Interpretation of ＂Administrative Measures for Medical Device Recall＂

In order to strengthen the supervision and management of medical device recall and effectively promote the implementation of the main responsibility of enterprise recall, according to the Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the Regulations), the State Food and Drug Administration has formulated and promulgated the Measures for the Administration of Medical Device Recall (hereinafter referred to as the Measures). The Measures will be implemented on May 1, 2017, and the relevant contents are now interpreted as follows:

I. Why should the Measures be revised?

As a special commodity, medical devices play an important and irreplaceable role in improving people’s health and quality of life. The safety and effectiveness of medical devices is directly related to people’s health and social harmony and stability, and is a major livelihood and public safety issue. If the listed products are defective and cannot be recalled and controlled in time, it may endanger the health and safety of consumers. Therefore, the establishment and implementation of the recall system of medical device products by the state plays an important role in controlling the risks of defective medical device products after listing, eliminating potential safety hazards of devices and protecting public safety. The practice in other countries and other fields also shows that the recall system is a powerful guarantee to safeguard the safety and rights of consumers. Based on the importance of the medical device recall system, in order to strengthen the supervision and management of the recall-related work, in 2011, the Ministry of Health of the People’s Republic of China issued the Administrative Measures for Medical Device Recall (Trial) (Order No.82), which came into effect on July 1, 2011. The publication and implementation of the "Measures (for Trial Implementation)" provides legal guarantee for timely controlling the risks of medical devices after listing and protecting the safety of public equipment. The implementation of medical device recall system is not only an effective method to control the risk of medical devices, promote the progress of production technology and improve product design, but also an important measure to promote production enterprises to improve product quality awareness and standardize market competition order.

The newly revised Regulations in 2014 included the recall system, which also became a highlight of the new version of the Regulations. In order to further strengthen the management of medical device recall, according to the requirements of the Regulations, on the basis of full investigation of recall systems at home and abroad in the early stage, combined with China’s national conditions and practice, and after soliciting opinions from all parties, the "Measures (Trial)" version was repeatedly discussed and revised, and the "Measures" was revised.

2. What are the main contents stipulated in the Measures?

(1) What is the definition of medical device recall?

The recall of medical devices mentioned in the Measures refers to the actions taken by medical device manufacturers to deal with the defective medical device products of a certain category, model or batch that they have sold on the market according to the prescribed procedures, such as warning, inspection, repair, re-labeling, modification and improvement of instructions, software update, replacement, recovery and destruction.

(2) What are the recall obligations of medical device manufacturers?

Medical device manufacturers are responsible for the quality and safety of their medical devices. We should establish and improve the management system of medical device recall in accordance with the provisions of the Measures, collect information related to the safety of medical devices, investigate and evaluate possible defective products, and recall defective products in time.

The agent designated by the overseas manufacturer of imported medical devices in China shall report the relevant information about the recall of medical devices only abroad to china food and drug administration in time; Where the recall is carried out in China, the designated agent in China shall organize the implementation in accordance with the provisions of the Measures.

(3) What are the recall obligations of medical device enterprises and users?

Medical device enterprises and users shall actively assist medical device manufacturers to investigate and evaluate defective products, actively cooperate with the manufacturers to fulfill the recall obligations, timely convey and feedback the recall information of medical devices according to the recall plan, and control and recover the defective products.

(4) What are the categories of medical device recalls?

According to the different starting conditions of medical device recall, medical device recall can be divided into active recall and ordered recall.

Voluntary recall is a legal obligation of medical device manufacturers to evaluate the quality of medical device products according to relevant requirements or information such as product adverse events, and to determine the defects of medical device products, which are voluntarily implemented by the manufacturers. Ordered recall refers to the recall of medical devices by the food and drug supervision and administration department after investigation and evaluation, which believes that medical device manufacturers should recall defective medical device products without taking the initiative to recall them. In practice, enterprises should take the initiative to recall, supplemented by government departments ordering recalls.

(5) What are the levels of medical device recall?

According to the severity of medical device defects, medical device recalls are divided into:

(1) First-class recall: the use of the medical device may or has caused serious health hazards;

(2) Secondary recall: the use of the medical device may or has caused temporary or reversible health hazards;

(3) Three-level recall: it is less likely that the medical device will cause harm, but it still needs to be recalled.

Medical device manufacturers should determine the recall level according to the specific situation and scientifically design the recall plan and organize its implementation according to the recall level and the sales and use of medical devices.

If a medical device manufacturer makes a decision on medical device recall, the first-level recall shall be within 1 day, the second-level recall shall be within 3 days, and the third-level recall shall be within 7 days, and the relevant medical device business enterprises, users or users shall be notified.

The recall notice shall at least include the following contents:

(1) Recall the basic information such as the name and batch number of medical devices;

(2) the reasons for the recall;

(3) requirements for recall, such as immediately suspending the sale and use of the product, forwarding the recall notice to relevant operating enterprises or users, etc.;

(four) the way to deal with the recalled medical devices.

(six) how to punish medical device manufacturers for refusing to recall medical devices?

Medical device manufacturing enterprises, in violation of the provisions of Article 24 of the Measures, refuse to recall medical devices. According to the provisions of Article 66 of the Regulations, the food and drug supervision and administration department of the people’s government at or above the county level shall order them to make corrections and confiscate the medical devices illegally produced, operated or used; If the value of medical devices illegally produced, operated or used is less than 10,000 yuan, a fine ranging from 20,000 yuan to 50,000 yuan shall be imposed; If the value of the goods is more than 10,000 yuan, a fine of more than 5 times and less than 10 times the value of the goods shall be imposed; If the circumstances are serious, it shall be ordered to stop production and business until the original issuing department revokes the registration certificate, production license and business license of medical devices.

