For the treatment of COVID-19 severe cases, we have our own "lifesaving device" - the domestic extracorporeal membrane oxygenation (ECMO) device. On January 5, the State Food and Drug Administration announced that, in order to ensure the treatment needs of patients with severe COVID-19 infection, it had recently approved the registration application of Shenzhen Hannuo Medical Technology Co., Ltd. for extracorporeal cardiopulmonary support auxiliary equipment and disposable membrane oxygenator kits. The State Food and Drug Administration said that this is the first domestic ECMO product in China, and its performance indicators have basically reached the international level of similar products. ECMO, commonly known as "artificial lung", is an auxiliary treatment method. Its main principle is to use a driving pump to introduce blood from the body to the outside, and then transfer fully oxygenated blood back into the body after gas exchange through a membrane oxygenator, completely or partially replacing the heart and lung functions. It can reduce the burden on the heart and lungs of critically ill patients and win more treatment time for medical staff. At the initial stage of the COVID-19, ECMO played an important role in the treatment of critically ill patients and reducing the death rate, known as the "magic weapon for saving lives". According to the data provided by the National Health Commission, as of December 25, 2022, there are more than 2600 ECMOs in China. With the progress and change of the epidemic situation, clinical needs are urgent. "As the first domestic ECMO equipment and consumables package, the above products have independent intellectual property rights, and their performance indicators have basically reached the international level of similar products." The State Food and Drug Administration said that the listing of domestic products will play an important role in meeting clinical needs, ensuring the treatment of COVID-19 severe patients, and ensuring the implementation of the goal of "health and severe prevention" in epidemic prevention and control. It is reported that in order to enable patients to use domestic ECMO as soon as possible, the State Food and Drug Administration has set up an emergency review team in the process of registration and application of the product. A special person is responsible for, guiding and releasing the guiding principles of technical review, increasing the guidance of product registration and application, speeding up the review and approval process, and promoting the product to market as soon as possible on the basis of ensuring safety and effectiveness. Subsequently, the drug regulatory authorities will strengthen the supervision of the product after it is launched to protect the safety of patients. (Outlook New Times)
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