Original title: new crown "life saving machine" ECMO equipment is hard to find, why there is no domestic manufacturer to produce
There is no enterprise in China to produce, which is restricted by multiple factors such as technical threshold, clinical use and market demand.
In novel coronavirus pneumonia patients, ECMO plays the role of "straw saving". Since January 22, Central South Hospital of Wuhan University successfully treated severe pneumonia patients with ECMO, according to incomplete statistics of the first financial reporter, at present, six hospitals have used ECMO technology to pull patients back from the edge of death.
In fact, ECMO is really well known to the public, but it failed to save the life of Li Wenliang, an ophthalmologist in Wuhan Central Hospital. However, novel coronavirus pneumonia is not the most important support for severe cardiopulmonary failure, and is regarded as the "ultimate weapon" for the treatment of severe cases of new crown pneumonia.
Strengthening the treatment of novel coronavirus pneumonia patients is the key point of epidemic prevention and control. On February 27th, novel coronavirus pneumonia leader Li Keqiang, leader of the State Council and the Central Committee of the State Council, pointed out that we should speed up the mobilization of ECMO from the whole country and reduce the mortality rate. Under the epidemic situation, the market demand for ECMO equipment has increased sharply, but its market stock is extremely limited, and there is no one in domestic manufacturers that can produce ECMO equipment.
What is the use of ECMO
In the past, the application of ECMO in hospitals was not universal, and the external cognition was very limited. In the rescue of novel coronavirus pneumonia patients, doctors used ECMO to compete with death for a race against time. ECMO was also greatly concerned by the market.
ECMO, commonly known as "Yeke membrane" and "artificial lung", is a kind of medical first-aid technical equipment. Its simple working principle is to drain venous blood from the body to the outside, oxygenate it with a gas exchange device and then pump it back into the body with a driving pump, so that the heart and lung can be fully rested. The support for lung function can effectively improve hypoxemia and avoid long-term hyperoxia inhalation For heart function, it can increase and maintain cardiac output, improve systemic circulation perfusion, ensure circulation stability, and win time for the recovery of cardiopulmonary function.
"We have recently received constant inquiries from our customers about ECMO." Lin Haiying, assistant general manager of Jiutai pharmaceutical, told the first financial reporter that it is expected to extend the rescue time by connecting ECMO equipment after people have no vital signs. ECMO plays an irreplaceable role in emergency treatment scenarios, including acute myocardial infarction and other severe cardiogenic shock, severe acute respiratory failure, and severe infectious shock.
According to the novel coronavirus novel coronavirus pneumonia treatment plan (trial version fifth) and the new coronavirus pneumonia diagnosis and treatment plan (trial version sixth), formulated by the National Health Protection Committee, it is recommended that ECMO be used as a salvage treatment for critically ill patients with poor conventional treatment.
In the treatment of novel coronavirus pneumonia patients, although ECMO has shown positive significance, it still needs systematic study. The novel coronavirus pneumonia, an expert consensus on the treatment of new coronavirus pneumonia, was published in the February 19, 2020 issue of the Chinese Journal of emergency medicine. The paper points out that the consensus draws on the experience of hospitals in Hubei province to use ECMO to treat COVID-19. ECMO can reduce the mortality of patients with covid-19. The median time from the first symptom onset to progression to ARDS (acute respiratory distress syndrome) in patients with covid-19 was 8 days, but no study showed when to start. There is no absolute contraindication for ECMO, which needs individualized evaluation of clinical risk and benefit. Some factors related to poor prognosis of ECMO are considered as relative contraindications, including: the combination of irrecoverable diseases or important organ failure; the existence of anticoagulation contraindications, etc. ECMO has no age-specific contraindications, but the risk of death increases with age.
Novel coronavirus pneumonia is also a new type of pneumonia. The above article also shows that there is no high-quality evidence supporting early use of ECMO in the treatment of severe new crown pneumonia, and the relevant recommendations need further clinical observation and research. However, it is still recommended to assess the opportunity of boarding based on the individualized condition and take full account of the objective impact of human resources, resources and equipment consumption restrictions on ECMO implementation during the epidemic.
No domestic manufacturer can produce it
According to the report of Huaxi Securities, citing the data of the professional committee of extracorporeal life support of Chinese Medical Association, as of December 31, 2018, ECMO treatment has been carried out in the extracorporeal life support centers of 260 hospitals in China, with a total of about 400 ECMO devices.