(seven) how to punish the medical device operating enterprises and users who refuse to cooperate with the medical device manufacturing enterprises to fulfill the recall responsibility?

Medical device enterprises and users who refuse to cooperate with the investigation of medical device defects or assist medical device manufacturers in recalling medical devices shall be given a warning and ordered to make corrections within a time limit; Those who refuse to make corrections within the time limit shall be fined up to 30,000 yuan.

3. What are the amendments to the Measures?

The Measures include six chapters and thirty-seven articles, including general principles, investigation and evaluation of medical device defects, voluntary recall, ordered recall, legal liability and supplementary provisions. The revision of the Measures retains the framework and main contents of the Measures (for Trial Implementation). According to the Regulations, the scope of recall and individual operating procedures are supplemented and adjusted, the main responsibility and legal responsibility of production enterprises are strengthened, and the punishment for violations of laws and regulations is intensified. The main amendments include:

(a) the implementation of the main responsibility of medical device recall. It is clear that the registrants or filers of domestic medical device products and the agents designated by overseas manufacturers of imported medical devices in China are the main bodies of medical device recall.

(2) The scope of application has been clarified. The Measures (for Trial Implementation) stipulates that "these Measures shall apply to the recall of medical devices sold in People’s Republic of China (PRC) and their supervision and management", and the Measures shall be amended as "the recall of listed medical devices in People’s Republic of China (PRC) and its supervision and management", which clarifies that all medical device products registered in China shall be implemented or reported in accordance with the requirements of these Measures.

(3) Adjusting the scope of defective products. The Measures (Trial) stipulates that "the recall of medical devices mentioned in these Measures refers to the behavior of medical device manufacturers to eliminate defects by warning, inspecting, repairing, relabeling, modifying and perfecting the instructions, upgrading the software, replacing, recalling and destroying a certain category, model or batch of products that have been sold in the market according to the prescribed procedures", "The defects mentioned in these Measures", It means that medical devices have unreasonable risks that may endanger human health and life safety under normal use, that is, the scope of recall is medical devices that have unreasonable risks that may endanger human health and life safety under normal use. According to the newly revised Regulations, the Measures expand the scope of defective products to "(1) products with unreasonable risks that may endanger human health and life safety under normal use; (two) products that do not meet the mandatory standards and the technical requirements of registered or filed products; (three) products that do not meet the relevant provisions of the quality management of medical device production and circulation, which may lead to unreasonable risks; (4) Other products that need to be recalled ".

(4) The content of defect assessment has been added. In response to the revision to expand the scope of defective products, the item "Does the product meet the mandatory standards, registered or filed product technical requirements" has been added in the main content of evaluating the defects of medical devices.

(5) The regulatory authorities that supervise the destruction of recalled products have been adjusted. The "Measures (Trial)" stipulates that "if it needs to be destroyed, it shall be destroyed under the supervision of the drug supervision and administration department at the place of destruction". But in practice, this method is not conducive to practical operation. At the same time, with the rapid development of information technology, the diversification of supervision methods is the general trend. Therefore, the "Measures" were amended as "Those that need to be destroyed shall be destroyed under the supervision of the food and drug supervision and administration department."

(6) Adjusted the requirements for notification of recall information. The "Measures (Trial)" stipulates that "the drug supervision and administration department shall review the report within 10 days from the date of receiving the summary report and evaluate the recall effect. The conclusion of the review and evaluation shall be notified to the medical device manufacturer in written form and copied to the health administrative department at the same level ". In practice, it is difficult to inform medical device manufacturers and health administrative departments at the same level in written form of review and evaluation conclusions. Therefore, the "Measures" cancel the requirement of notifying production enterprises in written form, and change the information notification to the health administrative department to "notify relevant information to the health administrative department at the same level when necessary".

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Heavy snowfall is coming, and Beijing Emergency Bureau will issue 6 early warning and response measures.

　　CCTV News:According to WeChat official account News of Beijing Emergency WeChat, according to the forecast of Beijing Meteorological Observatory, there will be heavy snowfall and cold wave weather in Beijing from 13th to 16th, and the temperature will drop obviously. From 15th to 20th, there will be continuous low-temperature weather, and the lowest temperature will be close to the historical extreme value in the same period. At 16: 30 on the 12th, the Beijing Meteorological Observatory issued a yellow warning signal for snowstorm and road icing. To this end, the Beijing Emergency Bureau issued six early warning response measures.

　　Response measures of yellow early warning for snowstorm and road icing in Beijing

　　1. Please pay attention to the weather forecast and early warning information, pay attention to cold, warm and anti-skid, and pay attention to the safety of fire, electricity and gas to prevent carbon monoxide poisoning.

　　2. Advocate citizens to take buses and subways, reduce driving trips, keep a safe distance when driving, slow down and ride bicycles and electric bicycles less.

　　3. Please avoid playing in mountainous areas and stay away from old trees, structures, plaques and snow-covered dangerous areas to avoid being crushed; When passing under the bridge and under the eaves, prevent the ice from melting and falling off and hurting people.

　　4. All units should pay close attention to the weather changes, arrange production and business activities reasonably, and pay attention to protection for outdoor operations to ensure safety. Implement the responsibility of "three guarantees in front of the door" and do a good job of sweeping snow and shoveling ice within the responsibility area.

