Medical device regulation in Mianyang City in recent years made a breakthrough in the effective protection of life and property safety. Union City, Mianyang City, Food and Drug Administration Health Bureau issued Mianyang City two and above medical institutions, medical device adverse event monitoring Assessment Rules for quantitative assessment of the city's medical institutions, medical device adverse event monitoring. The evaluation rules further strengthen the sense of responsibility of the medical device adverse event monitoring and awareness of risk control and regulate the use of units of the medical institutions of the medical device adverse event monitoring.
First, the medical establishment is to establish a monitoring organization. The establishment of the leading group of medical device adverse event monitoring, so that leaders attach importance to personnel to implement the measures in place. The second is a clear target management. The quantity and quality of the medical device adverse event monitoring into the unit's medical quality assessment, performance appraisal and annual assessment indicators, establish reward system linked to performance pay, job classification, and implement. Third, establish monitoring requirements and procedures. Clear medical device adverse event the suspicious information collection, disposal, evaluation and reporting procedures and requirements traceability management system, the establishment of high-risk medical devices. If you have any questions, please feel free to contact us.
|