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National Medical Device Adverse Event Monitoring Annual Report (2020)

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In order to fully reflect the monitoring of adverse events of medical devices in my country in 2020, the National Adverse Drug Reaction Monitoring Center compiled the "Annual Report on the Monitoring of Adverse Events of Medical Devices (2020)".

1.
Progress in monitoring of medical device adverse events

In 2020, China's medical device adverse event monitoring work will continue to adhere to the "four strictest" requirements, and implement the "Medical Device Adverse Event Monitoring and Re-evaluation Management Measures" (hereinafter referred to as the "Measures"), focusing on the evaluation of medical device risks , Focusing on the implementation of medical device registrants and recorders (hereinafter referred to as registrants) adverse event monitoring main responsibility, continue to strengthen the construction of the system, continue to expand publicity and training methods, in-depth exploration of monitoring and evaluation methods, and comprehensively improve risk early warning and handling capabilities, New progress has been made in the monitoring of medical device adverse events.

(1) Promote report collection and expand system coverage of users

In 2020, the National Medical Device Adverse Event Monitoring Information System received more than 530,000 medical device adverse event reports, with an average of 402 reports per million people.
The county-level coverage rate of medical device adverse event reports in 28 provinces (autonomous regions and municipalities) reached 100%.
In addition, the number of registered users of the medical device adverse event monitoring system continued to increase, reaching more than 350,000, of which 27,195 were medical device registrants.

(2) In-depth exploration of product risks and completion of key monitoring tasks

In 2020, the risk assessment and disposal of medical device adverse events will be carried out in depth.
Strengthen the daily monitoring, early warning analysis and quarterly summary of the national medical device adverse event reports.
According to the discovered risks, a total of 1 issue of "Medical Device Adverse Event Information Bulletin" and 12 issues of "Medical Device Alert Newsletter" were issued throughout the year.
To complete the key monitoring tasks for adverse events of medical devices during the 13th Five-Year Plan period, all undertaking units actively review the preliminary work, sort out product risks, and submit risk evaluation reports for key monitoring products and summary reports for key monitoring work during the 13th Five-Year Plan period.

(3) Carry out training on laws and regulations and actively participate in international exchanges

In 2020, the National Adverse Drug Reaction Monitoring Center will train more than 1,000 registrants, medical institutions, and monitoring agency personnel.
At the same time, it will provide teachers for related training courses organized by drug regulatory agencies and monitoring agencies at all levels to strengthen the main responsibility of registrants and improve The ability of monitoring personnel has achieved good training results.
In addition, actively follow up the progress of the Adverse Event Terminology and Coding (AET) and Patient Registration (PR) of the International Medical Device Regulatory Forum, and actively participate in the National Regulatory Report (NCAR) project to carry out report information exchange, The level of internationalization is further improved.

2.
The overall situation of national medical device adverse event reports

(1) The overall situation of the annual report

1.
Number of reports of adverse events of medical devices nationwide.
In 2020, the National Medical Device Adverse Event Monitoring Information System received a total of 536,055 medical device adverse event reports, an increase of 35.
25% over the previous year (Figure 1).

Figure 1 National Medical Device Adverse Event Reports from 2016 to 2020

The average number of reports per million population.
In 2020, my country’s average number of medical device adverse event reports per million population is 402, an increase of 35.
35% over the previous year (Figure 2).

Figure 2 Comparison of the average number of reported adverse events of medical devices per million population across the country from 2016 to 2020

(2) Number of registered grassroots users nationwide

As of December 31, 2020, there are 350,973 grassroots users (including registrants, operating companies and users) registered in the National Medical Device Adverse Event Monitoring Information System, of which 27,195 are registrants, accounting for 7.

75% of the total number of users; There are 198,833 operating companies, accounting for 56.
65% of the total number of users; 124,945 users, accounting for 35.
60% of the total number of users (Figure 3).

