Examination of the Quality Control Items for Digital Breast Tomosynthesis System in Japan

Abstract

Mammography equipment attached to the digital breast tomosynthesis (DBT) system is widespread in Japan. However, there are no guidelines for quality control methods for DBT in Japan. Therefore, it is necessary to rapidly establish a performance evaluation procedure and a quality control procedure for DBT. In this study, we conducted basic experiments using DBTs of five companies (Canon Medical, Fujifilm Medical, GE Healthcare, Hologic, Siemens) already sold in Japan and examined feasible common items. We aimed to establish a quality control method for DBT in Japan. The measurement was performed based on the European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services (EUREF) breast tomosynthesis quality control protocol, version 1.03. In this study, we tried to measure 18 items in DBT. We examined whether the 18 items could be measured using each device; it is not an evaluation of device performance based on the measured values. There were some management items that were difficult to implement due to the specifications of DBT, such as devices that required pressure on DBT operation, problems due to the shape of bucky, and devices that did not have stationary mode. There were also problems with measurement data; for example, devices could not retrieve projection data and reconstruction data. This study clarified points to be considered for establishing common quality control items. In the future, we will carefully refer to the recently published IEC 61223-3-6, consider international harmonization, and establish DBT guidelines customized for the Japanese market.