　　5. Urban operation guarantee units should fully carry out snow sweeping and ice shoveling, do a good job in heating service guarantee, strengthen traffic organization and guidance, deal with emergencies in time, and ensure the safe operation of urban lifelines such as water, electricity, gas and heat.

　　6. It is necessary to clear the snow on various venues such as school gymnasiums, long-span buildings, agricultural facilities greenhouses, temporary structures and dangerous houses in time to prevent collapse.

Five diseases that sound scary are actually not diseases.

Original, don’t scare yourself.

When women do some gynecological examinations every year, many people will find that the report will prompt words that sound terrible, such as "tumor", "effusion" and "erosion".

But in fact, most of these terrible gynecological diseases are not as serious as everyone thinks, and some of them are not diseases at all and do not need treatment.

Today, I will take stock of the five most common gynecological diseases ~

HPV infection

Can be found by special HPV testing.

Scary index: ★★★★★★★

Actual threat: ★★☆☆☆☆

Expert interpretation:

HPV infection is one of the main causes of cervical cancer. But it does not mean that you will get cervical cancer if you are infected with HPV.

In fact, most women who have sex may have been infected with HPV, but they are basically automatically cleared by human immunity within one or two years.

Only a small number of people may continue to be infected for many years, which will eventually lead to cervical cancer.

Therefore, pure HPV infection does not need special treatment, but more is to remind patients to screen regularly and find cancer or precancerous lesions in time.

What situations should we pay attention to?

The threat of HPV to reproductive parts can be divided into two categories: low risk and high risk.

If you are infected with high-risk HPV, it is recommended to have a cervical cytological examination (TCT or LCT). If you find any abnormality, you should have a colposcopy to comprehensively evaluate whether there are any vigilant lesions in the cervix and vagina.

In addition, the possibility of cancer caused by low-risk HPV infection is extremely small, but some patients may have warts of condyloma acuminatum locally in their genitals, and they need medical treatment if necessary.

ovarian cyst

Most of them were found by B-ultrasound.

Scary index: ★★★★★★★

Actual threat: ★★☆☆☆☆

Expert interpretation:

Ovarian cyst is not equal to ovarian tumor.

For women of childbearing age, most of them are physiological cysts, which are related to the development of follicles during ovulation every month. There is also a more complicated "chocolate cyst" which is a manifestation of endometriosis.

For the vast majority of women of childbearing age who find ovarian cysts for the first time, if the diameter is less than 5cm, they can be rechecked on the fourth to fifth day of the next menstrual period. If the cysts disappear, there is no need for treatment.

What situations should we pay attention to?

1. Ovarian cysts are larger than 5 cm in diameter;

2. The cyst didn’t disappear and shrink after follow-up;

3. B-ultrasound found that the cyst had solid components or was completely solid;

4. Postmenopausal women found ovarian cysts;

5, diagnosed as "chocolate cyst".

In the above situations, attention should be paid to timely medical treatment, and whether treatment is needed should follow the doctor’s advice.

hysteromyoma

Most of them were found by B-ultrasound.

Scary index: ★★★★★★★

Actual threat: ★★☆☆☆☆

Expert interpretation:

More than 90% of uterine fibroids are benign.

According to statistics, about 1/3 of women will have uterine fibroids in their lifetime.

Asymptomatic small fibroids generally do not need treatment, just check B-ultrasound regularly.

What situations should we pay attention to?

1. Myoma causes discomfort symptoms, such as menorrhagia, prolonged menstrual period and even anemia, or lower abdominal pain, frequent urination, difficulty in urination and defecation, etc.

2. Women’s infertility or abortion caused by fibroids;

3. A single myoma is large (more than 5cm), or the uterus volume is too large due to the myoma;

4. After observation and review, it was found that the growth rate of fibroids was too fast, and the doctor suspected that there was a possibility of malignant transformation;

5, fibroids in special parts such as submucosal fibroids;

In the above situation, it is necessary to pay attention to timely medical treatment, and doctors should judge whether treatment or surgery is needed.

Pelvic effusion

It is often found by B-ultrasound.

Scary index: ★★★★★☆.

Actual threat: ★★☆☆☆☆

Expert interpretation:

Almost every woman has a little pelvic effusion more or less, most of which are physiological phenomena, such as ovulating follicular fluid and countercurrent menstrual blood, and the human body will adjust itself to absorb the excess effusion.

Therefore, if B-ultrasound shows that pelvic effusion is only 10-30 mm and there are no other discomfort symptoms, most of them don’t need to worry, and most of them don’t need treatment.

What situations should we pay attention to?

If pelvic effusion is caused by other diseases, such as pelvic inflammatory disease and endometriosis, especially if there is a large amount of effusion or there are effusion in many places, or accompanied by abdominal pain, fever, abnormal leucorrhea and other symptoms, you need to seek medical attention in time.

erosion of cervix

Most of them were found by routine gynecological examination.

Scary index: ★★★★★★★

Actual threat: ★★☆☆☆☆

Expert interpretation:

Cervical erosion is not a disease, and this term is no longer used in the medical field.

"Erosion" has nothing to do with the commonly understood "decay".

The so-called cervical erosion refers to columnar epithelial displacement, which is a normal physiological phenomenon and does not need treatment in most cases. It can be understood that the cervix is just "ugly".

What situations should we pay attention to?

The so-called need for treatment of cervical erosion has nothing to do with the "mild, moderate and severe" suggested by some hospitals.

