In 2019, the National Medical Device Adverse Event Monitoring Information System received a total of 396300 valid suspicious medical device adverse event reports, and 96.7% of counties (districts, cities) nationwide reported medical device adverse events.
On December 3rd, the China Association for Drug Administration, the Medical Health Research Center of the Tsinghua University Association for Elderly Scientists, and the Social Science Literature Press jointly released the "Medical Device Blue Book: China Medical Device Industry Development Report (2020)" (hereinafter referred to as the "Medical Device Blue Book"), which disclosed the above data.
According to the introduction of the Blue Book of Medical Devices, adverse events of medical devices refer to various harmful events that occur under normal use of medical devices that 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 post market risks of products and ensure human health and life safety.
The Blue Book of Medical Devices believes that national monitoring of adverse events related to medical devices is an important aspect of medical device regulation, which helps to ensure the health and safety 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 national medical device regulatory regulations and policies, the regulatory efforts after the listing of medical devices will be further increased in accordance with the law.
Log in to the official website of the National Drug Administration and click to enter the "Medical Devices" section, where there is a column titled "Medical Device Adverse Event Notification".
A reporter from Rule of Law Daily found that throughout 2019, the National Drug Administration issued a total of three information notifications.
In June 2019, the risk of powdered medical gloves was reported.
The report states that medical gloves are indispensable medical device products in clinical medical work, mainly used to protect patients and medical staff during medical operations, control infections, and are widely used in large quantities. Medical gloves are limited by materials and production processes. In order to prevent gloves from becoming ineffective due to adhesion, powder (talcum powder, starch, or modified starch) is usually added as a isolating agent during the production process.
According to the report, these powders may cause wound infections in patients, allergic reactions among medical staff, formation of granulomas, organ adhesions, and other complications. During the production process of powdered medical gloves, the need to add powder to the gloves can also cause environmental pollution and harm to operators.
It is recommended that medical institutions choose to use appropriate medical glove products based on their own situation and specific operational needs, while complying with relevant regulations. They should be cautious in using powdered medical gloves in invasive operations such as clinical surgeries. Medical institutions with conditions can gradually phase out powdered medical gloves; units that do not currently meet the conditions for elimination can gradually reduce the use of powdered medical gloves, "the notice said.
In August and October of the same year, the State Food and Drug Administration issued circulars respectively, "concerned about the risk of incorrect use of acupuncture and moxibustion needles" and "concerned about the risk of rupture of disposable catheter balloons".
These notification information is only a microcosm of China's collection of suspicious medical device adverse event reports.
According to the data disclosed in the Medical Device Blue Book, in 2019, the National Medical Device Adverse Event Monitoring Information System collected 402700 suspicious medical device adverse event reports nationwide. After verification, after removing the erroneous reports, there were 396300 valid reports of suspected medical device adverse events, including 26723 reports of suspected serious injury adverse events and 213 reports of death.
A reporter from Rule of Law Daily found that in 2016, more than 350000 reports of adverse events related to medical devices were received nationwide, based on data from the National Drug Administration; In 2017, the number of adverse event reports on medical devices nationwide exceeded 370000; In 2018, it reached 406974 copies.
In addition, in 2019, the county-level coverage rate of adverse event reports in China was 96.7%, with 18 provinces (autonomous regions, municipalities directly under the central government) including Jiangsu, Shandong, and Beijing having a county-level coverage rate of 100%.
Yue Xianghui, a member of the editorial committee of the Medical Device Blue Book and a three-level researcher at the Monitoring and Inspection Department of the Medical Device Supervision and Administration Department of the National Drug Administration, said that monitoring adverse events of medical devices is an important measure to strictly prevent and control the risks of medical devices after they are launched, and it is also an important link in medical device supervision.
In 2019, the National Medical Device Adverse Event Monitoring Information System received 357799 suspicious medical device adverse event reports by source analysis, accounting for 90.27% of the total number of reports; The number of reports submitted by operating enterprises accounts for 7.53% of the total number of reports; The number of registrants and registrants reporting accounts for 2.17% of the total number of reports.
According to the analysis of actual usage places, there are 360166 reports using "medical institutions", accounting for 90.87% of the total number of reports; The number of reports using 'home' accounts for 7.09% of the total number of reports; The number of reports using 'other' accounts for 2.04% of the total number of reports.
According to the classification catalog analysis of medical devices, the top five categories in terms of quantity 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 the National Adverse Drug Reaction Monitoring Center has promptly handled 213 suspicious medical device adverse event reports with a degree of injury of death, urging registrants to conduct investigations and evaluations.
