Critical analysis of Brazilian Federal Legislation for quality control radiodiagnostic equipment

Image quality generated by such equipment has reached a high diagnostic standard as a result of modernization. All the modalities of medical and dental radiology have, in the last decades, incorporated new features of image acquisition and processing, including digital technology. However, normally, the regulations designed to assess the safety and quality of the image, have some level of outdatedness. Objectives: in this context, the objective of the present study was to critically evaluate the Brazilian regulations applicable to quality control in general diagnostic radiology, except mammography. Methodology: a comparative study was carried out between four documents: the Brazilian Federal legislation, and three international protocols that were adopted as a reference in this approach: EC Report 162; ARCAL XLIX; Spanish Protocol. The verification; the periodicity and tolerance of the selected tests were used as analysis criteria. For a better understanding, the parameters were analyzed in two sets: (1) generator and (2) image-receptor. Results: as result have been verified that for analogical systems the national regulation does not contemplate all the essential parameters. Discussion:for digital systems the Brazilian regulation leaves a gap of 100% of the specific tests for evaluation of the digital image-receptor. The same is true for new modalities, such as CBCT. The gaps and deficiencies occur by: physical definitions that do not apply to the purpose of the test; limit values and/or periodicity less than currently expected for the parameter. Conclusion: it is concluded that although Brazil is a signatory of some of these international documents, the outdated or omission of some fundamental items for the evaluation of image quality, produce unsatisfactory results in obtaining diagnostic images. (author)