CFDA: national medical device adverse reaction monitoring annual report (2014)

Source: CFDA 2015-7-22, the State Food and Drug Administration issued the annual report on adverse reactions monitoring of national medical devices (2014) The report includes the general situation of adverse event report of medical devices, statistical analysis of adverse event report of medical devices, measures taken for the safety problems of three kinds of medical devices, including catheter, special electromagnetic wave therapeutic apparatus and fumigation equipment, etc., which comprehensively reflects the monitoring work of adverse event of medical devices in 2014 in China Statistical analysis shows that in 2014, the reporting work of adverse events of medical devices in China showed a good development trend, with the number of reports growing continuously, which has exceeded 260000, and the average number of reports of one million people has reached 198 Among them, 208107 reports were submitted by users, accounting for 78.5% of the total number of reports; 6122 reports were submitted by production enterprises, accounting for 2.3% of the total number of reports; 50348 reports were submitted by operating enterprises, accounting for 19.0% of the total number of reports; 666 reports were from individuals; 42.7% of the reports involved class III medical devices, 36.7% of the reports involved class II medical devices, and 18.2% of the reports involved class I medical devices 1、 Overall situation of adverse event reports of medical devices in China In 2014, the national monitoring of adverse events of medical devices continued to develop steadily The annual number of reports has reached 260000, and the average number of reports of one million people has reached 198, an increase of 11.1% and 10.6% respectively compared with 2013, maintaining a good development trend While the number of reports continued to grow, the quality of adverse event reports has also improved significantly （1） Number of suspicious adverse event reports in 2014, the national ADR monitoring center received 265246 suspicious medical device adverse event reports, 1295 supplementary reports of medical device adverse event submitted by the enterprise, and 2509 annual summary reports of medical device adverse event (Table 1-1) Table 1-1 comparison between the number of suspicious adverse event reports in 2014 and that in 2013 (II) the number of death and serious injury event reports in 2014, the national ADR monitoring center received 98 death and adverse event reports, 40920 serious injury event reports, 41018 in total, accounting for 15.5% of the total number of suspicious adverse event reports, 34% of 2013, 599 shares increased by 18.6% （3） Number of supplementary reports In 2014, the national ADR monitoring center received 1295 supplementary reports on adverse events of medical devices, with a significant increase in annual growth rate of 83.7%, which shows that the reporting subject awareness of manufacturers is significantly enhanced; for device safety monitoring, these supplementary reports from manufacturers provide more comprehensive and accurate information about adverse events involving devices (Fig 1-2) Figure 1-2 number of supplementary reports on adverse events of medical devices in China from 2010 to 2014 (IV) number of annual summary reports According to the requirements of management measures for monitoring and reevaluation of adverse events of medical devices (Trial), the manufacturers of the second and third categories of medical devices shall summarize and analyze the monitoring of adverse events of medical devices in the previous year before the end of January every year, fill in the annual summary report of adverse events of medical devices, and report to the provinces, autonomous regions and municipalities directly under the central government where they are located Monitoring technical organization In 2014, the national ADR monitoring center received a total of 2509 annual summary reports on adverse events of medical devices, an increase of 39.0% compared with 2013 However, compared with the number of nearly 10000 second and third class medical device manufacturers in China, the annual summary report rate of enterprises is only about 1 / 4, and the monitoring institutions at all levels need to strengthen the supervision and guidance of production enterprises （5） The average number of reports per million population in 2014, the average number of suspicious medical device adverse event reports per million population in China was 198, an increase of 19 compared with 2013, but the development of the provinces is unbalanced, and the number of reports has a large gap Compared with the growth of the total number of reports, the report number of one million population can better reflect the growth of the number of reports (Figure 1-3) Figure 1-3 comparison of the reported number of millions of people in China from 2010 to 2014 (6) the number of registered basic level users as of December 31, 2014 In the national medical device adverse event monitoring system, there are 174372 registered basic level users (including production enterprises, business enterprises and users) Among them, there are 9255 medical device manufacturers, accounting for 5.3% of the total registered basic level users; 75002 operating enterprises, accounting for 43.0% of the registered basic level users; 90115 users, accounting for 51.7% of the registered basic level users (Figure 1-4) Figure 1-4 registration of primary users of national medical device adverse event monitoring system in 2014, of 174372 registered primary users, the number of reported units was 60080, accounting for 34.5%, 13.3% higher than that in 2013 See table 1-2 for details of basic level users' reporting Table 1-2 reports of grassroots users (VII) number of suspicious adverse events reported in China from 2002 to 2014 January 1, 2002 to December 31, 2014, the national ADR monitoring center has received 1000805 suspicious adverse events of medical devices (Figure 1-5) Figure 1-5 number of suspicious medical device adverse event reports in China from 2002 to 2014 2 Statistical analysis of medical device adverse event reports (1) statistical analysis of medical device adverse event reports by report source in 