Reinforced Endotracheal Tube

Allergenicity test evaluation method for biocompatibility of reinforced endotracheal tube
Reinforced endotracheal tube, as a high-end medical device designed to resist kinking or compression, is widely used in facial surgery, neurosurgery, and surgery that requires patients to maintain a non-supine position. The tube wall is embedded with stainless steel spirally wound reinforcement wire and bonded 15 mm connector to ensure the stability and reliability of the tube in complex surgical environments.
Biocompatibility is one of the key performances that medical devices must meet in clinical applications, which is directly related to the safety and comfort of patients. For reinforced endotracheal tubes, biocompatibility is mainly reflected in the following aspects: material safety, cell compatibility, tissue compatibility, and immune response. Among them, sensitization test is an important method to evaluate whether medical devices will cause allergic reactions in humans.
Sensitization test evaluation method
The main purpose of the sensitization test is to evaluate whether the reinforced endotracheal tube will cause allergic reactions in human skin or mucous membranes. By simulating the real environment of the human body, observe whether the test material will cause allergic reactions under specific conditions, thereby providing a scientific basis for the safe use of medical devices.
The test materials include reinforced endotracheal tube samples, extraction media (such as saline), test animals (such as guinea pigs), and necessary detection reagents and instruments.
Test steps
First, select representative samples from the reinforced endotracheal tubes and process them in accordance with relevant international and domestic standards to prepare samples for the test.
Soak the prepared samples in an extraction medium, such as saline, and extract them according to the prescribed proportion and time. After the extraction is completed, filter and sterilize the extract to prepare the extract for the test.
Select healthy guinea pigs with no history of allergies as test animals. Guinea pigs are commonly used animals for allergenic tests because they are sensitive to a variety of allergens and are easy to raise and observe.
Inject the extract into the guinea pig or apply it on the guinea pig's skin to observe whether the guinea pig has an allergic reaction. Allergic reactions usually manifest as symptoms such as skin redness, itching, and blisters. According to the observation results, it can be judged whether the enhanced endotracheal tube will cause allergic reactions.
When conducting sensitization tests, the following aspects should be noted:
Ensure the quality and safety of the test materials;
Conduct the test strictly in accordance with relevant international and domestic standards;
Select appropriate test animals and test methods;
Objectively and accurately evaluate the test results;
Take timely measures to improve and optimize.
The biocompatibility of the enhanced endotracheal tube is an important guarantee for its safety and reliability. As an important method to evaluate whether medical devices will cause allergic reactions, the sensitization test is of great significance to ensure the safe use of the enhanced endotracheal tube. Ningbo Yuxin Medical Instruments Co., Ltd., as a high-tech enterprise focusing on the production of anesthesia respiratory consumables and gynecological products, will continue to be committed to improving the biocompatibility and safety of enhanced endotracheal tubes and providing better medical services for patients.