Research And Application Of Risk Management In Aseptic Processing Of Medical Devices

Medical equipment is a special commodity,which is widely used in daily life of humanity.Sterile medical device is a product provided by the medical device manufacturing company in sterile form,using the terminal sterilization or aseptic processing techniques,with high risk level.Sterility is not absolute,and the generally accepted standard is that the probability of survival of the microorganism reaches 10-6.With the improvement of people's living standards and the increasing demand for the quality of sterile medical devices,aseptic medical device is divided into class III medical device in accordance with the medical device classification rules on January 1,2016,which is a medical equipment of high risk level,with many quality control points in the production process.How to effectively control the production process,and reduce the risk level of production to ensure product quality safety,and stability,is an issue that the same sterile medical device manufacturers pay close attention to.Taking the aseptic medical device product as an example,according to the requirements of the medical device GMP,drawing lessons from risk management concept in quality management of pharmaceutical production,this paper uses related risk management tools to carry out risk assessment on the quality control of the whole process of production.To identify,analyze and evaluate risks,such as personnel,machines,materials,methods,and environment in the production process of aseptic medical devices,and find out the main risk points that affect the quality of the product.According to the QbD concept,reduce the risk in the workshop expansion and equipment upgrading.Risk management methods and tools we use are fishbone diagram method,risk matrix method,method of hazard analysis critical control point(HACCP)and process management method(PDCA cycle).For the convenience of practical application,combined with the concept of semi quantitative analysis,the semi quantitative analysis and research model of risk matrix is proposed for the first time.The risk matrix is applied to the production practice,which makes up for the shortcomings of the qualitative description of the traditional risk matrix and the lack of quantitative expression.Risk assessment group are established within the enterprise.We set the assignment of risk points,bid for the severity,probability of risk,and,find out the main risk points affecting the product quality according to evaluation criteria by intuitive data expression the influence degree of the risk.Purposefully avoid,and reduce the impact of these risks in workshop expanded design and equipment modification,analyze the design risks of producing clean plant,air conditioning system and production equipment using risk management tools,we determine the rehabilitation programs.Continuous application of risk management in production and operation process,we implemented production management according to the quality management system during the production process,and adopted the process management(PDCA cycle)method to control the entire process of product realization.We improve the quality of aseptic medical devices.