Only when "cervical erosion" is complicated with abnormal cytology, or infection or bleeding, may it need treatment.

What should I pay attention to before doing gynecological examination?

1. Pay attention to the inspection time

General gynecological examination should avoid the physiological period, but some examinations will be a little special.

For example, check ovarian cyst and infertility, etc., it may be necessary to check immediately during the physiological period or just after. Specifically, we should strictly follow the doctor’s advice.

2. Don’t have sex for 24 hours before the examination.

3. Don’t apply drugs or excessively clean the vagina before the examination.

4. Choose a regular medical institution.

After reading the expert’s interpretation of these diseases, will everyone’s fear of these diseases be reduced a lot?

Although the incidence of these gynecological diseases is high, most of them are not a big problem. Rational treatment, active "observation" and "regular review" are the best treatments for most people.

This article is original for "Jing Yi Tong". If there is any content reproduced, please indicate the source.

Reviewer: Chief Physician, Sexual Medicine Clinic, Youchuan Beijing Maternity Hospital

Editor: medical cupping, medical pear sand white

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Original title: "The truth! Listen to the scary five diseases, but they are not diseases! Women must pay attention to … "

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Does the rear-end collision of a zero-running car cause brake failure？

Recently, according to jack bauer hotline, an educational science and technology channel of Zhejiang TV Station, a lady Yu in Hangzhou was driving her own zero-run car two days ago, and the brakes suddenly failed on the road, causing her to rear-end. She thinks this accident has something to do with this braking function of the zero-run car.

Ms. Yu: "Then I brake and step on it, and I feel empty. I feel that it is empty to step on it. Then I actually panic. If I continue to step on it, it will be empty. Then you will watch it hit the car in front."

Speaking of her own experience, Ms. Yu still has a lingering fear. Ms. Yu bought a new energy vehicle six months ago, and the price was about 60 thousand. A few days ago, Ms. Yu drove on the road and experienced a moment of shock.

Ms. Yu: "I went to work at noon on August 26, that is, around 1: 25, and the weather and road conditions were fine, with a speed of forty or fifty yards." Then there was a red light, that is, it was expected to brake and stop, and then it felt like stepping on the brakes, and then it continued to step on the air, feeling that the car could not stop at all, and then it hit the car in front. "

Ms. Yu said that she started to step on the brakes at least 50 meters away from the front car, but the car couldn’t stop and eventually chased the front car. Fortunately, at that time, the speed was not fast, the car damage was not too serious, and there were no casualties. After that, the car was sent to the 4S shop for repair.

Ms. Yu: "They said that my ABS system was activated. If the ABS system was activated, it would definitely be activated after stepping on the brakes. It certainly ruled out the possibility of misoperation at that time."

Ms. Yu provided a chat record to the reporter. The 4S shop staff said that the background data showed that you stepped on the brakes and ABS intervened. Since Ms. Yu did step on the brakes, why didn’t the car stop in time?

Ms. Yu: "The answer he gave me was that no problem was found, and the brake system was all good. Then they asked me to pick up the car. I said that this car was a hidden danger, and I couldn’t take this hidden danger on the road. Then the key point was that there was another problem. I did the first insurance on August 16, and I thought they should have tested the brakes during the first insurance. Then you said that it was tested ten days ago, and my brakes suddenly failed in ten days. Then I was concerned about this matter.

In response to the questions reflected by Ms. Yu, the reporter accompanied her to Xixi Road, Hangzhou Service Center of Zero Run Automobile, and wanted to know more about the situation.

Staff of Xixi Road Store in Hangzhou Service Center of Zero Run Automobile: "Because of this, I am on duty today. I have already contacted him just now, because the car docking person is not here today, so I also told him just now, including the appeal you just said. Then he may contact you. If you have any questions, you can dock with him directly."

The reporter asked: "What is the situation of the car now?" The staff of Xixi Road Store in Hangzhou Service Center of Zero Run Automobile: "The car accident maintenance is ready."

The reporter asked again: "Did you find out what the problem is, the brake system?" Staff of Xixi Road Store in Hangzhou Service Center of Zero Run Automobile: "If you have checked it, because I can’t do it now."

The on-site reporter left contact information, but before the deadline for publication, he never received a reply from the zero run. The reporter found on the Internet that many consumers reported that the T03 brakes failed at zero run. Some netizens reported in July this year that during normal driving, the rear-end traffic accident was caused by brake failure, immobility and partial system failure.

A netizen in Hubei posted that after the car started, the brakes could not be stepped on, and it almost hit the vehicle in front. Another netizen in Guangxi said that T03 was driven downhill for a long time, and the distance was about three kilometers, and the brakes suddenly failed at the bottom of the slope.

So, does the zero-run T03 have any related braking hazards? The reporter also reflected the situation to the national customer service of the zero-running car. The customer service staff of the zero-running car said: "At present, there is no relevant notice here. Even if there is such a situation, it needs to be tested by the offline after-sales store to locate what caused the brake failure."

In view of the situation encountered by Ms. Yu, the retail customer service said that it would give feedback to the after-sales department for handling. "What caused the brake failure, or it needs to be tested by the service store. It is normal for the store to tell you after testing, so we also need to feedback to the after-sales service department for further verification."

China-Central Asia Summit ｜ Kazakhstan experts： The Belt and Road Initiative helps Kazakhstan to diversify its development. There is great potential for cooperation between Kazakhstan and China.

