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Every medical use of X-rays involving human patients requires an indication which justifies it. Exceptions are allowed as part of organised early-detection examinations for which a scientific evaluation is needed.
After a modernisation of the German radiation protection law was carried out on the basis of Directive 2013/59/Euratom issued by the European Atomic Energy Community, a corresponding regulation covering such exceptions for the mammography screening programme was adopted for the Radiation Protection Act, which appeared in June 2017 and came into effect on 31.12.2018, as well as for the Radiation Protection Ordinance in force since 31.12.2018.
Approval for the early detection of breast cancer by means of mammography was given in 2018 by the Federal Radiation Protection Office, leading to the adoption of the Breast Cancer Early Detection Regulation, which, since 01.01.2019, has regulated the wide-ranging quality standards governing examinations for the early detection of breast cancer.
The evaluation of the quality of structures, processes and results in the mammography screening programme is carried out on the basis of reference values in line with the European Guidelines (European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis). The quality of individual examination steps is evaluated on the basis of process parameters such as the image refresh rate, the re-invitation rate or the proportion of insufficient biopsies.
The quality of structures also comprises requirements regarding the rooms and the equipment used at screening locations, as well as establishing the individual professional qualifications of the medical and non-medical staff. Technical quality assurance (TQS) has the task of ensuring a sufficient quality of diagnostic images at all times, while keeping exposure to radiation to an absolute minimum.
The aims of nationwide mammography screening, relating to a defined section of the population and governed by quality assurance, are the early detection of breast cancer among eligible women and an associated reduction in the number of deaths from breast cancer, as well as the application of gentler methods of treatment. These aims can only be reached if the national measures concerning quality assurance and quality management are implemented. The screening units are certified, and regularly re-certified, to ensure that these measures are implemented.
These quality requirements are described in detail in the texts of the standards on which the Screening Programme is based: Early Detection of Breast Cancer Guideline (KFE-RL) and Annex 9.2 of the Federal Framework Agreement for Physicians (BMV-Ä).
Responsibility for mammography screening lies with the lead programme radiologists who have received a medical care mandate from the Associations of Health Fund Physicians and who head the local screening units.
The aim of systematic early detection through the mammography screening programme is to detect breast cancer at an early stage when it can be treated well and before it becomes clinically apparent. At the same time, women taking part in the screening should suffer as little stress as possible during the testing. Both are ensured by comprehensive quality assurance.