Abstract
The quality assurance (QA) of radiographic images based on the operating conditions of X‐ray equipment is essential for good image quality, accurate medical diagnostics and for the prevention of health professionals and patients to unnecessary doses of ionizing radiation. This paper presents a historical analysis of 1,635 Quality Assurance Technical Reports of Health Institutions in the state of São Paulo, Brazil, over a seven‐year period. Based on acceptable limits for variations between nominal and measured parameters as the variable to determine the quality of X‐ray equipment operating conditions, a significant improvement was found in the percentage of acceptance of the overall parameters described in the QA technical reports over this period. As expected, we found a strong concentration in the categories of conventional and portable X‐ray equipment, which represent 72% and 84%, respectively, of the total number of equipments. A mechanical parameter such as half‐value layer (HVL), which is important not only for image quality but also for radiation protection, showed significant improvements. Again, only 58% of portable X‐ray equipment showed HVL values recommended for 80 kVp (above 2.3 mm Al), a percentage that improved to 76% in 2006. With regard to mammographers, which are newer machines, all the analyzed systems presented acceptable HVL values. Conventional X‐ray machines showed an increase of this conformity index from 89% in 2000 to 94% in 2006. All this improvement was attributed to the continuous and extensive enforcement of Regulation Act 453 in the state of São Paulo. The improvement in equipment quality control standards is expected to result in the improvement of diagnostic quality, as well as in the reduction of exam repetitions, and thereby reducing the patient's exposure to radiation.PACS number: 87.57.C
Highlights
The goal of achieving high quality standards today extends beyond regulatory requirements, since it is an intrinsic factor for a company’s good standing in the market
The establishment of a quality control program implies the implementation of a set of procedures for the regular and periodic testing of medical equipment and the evaluation of imaging quality to ensure the radiodiagnostic imaging process is in conformity with regulations.[5,6] Health Services and Radiology Sectors use a variety of quality systems and models, including Continuous Quality Improvement (CQI).(7) Due to the strong competitiveness of the sector, business administrators must focus on continuous improvements to reduce costs and enhance the efficiency and quality of these services
In this study to analyze the evolution of the quality parameters of X-ray equipment over time in alternate years from 2000 to 2006, we analyzed the reports based on the quality control measurements performed by Sapra Assessoria at health institutions providing radiodiagnostic services in the state of São Paulo, Brazil
Summary
The goal of achieving high quality standards today extends beyond regulatory requirements, since it is an intrinsic factor for a company’s good standing in the market. In Brazil, the Sanitary Surveillance Agency (ANVISA) of the Ministry of Health established a mandatory regulation, Regulation Act 453 (1998), which requires all radiodiagnostic and dental services to implement a quality assurance program (QAP).(3) This QAP includes a periodic quality control of all X-ray equipment and image processing systems.[4]. The image-recording subsystem consists mainly of the conventional imaging system including the intensifying screen radiographic film, film cassette, and processing system This aspect of quality assurance (QA) was analyzed previously by us in a study of the behavior of sensitometric curves obtained at the Diagnostic Centers in the state of São Paulo, where Sapra Assessoria provided quality control (QC) services and analysis during the period of 2000 to 2004. The results of that study were published in the Annals of the CLAEB – Latin American Congress on Biomedical Engineering 2007,(8) showing the tendency towards an improved quality of processing systems as a consequence of the Regulation Act 453
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