　　International Online Report (Reporter Wang Luping): May 18-19, China — The Central Asia Summit was held in Xi ‘an, and it continued to attract global attention. International online reporters interviewed Fatima Kukeyeva, a professor of international relations at Kazakh National University, on topics related to cooperation between China and Central Asian countries. Kukeyeva pointed out that Kazakhstan is the first place to advocate the Belt and Road Initiative, which has made positive contributions to promoting the diversified development of Kazakhstan, and there is great potential for cooperation between Kazakhstan and China.

China — Central Asia Summit | Kazakhstan experts: "One Belt, One Road" initiative helps Kazakhstan's diversified development. There is great potential for cooperation between Kazakhstan and China _fororder_ picture 1

　　Fatima Kukeyeva, Professor of International Relations, Kazakh State University

　　Kukeyeva said that the Belt and Road Initiative provides an open and inclusive platform for international cooperation and creates favorable conditions for Kazakhstan to integrate into the international transportation chain and industrial supply chain. Since 2013, Kazakhstan has gradually become an important transportation hub in Central Asia. At the same time, the construction and development of the logistics field has also brought convenience to the expansion of cooperation between Kazakhstan and China in the energy field. Various investments and economic and trade cooperation along with the "Belt and Road Initiative" have benefited Kazakhstan’s agriculture, industry, environment, culture and education.

　　As a university professor, Kukeyeva is particularly concerned about the achievements and potential of the Belt and Road Initiative in the field of education. She introduced that Kazakh National University has cooperated with more than 30 universities in China to jointly implement scientific research projects and organize expert training. She also specifically mentioned that "experience shows that the educational model adopted by the Shanghai Cooperation Organization University is feasible and effective."

　　Kukeyeva praised China for its great contribution to the development of green economy in Kazakhstan. She said that on the one hand, the optimization and adjustment of energy structure is the key to promote Kazakhstan’s economic diversification, on the other hand, the green economy has expanded the space for bilateral energy cooperation between Kazakhstan and China. In 2013, Kazakhstan proposed to transform into a green economy, and planned to increase the proportion of alternative energy and renewable energy in the country’s total power generation to 50% by 2050. In 2017, China released the "Cooperation Plan for Ecological Environment Protection of the Belt and Road", emphasizing the need to build the Belt and Road into a green, prosperous and friendly road, and defining the key tasks of the green Belt and Road construction. Kukeyeva believes that pragmatic cooperation in the field of green energy will play an increasingly important role in Kazakhstan-China friendly exchanges in the future.

　　Kukeyeva is willing to join hands with Central Asia to build a closer China for China — The concept of a community of destiny in Central Asia is highly appreciated. She pointed out that this shows that China fully cares for and supports the development of its neighbors while concentrating on its own development and construction. "The concept of promoting the building of a community of human destiny put forward by the Supreme Leader focuses on the common interests and common well-being of all mankind, is committed to building a free and inclusive prosperous world, and contributes wisdom and solutions to promoting the construction of new international relations."

　　Kukeyeva said that China and the five Central Asian countries are geographically linked by mountains and rivers, sharing weal and woe in security and complementing each other in economy, which has created broad prospects for cooperation. Today’s international situation is complicated and changeable, and she is very much looking forward to China — The Central Asia Summit will lead all parties to think together about the measures to deal with global risks and challenges. She believes that the summit will provide a more perfect dialogue platform for cooperation and exchanges between China and Central Asian countries, and the results of the summit will further enhance the non-governmental friendship and recognition between China and Central Asian countries, and achieve "common aspiration".

Chest tightness and shortness of breath, over 60 years old, please note that the heart ＂valve＂ is likely to age.

Original x popularization of science factory x popularization of science factory

Today, a grandmother Zhang came to the X clinic program. She said that she had chest tightness and breathlessness since three years ago, but she only had one or two episodes a year, so she didn’t take it seriously.

However, the situation is getting worse and worse. By December last year (2022), it was so serious that I couldn’t sleep on my back. When I went to the hospital for examination, it turned out to be a heart problem!

Wei lai | chief physician

■ Zhongshan Hospital affiliated to Fudan University

Deputy director of cardiac surgery

■ Executive Director of Cardiac Surgery, Shanghai Geriatrics Center

■ Director of minimally invasive cardiovascular surgery

■ Shanghai Heart Valve Engineering Technology Research Center

deputy director

Aging of heart valve

Even more dangerous than some cancers!

The main function of the heart is to pump blood, and the heart valve is an important "valve". Under normal circumstances, this "valve" is one-way and blood cannot flow back.

If the valve calcifies and this "door" cannot be fully opened, then the blood supply will be insufficient.

If this "door" is broken, the pumped blood will flow back and the heart will not be able to supply blood normally.

People will feel chest tightness and breathlessness, and even sudden death in severe cases!

According to statistics, the prevalence of valvular disease has increased since the age of 60, and one in every eight people over 75 suffers from moderate and severe valvular disease, which is very common!

There are four valves in the heart, namely tricuspid valve, pulmonary valve, mitral valve and aortic valve.

Among them, the most important thing is aortic stenosis. Because the aortic valve of the human body is the key "door" connecting the heart and various tissues of the body, once the aortic valve has problems, it will affect the blood supply to the whole body.

Aortic stenosis can be divided into three grades: mild, moderate and severe. Mild and moderate diseases will affect the quality of life of patients, and there will be a long incubation period from occurrence to symptoms, even up to decades.

Severe cases can be life-threatening. If not treated in time, about 50% patients with severe aortic stenosis will hardly live for five years! The survival rate is lower than that of some malignant tumors that make people talk about it.

