China's Medical Device Adverse Event Report Breaks Through 370,000

According to the medical website on May 24, the State Drug Administration of the People's Republic of China announced on the 23rd the 2017 annual report on the monitoring of medical device adverse events. Overall, in 2017, the national report on medical device adverse events showed a good momentum of development. The number of reports continued to grow. There are more than 370,000 people, and the average number of million people has reached 282 reports.

The report includes the overall situation of medical device adverse event reports, statistical analysis of medical device adverse event reports, release of medical device alert alerts, etc. The report more fully reflects the 2017 monitoring of medical device adverse events in China.

The report pointed out that in 2017, the country drug Adverse reactions The monitoring center received a total ofmedical instruments The number of adverse event reports was 376,157, which was an increase of 6.49% compared to 2016. Among them, 211 reports of suspicious adverse event deaths were reported, and 57,754 were reported to seriously damage suspicious adverse events, totaling 57,765, an increase of 10.38% over 2016.

According to the statistical analysis of medical device product names, in 2017, the top ten passive medical devices reported in the report of medical device adverse events reported by the country were disposable infusion sets, disposable sterile syringes, and intravenous catheterization needles. , IUD, catheterization kit, contact lens, vitreous thermometer, catheter, medical infusion stickers and disposable ECG electrodes, 35.89% of the total report.

The SFDA stated that 2017 was a fruitful year for the monitoring of adverse events in medical devices. While the number of reports continued to grow, the quality of reports has also been continuously improved. At the same time, the focus of 100 medical device varieties during the “Thirteenth Five-year Plan” period The monitoring work has also been steadily progressing, which has played a positive role in the discovery and control of post-marketing medical device risks.