The Research On In-use Medical Device Surveillance Of B District

Medical equipment is a special commodity to protect human life and health.The product must be integrated with the latest science and technology,and has a certain safety and effectiveness.The safety and effectiveness of medical device become the focus of attention of the community;the market alone cannot achieve effective management.The risk-controlis directly related to the life safety of patients,it is also related to the stable development of society,and its importance is self-evident.Medical device security has become one of the important problems of medical security in our country.Therefore,it is urgent to strengthen the supervision and management of medical equipment.Because the supervision of medical equipment in our country starts late,the foundation of supervision is weak.In particular,there are no comprehensive and detailed provisions on the supervision of medical devices.There are many problems in the use of medical device regulation,facing a severe test.Afterreform of Foodand Drug Agencysince from the 2013,the government of B District,Beijing city started with the current situation of medical device supervision with government regulation theory,and analyzed the necessity of strengthening the supervision of medical devices;after through a large number of data collection and administration of medical devices medical devices administration practice and experience,the government of Fengtai District summed up the main problems existing in current medical;such as the instrument of administrative supervision organization,team member is not strong in law enforcement professional quality,not integration in organization and team,"promotion difficult,low salary" of enthusiasm for workin the use of medical devices supervision is not enough,the technical support system is weak,the medical device regulatory system is not perfect;and so on.Based on the experience of American medical device supervision,the government of Fengtai District summed up and introduced a series of measures and suggestionsto cover regulatory departments,medical institutions and technical support department of medical device regulatory system.Hope through strengthening the team construction to form a continuous supervision;innovation supervision mode to establish a long-acting regulatory mechanism;increasing capital investment to strengthen technical support system construction,improving medical device regulatory pathway in medical devices for scientific and effective supervision.