Why is the heart "valve" damaged?

The valve of human body, especially aortic valve, is the key "door" connecting the heart and various tissues of the body. Once the aortic valve has problems, it will affect the blood supply to the whole body. It will appear:

Manifestations of valvular heart disease:

1. It is easy to feel tired, and I feel tired after doing a little work, and my constitution is very poor;

2. If you can’t breathe smoothly, you will not be able to breathe when you are active, that is, you will be short of breath.

3. The face, hands, feet or other parts are swollen.

4. Abdominal swelling and loss of appetite.

5. The heartbeat is irregular, and sometimes it will suddenly accelerate. In case of sudden syncope, you should pay special attention.

Therefore, regular physical examination for people over 60 years old is particularly important.

There are many reasons for valvular heart disease. To sum up, there are probably the following five reasons.

1. Age factor

The prevalence of valvular disease began to increase from the age of 60, and with the further aging, the incidence of aortic stenosis increased sharply. One in every eight people over 75 years old suffers from moderate and severe valve disease.

2. Congenital diseases

Congenital diseases, especially bicuspid aortic valve malformation. According to the study of Copenhagen Baby Heart Study, the incidence of bicuspid aortic valve malformation in different races is generally 0.5%-1.5%. According to the data of interventional therapy for valvular heart disease in China in 2022, more than 45% of patients with bicuspid aortic valve were treated with TAVR in China, which is close to half. It is mainly caused by the structural problems of bicuspid aortic valve.

3, rheumatic heart disease

This rheumatic valvular heart disease mainly occurs in the mitral valve position.

In 1970s and 1980s, valvular heart disease in China was mainly rheumatic valvular heart disease. Because of poor living and economic conditions at that time, people were prone to rheumatic heart disease after being infected by streptococcus.

The onset age of rheumatic heart disease is earlier, and the onset population is relatively young.

With the overall economic and cultural development in China, valvular heart disease caused by infection or malnutrition has decreased, and senile degenerative heart valve disease has gradually increased. It is a disease caused by age growth and long-term work overload.

4. Infectious and immune diseases

Infectious and immune diseases can also cause reflux, but the risk is lower than aortic stenosis.

5. Other rare diseases

How to repair the broken valve?

The valve in life is broken, just change it to a new one. Then the valve of the heart is broken, what should I do?

The answer is: repair or replace it with a new one.

Aortic valve stenosis has been detected, and there are currently three treatments.

1. Drug therapy

At present, drug therapy can only reduce the burden on the heart by draining water or slowing the heartbeat, but it can’t have an effect on calcified valves. Therefore, if patients with severe aortic valve stenosis, surgery can be considered.

2. Traditional surgical valve replacement (included in the scope of medical insurance)

Traditional surgery usually requires thoracotomy. This method is suitable for valve repair or valve replacement in young patients.

At present, the traditional surgical valve replacement technology is very mature in China, and a large number of clinical data have been accumulated.

If it is really necessary to open the chest after being judged by a regular doctor, then there is no need to panic too much, and surgery can be performed according to the doctor’s advice.

3, interventional therapy surgery (has been included in the scope of medical insurance)

As we said earlier, many patients with aortic stenosis are often in their sixties and seventies. When they are old, they are in poor health, and the risk of surgical valve replacement is great. For such patients, interventional surgery can be considered.

Only through a minimally invasive incision in the leg or chest, the artificial valve can be implanted into the heart. The whole operation takes less than an hour and the wound is very small. Patients can often get out of bed and go home the next day, which is simple and fast.

Generally speaking, there are two kinds of prosthetic valves that can be replaced:

Mechanical valve:

Mechanical valves, mostly made of pyrolytic carbon materials, have the advantages of long service life, not easy to be damaged and relatively cheap.

However, because of its hard texture, it can not be minimally invasive intervened by catheter, and it can only be replaced by traditional thoracotomy, and it is easy to produce thrombosis. So this kind of valve is more suitable for young patients.

Biological valve:

The elderly often choose biological valves, which are made of animal hearts, soft and can be performed through minimally invasive surgery without thoracotomy. But the disadvantage is that compared with the mechanical valve, it has a certain service life and the price is slightly expensive.

Everyone’s physical condition and disease progress are different, and the applicable treatment scheme is also different. Medical treatment or surgical treatment, when to operate and which surgical method to choose should be evaluated and judged by professional doctors after a comprehensive physical examination.

Doctor’s health tips:

It is still necessary to remind the majority of middle-aged and elderly people to have regular physical examinations, especially those over 50 years old should have a complete physical examination every year, including electrocardiogram, chest X-ray, color Doppler echocardiography and some blood-related tests, such as blood lipids, blood sugar and other indicators closely related to cardiovascular diseases.

If we can find possible heart disease-related diseases in advance through annual physical examination, and adjust our living habits or carry out medical intervention accordingly, the burden on individuals, families and society will be greatly reduced.

Expert outpatient information

Weilai

Deputy director of cardiac surgery, Zhongshan Hospital affiliated to Fudan University

Outpatient service time: all-day outpatient service every Wednesday.

Outpatient address: East Campus of Zhongshan Hospital affiliated to Fudan University

(No.1609 Xietu Road, Xuhui District)

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Baojun Automobile responded to the network transmission that Baojun Yue also failed to brake： some vehicles have software bugs.