2014, 208107 reports were submitted by users, accounting for 78.5% of the total number of reports; 6122 reports were submitted by production enterprises, accounting for 2.3% of the total number of reports; 50 reports were submitted by business enterprises, 348 reports, accounting for 19.0% of the total; 666 reports from individuals, accounting for 0.3% of the total; in addition, 3 reports from unknown sources In general, the device adverse event report is still mainly from the user of the device Compared with 2013, the proportion of reports submitted by manufacturers has declined, which is inconsistent with the status of the first person responsible for the safety of device use, and their consciousness of performing their duties needs to be improved In addition, the percentage of operating companies reported a decrease of 3.1 percentage points In 2014, the number of registered grassroots users reached 174372, an increase of 17.4% over 2013 34.5% of all registered basic users submitted adverse event reports Of the 9255 registered users of production enterprises, 3328 submitted reports, accounting for 36.0%, 5.5% higher than that in 2013; 20925 registered users of 75002 operating enterprises submitted reports, accounting for 27.9%, 12.3% higher than that in 2013; 35827 registered users submitted reports, 39.8%, 15.2% higher than that in 2013 (Figure 2-2, figure 2-3) （2） According to the statistics and analysis of the incident injury degree, in 2014, there were 98 reports of suspicious medical device adverse events, accounting for 0.04% of the total number of reports; 40920 reports of serious injury, accounting for 15.4% of the total number of reports; 224228 other reports of incident injury, accounting for 84.5% of the total number of reports In 2014, the absolute number of injury degree reports continued to increase, and the proportion was similar to that in 2013 In general, the number of suspicious medical device adverse event reports has continued the growth trend in recent years, and the quality of reports and the availability of information have been greatly improved （3） According to the statistics and analysis of medical device management categories, in 2014, there were 113220 reports involving class III medical devices (including 25398 reports of death and serious injury events), accounting for 42.7% of the total number of reports, followed by 97337 reports involving class II medical devices (including 11 reports of death and serious injury events), 722), accounting for 36.7% of the total report; the report involving class I medical devices is the least, 48152 in total (3381 of which are reports of death and serious injury events), accounting for 18.2% of the total report; the device management category involved in some reports is unknown, 6537 in total (517 of which are reports of death and serious injury events), accounting for 2.5% of the total report The data shows that the report of class II and class III medical devices is the main body, which is consistent with the risk level of medical devices (Figure 2-7) Figure 2-7 adverse event report of death and serious injury of medical devices in 2014 involving product management category (IV) statistical analysis by product catalog of medical devices According to the current medical device classification catalog, the 2014 suspicious medical device adverse event report involved 43 categories of products (except for the product classification is not detailed or not filled in), covering all categories of medical devices in the medical device classification catalog Among them, the top ten reported product categories are medical polymer materials and products, injection and puncture equipment, medical hygiene materials and dressings, physical treatment equipment, implant materials and artificial organs, medical optical equipment, instruments and endoscope equipment, common diagnostic equipment, medical electronic equipment, operating room, emergency room, diagnosis and treatment room equipment and clinical equipment Test analytical instruments Compared with 2013, clinical analytical instruments replaced medical suture materials and adhesives to become the 10th product category, while other product categories only slightly changed Table 2-1 product classification of 2014 medical device adverse event report (V) statistical analysis of the top five products according to the number of suspicious medical device adverse event reports In 2014, the top five passive medical devices reported were disposable infusion set, disposable sterile syringe, intrauterine device, corneal contact lens and intravenous indwelling needle, accounting for 32.1% of the total report, as shown in table 2-2 The top five active medical devices in the number of reports are patient monitor, infusion pump and injection pump, electronic sphygmomanometer, electrocardiograph and ventilator, accounting for 4.5% of the total number of reports, see table 2-3 for details Table 2-2 passive medical devices with the top five reported quantity table 2-3 active medical devices with the top five reported quantity (VI) statistical analysis by the users involved In 2014, 71.9% of the medical devices involved in the suspicious medical device adverse event report were operated by professionals; 1.7% of the medical devices involved in the report were operated by non professionals; 8.8% of the medical devices involved in the report were operated by patients themselves, and 17.6% of the reported operators were unknown The proportion of reports operated by professionals is basically the same as 70.1% in 2013 The existing information indicates that the operator is one of the important factors to be considered when analyzing the cause of the event, while the proportion of the unknown report operator is too large, indicating that the report quality still needs to be improved （7） According to the statistics and analysis of the reports of adverse events of suspicious medical devices in 2014, 187766 (70.8%) were reported in "medical institutions"; 34439 (13.0%) were reported in "family"; 33975 (12.8%) were reported in "unknown" places of use The use places of medical devices show a trend of diversification The complexity of the use places is one of the factors to be considered when analyzing the causes of adverse events.