The medical website of May 11 

 

Report on the overall situation of adverse events in medical devices nationwide 

 

In 2016, the monitoring of medical devices in China continued to develop steadily, and over 350,000 cases of suspected medical devices were reported in the whole year. As the report continues to grow, the quality of the report continues to improve, providing the basis for the analysis and evaluation of the risk of post-marketing medical devices. 

 

(1) the overall report on the country's suspected adverse events in 2016 

 

The number of suspected adverse events in the country between 2002 and 2016 

 

In 2016, the national drug response monitoring center received a total of 353240 cases of suspected medical devices, up 10.0% from 2015 (figure 1-1). January 1, 2002, December 31, 2016, the national drug adverse reaction monitoring center received 1,675,299 in the report on the adverse events of suspected medical devices. 

 

 

Figures 1-1-2011 - the number of reported adverse events in the country 

 

Death and the number of reported adverse events reported 

 

In 2016, the national adverse drug reaction monitoring center received serious injuries suspicious adverse events report 52331, deaths suspicious adverse events report 181, a total of 52512, than in 2015 increased by 11.1% (figure 1-2). The number of reported deaths and serious injuries reported in 2016 was 14.9 percent, up 0.2 percent from 2015. 

 

 

Figures 1-2 2011-2016 were compared to the number of reported adverse events reported in the country 

 

The average number of reports per million people 

 

In 2016, the number of reported adverse events in China per million people was 264, up 24 from 2015 (FIG. 1-3). 

 

 

Figures 1-3, 2011-2016 compare the average number of people per million people in the country 

 

(2) the number of registered primary users 

 

As of December 31, 2016, in medical device adverse event monitoring system in the country, registered users at the grass-roots level (including medical equipment producing enterprises, trading enterprises and the use of units), a total of 231872. Among them, medical device manufacturers 10,534, accounting for 4.5% of the total number of registered users. There were 115,622 operating enterprises, accounting for 49.9% of the registered primary users. The use unit 105,716, accounting for 45.6% of the registered primary users (FIG. 1-4). 

 

 

FIG. 1-4: the national health and equipment monitoring system in 2016 registered the status of the primary users 

 

In 2016, the total number of registered primary users, including medical device manufacturers, businesses and use units, increased by 16.8 percent from 2015. Among them, the number of registered primary users of medical device manufacturing enterprises, operating enterprises and using units increased by 1.8%, 26.6% and 9.1% respectively in 2015 (figure 1-5). 

 

 

Figure 1-5 2015 and 2016 national registered grassroots user classification comparison 

 

Statistical analysis of adverse events in medical devices in 2016 

 

(1) statistical analysis by reporting source 

 

In 2016, the national report on suspected medical devices reported that the unit reported 297,435 units, accounting for 84.2 percent of the total report. Production enterprises reported 6,604, accounting for 1.9% of the total report. Business enterprises reported 49,002, accounting for 13.9% of the total report; 190 reports came from individuals, accounting for 0.05% of the total report. There are also nine reports of unknown provenance (figure 2-1). 

 

 

Figure 2-1: the report on adverse events in medical devices in 2016 

 

In general, the report of adverse events is still mainly derived from the use of units, followed by the management enterprises. Less than 2 per cent of the report submitted by the production enterprise is not in conformity with the position of the safety first responsible person, and the performance of the responsibility of the production enterprise has yet to be improved. 

 

(2) statistical analysis of the extent of incident injury 

 

In 2016, the report on the report on suspected medical devices reported in the country reported that the number of deaths reported in the report was 181, accounting for 0.05% of the total report. The total number of reported injuries was 52,331, or 14.8% of the total report. The incident injuries accounted for 300,728 other reports, accounting for 85.1 percent of the total report (figure 2-2). In 2016, the proportion of reported injuries was roughly the same as in 2015. 

 

 

Figure 2-2 in 2016 the adverse events of medical devices report the extent of injury 

 

(3) statistical analysis of the management of medical devices 

 

In 2016, the report suspicious medical device adverse event report, involving the class Ⅲ medical devices report 146689, accounting for 41.5% of the total number of the report; Involving Ⅱ class medical device report 148945, accounting for 42.2% of the total number of the report; Involving Ⅰ class medical device report 38728, accounting for 11.0% of the total number of the report; Part of the report involved an unknown number of device management categories, of 18,878, which accounted for 5.3% of the total report. Data show that involves Ⅲ classes and class Ⅱ medical device reports the vast majority of it in conformity with the medical instrument risk level (FIG. 2-3). 

