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Tighter supervision of medical devices after listing

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Author : Joe Wong
Update time : 2020-12-16 10:17:37

Tighter supervision of medical devices after listing

 In 2019, the National 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 adverse events of medical devices refer to various harmful events that occur under normal use of medical consumables device on the market that cause or may cause harm to the human body. 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 products are on the market and protect human health and life safety.


  The Blue Book of Medical Devices believes that the state's monitoring of medical device adverse events is an important part of medical device supervision and helps to protect 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 supervision regulations and policies, the supervision of medical devices 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 State 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 2019, the State Drug Administration issued a total of 3 notifications.


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


 The report stated that oxygen mask are an indispensable medical device product in clinical medical work. The 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 limited 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 select and use appropriate medical glove products based on their own conditions and specific operational requirements and meet 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 currently 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 National Medical Products Administration issued separate notices, “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.


  The data disclosed in the Blue Book of Medical Devices shows that in 2019, the national medical device adverse event monitoring information system collected 402,700 suspicious medical device adverse event reports nationwide. After verification, after excluding wrong reports, there were 396,300 effective suspicious medical device adverse event reports, of which 26,723 were suspicious severe adverse event reports and 213 were death reports.


  A reporter from the Rule of Law Daily found that in 2016, more than 350,000 medical device adverse event reports were received nationwide; in 2017, the number of medical device adverse event reports nationwide exceeded 370,000; in 2018, it reached 406,974 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 100%.


 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 State 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, and it is also a medical device supervision. Important link.


 The report follows the principle of reporting when suspicious

 Risk signals through monitoring

In 2019, among the suspicious medical device adverse event reports received by the National 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 "household" 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 mentioned that the National Adverse Drug Reaction Monitoring Center promptly handled the 213 suspicious medical device adverse event reports with deaths 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 Book of Medical Devices.


 Yue Xianghui stated 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 technical agency for monitoring of adverse events are all suspicious medical device adverse event reports, which cannot explain the 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 by 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; fewer adverse product events does not mean its risk is low.


"Generally speaking, medical device adverse event monitoring 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 derived, 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 discovered and confirmed, and risk prevention and control measures can be taken in a targeted manner, thereby effectively reducing product risks and achieving risk management effects ." said the Blue Book of Medical Devices.