Research Of Information-based Clinical Accreditation Program To Medical Imaging Equipment

Research of information-based clinical accreditation program to medical imaging equipment[Background]The clinical accreditation program to medical imaging equipment started late in our country and nowadays it is still at the exploration stage. The relevant laws and principles are not perfect meanwhile the implementation process is not strict. The lack of strict validated standard whether the accreditation program pass or not made it even worse. There were only some general rules for the clinical trial process and was short of strict standards to specific implementation process, the responsibility of the participating clinical trial staff as well as the validated standard whether the accreditation program pass or not. The audit of the paper version clinical results by the national FDA decided whether the medical equipment went public or not, never knowing the specific clinical trial process and the examination detail of the test subjects during the program. The clinical practice program can be hardly controlled. In order to realize the standardization of imaging accreditation program within our nation from filling out of the informed consent to imaging analysis and to submitting the clinical trial report, it was necessary to explore the automatic clinical trial software.Reduced the impact of human factors and realized the whole process real-time record.Part ⅠThe study of the theoretical basis and the feasibility of the automatic medical imaging equipment accreditation software in our nation.ObjectiveExplore the key points which influence the standardization of clinical validation program and the quality of clinical trial.Develop real-time recording and tracing information system.Background Analyzed the relevant problems within the laws and the implementation process within our nation and abroad. Indicated the theoretical basis and technical basis of the research and development of the clinical accreditation program to medical imaging equipment.Materials and methodsWe would come up with the standard advice of the medical equipment clinical trial according to ACR and EUR16261and EUR16262. Combined with the actual situation in China, Explore the key points which influence the standardization of clinical validation program and the quality of clinical trial.This advice mainly involved three aspects including the quality of diagnostic imaging and the assimilated radiation as well as the selection of the check technology.With the reference of acknowledged clinical trial software and the combination with the current situation of clinical trial in our country, the improvement and innovation of existing software, developed the appropriate software for China.Results1. Our research group would come up with the suggestive validated standard whether the accreditation program pass or not.2. The software developed by the radiologists and by the research group of Shanghai biological information technology research center, pointing out the flow chart which in order to realize the automation of the medical instrument clinical validation program. Part ⅡThe study of the test and the application prospect of the automatic medical imaging equipment accreditation software.ObjectiveResearched and developed the first automatic medical imaging equipment accreditation software within our nation. According to a plurality of medical image instrument clinical verification projects in our hospital in the past, software testing and comparative analysis with foreign clinical trial software, illustrated the application prospect of this software and the advantages and disadvantages.Materials and methodsFour systems were contained in the software. They were eCRF reporting system, EDC electronic data acquisition system, EDM electronic data management system, conventional clinical trial statistical system. Four basic functions were included:Electronic CRF (CRF definition, CRF-PDF template definition), data input (CRF items), statistical analysis, editable PDF and statistical analysis report generating(CRF export); A plurality of medical image instrument clinical verification programs were applied to this study to test the software. Took Philips Medical (Suzhou) Co.Ltd. CT, Ingenuity Core128for example, tested the automatic statistical function of the software.ResultsThe research group developed the country’s first medical image instrument clinical verification software. Through the test based on the multiple medical clinical image verification device projects conducted in our hospital, we found good compatibility and convenience during the application of the software and the statistical results were accurate and reliable.The projects we validated our software were Digital medical X ray photography system of Shanghai Xinhuangpu medical instrument limited company(including KD-1500DR、KD-1800DR),medical diagnostic X ray machine ZKXZ-500of Shanghai Zhongke medical equipment limited company(including ZKXZ-50, ZKXZ-50S),Philips Medical (Suzhou) Co., Ltd. X ray computer tomography apparatus Ingenuity Core128,Jiaheng medical technology (Shanghai) Co., Ltd. medical digital X-ray radiography system JHDX50P02-T.The statistical results were accurate and reliable.ConclusionThe automated medical image instrument clinical validation program and the electronization from the filling out of CRF to the statistic analysis of the clinical results had been realized. Not only ensured the standardization of the entire clinical validation process and the real-time data filling out, but was also conducive to the data preservation. Detailed information could be accessed at any time in the root directory for each subject and was convenient to the National Board Review. The obvious advantages of this software were that it could automatic statistical analyze the clinical validation data and could generate editable PDF. It could directly edit the data and change or add a text message to the PDF in accordance with the requirements of the Sponsor-Investigator, saving a lot of manpower and financial resources. Compared with the foreign software, this software had advantages and disadvantages and further improvements to some functions were needed.This software absorbed foreign advanced technology, and has new characteristics, convenient operation, strong applicability, suitable for China’s national conditions,easy to further promote the use of the software.The software still need further improvement because of its initial development stage.