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Medical devices are auxiliary tools in the hospital medical process, directly or indirectly acting on the human body, closely related to patient safety, the importance of its safety management is self-evident。
However, the reality seems more "grim"。
According to the "National Medical Device Adverse Event Monitoring Annual Report (2020)" recently released by the State Medical Products Administration, the National medical device Adverse event Monitoring information system received a total of 53 medical device adverse event reports in 2020.60,000 copies, 35 more than last year.25%。
It can be seen that the number of medical device adverse event reports in 2019 has declined compared with the previous year, but the 2020 data has shown a clear "rise" trend, which has increased to a double-digit level。
Does the sudden increase in medical device adverse event reporting data indicate that the quality of medical devices is worse or that medical care is more unsafe？
The "reluctance to report" problem has improved
"When it comes to medical device adverse events, many people in the past have equated them with medical malpractice and thought that they should be held responsible, but in fact, this is not the case。CAI Kui, president of the Application Evaluation Branch of the China Medical Equipment Association, told the health community that adverse medical device events refer to various harmful events that occur under normal use of listed medical devices and lead to or may lead to human injury。
The two important prerequisites of "approved listing" and "normal use" mean that adverse events of medical devices are problems such as product design or production process, which should be focused on by the medical device registration holder, and medical institutions do not focus on them。
The purpose of establishing the medical device adverse event reporting system is to conduct safety early warning, that is, once a device-related adverse event occurs, it is necessary to warn all personnel using the device。
"The first is discontinuation, and the second is to trace the cause of the adverse event, whether it is a production problem, a design problem, or some other problem.。CAI Kui said that this is mainly to avoid greater damage to the quality of medical care and patient safety, rather than to punish medical institutions or production enterprises。
Therefore, once there is an adverse event of a medical device, as a medical institution, the focus is to report to the superior, and then the medical device owner and business enterprise need to track the whole process of the event。
"The increase in data shows that the implementation of relevant provisions has achieved results。Xie Songcheng, consultant of the Medical Engineering Branch of the Chinese Medical Association, told the health community that the monitoring and re-evaluation management of adverse events of medical devices has always been an important means for the state to control the risk after the listing of medical devices。
In 2018, the two departments of the State jointly issued the "Medical Device Adverse Event Monitoring and Reevaluation Management Measures";In the new version of the Regulations on the Supervision and Administration of Medical Devices officially released by The State Council this year, it is also once again clear that adverse event monitoring and reevaluation of medical devices should be carried out。
An analysis of the specific situation of the medical industry in 2020 can see the reasonable reasons for the rise in data。
"This year, due to the COVID-19 epidemic, the use of medical protective materials such as masks, protective clothing, isolation clothing and disinfectant has increased significantly.The use of CT machines, ventilators and monitors has also increased, so the number of problems has also increased。"Xie Songcheng said。In addition, the data reported by the three reporting subjects: user units, device owners, and operating units are all increasing, which is a good phenomenon。
The health community consulted two years of data comparison and found that according to the rankings of medical device classification catalogs of adverse event reporting data for medical devices in 2020, protective supplies and diagnosis and treatment equipment related to the prevention and control of the novel coronavirus epidemic have increased significantly。
其中，Infusion, care and protective devices were the categories with the highest number of medical device adverse events，The number of reports in 2020 is 226,536，The data for 2019 was 166,734，An increase of about 60,000 copies;In addition，The number of adverse events increased more in medical diagnostic and monitoring devices, physical therapy devices, clinical testing devices, respiratory, anesthesia and first aid devices，It is widely used in the diagnosis and treatment of COVID-19 patients。
According to the data source analysis, the use of medical devices, that is, medical institutions are still the mainstream, and the proportion of medical device registrants and operating enterprises is slightly increased。
Specifically, 455,782 units reported in 2020, an increase of nearly 100,000 from 357,799 in 2019;In terms of proportion, the data reported by users in 2020 accounted for 85 percent of the total number of reports.03%, up from 90% in 2019.The proportion of 27% decreased slightly;
Medical device registrants reported 11,191 reports in 2020, accounting for 2 of the total number of reports.09%。Compared to 8600 registrants reported in 2019, accounting for 2.17%, the number slightly increased, the proportion slightly decreased;
Operating enterprises reported 68,902 reports, accounting for 12 percent of the total.85%;29,833 data corresponding to 2019, 7.53%;The number has increased by nearly 40,000, and the proportion has increased significantly。
There are difficulties in assigning responsibility for adverse events
The premise of "normal use" is tantamount to a "disclaimer commitment" for the medical institution of the user.。So, for medical device adverse event reporting, what are the issues worth paying attention to？