 

 

The report on the adverse events of medical devices in 2016 involves the product management category 

 

(4) according to the statistical analysis of the classified catalogue of medical devices 

 

According to the current the catalog of medical device classification, 2016 national reporting suspicious medical device adverse event reports involved 43 products, covers all medical devices in the catalog of medical device classification categories. In this case, the number of reports in the top 10 is shown in table 2-1. Compared with 2015, the number of product categories in the top 10 was unchanged, with only a slight variation in the number of product categories. 

 

 

Table 2-1 the number of product categories in the top 10 list of reported adverse events reported in 2015 

 

(5) according to the statistical analysis of product names of medical devices 

 

In 2016, the report suspicious medical device adverse event report, report the number of the top 10 passive medical apparatus and instruments, respectively for the use of disposable infusion sets, disposable sterile syringes, intrauterine device, venous indwelling needle, corneal contact lens, glass thermometer, urethral catheterization bag, medical tape, medical infusion and catheters, accounting for 38.26% of the total number of the report, see table 2-2. 

 

 

Table 2-2 reports the number of unsourced medical devices in the top 10 

 

In 2016, the report suspicious medical device adverse event report, report the number of the top 10 active medical devices respectively for patient monitor and infusion pump and syringe pump, electronic sphygmomanometer, electrocardiogram, blood dialysis machine, breathing machine, glucose meter, infant incubator, electronic thermometers and microwave therapy apparatus, accounting for 8.79% of the total number of the report, see table 2-3. 

 

 

Table 2-3 reports the number of active medical devices in the top 10 

 

(6) according to the actual use site statistical analysis 

 

In 2016, 79 percent of the reported cases of suspected medical devices reported in the country were reported to be "medical institutions". The use of the site was 37,343, or 11%. The use of sites for "other" reports 7,559, or 2%; The use of unfilled reports was 29,777, 8% (figure 2-4). The complexity of using the site is one of the factors that needs to be considered when analyzing the causes of adverse events. 

 

 

The report on the adverse events of medical devices in 2016 involved practical use of the site 

 

Third, the key monitoring of the adverse events of medical devices 

 

(1) the key monitoring results of the 12th five-year plan are applied 

 

Administration of "twelfth five-year" period, the group of 100 varieties of medical equipment to carry out the key monitoring, active product the adverse events of information collection, analysis and evaluation of exposure risks, risk to find interesting products, in-depth analysis of its causes, put forward the corresponding risk control measures are suggested. Administration of medical devices and supervision of the risk control measures suggested summary analysis, and how to take the corresponding regulation measures on this basis, the relevant evaluation results feedback to the production enterprise, national health development planning commission and the provincial bureau, in order to better provide reference post-marketing surveillance of medical equipment. 

 

(2) the key monitoring of the 13th five-year plan 

 

In 2016, the administration on "twelfth five-year" period to carry out 100 varieties key monitoring based on experience, carefully chose the 100 key monitoring carried out during the period of "much starker choices-and graver consequences-in" varieties. On selecting varieties, fully consider the risk of product characteristics, use of proper conditions, adverse event data, the problems found in the just listed, risks exist in the literature and clinical cases of innovative products, such as less factors, clinical, engineering, and administration and invite relevant experts to many discussions, screening of varieties, eventually to be sure. Among them, the infusion pump and other 46 products for the "twelfth five-year" period has been carried out before products, during the period of "much starker choices-and graver consequences-in" will focus on "twelfth five-year" key monitoring has been found that the risk of point in continue to carry out targeted monitoring. 

 

Report the quality assessment of adverse events in medical devices 

 

(1) publication of the quality assessment provisions of the report on adverse events in medical devices (trial) 

 

2016 is the year of the quality of the report on adverse events reported by the administration. For the implementation of the work, in June 2016, national center issued a "medical device adverse event report on the quality evaluation regulation (try out)", as the report at the grass-roots level unit increase the integrity and accuracy of the medical device adverse event report provides a specific reference standard. 

