Xinhua News Agency, Guangzhou, April 2nd, Topic: Where is the localization of ECMO, a "lifesaving artifact" difficult?

Xinhua News Agency Xinhua Perspectives reporters Ma Xiaocheng and Jing Huaiqiao

During the anti-epidemic in Wuhan, ECMO (External Membrane Oxygenation, commonly known as "artificial lung") was used clinically in hospitals to successfully treat patients with severe new coronary pneumonia, and was included in the new coronavirus pneumonia diagnosis and treatment program issued by the National Health Commission, known as " Life-saving artifact. "

At present, all of this important medical equipment in China relies on imports, and the cost of equipment and consumables is very high. Industry experts believe that the localization of ECMO should be promoted as soon as possible to reduce the cost of use and benefit more patients. Some domestic companies are committed to the localization of ECMO, but have not yet succeeded. What are the difficulties?

Total reliance on imports for two weeks costs 200,000 yuan

ECMO is a device for the cardiopulmonary system intensive treatment. The principle is to draw venous blood out of the body, allow the blood and oxygen to fully oxygenate, and then pump it back into the body to replace cardiopulmonary function. It can be widely used in the emergency treatment of critically ill patients.

For severe patients with new coronary pneumonia, the use of ECMO equipment can temporarily replace the human heart and lungs, and the use time can be up to 14 days. ECMO was used in hospitals during SARS in 2003, but it has not been widely used until recent years. In 2019, China's ECMO centers reported more than 5,000 cases of use.

During the new crown pneumonia epidemic, the demand for ECMO use by hospitals has skyrocketed. According to the requirements of the new coronary pneumonia diagnosis and treatment plan, it is recommended that ECMO be used for rescue treatment of severe and critically severe cases with poor conventional treatment. Luo Junjie, director of the First Division of Equipment Industry of the Ministry of Industry and Information Technology, said at a press conference on March 4 that the Ministry of Industry and Information Technology sent 67 ECMO equipment to Hubei. It is understood that after emergency procurement and domestic solicitation, coupled with the equipment brought by Hubei medical teams in various places, Hubei Province has concentrated more than 100 ECMOs. Even so, in the face of many critically ill patients, ECMO resources are still stretched.

At present, the mainstream ECMO brands in the domestic market are mainly Medtronic, Midos, Mai Kewei and Solin in Europe and America. According to the data from the Professional Committee of External Life Support of the Chinese Medical Association, as of the end of 2018, there were more than 400 ECMO devices in China, of which the products of Mai Kewei and Solin accounted for the majority of the domestic market.

The price of an ECMO ranges from 1 million yuan to 3.5 million yuan, and the cost of startup and consumables is high. According to Liu Yang, director of the Chinese Project Department of the German German Chinese Medical Association, the average ECMO boot consumable kit is 50,000 yuan, which is equipped with blood tubing, membrane oxygenator, centrifugal pump head, intubation and various connectors, plus severe ICU every day For treatment costs exceeding 10,000 yuan, patients need to spend 200,000 yuan on ECMO for two weeks.

The use of more and more domestic key technologies remains to be broken

Many experts believe that the application of ECMO is relatively wide, including severe acute and chronic heart failure caused by various reasons, such as cardiogenic shock, low cardiac output after cardiac surgery, myocardial infarction, cardiomyopathy, myocarditis, cardiac arrest, and Before heart transplantation, etc .; severe acute and chronic respiratory failure caused by various reasons, such as fulminant viral pneumonia, fulminant bacterial pneumonia, acute respiratory distress syndrome, pulmonary embolism, and lung transplantation.

ECMO equipment has been widely used in some developed countries. Liu Yang said that in Germany, there is an ECMO for every 20,000 to 40,000 people. In the United States, the number of hospitals providing ECMO services has increased from 108 in 2008 to 264 in 2019, according to data from the International Extracorporeal Life Support Organization (ELSO).

According to the statistics of the extracorporeal circulation branch of the Chinese Society of Biomedical Engineering in 2018, there are 260 hospitals in China that can do ECMO. But even if you add ECMOs that have recently been urgently purchased from abroad, there are only about 500 in the country, which is equivalent to an ECMO per 2.8 million people.

The high use price is one of the important reasons restricting the widespread use of ECMO. Many experts believe that localization of the device is critical to reducing the cost of use and increasing patient acceptance. Localization can increase market competition and drive product prices down.

However, the localization of ECMO equipment faces many constraints, the most important of which is that key materials and technologies have not been mastered. Guangdong Institute of Medical Device Quality Supervision and Inspection is the location of the Key Laboratory of Extracorporeal Circulation Devices of the State Drug Administration. The director of Li Weisong introduced that the basic structure of ECMO includes endovascular cannula, connection tubing, centrifugal pump (artificial heart), oxygenation Membrane lung (artificial lung), sensor monitoring system, etc., the core parts are oxygenator and centrifugal pump, which play the role of artificial lung and artificial heart respectively, which is the current difficulty of localization.

Ke Jun, director of the Office of the State Key Laboratory of Extracorporeal Circulation Devices, said that the core of the new generation of centrifugal pumps is the design of magnetic levitation technology and high-efficiency impellers. The difficulty lies in how to reduce the damage and damage to the blood by the pump head while improving the blood efficiency This requires the support of sophisticated biomedical engineering technology. In the development of the oxygenator, the key material is the hollow fiber membrane of polymethylpentene (PMP), which allows oxygen to enter the blood efficiently, replacing the gas exchange function of the human lung. All these require scientific research breakthroughs.

The problem of non-cooperation between the upstream and downstream industry chains is also prominent. ECMO's research and development is a systematic project involving a number of important technologies and components. Yan Lin, executive deputy director member of the National Technical Committee for the Standardization of Medical Extracorporeal Circulation Equipment, said that in recent years, some domestic enterprises have invested resources in the research and development of ECMO products, but they are relatively scattered and have not formed a joint force.

In addition, the use of ECMO may cause complications such as bleeding, embolism, and infection. Even within the scope of the application, it depends on the individual situation. Therefore, the use of medical staff is more cautious and the market capacity is relatively small.

Localization progress should integrate upstream and downstream industry chain resources

After the epidemic, increasing capital investment and R & D efforts, and promoting the localization of high-end medical rescue equipment represented by ECMO, have become the common voice of many people in the industry.

The reporter learned that some progress has been made in the localization of ECMO. Relying on the Sino-German joint research and development team, Shenzhen Hannuo Medical Group has designed oxygenators and centrifugal pumps after 3 years of scientific research. At present, it has completed the functional prototypes of the entire set of equipment including oxygenators, centrifugal pumps and system hosts. Design stereotypes. Liu Shuqin's team at Shandong University said that they have developed a magnetic levitation centrifugal pump with independent intellectual property rights, and look forward to the results of incubation and cooperation.

Li Weisong believes that it is necessary to apply for projects or funds through competition to allow qualified enterprises and scientific research institutions to receive support. It is necessary to integrate the resources of upstream and downstream enterprises scattered in the industrial chain of machines, consumables and pipelines across the country, and provide standardized support.

People in the industry suggest that government departments can strengthen the connection with enterprises, provide quality standard guidance for enterprise research and development, and improve the connection and efficiency with enterprises in the approval process, and accelerate the speed of products from research and development to market. Liu Yang said that domesticization is not to close the door and do it on its own. Enterprises should strengthen international cooperation and improve the level of core technology and manufacturing.