Research On Risk Management In Product Design And Development For Disposable Infusion Set

Medical device is closely linked with people’s life and health. Disposable infusion set is one of the disposable sterile products, which are widely used in clinical. Also this product has the characteristics of high risk and large use number. This product appears repeatedly in the lists of the National Quality Supervision Inspection and adverse event monitoring in medical device. Design and development based on risk management is the effective method to control the product risk. Thus, it is necessary to study the risk management through design and development for the product.This thesis will take the disposable infusion set as the research object, take the enterprise risk management as the research target, By analyzing the characteristics of the industry and product, referring to relevant literature and expert opinions, combining the project management and risk management, in-depth research has been conducted in these risk management areas of risk identification, risk analysis, risk assessment and risk control, and the project risk identification, risk analysis, risk assessment and control of risk management, the main work is done as follows:(1) Use project risk management theory, combining the medical device industry’s national standards and disposable infusion set features, analyzing intended use and features, to identify the expected or foreseeable hazards.(2) Using a combination of qualitative and quantitative methods, take qualitative method to analyze the type of hazards in the process of disposable infusion set project design and development, quantifing the different types of hazards’ probability of occurrence and severity of damage and evaluate.(3) Combined risk rating criteria to assess the design and development of disposable infusion set of different types of risk levels, determine whether the risk needs to be reduced, using a variety of combinations of programs to develop appropriate control measures, monitoring the risks during the project.(4) Using the remaining risk assessment to verify the effectiveness of control measures, ensured that project risks has been reduced and successful operation. Through the research, a new product risk management mode will be built, which can be extended to domestic disposable infusion products enterprises for use, promote the scientific and systematic risk management in the industry, enhance the capability of risk management and ensure the validity and security for products.