In 2019, the **Medical Device Adverse Event Monitoring Information System received a total of 396,300 effective suspicious medical device adverse event reports, and 96.7% of counties (districts, cities) across the country reported medical device adverse events.

On December 3, the Chinese Society for Drug Administration, the Medical and Health Research Center of the Old Association for Science and Technology of Tsinghua University and the Social Science Literature Press jointly issued the "Medical Device Blue Book: China Medical Device Industry Development Report (2020)" (hereinafter referred to as the medical device blue book) ), disclosed the above data.

According to the introduction of the Blue Book of Medical Devices, medical device adverse events refer to the ** harmful events that occur under normal use of medical devices that have been on the market, which cause or may cause human injury. Medical device adverse event monitoring refers to the process of collecting, reporting, investigating, analyzing, evaluating and controlling medical device adverse events. The purpose of monitoring is to effectively control the risks after the product goes on the market and protect human health and life**.

The Blue Book of Medical Devices believes that monitoring of medical device adverse events is an important part of medical device supervision and helps to protect the health and health of medical device users and patients. At present, the "Regulations on the Supervision and Administration of Medical Devices" are being revised. With the continuous improvement of the ** medical device supervision regulations and policies, the supervision of medical devices after the market will be further strengthened in accordance with the law.

Hundreds of thousands of reports received every year

Monitor risks related to medical devices

Log in to the official website of the ** Drug Administration, click to enter the "Medical Devices" section, there is a column for "Medical Device Adverse Events Notification".

A reporter from the "Rules of Law Daily" combed through the notifications and found that in the whole year of 2019, the ** Drug Administration issued a total of 3 notifications.

In June 2019, the “risk of powdered medical gloves” was notified.

According to the report, medical gloves are the most advanced medical device products in clinical medical work. Their main function is to protect patients and medical staff and control infections in medical operations. They are widely used and used in large amounts. Medical gloves are restricted by materials and production processes. In order to prevent the gloves from failing due to adhesion, powder (talcum powder, starch or modified starch) is usually added as a release agent during the production process.

According to the report, these powders “may cause wound infections in patients and cause allergic reactions of medical staff, formation of granulomas, organ adhesions and other complications. In the production process of powdered medical gloves, the need to add powder to the gloves will also cause Environmental pollution and harm to operators".

"It is recommended that medical institutions choose appropriate medical glove products based on their own conditions and specific operational requirements, and in compliance with relevant regulations, and use powdered medical gloves with caution in clinical operations and other invasive operations. Medical institutions with conditions can be phased out. Powdered medical gloves; units that do not have the conditions for elimination can gradually reduce the use of powdered medical gloves." The notification stated.

In August and October of the same year, the ** Drug Administration issued notices separately, "Focus on the risk of incorrect use of acupuncture needles" and "Focus on the risk of rupture of disposable catheter balloons."

These notified information is only a microcosm of my country's collection of suspicious medical device adverse event reports.

According to the data disclosed in the Blue Book of Medical Devices, in 2019, the number of suspicious medical device adverse event reports collected by the **Medical Device Adverse Event Monitoring Information System nationwide was 402,700. After verification, after excluding wrong reports, there were 396,300 effective suspicious medical device adverse event reports, including 26,723 suspicious serious injury adverse event reports and 213 death reports.

A reporter from the "Rules of Law Daily" checked the data of the ** Drug Administration and found that in 2016, more than 350,000 medical device adverse event reports were received across the country; in 2017, the number of medical device adverse event reports nationwide exceeded 370,000; in 2018, it reached 406974 copies.

In addition, in 2019, the county-level coverage rate of adverse event reports in my country was 96.7%. Among them, the county-level coverage rate of 18 provinces (autonomous regions and municipalities) including Jiangsu, Shandong, and Beijing reached **.

Yue Xianghui, a member of the editorial committee of the Blue Book of Medical Devices and a third-level investigator of the Monitoring and Sampling Office of the Medical Device Supervision and Administration Department of the ** Drug Administration, said that the monitoring of medical device adverse events is an important measure to strictly prevent and control the risks of medical devices after the market is launched. It is also a medical device. An important part of supervision.

The report follows the principle of being suspicious and prompts risk signals through monitoring

In 2019, among the suspicious medical device adverse event reports received by the **Medical Device Adverse Event Monitoring Information System, according to the source report analysis, 357,799 were reported by user units, accounting for 90.27% of the total number of reports; the number of reports reported by operating companies accounted for 7.53 of the total number of reports %; The number of registrants and filing holders accounted for 2.17% of the total number of reports.

According to the analysis of actual places of use, 360,166 reports where the place of use is "medical institution", accounting for 90.87% of the total number of reports; the number of reports where the place of use is "family" accounts for 7.09% of the total number of reports; the number of reports where the place of use is "other" It accounts for 2.04% of the total number of reports.

According to the analysis of the classification catalog of medical devices, the top five categories by number are: infusion, nursing and protective equipment, medical diagnosis and monitoring equipment, physical therapy equipment, clinical testing equipment, respiratory, anesthesia and first aid equipment.