Since the outbreak of the epidemic, the demand for ECMO in hospitals has greatly increased.
"The company has donated equipment including ECMO and ventilator to medical institutions in Wuhan, and the company's inventory is still difficult to meet the current surging market demand. The proportion of ECMO business in the company is not high," an internal employee of Medtronic China told first financial reporter
Throughout the world, there are only three ECMO manufacturers, but all of them are abroad. In addition to Medtronic, there are also Renault (ECMO brand is SOLIN) and macowell.
However, there is no enterprise in China that can produce, which is restricted by technical threshold, clinical use and market demand.
First of all, the production of ECMO system has a high technical threshold. ECMO consists of a complete set of equipment system, including various types of raw materials, electronic components, high-end materials, etc.; ECMO equipment manufacturers produce core membrane lung, pumps, consumables, etc.
Membranous lung is the core component of ECMO system. Three generations of products have been developed for gas exchange. At present, the materials of membrane lung on the market include the first generation solid silica membrane, the second generation microporous hollow fiber membrane and the third generation solid hollow fiber membrane (PMP polyolefin material). The third generation solid hollow fiber membrane, which is mainly used in the market, combines the advantages of the first generation material solid silica gel membrane and the second generation material microporous hollow fiber membrane, overcomes the problem of plasma leakage, and effectively prolongs the clinical use time of ECMO.
However, PMP polyolefin materials are exclusively supplied by membrana, a subsidiary of 3M company. Due to the shortage of production capacity, the capacity of downstream ECMO enterprises is also limited.
"PMP polyolefin material supply is monopolistic, and the price is also monopolistic, so the rare goods can be found." Said the employees.
Lin Haiying also introduced to the first financial reporter that the common complications of ECMO in the application process include catheter rupture, blood pump or oxygenator dysfunction, limb ischemia, necrosis, hemorrhage and nervous system abnormalities, infection, thrombosis, etc. The key technology of centrifugal blood pump design also restricts the effect of clinical application. Sufficient output, minimum thrombosis and blood component destruction are also the development threshold of the module.
In the promotion of Chinese market, ECMO has some limitations. In 2012, Chinese Society for extracorporeal life support (checls) began to propose that Chinese hospitals carrying out ECMO support treatment report ECMO cases. Although in 2018, the total number of ECMO cases carried out by 260 hospitals in China reached 3923, an increase of 38.8% compared with 2826 cases in 2017, there are still less than 5 ECMO cases carried out by more than 40 centers.
The price range of domestic ECMO equipment is from 1 million yuan to 3 million yuan, with an average price of 1.65 million yuan. The price of mobile ECMO is about 3 million yuan / set. The expensive treatment cost keeps the patients away. In the actual treatment process, each quotation of consumables package required by ECMO equipment is as high as 30000 to 60000 yuan. In addition, there are various costs such as continuous detection, replacement of equipment, medication, etc. According to rough estimation, the domestic treatment cost starts from 50000 yuan. "ECMO in the application process must face a series of problems such as limb ischemia, necrosis, hemorrhage, nervous system abnormality, infection, thrombosis, hemolysis and so on. In addition, in individuals, it is often necessary to add circulatory support together with intra aortic balloon counterpulsation, left ventricular assist device, right ventricular assist device or bicardiac assist device, together with other life monitoring and support means, there will be More risk of complications and higher cost of treatment. " Lin Haiying said.
In addition, ECMO requires strict operation management. In general, it needs to involve multiple professionals such as cardiac surgery or macrovascular surgery, cardiopulmonary bypass, critical cardiac disease, respiratory disease, ultrasound imaging, and testing. An ECMO operation team should have at least four or more people, and special ECMO principals, coordinators, instrument consumables administrators, information administrators and doctors, all of whom are from professional severe and clinical background. Because ECMO is very critical to treat patients, the industry also suggests that ECMO center should be set up in a tertiary hospital, and should have a considerable level of ICU.
It is worth mentioning that the success of ECMO treatment is also uncertain under the huge cost. According to the data provided by Lin Haiying to the first financial reporter, the success rate of ECMO treatment in the past is as follows: as of January 2020, the total number of registered cases in elso has reached 129037, and 55% of them have survived to discharge or transfer.
However, according to the first financial reporter, at present, there are also companies in China that are studying and developing ECMO related supporting equipment.