 

The regulations clarify the quality assessment work responsibilities, the scope of reporting for the quality assessment and the specific reporting criteria, which are operational. The report's rating standards stipulate that the report's authenticity is rejected. The scoring items included reporting timelines, reporting sources, patient information, adverse events, device information and evaluation of the six sections, totaling 100 points. Score in the project information of adverse events and instruments to score point, respectively accounted for 46 points and 34 points, because the two parts to carry out the report of analysis and evaluation to provide main information. 

 

Report on the quality assessment of adverse events in national medical devices 

 

The medical device adverse event report on the quality evaluation regulations (try out) ", issued by the national center held the national medical device adverse event reporting quality assessment training, to the national 31 provinces (autonomous regions and municipalities), national health planning commission, the xinjiang production and construction corps, and the Chinese people's liberation army (PLA) adverse drug reaction monitoring center and all prefecture-level adverse drug reaction monitoring center for training, greatly improve the country's medical device adverse event monitoring system of staff awareness of the quality of the report, to our country medical device adverse event monitoring has played a positive role in promoting. 

 

Quality assessment rules according to the report on the medical device adverse events (try out) "requirements, the provinces (autonomous regions and municipalities) since the third quarter of 2016 to the province of medical device adverse event reports conducted quarterly quality evaluation work. 

 

The release of medical device alerts in 2016 

 

In 2016, the national adverse drug reaction monitoring center released a total of 10 times the medical device vigilance express, including article 49 foreign medical device regulatory release, the security of the information involved in electronic duodenum mirror, neurosurgery head holder, artificial knee joint, injection pumps, portable emergency oxygen supply system, etc. 

 

Tips for monitoring adverse events in medical devices 

 

1. Medical equipment: refers to the instruments used in the human body directly or indirectly, equipment, instruments, in vitro diagnostic reagents and calibration, materials, and other similar or related items, including computer software needed to; Its utility by physical methods such as get, not by way of pharmacology, immunology or metabolism, or despite these ways to participate in but only a supplementary role; The aim is to: 

 

(1) diagnosis, prevention, guardianship, treatment or remission of the disease; 

 

(2) diagnosis, monitoring, treatment, mitigation or function compensation of injury; 

 

(3) the examination, replacement, modulation or support of the physiological or physiological processes; 

 

(4) the support or maintenance of life; 

 

(5) pregnancy control; 

 

(6) to provide information for medical or diagnostic purposes by examining samples from the human body. 

 

2. Medical device adverse events: refers to the registration or has been put on record, quality qualified medical equipment, in normal use, cause or may cause the human body harm the various harmful events. 

 

Based on the endangering degree from the medical device adverse events and causes of medical device production enterprise shall, when necessary, take warning, inspection, repair, labels, modify the manual, software upgrades, replace, recall and destroy such as control measures. 

 

At present, the monitoring of adverse events of medical devices in our country is collected in accordance with the principle of "suspicious and reported", which is the report of adverse events for suspected medical devices. 

 

Monitoring of adverse events in medical devices: the process of discovery, reporting, investigation, evaluation and control of adverse events in medical devices. 

 

Serious medical device adverse events: refers to one of the following: 

 

(1) death; 

 

(2) life threatening; 

 

(3) permanent injury to the body's function or permanent damage to the body's structure; 

 

(4) medical measures must be taken to prevent such permanent injuries or injuries. 

 

(5) problems such as malfunctions and availability of medical devices may lead to these conditions. 

 

Reports of suspected adverse events of death: the report of adverse events in which the patient is ultimately killed. There is no clear link between the death of the patient and the use of medical devices. 

 

The difference between adverse events in medical devices and quality accidents and medical accidents 

 

Medical device adverse events (1) is mainly due to the design of the product defects, have already registered the audit instructions to causes such as inaccurate or inadequate, but the quality of its products are qualified. 

 

(2) the quality accidents of medical devices mainly refers to the accidents caused by the quality of the medical devices which do not conform to the standards of the registered product. 

 

(3) medical accident is refers to the medical institutions and medical personnel in medical activities, in violation of the medical and health management regulations of laws, administrative regulations, department and diagnosis and treatment to nurse standard, conventional, error causes the accident that personal injury patients. (from the ministry of health's regulations on medical accidents.)