Wuxi advancing medical device adverse event monitoring work

Recently, all over increased medical device adverse event monitoring work, such as anhui on the introduction of the new requirements that must be reported within 24 hours. Recently, the administration's place from jiangsu province came news, in order to further strengthen the effective medical device adverse event monitoring work, this year the wuxi food and drug supervision bureau take six measures, effectively promoting medical device adverse event monitoring work and achieved good effect of the work.

One is to strengthen the system construction. Wuxi bureau joint health department promulgated the "wuxi medical device adverse event monitoring and reassess the detailed rules for the implementation of work (for trial implementation)".

The second is to strengthen the department communication and coordination. Efforts to guide within the jurisdiction of the medical institutions and drug retail business enterprise, medical equipment management enterprise become online report unit, and promote medical device adverse event monitoring work.

The third is to focus on training and tutorial combination. To strengthen within the jurisdiction of medical institutions, medical equipment production management enterprise, family planning system, and other units of the ADR business training.

The fourth is to strengthen the basic work of ADR of protecting assessment. Help promote each unit will medical device adverse event monitoring work into the institutionalized and standardized track.

The fifth is to strengthen the monitoring of key monitoring varieties efforts. The key monitoring varieties follow "suspicious that quote" principle, not collect adverse events provided by the month zero report, point to an area promote monitoring work.

The sixth it is combined with the daily supervision ADR propaganda knowledge. Finishing and the release of the medical device adverse event monitoring propaganda manual "more than 1000 copies, improve the masses of medical device adverse event monitoring work understanding.

Up to now, the medical device manufacturing enterprise, the second class above medical institutions are all in countries registered ADR monitoring system, through the Internet to declare the registered unit 1049 home, online report unit 289; The report medical device adverse events monitoring report 917 cases, of which every populations report number to 195.