After investigation and verification, the suspected death of medical device adverse events collected are all individual case reports without mass occurrence. After analysis and evaluation, the vast majority of them have no clear relationship with the use of medical devices, and only 1.41% of the events are related to the medical devices involved, "said the Medical Device Blue Book.
Yue Xianghui stated in the medical device blue book that a particularly important thing is "a correct understanding of monitoring data".
Yue Xianghui explained that the reporting of adverse events related to medical devices follows the principle of "reporting when suspicious", which means that as long as a certain event is suspected to be a medical device adverse event, it can be reported. Therefore, the reports collected by adverse event monitoring technology institutions are all suspicious medical device adverse event reports, and cannot indicate the inevitable causal relationship between the injury and the medical device used. The occurrence of adverse events on medical devices does not necessarily mean that there are quality issues with the medical device products involved.
The number of suspicious adverse event reports for different types of medical devices also does not have direct comparability, "said Yue Xianghui
In Yue Xianghui's view, the number of adverse event reports for medical devices cannot directly reflect the occurrence of adverse events for different types of medical devices, nor can they directly reflect product risks. Simply put, the large number of adverse event reports on products does not necessarily indicate a high risk, but may also be caused by a large amount of usage; The occurrence of fewer adverse events does not necessarily mean that the risk is low.
Generally speaking, the monitoring of adverse events in medical devices is more like big data analysis. By collecting and analyzing adverse event reports, the risk level of products over a period of time can be evaluated, the development trend of risks can be identified, the overall risk status of products can be analyzed, and risk signals can be prompted. By investigating, analyzing, and evaluating these risk signals, existing product risks can be identified and confirmed, and targeted risk measures can be taken Risk prevention and control measures can effectively reduce product risks and achieve the effect of risk management The medical device blue book states.
In December 2008, the former State Food and Drug Administration and the former Ministry of Health jointly issued the "Management Measures for Monitoring and Reevaluation of Adverse Events of Medical Devices (Trial)", officially establishing a medical device adverse event monitoring system in China.
By June 2014, the medical device adverse event monitoring system had been incorporated into the scope of regulations. When the State Council revised the Regulations on the Supervision and Administration of Medical Devices, a special chapter was established to provide for the handling of adverse events and the recall of medical devices, clearly proposing the establishment of a regulatory system for monitoring and recalling 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 requested in the "Opinions on Deepening the Reform of the Evaluation and Approval System to Encourage Innovation in Pharmaceutical and Medical Devices" to establish a system for direct reporting of adverse events by holders of marketing permits, clarify the main responsibilities of holders for monitoring, and improve the monitoring system for adverse events of medical and medical devices.
In August 2018, the newly established State Administration for Market Regulation and the National Health Commission jointly issued the "Management Measures for Monitoring and Reevaluation of Adverse Events of Medical Devices" (hereinafter referred to as the "Management Measures"), which determined to focus on monitoring adverse events of medical device product holders.
On January 1, 2019, the "Management Measures" were officially implemented, and a new medical device adverse event monitoring information system was put into operation. Drug regulatory departments at all levels, medical device adverse event monitoring technology institutions, production enterprises, circulation enterprises, and user units carried out adverse event monitoring work in accordance with the requirements of the new "Management Measures".
It can be said that the monitoring of adverse events in medical devices in 2019 is a transitional milestone in the process of monitoring adverse events in medical devices, "said Yue Xianghui.
It is worth noting that the revision of the Regulations on the Supervision and Administration of Medical Devices has also been put on the agenda.
In June of this year, the General Office of the State Council issued the 2020 Legislative Work Plan of the State Council, which was revised by the State Administration for Market Regulation and the State Administration for Drug Administration.
Chen Qiulin, deputy director of the Health Industry Development Research Center of the Chinese Academy of Social Sciences, once said in an interview with the reporter of the Rule of Law Daily that the State Council's revision of the Regulations on the Supervision and Administration of Medical Devices and their inclusion in the above content will strengthen the security responsibility of medical device listing holders, i.e. medical device product providers, for devices and ensure the safety of public devices.
The Blue Book of Medical Devices suggests accelerating the revision process of the "Regulations on the Supervision and Administration of Medical Devices", simultaneously carrying out the revision of relevant regulations and normative documents supporting the regulations, and further enhancing the regulatory capacity of medical devices after listing in accordance with the law.
Geng Hongwu, editor in chief of the Blue Book of Medical Devices and executive deputy director of the Medical Health Research Center of the Tsinghua University Association for Retired Science and Technology, told the Legal Daily that strict supervision of medical devices after their launch can help improve the quality of medical device products and ensure the health and safety of medical device users and patients. (Reporter Chen Lei and Liu Ziwei)
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