Yichexun A few days ago, Baojun Automobile made a public response to the recent "brake failure" incident in Guanwei. Baojun Automobile said that the Yueye incident was not a "brake failure" described by the network, but a software BUG in some vehicles, which led to the degradation of brake power. This part of the vehicle will enter the speed limit protection state when it is reminded by the indicator light when it is started.

Baojun Automobile said in the response statement that after receiving relevant feedback, we intervened at the first time and solved the problem of users’ vehicles. Please feel free to use them. This Yueye incident is not a "brake failure" described by the network, but a software BUG in some vehicles, which leads to the degradation of braking power. This part of the vehicle will enter the speed limit protection state when it is reminded by the indicator light when it is started. Without knowing the facts, the relevant media described the words such as "brake failure" as inaccurate. We will sincerely and properly cooperate with the owner’s aftermath.

Editor in Charge: Xu Zhenyu

Steady start, busy production and full confidence (new economic orientation, vigorously boosting market confidence)

　　The Central Economic Work Conference emphasized that "more efforts should be made to promote the stable scale and excellent structure of foreign trade". In 2022, China’s import and export of goods broke the 40 trillion yuan mark for the first time, increasing by 7.7% to 42.07 trillion yuan; In 2023, it is necessary to maintain a continuous good trend of imports and exports and realize the important supporting effect of stable foreign trade on stable growth.

　　At the beginning of the new year, all localities and departments launched "service packages" and made every effort to achieve a "good start", laying a solid foundation for maintaining stability and improving quality of foreign trade imports and exports throughout the year. Our reporter interviewed this, watching foreign trade enterprises "run up", manufacturing "strengthen" and logistics channels "smooth up", and feeling the vitality and toughness of import and export.

　　Expand the market — —

　　An order to cross the ocean

　　The plane landed in Kuala Lumpur, Malaysia, and the tropical sunshine penetrated through the porthole, but Zheng Yijun’s heart was still uneasy.

　　As the chairman of Zhaotai Trading (Chongqing) Co., Ltd., he received a questionnaire from Chongqing Municipal Commission of Commerce at the end of last year: Are you interested in exploring markets in Southeast Asia? The company specializes in motorcycles, generators and micro-tillers, and goes deep into strange markets. No one takes the lead in organizing, so Zheng Yijun dare not take risks.

　　At the end of the year and the beginning of the year, the economic recovery ushered in a window period, and Chongqing took advantage of the situation to implement the international market development plan. "The survey shows that 96% of enterprises are interested, and 85% are willing to charter flights or assemble air crews." According to the relevant person in charge of the Chongqing Municipal Commission of Commerce, ASEAN is an important trading partner of Chongqing, and combined with the wishes of enterprises, the destination is Malaysia and Thailand.

　　The business group was busy, and Zheng Yijun kept on: the business office of the Chinese embassy, local departments and chambers of commerce visited them one by one; Local market inspection teams, offline matchmaking meetings of enterprises, and field connection … … During the activity, he also met "netizens" — — A motorcycle and agricultural machinery parts supplier, "in the past, online contact was intermittent, and cooperation failed."

　　This time, Zheng Yijun, with product brochures and samples, was finally able to sit down and talk with the other party: "We can provide all technical support and after-sales service; Goods are transported through the new land and sea passage in the west, with short time and favorable price, and can provide a package of logistics services … …”

　　"A thousand emails are not as good as meeting one another." Zheng Yijun said that the two sides signed a cooperation framework agreement on the spot.

　　During the visit, the delegation members of Chongqing Municipal Commission of Commerce introduced the basic situation and development advantages of Chongqing to foreign businessmen, while helping enterprises understand the local trade policies and investment environment. At the centralized signing ceremony of the first stop in Malaysia, nine Chongqing enterprises signed contracts with foreign parties for 11 projects, with an amount exceeding 100 million yuan.

　　This is the significance of "going out to sea in groups", which supports enterprises to meet customers, expand markets, sign orders and stabilize production. According to statistics, the total contracted amount of the business group this time is 30.88 million US dollars, involving the fields of communication, hardware, automobile and motorcycle, access control system, logistics full chain service, etc., and the largest single order reaches 5 million US dollars. The relevant person in charge of the Chongqing Municipal Commission of Commerce said: "This year, we plan to organize more than 100 delegations to support more than 1,000 enterprises to go abroad, participate in exhibitions, conduct business docking and visit customers."

　　Originally planned to talk about a contract of 1.85 million US dollars, but it didn’t happen. When I returned, I had already received a total order of 5 million US dollars. Zheng Yijun is no longer nervous when he first came, and he is full of confidence in his next trip.

　　Catch orders — —

　　A factory running at full speed

　　Dust-proof clothing, hats, masks and gloves … … Workers in full gear are busy and orderly.

　　In Shangyu District, Shaoxing, in the packaging workshop of Zhejiang Axilong Shunhua Aluminum Plastic Industry Co., Ltd., more than 40 production lines and more than 100 injection molding machines are fully powered.

　　Before and after the Spring Festival, Zhejiang foreign trade enterprises organized a delegation to go to sea and gained a lot. Axilong Shunhua, who specializes in the production of lipstick tubes, perfume covers and other cosmetic packaging materials, is ready to grab production and orders early.

　　Since the fourth day of the first month, Zhang Fang, a worker in the injection workshop, has been busy. This year, instead of returning to her hometown in Anhui, she responded to the call to stay in the factory for the New Year. "The government issued a subsidy from 1000 yuan, and our foreign employees also received an additional 1,500 yuan from the company." Zhang Fang said that the heavier the task, the higher the income, and everyone is full of energy.

