The national medical device adverse events surged by 130,000, but experts said it was a good phenomenon

Medical devices are auxiliary tools in the medical process of hospitals, which directly or indirectly act on the human body and are closely related to patient safety
.

The importance of its safety management is self-evident .

Medical devices are auxiliary tools in the medical process of hospitals, which directly or indirectly act on the human body and are closely related to patient safety

According to the National Medical Device Adverse Event Monitoring Annual Report (2020) recently issued by the National Medical Products Administration, the National Medical Device Adverse Event Monitoring Information System received 536,000 medical device adverse event reports in 2020, an increase from the previous year 35.
25%
.

2016-2020 National Medical Device Adverse Event Reports

2016-2020 National Medical Device Adverse Event Reports

It can be seen from the table that the number of medical device adverse event reports in 2019 has decreased compared with the previous year, but the data in 2020 has shown a clear trend of "rising", which has surged to double-digit levels
.

The sudden increase in the number of reported adverse events of medical devices means that the quality of medical devices is worse, or the medical treatment is more unsafe?

"Unwilling to report" issue has changed

"Unwilling to report" issue has changed

"When it comes to medical device adverse events, many people in the past equated it with medical accidents, thinking that they should bear responsibility, but in fact it is not the case
.

" Cai Kui, chairman of the Application Evaluation Branch of China Medical Equipment Association, told the health industry that medical device adverse events refer to All kinds of harmful events that occur under normal use of medical devices that have been on the market that cause or may cause harm to the human body

The two important prerequisites of "approved for marketing" and "normal use" mean that medical device adverse events are issues such as product design or production process, which should be paid attention to by medical device registration holders, and medical institutions should not pay attention to them
.

The purpose of establishing a medical device adverse event reporting system is to provide safety early warning, that is, once a device-related adverse event occurs, all personnel who use the device must be warned
.

"The first is to stop, and the second is to trace the cause of the adverse event, whether it is a production problem, a design problem, or other problems
.

" Cai Kui said, this is mainly to avoid greater damage to the quality of medical care and patient safety.

Therefore, once there is an adverse event of a medical device, as a medical institution, the focus is to report to the superior.
After that, the medical device holder and operating company need to track the event throughout the process
.

"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 implementation of medical device adverse event monitoring and re-evaluation management has always been an important means for the country to control the risks of medical devices after the market.

In 2018, the two national departments jointly issued the "Administrative Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events"; and in the new version of the "Regulations on the Supervision and Administration of Medical Devices" officially released by the State Council this year, it was once again clarified that the monitoring and management of medical device adverse events should be carried out.
Re-evaluate the work
.

Analyzing the specific situation of the medical industry in 2020, we can see the reasonable reasons for the increase in data
.

"This year, due to the new crown epidemic, the use of medical protective materials such as medical protective masks, protective clothing, isolation gowns, and disinfectants has increased significantly; the use of CT machines, ventilators, and monitors has also increased, so problems have arisen.
The number has also increased accordingly
.

" Xie Songcheng said

According to the comparison of the two-year data in the health sector, it is found that according to the ranking of the data in the medical device classification catalogue of the reported data of medical device adverse events in 2020, the protective equipment and diagnosis and treatment equipment related to the prevention and control of the new crown epidemic have increased significantly
.

Among them, infusion, nursing and protective devices are the category with the largest number of medical device adverse events.
The number of reports in 2020 is 226,536, and the data in 2019 is 166,734, an increase of about 60,000; in addition, the number of adverse events has increased significantly.
Medical diagnosis and monitoring equipment, physical therapy equipment, clinical testing equipment, respiratory, anesthesia and first aid equipment, etc.
, are widely used in the diagnosis and treatment of new crown patients
.

The 2020 medical device adverse event report involves the classification of medical devices

The 2020 medical device adverse event report involves the classification of medical devices

According to the analysis of data sources, the users of medical devices, that is, medical institutions, are still the mainstream, and the proportion of medical device registrants and operating companies has increased slightly
.

Specifically, in 2020, users reported 455,782 copies, which was an increase of nearly 100,000 from 357,799 in 2019.
From the perspective of the proportion, the data reported by users in 2020 accounted for 85.
03% of the total number of reports.
In 2019, the proportion of 90.
27% decreased slightly;

In 2020, 11,191 medical device registrants reported, accounting for 2.
09% of the total number of reports
.

Compared with the 8,600 registrants reported in 2019, which accounted for 2.

Operating companies reported 68,902 reports, accounting for 12.
85% of the total number of reports; 29,833, 7.
53% of the corresponding data in 2019; the number increased by nearly 40,000, and the proportion has increased significantly
.

