Analysis of Failure Causes in the Mammography Machines

Patient safety arises from the need to prevent and protect patients from avoidable mistakes. Two fundamental concepts that shape patient safety are error and adverse events, the consequences may range from potentially dangerous complications, slow recoveries, high medical costs, or unnecessary deaths. Breast cancer has become a global health problem with one of the most expensive burdens among non-communicative diseases. Since screening mammography is the most used method for tumor identification, patient safety applied to this technology is focused on delivering safe and effective service that results in an accurate and reliable diagnosis. This paper presents the analysis of the causes that can induce a potential failure in the mammography machine, and the actions to correct them. We used a risk analysis approach to identify the failures that may occur while using a mammography machine in screening programs. We extracted the information about the failures from specialized consultation and discussion forums and technical and operation manuals. We adapted the concepts of severity, occurrence, and detection involved in calculating the risk priority number according to the Failure Mode and Effects Analysis method, assigning them one of three levels (low, medium, and high). The adapted risk priority level was calculated from the averaged product of levels from the mentioned components. The results were mapped into an Ishikawa diagram, and an action procedure proposal was shown. The causes found are defined mainly concerning the handling of the equipment components, although causes related to the acquisition technique, patient handling, and availability of support information.