Development Of On-line Reporting System For Medical Device Adverse Event

Medical device adverse event reporting is an important basis for carrying out monitoring work of medical device, and it is also a primary means for evaluating the safety of listed products. In recent years, with the in-depth development of medical device adverse event monitoring work, the original adverse event reporting models cause a series of problems. For example, the process of reports collection is interminable, the statistical analysis is not normative, and the information feedback is hysteretic. These problems not only make the monitoring work lack the scientific nature and time-effectiveness, but also hinder the development of medical and health service of our province.Therefore, according to our province's actual situation, the development of medical device adverse event on– line reporting system has important realistic significance.The thesis is based on the actual demand of adverse event reporting work of our province. And it develops the medical device adverse event on– line reporting system through using mixed survey procedure, step analysis, systematic analysis. The main research work of this paper include:1. Analysised present situation and problems of the adverse events survey at home and abroad. With combining the virtues of on– line reporting model, provided the target and details to deal with the problems of adverse event reporting work of our province.2. According to the demand of the system, the detailed design plans of the on– line reporting system were given, included database structure, data processing procedure, input/output design and so on.3. Realized all functional modules by using the PHP5 technical route, and achieved the desired results through system test and taking-over test with the participants of user-units.Now this system has been widely used in our province after tested in Ningbo and Taizhou areas. The development of the system provides a public reporting platform in efficience and convenience, and makes the reporting work more standard, it plays a positive role in the medical device adverse event monitoring work.