In addition, the Blue Book of Medical Devices specifically mentions that for the 213 suspicious adverse event reports of medical devices with deaths from the incident, the ** Adverse Drug Reaction Monitoring Center all handled them in a timely manner, and urged registrants to conduct investigations and evaluations.

"After investigation and verification, the collected adverse events of suspicious death medical devices are all individual case reports, and there are no mass incidents; after analysis and evaluation, most of them have no clear relationship with the use of medical devices. Only 1.41% of the incidents are related to the use of medical devices. Medical devices are related." said the blue paper on medical devices.

Yue Xianghui said in the blue paper on medical devices that a particularly important thing is "a correct understanding of monitoring data."

Yue Xianghui explained that the report of medical device adverse events follows the principle of “report if suspicious”, that is, as long as an event is suspected of being a medical device adverse event, it can be reported. Therefore, the reports collected by the adverse event monitoring technical institutions are all suspicious medical device adverse event reports, and it does not indicate that there is an inevitable causal relationship between the injury and the medical device used. The occurrence of medical device adverse events does not mean that the medical device products involved have quality problems.

"The number of suspicious adverse events reported for different types of medical devices is not directly comparable." Yue Xianghui said, "Medical devices with a large amount of use often report more suspicious adverse events; the same goes for the same occurrence. Probably, the number of medical devices that are used less frequently will have a correspondingly smaller number of adverse events."

In Yue Xianghui's view, the number of medical device adverse event reports does not directly reflect the occurrence of different types of medical device adverse events, nor does it directly reflect product risks. To put it simply, the large number of reports of product adverse events does not mean that its risk is high, and it may also be caused by a large amount of use; the occurrence of product adverse events does not mean that its risk is low.

"Generally speaking, medical device adverse event monitoring work is more like big data analysis. Through the collection and analysis of adverse event reports, the risk level of the product over a period of time can be evaluated, the development trend of the risk can be obtained, and the overall risk of the product can be analyzed. Status and prompt risk signals. Through the investigation, analysis and evaluation of these risk signals, the existing product risks can be found and confirmed, and risk prevention and control measures can be taken in a targeted manner, thereby effectively reducing product risks and achieving the effect of risk management. ." said the Blue Book of Medical Devices.

Continuous improvement of regulatory laws and regulations to enhance medical device regulatory capabilities

In December 2008, the former ** Food and Drug Administration and the former Ministry of Health jointly issued the "Administrative Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events (Trial)", officially establishing a medical device adverse event monitoring system in my country.

By June 2014, the medical device adverse event monitoring system was included in the scope of regulations. When the State Council revised the "Regulations on the Supervision and Administration of Medical Devices", a special chapter was set up to stipulate "The handling of adverse events and the recall of medical devices", and clearly proposed the establishment of a regulatory system for the monitoring and recall of medical device adverse events.

In 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council required in the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" to establish a system for direct reporting of adverse events by marketing license holders, and clarify the main responsibility of the holder for monitoring , Improve the monitoring system for medical device adverse events.

In August 2018, the newly formed ** General Administration of Market Supervision and ** Health Commission jointly issued the "Administrative Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events" (hereinafter referred to as the "Administrative Measures"), which determined that medical device product holders Adverse event monitoring is the main body to carry out work.

On January 1, 2019, the "Administrative Measures" were formally implemented, and the new medical device adverse event monitoring information system was put into operation. The drug regulatory authorities at all levels, medical device adverse event monitoring technical institutions, manufacturers, circulation enterprises and users in accordance with the new According to the requirements of the "Management Measures," the monitoring of adverse events should be carried out.

"It can be said that the monitoring of medical device adverse events in 2019 is a link between the previous and the next, and it is a phased watershed in the process of medical device adverse event monitoring." Yue Xianghui said.

It is worth noting that the revision of the "Regulations on the Supervision and Administration of Medical Devices" is also on the agenda.

In June this year, the General Office of the State Council issued the State Council’s 2020 legislative work plan, and the ** General Administration of Market Supervision and ** Drug Administration is responsible for revising the "Regulations on the Supervision and Administration of Medical Devices."

Chen Qiulin, deputy director of the Health Industry Development Research Center of the Chinese Academy of Social Sciences, once said in an interview with a reporter from the Rule of Law Daily that the State Council’s amendment to the “Regulations on the Supervision and Administration of Medical Devices” and the inclusion of the above content will strengthen the holders of medical devices, that is, medical devices. The provider of the device product has the responsibility to protect the device and protect the public's use of the device.

The Blue Paper on Medical Devices recommends to accelerate the revision process of the Regulations on the Supervision and Administration of Medical Devices, and simultaneously carry out the revision of relevant regulations and normative documents supporting the regulations, so as to further enhance the post-marketing supervision capabilities of medical devices in accordance with the law.

Geng Hongwu, editor-in-chief of the Blue Book of Medical Devices and Executive Deputy Director of the Medical and Health Research Center of the Old Association for Science and Technology of Tsinghua University, told the reporter of "Rules of Law Daily" that strict supervision of medical devices after they are on the market will help improve the quality of medical device products and help protect medical device users , The patient’s health and health. (Reporter Chen Lei and Liu Ziwei)

Source: Legal Daily