Figure 3 Status of registered users of the National Medical Device Adverse Event Monitoring Information System in 2020

In 2020, the total number of registered grassroots users will increase by 10.

03% over the previous year.
Among them, the registered basic users of registrants increased by 38.

Figure 4 Comparison of the classification of registered users of the National Medical Device Adverse Event Monitoring Information System in 2019 and 2020

Statistical analysis of national medical device adverse event reports

3.
Statistical analysis of national medical device adverse event reports

(1) Statistical analysis according to the source of the report

In 2020, among the medical device adverse event reports received by the National Adverse Drug Reaction Monitoring Center, users reported 455,782 reports, accounting for 85.
03% of the total number of reports; registrants reported 11,191 reports, accounting for 2.
09% of the total number of reports; operating companies reported 68,902 reports , Accounting for 12.
85% of the total number of reports; 180 reports from other sources, accounting for 0.
03% of the total number of reports (Figure 5).

Figure 5 Sources of medical device adverse event reports in 2020

(2) Statistical analysis according to the degree of incident injury

In 2020, among the medical device adverse event reports received by the National Adverse Drug Reaction Monitoring Center, 218 reports of injuries were fatal, accounting for 0.

04% of the total; 32,874 reports of severe injuries were reported, accounting for 6.
13 of the total reports %; The degree of injury is 502,963 other reports, accounting for 93.

Figure 6 The degree of injury involved in the medical device adverse event report in 2020

In 2020, the National Adverse Drug Reaction Monitoring Center will promptly deal with the adverse event reports of medical devices whose injury degree is death, and urge registrants to conduct investigations and evaluations.

In the current analysis and evaluation events, most of them have no clear correlation with medical devices.
In follow-up monitoring, it has not been found that the above incidents involve abnormally increased risks of medical devices.

(3) Statistical analysis by medical device management category

In 2020, among the medical device adverse event reports received by the National Adverse Drug Reaction Monitoring Center, 178,305 reports related to Class III medical devices, accounting for 33.

26% of the total number of reports; 242,457 reports involving Class II medical devices, accounting for the total number of reports 45.

Figure 7 The medical device management category involved in the medical device adverse event report in 2020

(4) Statistical analysis according to the classification catalog of medical devices

In 2020, the medical device adverse event report received by the National Medical Device Adverse Event Monitoring Information System covers all categories in the medical device classification catalog.

Among them, the top ten medical device categories by the number of reports are shown in Table 1.

Table 1 The 2020 medical device adverse event report involves the classification of medical devices

(5) Statistical analysis according to the structural characteristics of medical devices

In 2020, among the medical device adverse event reports received by the National Adverse Drug Reaction Monitoring Center, 345,326 reports related to passive medical devices, accounting for 64.
42% of the total number of reports; 118,730 reports involving active medical devices, accounting for the total number of reports 22.
15%; 3,672 reports involving in vitro diagnostic reagents, accounting for 0.
69% of the total number of reports; 68,327 reports that did not fill in the structural characteristics of medical devices, accounting for 12.
75% of the total number of reports (Figure 8).

Figure 8 The medical device adverse event report in 2020 involves the structural characteristics of the medical device

(6) Statistical analysis based on actual use places

In 2020, among the adverse event reports of medical devices received by the National Adverse Drug Reaction Monitoring Center, there were 459,553 reports where the use place was “medical institution”, accounting for 85.

73% of the total; 64,109 reports where the use place was “family”, accounting for 11.
96% of the total number of reports; 12,393 reports where the place of use is "other", accounting for 2.
31% of the total number of reports (Figure 9).

Figure 9 The medical device adverse event report in 2020 involves the actual use of the place

Fourth, the release of information on adverse events of medical devices

In order to control the risks of medical devices in a timely manner and raise warnings about possible risks, in 2020, the National Adverse Drug Reaction Monitoring Center will summarize the main adverse event performance of related medical devices based on the risk situation found in daily monitoring, and publish the first phase of "Medical Devices Adverse Event Information Bulletin, which involves stapler products, and proposes risk control recommendations to relevant registrants, users, etc.

