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According to the needs of epidemic prevention and control, in order to ensure the treatment needs of severe patients with novel coronavirus pneumonia, on January 4, 2023, the State Food and Drug Administration approved the registration application of Shenzhen Hannuo Medical Technology Co.
, Ltd.
for extracorporeal cardiopulmonary support auxiliary equipment and disposable membrane oxygenator package after review, which are used together for adult patients
with acute respiratory failure or acute cardiopulmonary failure, difficult to control by other treatments, and at foreseeable risk of continuous 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 international level of similar products
.
, Ltd.
for extracorporeal cardiopulmonary support auxiliary equipment and disposable membrane oxygenator package after review, which are used together for adult patients
with acute respiratory failure or acute cardiopulmonary failure, difficult to control by other treatments, and at foreseeable risk of continuous 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 international level of similar products
.
Among them, the extracorporeal cardiopulmonary support auxiliary equipment is composed of
a host, a pump drive device, an emergency pump drive device, a backup battery, and a flow bubble sensor.
The single-use membrane oxygenator kit consists of
a membrane oxygenator and arteriovenous pipeline components (including centrifugal pump pump heads), pre-filled pipeline components, accessory kit components and oxygen lines.
a host, a pump drive device, an emergency pump drive device, a backup battery, and a flow bubble sensor.
The single-use membrane oxygenator kit consists of
a membrane oxygenator and arteriovenous pipeline components (including centrifugal pump pump heads), pre-filled pipeline components, accessory kit components and oxygen lines.
ECMO products, as a salvage treatment device for critical patients with novel coronavirus pneumonia who are ineffective in conventional treatment, are the clear treatment measures in the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia", and the listing of domestic products will play an important role
in meeting the urgent clinical needs, ensuring the treatment of critically ill patients with the new crown epidemic, and ensuring the implementation of the goal of "maintaining health and preventing severe disease" in epidemic prevention and control.
in meeting the urgent clinical needs, ensuring the treatment of critically ill patients with the new crown epidemic, and ensuring the implementation of the goal of "maintaining health and preventing severe disease" in epidemic prevention and control.
In the process of registration and application of the product, the State Food and Drug Administration established an emergency review working group in accordance with the principle of "unified command, early intervention, rapid and efficient, and scientific approval", with a special person responsible, guiding the whole process, issuing technical review guidelines, increasing the guidance of product registration application, accelerating the review and approval process, and promoting 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.
of epidemic prevention and control.
The drug administration department will strengthen the post-marketing supervision of the product to protect the safety of
patients.
patients.
