ABSTRACT
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.
Subject(s)
Radiology Information Systems , Humans , Radiography , Software , WorkflowABSTRACT
BACKGROUND: Digital radiography devices are still the gold standard for diagnosis or therapy guidance in medicine. Despite the similarities between all direct digital x-ray systems, researchers and new companies face significant challenges during the development phase of innovative x-ray devices; each component is manufactured independently, guidance towards device integration from manufacturers is limited, global standards for device integration is lacking. METHOD: In scope of this study a plug-integrate-play (PIP) conceptual model for x-ray imaging system is introduced and implemented as an open hardware platform, SyncBox. The researchers are free to select each individual device component from different vendors based on their intended application and target performance are utilized in criteria. RESULT: As its first implementation, SyncBox and its platform a full body high resolution radiographic scanner that employs a novel TDI digital detector. CONCLUSION: We believe that SyncBox has a potential for introducing an open source hardware platform to x-ray equipment design.
ABSTRACT
A device-independent software package, named iBEX, is developed to accelerate the research and development efforts for X-ray imaging setups such as chest radiography, linear and multidirectional tomography, and dental and skeletal radiography. Its extension mechanism makes the software adaptable for a wide range of digital X-ray imaging hardware combinations and provides capabilities for researchers to develop image processing plug-ins. Independent of the X-ray sensor technology, iBEX could integrate with heterogeneous communication channels of digital detectors. iBEX is a freeware option for preclinical and early clinical testing of radiography devices. It provides tools to calibrate the device, integrate to health information infrastructure, acquire image, store studies on local storage, and send them to Picture Archiving and Communication System (PACS). iBEX is a unique open-source project bringing X-ray imaging devices' software into the scope of the open-source community to reduce the X-ray scanners' research effort, potentially increase the image quality, and cut down the production and testing costs of radiography devices.