"We should pay attention to the problems after the report of adverse events of medical devices," Xie Songcheng said, each device has an electronic ID UDI, so that in medical device-related adverse events, it is not difficult to trace back to which manufacturer it is produced, which batch of times and which model of product。However, after the report, there are still many problems at the level of cause analysis and responsibility attribution of medical device adverse events。"Especially between medical device adverse events and medical device use safety events, there is a phenomenon of 'kicking the ball'.。”
According to the current regulations, once a medical institution reports a suspicious medical device adverse event, the medical device registrant and business enterprise will immediately receive the relevant message reminder, and need to investigate and analyze the reported event to find out the cause of the problem。
"However, I heard a lot of feedback from manufacturers, and many medical institutions reported adverse events of medical devices that were not product quality problems, but clinical use problems.。Xie Songcheng said that unless it is a small problem such as broken packaging and impurities in the syringe, the business enterprise can not escape its responsibility。When there are problems in clinical use, it is difficult to clarify what is the reason, and it is difficult to trace the source。
Taking orthopedics as an example, some patients have problems after leaving the hospital, such as broken plates, loose screws, etc., it is difficult to tell whether it is a production problem, a problem when loading, or a patient did not follow the doctor's instructions for improper exercise。Xie Songcheng revealed that encountered this kind of problem, usually by the manufacturer to pay, appease good patients so as not to make things big, and finally often nothing。
However, according to his years of work experience in the clinical use of medical device quality control, retrospective investigation, even if it is conducted by professionals, is difficult to understand the reasons, let alone administrative investigation, and more often it is a formality。
The reason, Xie Songcheng believes that between medical device adverse events and medical device use safety events, the definition and nature are different, and the treatment channels are different, which is an important factor that is easy to produce the phenomenon of "kicking the ball"。
Lack of data on clinical improper use of medical devices
On February 4, 2021, the "Measures for the Management of Clinical Use of Medical Devices" (hereinafter referred to as the "Measures") was officially published on the official website of the National Health Commission。In this paper, the concept of "clinical use of medical devices safety incident" is clearly elaborated, and it is defined as: medical institutions and their medical personnel in the diagnosis and treatment activities, due to the use of medical devices, there are mistakes, resulting in personal damage to patients。
此外，This document is tightly organized around the theme of "Safety in clinical use of medical devices"，It pointed out that medical institutions should establish a risk management system for clinical use of medical devices，Continuous improvement of clinical use behavior of medical devices;Medical institutions shall collect, analyze, evaluate and control the safety incidents of medical device use，Follow the principle of reporting when suspicious，Timely report。In the eyes of medical engineering practitioners, this is a kind of progress。
However, what makes Xie Songcheng more worried is that it is difficult for medical institutions to implement the risk management system for the clinical use of medical devices。"Patient injury incidents caused by the use of medical devices are very difficult to collect data。
Medical staff are afraid of causing medical disputes and taking medical responsibility, and are usually reluctant to report, and some are treated as complications."。According to the latest foreign survey report, 60% of medical device-related injuries are caused by improper use。At present, there is no data reporting system in China。
According to Xie Songcheng, the biggest difference between us and foreign countries is that foreign countries have an exemption mechanism and even legal protection on the report of injury incidents involving the use of medical devices。Although China now also emphasizes the reporting and exemption of adverse medical events, the atmosphere has not yet formed, so most medical institutions are not willing to report。
Today, he says, the system is improving and the data being reported is increasing, and relatively speaking it is much better than before。However, the development of medical devices is too fast, many of which were previously used by large hospitals, and now basic hospitals are gradually introduced and used, and the technical level is uneven, making the safety problem of clinical use of medical devices is still more complicated。
With the new round of expansion of large hospitals, new instruments and equipment have been put into use。Medical quality and safety management issues related to medical devices need more attention。
It is worth affirming that on May 10, the National Health Commission issued a document to establish the National Expert Committee on the Clinical use of medical devices, with the purpose of better implementing the "Measures", further strengthening the clinical use management of medical devices, and ensuring the safe and effective clinical use of medical devices。
Xie Songcheng revealed that whether it is the introduction process of the "Measures" or the establishment of the national Expert Committee on the clinical use of medical devices, there are actually many disputes and twists and turns。This also reflects the road of clinical use safety management of medical devices in China, although the future is bright, but destined to be bumpy。 | 
