| Objective: To study the quality control programs in the processes of design, production and clinical trials of new breast cancer diagnostic instruments, especially statistical specification of clinical trials; to establish a set of indicator system for evaluating the development of new breast cancer diagnostic instruments and to provide references for establishing the quality control system in the development process of medical apparatus and instruments in the future.Methods: We studied the basic content and quality control requirements in the development process of new breast cancer diagnostic instruments preliminarily. And we used the combination of questionnaire survey, quantitative and qualitative research to evaluate development effects based on design, instruments and patients and got the quality feedback by the results of effect evaluation. The development of ATIR-M313 was taken as an example to be analyzed.Results: The statistical quality control in the development of new breast cancer diagnostic instruments need a set of indicator system of evaluation to be normalized in the phases of design, production and clinical trials. The design value of ATIR-M313 is 0.78 and it suggested the innovation was not high because of the interpolation design. In the preliminary trial the sensitivity, specificity, technical value and economic value of the trial-produced M313 were 0.8684, 0.8205, 0.7745 and 0.856. It suggested the instruments'volume and weight should be adjusted. When the instruments were produced with a small scale and the formal trial started, the sensitivity, specificity, technical value and economic value of the instruments were 0.8361, 0.7458, 0.776 and 0.840. And the patients'degree of satisfaction was 0.78.Conclusion: we should establish the effect evaluation system in SQC about new diagnostic instrument developed for breast cancer, timely feedback problems found correct deviation. The whole development process of statistical quality control is actually quality control standard and effect evaluation of process control, one plays the role of prevention afterwards controls. |
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