Summary of major medical device adverse events in 2015
In 2015, the nationwide monitoring of medical device adverse events continued to develop steadily, and the number of reports of suspicious medical device adverse events in the year exceeded 320,000. While the number of reports continues to grow, the quality of reports continues to increase, providing a basis for the analysis and evaluation of risks after the listing of medical devices. According to the adverse event report data, medical device adverse events are analyzed in terms of report source, event Shanghai degree, medical device management category, medical device classification catalog, medical device product name, and actual use place. analyse as below: (1) Statistical analysis by source of reports In 2015, in the report of suspicious medical device adverse events reported by the whole country, 259,219 units were reported, accounting for 80.6% of the total number of reports; 5,352 production enterprises reported, accounting for 1.7% of the total number of reports; 56,315 business enterprises reported, totaling 17.5% of the reports; 364 reports were from individuals, accounting for 0.1% of the total number of reports; in addition, four reports were unknown (Figure 2-1). Figure 2-1 Sources of Reports on Medical Device Adverse Events in 2015 Overall, adverse event reports are still mainly derived from the use of units. Compared with 2014, the proportion of reports submitted by manufacturers has declined, which is inconsistent with the status of the first person responsible for the safety of equipment use, and the consciousness of fulfilling their duties needs to be improved. (2) Statistical analysis of the degree of injury by event In 2015, in the report of suspected medical device adverse events reported nationwide, there were 184 reports of incident injuries as deaths, accounting for 0.05% of the total number of reports; 47,065 reports of serious injuries were reported, accounting for 14.7% of the total number of reports; Event injuries were 274,005 for other reports, accounting for 85.2% of the total number of reports (Figure 2-2). In 2015, the absolute number of reports of various levels of injury increased, and its proportion was similar to that of 2014. Figure 2-2 2015 medical device adverse event report event damage degree Water Test Strips 15 Parameters Detection method:
2. Put the edge of the strip against the edge of the container to remove excess water samples;
3. Compare the test strip with the colorimetric table on the bottle label, and record the test result in the determination time: 0 ~ 60 seconds. Use visual.
Storage conditions: Water Test Strips 15 Parameters,Water Quality Test Kit,Professional Water Test Kit,Drinking Water Test Strips Changchun LYZ Technology Co., Ltd , https://www.lyzstrips.com.jpg)
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Operation method:
1. Visual inspection: Immerse the test area of the test paper into the fully stirred fresh drinking water, and take it out immediately;
The test paper should be stored in room temperature, dry environment, away from a variety of chemical reagent environment, avoid direct sunlight. This product does not need to be refrigerated (if it is stored for a long time, it should be restored to room temperature and opened for use).