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Stricter Supervision After The Listing Of Medical Devices

2022-03-25 Author: Views: 0

In 2019, the national medical device adverse event monitoring information system received a total of 396300 effective suspicious medical device adverse event reports, and 96.7% of counties (districts and cities) in China reported medical device adverse events.

On December 3, the blue book of medical devices: development report of China's medical device industry (2020) (hereinafter referred to as the blue book of medical devices) was jointly released by the China Institute of drug administration, the medical and health research center of Tsinghua University Association for veteran science and technology and the social science Literature Publishing House.

According to the blue book of medical devices, adverse events of medical devices refer to various harmful events that occur under normal use of listed medical devices and lead to or may lead to human injury. Adverse event monitoring of medical devices refers to the process of collecting, reporting, investigating, analyzing, evaluating and controlling adverse events of medical devices. The purpose of monitoring is to effectively control the post marketing risks of products and ensure human health and life safety.

The blue book of medical devices believes that the national monitoring of adverse events of medical devices is an important link in the supervision of medical devices and helps to ensure the health and safety of users and patients of medical devices. At present, the regulations on the supervision and administration of medical devices are being revised. With the continuous improvement of national regulations and policies on the supervision of medical devices, the supervision of medical devices after listing will be further strengthened according to law.

Log in to the official website of the State Drug Administration, click to enter the "medical devices" section, with the column of "notification of adverse events of medical devices".

The reporter of rule of law daily found that in 2019, the State Drug Administration issued three information circulars.

In June 2019, "risk of powdered medical gloves" was notified.

According to the circular, medical gloves are indispensable medical devices in clinical medical work. Their main function is to protect patients and medical staff in medical operation and control infection. They are widely used and used in large amounts. Medical gloves are limited by material and production process. In order to prevent gloves from failure due to adhesion, powder (talc powder, starch or modified starch) is usually added as isolation agent in the production process.

According to the circular, these powders "may cause wound infection of patients and complications such as allergic reaction, granuloma formation and organ adhesion of medical staff. In the production process of powdered medical gloves, due to the need to add powder to the gloves, it will also lead to environmental pollution and injury to operators".

"It is suggested that medical institutions choose to use appropriate medical gloves products according to their own conditions and specific operation needs, and be careful to use powdered medical gloves in invasive operations such as clinical surgery. Qualified medical institutions can phase out powdered medical gloves; units that do not meet the conditions for phase out can gradually reduce the use of powdered medical gloves." Informed that.

In August and October of the same year, the State Drug Administration issued circulars respectively to "pay attention to the risk of incorrect use of acupuncture needles" and "pay attention to the risk of rupture of disposable catheter balloon".

These notification information is only an epitome of the collection of adverse event reports of suspicious medical devices in China.

According to the data disclosed in the blue book of medical devices, in 2019, the national medical device adverse event monitoring information system collected 402700 suspicious medical device adverse event reports nationwide. After verification, after excluding the error reports, there were 396300 effective reports of suspected adverse events of medical devices, including 26723 reports of suspected serious injury adverse events and 213 reports of death.

The reporter of rule of law daily checked the data of the State Drug Administration and found that in 2016, more than 350000 adverse event reports of medical devices were received across the country; In 2017, the number of adverse event reports of medical devices in China exceeded 370000; In 2018, it reached 406974 copies.

In addition, in 2019, the county-level coverage of adverse event reports in China was 96.7%, of which the county-level coverage of 18 provinces (autonomous regions and municipalities directly under the central government) such as Jiangsu, Shandong and Beijing reached 100%.

Yue Xianghui, a member of the Editorial Committee of the blue book of medical devices and a third-class researcher of the monitoring and sampling Department of the medical device supervision and Administration Department of the State Drug Administration, said that the monitoring of adverse events of medical devices is an important measure to strictly prevent and control the risks after the listing of medical devices, and it is also an important link in the supervision of medical devices.

In 2019, among the reports of suspected adverse events of medical devices received by the national adverse event monitoring information system of medical devices, according to the analysis of source reports, the user reported 357799, accounting for 90.27% of the total reports; The number reported by operating enterprises accounts for 7.53% of the total number of reports; The number reported by registrants and recorders accounts for 2.17% of the total number of reports.

According to the analysis of the actual place of use, 360166 reports were used in "medical institutions", accounting for 90.87% of the total reports; The number of reports using "family" accounts for 7.09% of the total reports; The number of reports using "other" accounts for 2.04% of the total reports.

According to the analysis of the classified catalogue of medical devices, the top five categories are: infusion, nursing and protective devices, medical diagnosis and monitoring devices, physiotherapy devices, clinical testing devices, respiratory, anesthesia and first-aid devices.

In addition, the blue book of medical devices specifically mentioned that the national adverse drug reaction monitoring center handled 213 reports of suspected adverse medical device events with the degree of injury of death in time, and urged the registrant to carry out investigation and evaluation.

"After investigation and verification, the collected adverse events of suspected dead medical devices are individual 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." According to the blue book of medical devices.

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

Yue Xianghui explained that the reporting of adverse events of medical devices follows the principle of "suspicious reporting", that is, as long as an event is suspected to be an adverse event of medical devices, it can be reported. Therefore, the reports collected by the adverse event monitoring technical organization are all suspicious adverse event reports of medical devices, which can not explain the inevitable causal relationship between the injury and the medical devices used. The occurrence of medical device adverse events does not mean that the involved medical device products have quality problems.

"The number of suspicious adverse event reports of 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; similarly, under the same probability of occurrence, the number of adverse events of medical devices with a small amount of use is correspondingly much less."

According to Yue Xianghui, the number of adverse event reports of medical devices can not directly reflect the occurrence of adverse events of different types of medical devices, nor can it directly reflect the product risk. In short, the large number of adverse event reports of products does not mean that the risk is high, but may also be caused by the large amount of use; The low occurrence of adverse events does not mean that the risk is low.

"Generally speaking, the monitoring of adverse events of medical devices is more like big data analysis. Through the collection and analysis of adverse event reports, we can evaluate the risk level of products over a period of time, obtain the development trend of risks, analyze the overall risk status of products, and prompt risk signals. Through the investigation, analysis and evaluation of these risk signals, we can find and confirm the existing product risks and take targeted measures Risk prevention and control measures, so as to effectively reduce product risks and achieve the effect of risk management. " Blue Book medical device.

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