China's domestic extracorporeal membrane oxygenation (ECMO) products have been approved for market

According to the needs of epidemic prevention and control work, in order to ensure the treatment needs of severe patients with novel coronavirus pneumonia, on January 4, 2023, the State Food and Drug Administration reviewed and approved the registration application of Shenzhen Hanno Medical Technology Co., Ltd. for external cardiopulmonary support auxiliary equipment and disposable membrane oxygenator kits, which are used together. For adults with acute respiratory failure or acute cardiopulmonary failure who are difficult to control with other treatments and are at a foreseeable risk of continued deterioration or death. As the first domestic ECMO equipment and consumables package, the above products have independent intellectual property rights, and the performance indicators basically reach the level of similar international products.

Among them, the external cardiopulmonary support auxiliary equipment is composed of a main engine, a pump driving device, an emergency pump driving device, a backup battery, and a flow bubble sensor. The disposable membrane oxygenator package consists of a membrane oxygenator, a dynamic and static tube assembly (including a centrifugal pump pump head), a pre-filled pipe assembly, an accessory pack assembly and an oxygen pipeline.

ECMO products, as a rescue treatment device for critically ill novel coronavirus pneumonia patients who have failed conventional treatment, are a treatment measure specified in the novel Coronavirus Pneumonia Diagnosis and Treatment Plan. The launch of domestic products will play an important role in meeting clinical needs, ensuring the treatment of severely ill patients, and ensuring the implementation of the epidemic prevention and control goals of "protecting health and preventing severe diseases".

In the process of registration and application of the product, the State Food and Drug Administration, in accordance with the principle of "unified command, early intervention, fast and efficient, scientific approval", set up an emergency review working group, dedicated personnel are responsible for the whole process of guidance, issue technical review guidelines, increase the guidance of product registration and application, speed up the review and approval process, and promote the product to market as soon as possible on the basis of ensuring safety and effectiveness. To meet the urgent needs of epidemic prevention and control.

The drug regulatory authorities will strengthen post-market supervision of the product to protect the safety of patients.