V.
Release of Medical Device Alert Newsletter

In 2020, the National Adverse Drug Reaction Monitoring Center will closely follow the global medical device supervision and release 12 issues of "Medical Device Alert News", which summarizes the releases of the United States, the United Kingdom, Australia and Canada, including heart valves, urinary catheters, monitors, and insulin A total of 79 safety information for medical devices such as pumps and ventilators provide reference for the safety evaluation and risk control of related medical devices in my country.

6.
Explanation of relevant situation

(1) Like most countries, my country's medical device adverse event reports are collected through a spontaneous reporting system and entered into the database, that is, when a certain event is suspected to be related to medical devices, it can be reported.
Affected by the reporter’s subjective awareness, experience level, cognition, and even the position held, the report of medical device adverse events may have one-sidedness and limitations, such as inaccurate interpretation of the degree of injury, irregular report filling, imperfect information, etc.
, or even Events that are not related to medical devices are also reported as adverse events, so the statistical results are deviated from the actual occurrence of medical device adverse events.

(2) The number of adverse event reports for different medical devices is affected by many factors such as the number of uses, risk levels, and reporting awareness.
Therefore, the number of reports does not directly represent the incidence of medical device adverse events or the severity of the risk.

(3) The above statistical data comes from the data received from January 1, 2020 to December 31, 2020 in the National Medical Device Adverse Event Monitoring Information System.
Due to the rounding rule in the statistics, the sum of percentages may not equal 100 %Case.

(4) At the completion of this year’s report, some of the serious injury medical device adverse event reports are still in the process of investigation and evaluation.
Therefore, the statistical results are true reflections of the data collection at the time of statistics, and do not represent the final conclusions of the medical device safety evaluation.
.

Tips

1.
Medical devices: refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the required computer software; its effectiveness is mainly through physical methods Obtained is not obtained through pharmacology, immunology or metabolism, or although these methods are involved but only play a supporting role; its purpose is:

1.
Medical equipment:

(1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;

(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;

(3) Inspection, substitution, adjustment or support of physiological structure or physiological process;

(4) Life support or maintenance;

(5) Pregnancy control;

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

2.
Medical device adverse event monitoring: refers to the process of collecting, reporting, investigating, analyzing, evaluating and controlling medical device adverse events.

2.
Monitoring of adverse events of medical devices:

3.
Medical device adverse events: refer to the various harmful events that have occurred under normal use of medical devices that have caused or may cause harm to the human body.

3.
Adverse events of medical devices:

4.
Death medical device adverse event report: Refers to the medical device adverse event report for which the final outcome of the patient is death.
It does not mean that the death of a patient is clearly related to the use of medical devices.

4.
Adverse event report of death medical device:

5.
Principles for reporting medical device adverse events : Reporting medical device adverse events should follow the principle of reporting if they are suspicious, that is, when an event is suspected to be a medical device adverse event, it can be reported as a medical device adverse event.
The content of the report should be true, complete and accurate.

5.
Principles for reporting adverse events of medical devices:

Medical device adverse events that cause or may cause serious injury or death should be reported; innovative medical devices should report all medical device adverse events of the product during the first registration cycle.

6.
Registration requirements for the National Medical Device Adverse Event Monitoring Information System: Registrants, operating companies, and second-level or higher medical institutions should register as users of the National Medical Device Adverse Event Monitoring Information System, actively maintain their user information, and report medical device adverse events.
The registrant shall continue to track and process the monitoring information; if the product registration information changes, it shall be updated in the system immediately.
Encourage other users to register as users of the National Medical Device Adverse Event Monitoring Information System and report information about medical device adverse events.

6.
Registration requirements for the National Medical Device Adverse Event Monitoring Information System:

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