Difficulties in the attribution of responsibility for adverse events

Difficulties in the attribution of responsibility for adverse events

The premise of "normal use" is tantamount to a kind of "exemption undertaking" for the user's medical institution
.

So, what are the issues worthy of attention for the reporting of medical device adverse events?

"We should pay attention to the problems after the medical device adverse events are reported," Xie Songcheng said.
Every device has an electronic ID card UDI, so that the medical device-related adverse events can be traced back to which manufacturer, which batch and which batch.
The model of the product is not difficult
.

However, after the report, there are still many problems in the analysis of the causes of adverse events of medical devices and the identification of responsibility attribution

According to current regulations, as soon as a medical institution reports a suspicious medical device adverse event, the medical device registrant and the operating company will immediately receive the relevant message reminder, and need to investigate and analyze the reported event to find the cause of the problem
.

"However, I have heard feedback from many manufacturers that the medical device adverse events reported by many medical institutions are not product quality problems, but clinical use problems
.
" Xie Songcheng said, unless it is a small problem such as broken packaging and impurities in the syringe.
, The operating enterprise cannot evade responsibility
.
However, it is difficult to clarify the cause of problems in clinical use, and it is difficult to trace the source
.

Taking orthopedics as an example, some patients have problems after leaving the hospital, such as broken steel plates, loose screws, etc.
, it is difficult to distinguish whether it is a production problem, a problem at the time of installation, or the patient has not followed the doctor’s precautions and performed improperly Sports
.
Xie Songcheng revealed that when this type of problem is encountered, the manufacturer usually comes forward to pay compensation, so as to calm the patient so as not to cause trouble, and it often ends up in the end
.

However, based on his years of experience in quality control of the clinical use of medical devices, retrospective investigations, even if professionals conduct investigations, are difficult to clarify the reasons, let alone administrative investigations, which are more often a cutscene
.

Investigating the reasons, Xie Songcheng believes that medical device adverse events and medical device use safety events have different definitions, different natures, and different processing channels, which are important factors that are prone to "kick the ball" phenomenon
.

Missing data on improper clinical use of medical devices

Missing data on improper clinical use of medical devices

On February 4, 2021, the "Administrative Measures for the Clinical Use of Medical Devices" (hereinafter referred to as the "Measures") was officially published on the official website of the National Health Commission
.
The article clearly expounds the concept of "safety incidents in the clinical use of medical devices", which is defined as: incidents in which medical institutions and their medical staff have made mistakes in the use of medical devices during diagnosis and treatment activities, causing personal injury to patients
.

In addition, this document focuses on the theme of "safety of clinical use of medical devices", pointing out that medical institutions should establish a risk management system for the clinical use of medical devices, and continuously improve the clinical use of medical devices; medical institutions should collect medical device use safety incidents , Analysis, evaluation and control, follow the principle of reporting when suspected, and report in a timely manner
.
This is an improvement in the eyes of medical engineering practitioners
.

However, what worries Xie Songcheng is that it is difficult for medical institutions to implement the risk management system for the clinical use of medical devices
.
"It is very difficult to collect data on patient injury incidents caused by the use of medical devices
.

Medical staff are worried that they will cause medical disputes and assume medical responsibility.
They are usually unwilling to report, and some are dealt with as complications
.
" He said, according to the latest foreign investigation reports, medical device-related injuries were caused by improper use.
It accounts for 60%
.
There is currently no system for data reporting 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 for the reporting of injury incidents caused by the use of medical devices
.
Although China now emphasizes the reporting and exemption of medical adverse events, the atmosphere has not yet formed, so most medical institutions are still reluctant to report
.

He said that the current system is constantly improving, and the reported data is also increasing, which is relatively better than before
.
However, the development of medical devices is too fast.
Many of the devices used in large hospitals are now gradually being introduced and used in grassroots hospitals.
The level of technology is uneven, making the safety of clinical use of medical devices still more complicated
.

With the new wave of expansion of large hospitals, new instruments and equipment are constantly being put into use
.
Medical quality and safety management issues related to medical devices require more attention
.

What is worthy of recognition is that on May 10, the National Health Commission issued a document to establish a National Expert Committee on the Clinical Use of Medical Devices.
The purpose is to better implement the Measures, further strengthen the management of the clinical use of medical devices, and ensure the safe and effective clinical use of medical devices.

.

Xie Songcheng revealed that there are actually a lot of controversies and twists and turns in both the promulgation process of the "Measures" and the establishment of the personnel of the National Committee of Experts on the Clinical Use of Medical Devices
.
This also reflects the road of safety management of clinical use of medical devices in China.
Although the future is bright, the road is destined to be bumpy
.