A Workflow for Ensuring DICOM Compatibility During Radiography Device Software Development.

In medical devices, nonconformance with Digital Imaging and Communications in Medicine (DICOM) standard is a serious risk. DICOM nonconformance radiology devices could cause undetected image loss, increasing examination time, and costs in health centers and could even result in the wrong patient treatment. However, there is a rich literature on medical standards that identify the best practices for producing safe and effective medical software. However, these standards do not expressly provide tools to deal with all the relevant DICOM compatibility issues in a specific case. This study aims to introduce a systematic software development workflow that complies with medical standards and ensures DICOM conformance of a new or upgraded radiology software project. In this approach, DICOM conformance gets the highest priority, and the whole software project is organized around it. Software requirement analysis, risk evaluation, and test management tasks are arranged systematically to make the final device DICOM conformant. This conceptual framework was developed during the R&D work towards a novel radiography device, and it could be employed as a roadmap in other medical imaging software projects. The proposed methodology controls the DICOM compatibility risk of the final software, and its systematic evaluation complied with medical standards.

Efficiency and reporting confidence analysis of sequential dual-energy subtraction for thoracic x-ray examinations.

Rationale and objectives: We aimed to report and compare accuracy, reproducibility, and reporting confidence between thoracic dual-energy subtraction (DES) and routine posterior-anterior chest radiography (PA-CR) techniques. Materials (patients) and methods: We obtained DES (D1-D4) images from 96 patients using DES and a high-resolution dynamic flat-panel detector in combination. We compared the DES images of these patients with their PA-CR images. The maximum time interval between performing DES and PA-CR was nine weeks. Two radiologists evaluated abnormal findings on DES and PA-CR images using a three-point scale, and reporting confidence was scored using a four-point scale. The intra- and interobserver agreement values of the scores were analyzed. Further, the radiation exposure doses during PA-CR and DES acquisitions were calculated. Results: The intra- and interobserver agreement values of PA-CR and DES images were good. The reporting confidence scores for DES were generally higher than those for PA-CR. Between bone-subtracted (D3) and soft-tissue-subtracted (D4) images, the former was more successful and useful in the evaluation of bone structures, whereas the latter was better in the evaluation of consolidation and/or solitary nodules. Conclusions: DES has the potential to improve the accuracy, reproducibility, and reporting confidence of thoracic radiography. It also has the potential to provide a better diagnosis of chest pathologies using relatively low dose radiation.