　　"Not only employees, but also all aspects." Xu Baihua, general manager of the company, introduced that Shangyu Power Supply Company of Shaoxing City, State Grid, together with District Water Group and District Natural Gas Company, jointly inspected and maintained equipment and lines, providing reliable guarantee for enterprises to start construction.

　　On the basis of implementing 12 measures of "seizing the start and stabilizing growth" in the early stage, Shangyu District successively issued 24 policies, and arranged over 2 billion yuan of policy funds throughout the year to encourage enterprises to return to work quickly and stabilize production with "real money and silver".

　　Axilong Shunhua has a new factory building, which is expected to be put into trial operation in the second quarter. This is a water-based coating production line for cosmetic packaging materials, which can replace high-content volatile organic compounds such as ink and solve the problem of pollutant discharge from the source. "The government encourages source substitution and technology upgrading, and can get up to 30% subsidy for enterprise equipment investment!" Xu Baihua said.

　　Outside the factory, Chen Fengfei, director of the company’s marketing center, is seeing off visiting customers. "We intend to further explore overseas markets." She simply "settled down" in the office and studied the policy package of full dry goods: the company plans to go to Dubai, Monaco and other places to participate in exhibitions, and the booth fee subsidy can reach up to 100%; Inviting foreign businessmen to enter the country for business talks, enterprises can get a reward of 5,000 yuan/person … …

　　"We should take more measures to stabilize production, so that enterprises can gain a stronger sense of gain." According to the relevant person in charge of the Zhejiang Provincial Department of Commerce, this year, Zhejiang will further implement the action of expanding the market to grab orders and attract projects, and plans to hold 600 events, focusing on holding and supporting more than 130 exhibitions; Measures such as increasing special loans for foreign trade industries and speeding up the construction of foreign trade financial system will also be implemented continuously.

　　The policy is strong and the enterprise is confident. Chen Fengfei said: "In early February, we reached a follow-up cooperation intention with two foreign companies." According to the production situation of various factories, the company’s output value in the first quarter increased by at least 5% year-on-year, and the annual sales are expected to return to the peak before the epidemic.

　　Clear the way — —

　　An efficient and fast route

　　The whistle is long and spreads to the shore of Qingdao Port, Shandong Port, with the sea breeze in the morning. This is the sixth largest container port in the world and the largest port with the highest density of routes in northern China, with more than 220 container routes.

　　On February 19th, the "Oriental Belgium" freighter from the RCEP route firmly docked at the 105 berth in Qianwan Port Area, but the operation area was empty — —

　　"This is a fully automated terminal that has set a new world record for loading and unloading efficiency for 9 times. It integrates the Internet of Things, big data, artificial intelligence and automatic control, and runs automatically throughout the process." Li Qiang, deputy manager of Qingdao Port Automation Terminal Operation Department, explained that relying on the intelligent management and control system independently developed by Qingdao Port, the bridge crane automatically scans the outline of the ship and identifies the target position in real time; The guided vehicle is equipped with laser anti-collision system and ultrasonic sensing system to transport containers to the yard without interruption; According to the task issued by the system, the track crane completes the stacking and receiving operation … …

　　After the unloading, the container trucks next to the "Oriental Belgium" freighter came and went, while sending the imported goods to the Qingdao Customs inspection platform, accepting the supervision of customs information checking and machine inspection image inspection, and loading the exported goods for bridge crane loading.

　　The shipment has not been completed, and the customs supervision procedures have been completed. This efficiency is due to the convenience measures for the passage of ships on the RCEP route introduced by Qingdao Customs, and the perishable goods originating from RCEP member countries that have arrived at the supervision workplace and submitted the information completely are released within 6 hours.

　　Export customs clearance procedures can be handled online. "View, download and print online, without running errands and waiting on shore, saving time and reducing costs." Zhao Wenjuan, business manager of Rizhao Jinhe Biochemical Group Co., Ltd., shook the paper in his hand: "Look, the RCEP certificate of origin has also been completed in advance."

　　With this certificate, the tariff rate of the company’s 380 tons of citrate can be reduced from the original 5% to zero, and the tax reduction is over 120,000 yuan. Thanks to RCEP, the company expects export orders to increase by more than 15% this year.

　　In January 2022, the first RCEP certificate of origin in China was issued here. In January this year, Qingdao Customs issued 7,451 certificates, and the value of export goods was 1.67 billion yuan, up by 62.4% and 16% respectively. A total of 430 million yuan of imported goods were subject to RCEP preferential tax rate, and the tax concession was 24 million yuan, up 3 times and 3.6 times respectively. Bi Haijun, director of the Customs Department of Qingdao Customs, said: "We have also developed a smart collection and management system to accurately locate enterprises that are not enjoying benefits in the jurisdiction and guide them to enjoy dividends such as tariff concessions."

　　With the official entry into force of RCEP last year, the port economy has become more and more active. Qingdao Port has strengthened cooperation with key companies and opened up nearly 100 RCEP routes. Li Qiang said: "Since the beginning of this year, container throughput has increased by 10.4% year-on-year, berth efficiency has increased by 9.9% year-on-year, and the best results have been achieved in the same period."

　　At night, the "Oriental Belgium" freighter whistled again and set sail with full load. The cargo ship imported and exported a total of 1,129 natural containers, and the ship’s hourly efficiency reached 111.77 natural containers, leaving the berth two hours earlier than originally planned and arriving at the destination three days later.

　　Coordination in this period: Cheng Juxin