing our ratings primarily on the units' ability to safely and consistently produce acceptable images with minimal patient dose during screen-film mammography. Below, we focus on the definition, measurement, and significance of image quality within the context of screen-film mammography. We evaluated seven mammography units from seven manufacturers. We also retested the Automatic Exposure Control (AEC) mode of the Soredex Mamex dc Mag, which we evaluated last year and rated Conditionally Acceptable because of its AEC performance (see "Soredex Mamex dc Mag"). Our ratings are based on our minimum criteria of acceptability: that the units safely and reliably produce the best possible image quality while delivering the lowest possible dose to the patient. Except for the Kramex HF-45, all of the evaluated units-the Acoma ESP-200, GE-CGR Senographe 600T, Instrumentarium/Ausonics (I/A) Alpha III, Lorad M II-D, Philips MammoDiagnost UC, Picker Sureview, and the Soredex Mamex dc Mag-exceed our minimum criteria and are rated Acceptable for both screening and magnification (diagnostic) applications. The Kramex HF-45, the only dedicated screening unit we evaluated, is rated Acceptable-Not Recommended because of its limitations in achieving optimal image quality. The units are ranked according to their AEC performance and human factors (ergonomic) design, as well as on technical phantom image quality results, within the two applications. Clinical phantom image quality results are listed, but were not used to rank the units. Refer to our previous study for further discussions of breast imaging technology and terminology, as well as radiation risks. Terms set below in small caps are defined in the Glossary.

UI MeSH Term Description Entries
D008327 Mammography Radiographic examination of the breast. 3D-Mammography,Digital Breast Tomosynthesis,Digital Mammography,X-ray Breast Tomosynthesis,3D Mammography,3D-Mammographies,Breast Tomosyntheses, Digital,Breast Tomosyntheses, X-ray,Breast Tomosynthesis, Digital,Breast Tomosynthesis, X-ray,Digital Breast Tomosyntheses,Digital Mammographies,Mammographies,Mammographies, Digital,Mammography, Digital,X ray Breast Tomosynthesis,X-ray Breast Tomosyntheses
D011785 Quality Assurance, Health Care Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps. Quality Assessment, Health Care,Health Care Quality Assessment,Health Care Quality Assurance,Healthcare Quality Assessment,Healthcare Quality Assurance,Quality Assessment, Healthcare,Quality Assurance, Healthcare,Assessment, Healthcare Quality,Assessments, Healthcare Quality,Assurance, Healthcare Quality,Assurances, Healthcare Quality,Healthcare Quality Assessments,Healthcare Quality Assurances,Quality Assessments, Healthcare,Quality Assurances, Healthcare
D011856 Radiographic Image Enhancement Improvement in the quality of an x-ray image by use of an intensifying screen, tube, or filter and by optimum exposure techniques. Digital processing methods are often employed. Digital Radiography,Image Enhancement, Radiographic,Radiography, Digital,Enhancement, Radiographic Image,Enhancements, Radiographic Image,Image Enhancements, Radiographic,Radiographic Image Enhancements
D004867 Equipment Design Methods and patterns of fabricating machines and related hardware. Design, Equipment,Device Design,Medical Device Design,Design, Medical Device,Designs, Medical Device,Device Design, Medical,Device Designs, Medical,Medical Device Designs,Design, Device,Designs, Device,Designs, Equipment,Device Designs,Equipment Designs
D005069 Evaluation Studies as Topic Works about studies that determine the effectiveness or value of processes, personnel, and equipment, or the material on conducting such studies. Critique,Evaluation Indexes,Evaluation Methodology,Evaluation Report,Evaluation Research,Methodology, Evaluation,Pre-Post Tests,Qualitative Evaluation,Quantitative Evaluation,Theoretical Effectiveness,Use-Effectiveness,Critiques,Effectiveness, Theoretical,Evaluation Methodologies,Evaluation Reports,Evaluation, Qualitative,Evaluation, Quantitative,Evaluations, Qualitative,Evaluations, Quantitative,Indexes, Evaluation,Methodologies, Evaluation,Pre Post Tests,Pre-Post Test,Qualitative Evaluations,Quantitative Evaluations,Report, Evaluation,Reports, Evaluation,Research, Evaluation,Test, Pre-Post,Tests, Pre-Post,Use Effectiveness
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013673 Technology Assessment, Biomedical Evaluation of biomedical technology in relation to cost, efficacy, utilization, etc., and its future impact on social, ethical, and legal systems. Assessment, Biomedical Technology,Assessment, Technology,Biomedical Technology Assessment,Technology Assessment,Technology Assessment, Health,Assessment, Health Technology,Assessments, Biomedical Technology,Assessments, Health Technology,Assessments, Technology,Biomedical Technology Assessments,Health Technology Assessment,Health Technology Assessments,Technology Assessments,Technology Assessments, Biomedical,Technology Assessments, Health

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