ECMO equipment introduction and clinical trial design ideas
On January 4, 2023, the State Food and Drug Administration reviewed, emergency approval of Shenzhen Hanno Medical Technology Co., Ltd. in vitro cardiopulmonary support assistance equipment, disposable membrane oxygenator package registration application, as the first domestic ECMO equipment and consumables package, the product has independent intellect
On January 4, 2023, the State Food and Drug Administration reviewed, emergency approval of Shenzhen Hanno Medical Technology Co., Ltd. in vitro cardiopulmonary support assistance equipment, disposable membrane oxygenator package registration application, as the first domestic ECMO equipment and consumables package, the product has independent intellectual property rights, performance indicators basically reached the international level of similar products.
ECMO, full name extracorporeal membrane oxygenation, Chinese name Extracorporeal membrane oxygenation, as an important extracorporeal life support technology, it is mainly used clinically to support cardiac and/or respiratory dysfunction. Compared with artificial heart-lung machine, ECMO has a longer duration (> 24h) cardiopulmonary bypass function, providing an important time window for the primary disease treatment of critically ill patients, deepening doctors' understanding of the primary disease treatment, and gaining time for the diagnosis and treatment of the primary disease.
Introduction to ECMO equipment
1, ECMO equipment classification code and management category
Refer to the Medical Device Classification Directory, ECMO devices belong to the subdirectory “ 10- Blood transfusion, dialysis and extracorporeal circulation devices” “ Level I Product Category 05- Cardiopulmonary Bypass Equipment” , specifically involving three secondary product categories:
(1) 10-05-01- Cardiopulmonary Bypass pump
(2) 10-05-02- Cardiopulmonary Bypass Monitoring Equipment
(3) 10-05-04- External cardiopulmonary Support Assistance System.
2, How it works:
Blood is drawn outside the patient's body using a catheter and pump system, in a gas exchanger, carbon dioxide is removed and oxygen is added. The oxygenated blood is then pumped back into the patient's circulatory system to maintain the oxygenated blood supply to the body's organs and tissues, which can help patients with cardiac arrest or not breathing to stay alive through the dangerous phase of the disease.
3. Healing mode:
According to the different ways of blood transfusion, it can be divided into: V-A mode, V-V mode, mixed mode.
(3) Mixed mode: VV-A, V-AV, VV-AV, VVV-A, etc.
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